A Phase II, Randomised, Double Blind, Placebo-controlled Study of the Pharmacokinetics, Pharmacodynamic Effects, and Safety, of Oral FT011 in Participants With Diffuse Systemic Sclerosis
Phase: PHASE2
Conditions: Scleroderma, Systemic, Scleroderma, Diffuse, Sclerosis, Systemic
Sponsor: Certa Therapeutics

Certa Therapeutics Pty Ltd 
Clinical Trial Protocol:  CER-FT011-SSc01 
Version:  2.1 
Date:  01 November 2021 
 
Page 1 of 55 
 
CONFIDENTIAL 
 
 
 
Study Title: 
A phase II, randomised, double blind, placebo-controlled study of 
the pharmacokinetics, pharmacodynamic effects, and safety, of 
oral FT011 in participants with diffuse systemic sclerosis 
Protocol ID: 
CER-FT011-SSc01 
UTN: 
U1111-1259-3503 
IND number: 
148214 
EudraCT number: 
2020-005116-21 
Test Drug: 
FT011 
Indication: 
Diffuse Systemic Sclerosis 
Study Sponsor: 
Certa Therapeutics Pty Ltd 
Level 9, 31 Queen Street 
Melbourne VIC 3000 
Australia 
Telephone +61 (3) 9657 0704 
Sponsor protocol approval 
Dr Darren Kelly, CEO 
Version: 
2.1 
Date: 
01 November 2021 
CONFIDENTIALITY STATEMENT 
All information relating to the investigational medicinal product, Investigator’s Brochure, Clinical 
Protocol, Case Report Forms and any information and results developed during, or arising from the 
study, is considered confidential and proprietary information of Certa Therapeutics Pty Ltd 
(‘Confidential Information’).  This Confidential Information shall remain the sole property of Certa 
Therapeutics Pty Ltd, and shall not be disclosed to others without prior written consent from Certa 
Therapeutics Pty Ltd and shall not be used except in the performance of this study. 

Certa Therapeutics Pty Ltd 
Clinical Trial Protocol:  CER-FT011-SSc01 
Version:  2.1 
Date:  01 November 2021 
 
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CONFIDENTIAL 
INVESTIGATOR’S STATEMENT 
The undersigned Investigator agrees: 
1. 
To conduct the study in accordance with the study protocol, International Conference on 
Harmonisation Good Clinical Practice and any national and local laws and regulations. 
2. 
That alteration of the procedures described in the study protocol, other than to protect 
participant safety, rights, or welfare, is not allowed without prior written approval from Certa 
Therapeutics Pty Ltd. 
3. 
The study-specific data of the participants will be kept in the participants’ files and documented 
in the case report form in a complete and accurate manner.  All requested study-related 
records will be made available for direct access to Certa Therapeutics or designee 
representatives for monitoring or auditing the study. 
4. 
To allow authorised qualified delegates of Certa Therapeutics Pty Ltd or designee to perform 
regular visits to monitor the study data. 
5. 
To dispose of used and unused investigational medicinal product and materials as instructed 
by Certa Therapeutics Pty Ltd. 
6. 
To ensure that all persons at their site assisting with the clinical study are adequately informed 
and trained about the study protocol, the investigational medicinal product and their study-
related duties and functions. 
 
 
Investigator signature 
 
 
Date 
Name 
 
Site number 
 

Certa Therapeutics Pty Ltd 
Clinical Trial Protocol:  CER-FT011-SSc01 
Version:  2.1 
Date:  01 November 2021 
 
Page 3 of 55 
 
CONFIDENTIAL 
1 
PROTOCOL SYNOPSIS 
Study Title: 
A phase II, randomised, double blind, placebo-controlled study of the 
pharmacokinetics, pharmacodynamic effects, and safety, of oral FT011 in 
participants with diffuse systemic sclerosis 
Study Period: 
2021 - 2022 
Objectives: 
Primary objective: 
• 
To assess the pharmacokinetics (PK) of oral FT011 in participants with diffuse 
systemic sclerosis (SSc). 
Secondary objectives: 
• 
To assess the safety and tolerability of oral FT011 compared to placebo in 
participants with diffuse SSc. 
• 
To evaluate the short-term efficacy of oral FT011 compared to placebo in 
improving disease activity in participants with diffuse SSc. 
 
 
 
 
 
 
 
 
 
 
 
 
 
Number of 
participants: 
Approximately 30 participants will be randomised and treated. 
Study design 
This is a multi-centre, randomised, double blind, placebo-controlled study to 
assess the pharmacokinetic pharmacodynamic effects and safety of FT011 in 
participants with diffuse systemic sclerosis. 
The targeted study population is patients with diffuse SSc with a disease duration 
of ≤10 years from onset of first non-Raynauds symptom, and a modified Rodnan 
Skin Score (mRSS) of 15 to 40 at the screening visit.  Patients meeting all eligibility 
criteria will have a baseline skin biopsy (2 x 3mm punch biopsies) taken before 
being randomised 1:1:1 to FT011 200mg, FT011 400mg, or placebo. 
Participants will take their investigational medicinal product (IMP) once a day for 
3 months (12 weeks), in addition to their standard-of-care scleroderma 
medications.  They will return to the site for study visits at Weeks 4, 8, and 12.  
Week 12 is the end of the study Treatment Period.  A final study follow-up visit 
will be conducted one month after they complete treatment (Week 16). 

Certa Therapeutics Pty Ltd 
Clinical Trial Protocol:  CER-FT011-SSc01 
Version:  2.1 
Date:  01 November 2021 
 
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CONFIDENTIAL 
Visit procedures will include skin thickness assessments using the mRSS at every 
visit, and forced vital capacity (FVC), the Scleroderma Health Assessment 
Questionnaire- Disability Index (SHAQ-DI), and physician and patient global 
assessments at all visits during the Treatment Period.  A follow up skin biopsy will 
be taken at Week 12.  On Day 1 and at Week 12 participants will have serial PK 
samples collected out to 8 hours post-dose, and trough samples will be collected 
at each interim visit.  Other on-study visit assessments will include additional 
participant questionnaires, physical examinations, vital signs measurements, 
safety laboratory blood and urine tests, and electrocardiograms.  Adverse events 
and concomitant medications will be assessed and recorded at each study visit.  
Additional blood samples will be collected at Day 1 and Week 12 for exploratory 
assessments. 
With the exception of methotrexate, which is excluded, participants should be 
maintained on their current SSc medications during the course of the Treatment 
Period unless they meet the following progression criteria; those who have a 
mRSS increase from Baseline of 5 or more may start immunosuppressive 
medications, or, if already taking these, have their immunosuppressive 
medications or doses changed. 
A Data Safety Monitoring Board (DSMB) will review safety and PK data at agreed 
recruitment and progression milestones to provide independent oversight of 
participant safety. 
Criteria for 
inclusion: 
Participants must meet all the following criteria: 
• 
Provide written informed consent prior to any study procedures and who 
agree to adhere to all protocol requirements. 
• 
Aged 18 to 75 years inclusive at the time of consent. 
• 
Have a classification of systemic sclerosis, as defined by American College of 
Rheumatology (ACR) and European League Against Rheumatism (EULAR) 
criteria with disease duration ≤10 years from first non-Raynaud 
phenomenon manifestation. 
• 
Have a diagnosis of diffuse cutaneous SSc defined as systemic sclerosis with 
skin thickening on the upper arms proximal to the elbows, on the upper legs 
proximal to the knees, or on the trunk. 
• 
Have skin thickening in a body area suitable for repeat biopsy. 
• 
Have a mRSS at Screening of ≥15 to ≤40. 
• 
FVC ≥50% of predicted at Screening. 
• 
If on azathioprine, mycophenolate mofetil, or hydroxychloroquine, have 
been on a stable dose for at least 2 months prior to baseline. 
• 
Participants must agree to use contraception according to protocol section 
5.4.4. 

Certa Therapeutics Pty Ltd 
Clinical Trial Protocol:  CER-FT011-SSc01 
Version:  2.1 
Date:  01 November 2021 
 
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CONFIDENTIAL 
Criteria for 
exclusion: 
Participants must not meet any of the following criteria: 
• 
Pregnant or breast-feeding, or plan to become pregnant during the study. 
• 
Have received any IMP within 30 days or 5 half-lives prior to randomisation 
(4 months if the previous drug was a new chemical entity), whichever is 
longer. 
• 
Have known or suspected contraindications to the IMP. 
• 
Have severe or unstable SSc or end-stage organ involvement as evidenced 
by: 
o On an organ transplantation list or has received an organ transplant 
including autologous stem cell transplant. 
o Renal crisis within 1 year prior to Baseline. 
• 
Interstitial lung disease or pulmonary hypertension requiring constant 
oxygen therapy.  This excludes oxygen used to aid sleep or exercise. 
• 
Gastrointestinal dysmotility requiring total parenteral nutrition or requiring 
hospitalisation within the 6 months prior to Baseline. 
• 
Concomitant inflammatory myositis, rheumatoid arthritis, or systemic lupus 
erythematosus when definite classification criteria for those diseases are 
met (Bohan and Peter criteria for polymyositis and dermatomyositis) 
• 
SSc-like illnesses related to exposures or ingestions 
• 
The use of the following drugs within the specified periods: 
o Methotrexate in the 2 weeks prior to Day 1 
o Other anti-fibrotic agents including D-penicillamine or tyrosine 
kinase inhibitors (nilotinib, imatinib, dasatinib) in the month prior to 
Screening. 
o Biologic drugs such as tumour necrosing factor (TNF) inhibitors, 
tocilizumab, or Janus kinase (JAK) inhibitors, in the 3 months prior to 
Screening. 
o Rituximab in the 6 months prior to Screening. 
o Cyclophosphamide oral or intravenous (IV) in the 3 months prior to 
Screening. 
o Oral prednisolone >10 mg per day or IV steroids in the month prior 
to Screening. 
• 
Have any malignancy not considered cured (except basal cell or squamous 
cell carcinoma of the skin, or carcinoma in situ of the cervix); a subject is 
considered cured if there has been no evidence of cancer recurrence for the 
6 years prior to randomisation. 

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Clinical Trial Protocol:  CER-FT011-SSc01 
Version:  2.1 
Date:  01 November 2021 
 
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CONFIDENTIAL 
• 
Have aspartate transaminase (AST), alanine transaminase (ALT), gamma-
glutamyl transferase (GGT), lactate dehydrogenase (LDH), or bilirubin values 
above the upper limit of normal (ULN) at Screening or Baseline, or evidence 
of hepatic disease as determined by any one of the following: history of 
hepatic encephalopathy, history of oesophageal varices, or history of 
portacaval shunt. 
• 
Estimated 
glomerular 
filtration 
rate 
(eGFR) 
<60mL/min, 
urinary 
albumin/creatinine ratio >30mg/g. 
• 
Haemoglobin < 80 g/L, platelets < 90 x 109/L, or neutrophil count < 1.4 x 109/L 
• 
Other than SSc, have any other medical condition or significant co-
morbidities, clinically relevant social or psychiatric conditions, or any finding 
during Screening, which in the investigator’s opinion may put the subject at 
risk or interfere with the study objectives. 
Test product, dose, 
and mode of 
administration: 
FT011 and placebo will be presented as oral capsules. 
FT011 capsules will contain 100mg or 200mg of FT011 and excipients. 
Placebo will contain microcrystalline cellulose. 
Participants will take two capsules once a day for the 12-week treatment 
period, for a total daily dose of 200mg or 400mg FT011, or matching placebo. 
Duration of study 
per participant: 
The Screening period may be up to 28 days. 
The on-study period consists of a 12-week treatment period and a 4 week follow 
up period.  Total duration of the study may be up to 20 weeks. 
Criteria for 
evaluation: 
Primary Outcome Measures 
• 
FT011 maximum concentration (cmax), time to maximum concentration (tmax), 
and area under the curve (AUC) in plasma after a single dose and after 12-
weeks of treatment. 
• 
Measurement of steady state FT011 levels in plasma. 
Secondary Outcome Measures 
Safety will be assessed by: 
• 
Treatment emergent adverse events from first dose of study drug to End of 
Study 
• 
Physical examination 
• 
Vital signs (blood pressure, heart rate, respiratory rate, and temperature) 
• 
12-lead electrocardiograms (ECG) 
• 
Safety laboratory results (haematology, biochemistry, coagulation, and 
urinalysis) 
• 
Use of concomitant medications 
Efficacy will be measured by: 
• 
Change in mRSS from Baseline at each visit. 

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Clinical Trial Protocol:  CER-FT011-SSc01 
Version:  2.1 
Date:  01 November 2021 
 
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• 
Change in percent predicted FVC from Baseline to Week 4, Week 8, and 
Week 12. 
• 
Change in SHAQ-DI Score from Baseline to Week 4, Week 8, and Week 12. 
• 
Change in Patient Global Assessment Score from Baseline to Week 4, Week 
8, and Week 12. 
• 
Change in Physician Global Assessment Score from Baseline to Week 4, Week 
8, and Week 12. 
• 
The proportion of patients showing an improvement (defined as ACR 
Composite Response Index in Diffuse Cutaneous Systemic Sclerosis (CRISS) 
score predicted probability of ≥0.60) at Week 12. 
• 
Change in the Scleroderma Clinical Trials Consortium Damage Index (SCTC-
DI) score from Baseline to Week 12. 
• 
Change in the 5-D Itch Scale from Baseline to Week 12. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Safety Monitoring 
and Oversight 
Participants with confirmed ALT or AST levels > 3 x ULN must have close 
observation that includes elicitation of a detailed history and performance of 
diagnostic lab studies to exclude other causes of acute liver injury.  In addition, 
they should have their liver chemistry (ALT, AST, ALP, international normalised 
ratio (INR) and total bilirubin) retested at least once weekly until levels normalise 
or return to baseline. 
In the event of confirmed laboratory results meeting any of following criteria, 
IMP will be stopped permanently for that participant: 
• 
ALT or AST >8 x ULN 
• 
ALT or AST >5 x ULN for more than 2 weeks 
• 
ALT or AST >3 x ULN and either bilirubin >2 x ULN or INR >1.5 
• 
ALT or AST >3 x ULN with the appearance of fatigue, nausea, vomiting, right 
upper quadrant pain or tenderness, fever, rash, and/or eosinophilia (>5%) 
If serum creatinine is ≥ Grade 3, IMP will be stopped for that participant and they 
will be monitored until values return to Grade 1.  IMP may then be restarted but 
stopped permanently if there is a recurrence of serum creatinine levels 
≥ Grade 3. 

Certa Therapeutics Pty Ltd 
Clinical Trial Protocol:  CER-FT011-SSc01 
Version:  2.1 
Date:  01 November 2021 
 
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An independent DSMB will be established prior to recruitment start, with 
appropriate charter that defines its roles and responsibilities.  The DSMB will 
monitor accruing trial safety results, and PK data, at intervals throughout the 
study.  The main purpose of the DSMB will be to protect the safety interests of 
the participants included in the trial.  
If pre-defined study stopping rules are met, recruitment will be halted and the 
DSMB will review the data and advise whether recruitment and dosing may 
continue, or whether the study should be stopped. 
The charter will specify the intervals for formal DSMB meetings. 
The DSMB will convey to Certa Therapeutics Pty Ltd their recommendations as 
to whether the trial may continue as planned or if the trial should be modified or 
stopped.  The final decision on whether the study should be modified or stopped 
will be the responsibility of Certa Therapeutics Pty Ltd; any decision to modify or 
stop will be communicated to investigators and regulatory authorities (RA) by 
Certa Therapeutics Pty Ltd or their representatives. 
Statistical methods 
and analyses: 
Sample Size Justification 
The sample size for this study is sized based on practical considerations and no 
formal sample size calculation was performed.  A total of approximately 30 
participants, 10 per treatment group, will be randomised and treated. 
Statistical Analyses 
A statistical analysis plan (SAP) will be written and finalised prior to database 
lock.  The SAP will contain detailed and complete descriptions of the analyses 
that will be performed. 
Analysis Sets 
The following analysis sets will be defined: 
Intention-to-Treat (ITT) Set:  The ITT set is defined as all participants who were 
randomised.  Participants in this set will be analysed based on the treatment that 
they were randomised to. 
Safety Set:  The safety set is defined as all participants who were randomised and 
received at least one dose of study medication.  Participants in this set will be 
analysed based on the actual treatment that they received.  All safety analyses 
will be based on the safety set. 
Modified Intention-to-Treat (mITT) Set:  The mITT set is defined as all randomised 
participants who received at least one dose of study medication and who have 
post-baseline efficacy data for at least one of the outcome measures.  All efficacy 
analyses will be based on the mITT set. Participants in this set will be analysed 
based on the treatment that they were randomised to. 
PK Set:  The PK set is defined as all participants included in the safety set who 
have sufficient concentrations to allow for the calculation of at least one PK 
parameter. Participants who experience any adverse events or have protocol 

Certa Therapeutics Pty Ltd 
Clinical Trial Protocol:  CER-FT011-SSc01 
Version:  2.1 
Date:  01 November 2021 
 
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CONFIDENTIAL 
deviations that could affect the PK profiles may be excluded from the PK set at 
the pharmacokineticist’s discretion. All PK analyses will be based on the PK set. 
Participants in this set will be analysed based on the actual treatment that they 
received. 
General Considerations 
Results will be presented by treatment group, pooled FT011 group and overall. 
In general, data will be summarised using descriptive statistics (number of 
observations, mean, median, standard deviation [SD], minimum and maximum) 
or frequency counts and percentages, as appropriate to the type of data. The 
coefficient of variation (CV), geometric mean and geometric CV will also be 
presented for the PK tables. 
Confidence intervals will be reported where appropriate. If not mentioned 
otherwise, all statistical tests will be performed with a type I two-sided error rate 
of 5%. 
Where appropriate, results will be presented graphically.  All reported data will 
be presented in data listing. 
The baseline value for each endpoint is defined as the last available, non-missing 
value obtained prior to the first study medication administration. 
The handling of missing data and adjustments for multiplicity will be described 
in the SAP. 
Pharmacokinetic Analyses 
All PK analyses will be based on the PK set. 
Descriptive statistics by nominal collection time will be presented for the PK 
concentrations. Concentrations will also be presented graphically on both linear 
and semi-logarithmic scales.  
The PK parameters will be calculated using non-compartmental analysis 
methods.  Full details will be provided in the SAP.   
Descriptive statistics will be presented for the PK parameters. 
Safety Analyses 
All safety analyses will be based on the safety set. 
Medical history findings and AEs will be coded by Medical Dictionary for 
Regulatory Activities (MedDRA) codes and medications the World Health 
Organisation Drug Dictionary (WHO-DD) Anatomical Therapeutic Chemical (ATC) 
classification codes. 
Treatment-emergent adverse events (TEAEs) are defined as AEs that started or 
worsen on or after the first study medication administration.  The incidence of 
TEAEs will be summarised by MedDRA terms and treatment group.  Drug-related, 
serious AEs (SAEs) and TEAEs leading to early study withdrawal will also be 
summarised.  Separate summaries will be produced based on severity and 
relationship to study drug categories. 

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Clinical Trial Protocol:  CER-FT011-SSc01 
Version:  2.1 
Date:  01 November 2021 
 
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Other safety endpoints including, vital signs, ECGs, safety laboratory results will 
be analysed descriptively. 
Efficacy Analyses 
All efficacy analyses will be based on the mITT set. 
Descriptive statistics will be presented for all efficacy endpoints and results will 
be presented graphically where appropriate. 
Whilst no formal hypothesis testing is planned, exploratory analyses may be 
performed to assess the treatment effect of FT011 on the efficacy outcomes.  Full 
details of any inferential analyses will be provided in the SAP. 
 
 

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Version:  2.1 
Date:  01 November 2021 
 
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2 
STUDY SCHEDULE OF ASSESSMENTS 
Table 1:  Schedule of Assessments 
 
Screening 
Treatment Period 
End of 
Treatment 
Follow 
Up1 
Day 
Day -28 
to -1 
Day 12 
Week 4 
Week 8 
Week 12 
Week 16 
Window 
N/A 
N/A 
±3 days 
±3 days 
±3 days 
+1 week 
Written informed consent 
X 
 
 
 
 
 
Inclusion/Exclusion Criteria 
X 
X3 
 
 
 
 
Demographics 
X 
 
 
 
 
 
Medical History 
X 
X 
 
 
 
 
Patient Global Assessment 
 
X 
X 
X 
X 
 
Scleroderma signs and symptoms 
X 
X 
X 
X 
X 
X 
mRSS 
X 
X 
X 
X 
X 
X 
SHAQ-DI 
 
X 
X 
X 
X 
 
SCTC-DI 
 
X 
 
 
X 
 
5-D Itch Scale 
 
X 
 
 
X 
 
Physical Examination 
X4 
X5 
X5 
X5 
X5 
X5 
Weight 
X 
X 
X 
X 
X 
X 
Vital Signs6 
X 
X7 
X 
X 
X7 
X 
Spirometry 
X 
X 
X 
X 
X 
 
Physician Global Assessment 
 
X 
X 
X 
X 
 
12-lead ECG 
X 
X 
X 
X 
X 
X 
Immune cell activation markers 
 
X8 
 
 
X9 
 
Plasma PK 
 
X10 
X11 
X11 
X10 
 
Biochemistry12 
X 
X 
X 
X 
X 
X 
Haematology 
X 
X 
X 
X 
X 
X 
Coagulation panel 
X 
X 
X 
X 
X 
X 
 
1 The follow up visit will be conducted 4 weeks after the end of treatment period, or, if the participant withdraws early, 4 
weeks after their last dose of IMP 
2 For scheduling purposes, Day 1 assessments may be conducted over 2 consecutive days, as long as dosing and PK samples 
are collected on the second day 
3 Review and confirmation that participant continues to be eligible. 
4 Including height 
5 Symptom directed physical examination 
6 Vital signs will include supine blood pressure (systolic and diastolic), heart rate, respiratory rate, and temperature 
7 Vital signs will be measured pre-dose and immediately prior to the 8-hour post-dose PK sample 
8 To be collected pre dose and prior to other blood samples 
9 Collected pre dose and prior to other blood samples, and at 4 hours post dose 
10 Plasma collection within the 30 minutes prior to dosing, and at 1, 2, 3, 4, 5, 6, 7- and 8-hours post-dose 
11 Trough plasma collection within the 30 minutes prior to dosing 
12 Includes serum pregnancy test for women of child-bearing potential. 

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Clinical Trial Protocol:  CER-FT011-SSc01 
Version:  2.1 
Date:  01 November 2021 
 
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Screening 
Treatment Period 
End of 
Treatment 
Follow 
Up1 
Day 
Day -28 
to -1 
Day 12 
Week 4 
Week 8 
Week 12 
Week 16 
Window 
N/A 
N/A 
±3 days 
±3 days 
±3 days 
+1 week 
Urinalysis 
X 
X 
X 
X 
X 
X 
Plasma/serum 
cytokines 
and 
chemokines (pre-dose) 
 
X 
X 
X 
X 
 
Skin punch biopsies (two pre-dose) 
 
X13 
 
 
X 
 
Prior and Concomitant Medication 
X 
X 
X 
X 
X 
X 
Adverse Events 
 
X 
X 
X 
X 
X 
Randomisation 
 
X 
 
 
 
 
Dispense IP 
 
X 
X 
X 
 
 
IMP accountability 
 
 
X 
X 
X 
 
IMP administration 
 
X 
 
 
 
 
13 Baseline (Day 1) biopsies may be collected at any time pre-dose once the participant has been confirmed as eligible, 
including on a different day. 

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TABLE OF CONTENTS 
1 
PROTOCOL SYNOPSIS ....................................................................................................... 3 
2 
STUDY SCHEDULE OF ASSESSMENTS ............................................................................... 11 
3 
BACKGROUND AND RATIONALE...................................................................................... 19 
3.1 
SCLERODERMA ......................................................................................................................... 19 
3.2 
FT011 .................................................................................................................................... 19 
3.2.1 
FT011 for treatment of Scleroderma ........................................................................... 19 
3.3 
NONCLINICAL STUDIES WITH FT011 ............................................................................................ 20 
3.3.1 
Pharmacodynamics ..................................................................................................... 20 
3.3.2 
Toxicology .................................................................................................................... 20 
3.3.3 
Pharmacokinetics ........................................................................................................ 21 
3.4 
CLINICAL STUDIES WITH FT011 .................................................................................................. 21 
3.5 
STUDY AND DOSE JUSTIFICATION................................................................................................. 21 
3.6 
RISK: BENEFIT ASSESSMENT ....................................................................................................... 22 
4 
STUDY OBJECTIVES ......................................................................................................... 23 
5 
STUDY PLAN ................................................................................................................... 24 
5.1 
OVERALL TRIAL DESIGN ............................................................................................................. 24 
5.2 
NUMBER OF PARTICIPANTS ........................................................................................................ 25 
5.3 
STUDY PERIOD/DURATION OF PARTICIPANT PARTICIPATION ............................................................ 25 
5.4 
PARTICIPANT SELECTION AND WITHDRAWAL ................................................................................. 25 
5.4.1 
Trial selection record ................................................................................................... 25 
5.4.2 
Inclusion criteria .......................................................................................................... 25 
5.4.3 
Exclusion criteria ......................................................................................................... 26 
5.4.4 
Contraception requirements ....................................................................................... 27 
5.4.5 
Concomitant Medications and Treatments ................................................................. 28 
5.4.6 
Study Restrictions ........................................................................................................ 28 
5.4.7 
Withdrawal of Participants from Study ....................................................................... 28 
5.4.8 
Stopping Rules / Discontinuation Criteria ................................................................... 29 
5.4.9 
Replacement of Participants ....................................................................................... 30 
5.5 
STUDY TREATMENT ................................................................................................................... 30 
5.5.1 
Description of the Investigational Medicinal Product ................................................. 30 
5.5.2 
Packaging and labelling .............................................................................................. 30 
5.5.3 
Investigational Medicinal Product handling and storage ........................................... 30 
5.5.4 
Accountability of study supplies .................................................................................. 30 
5.5.5 
Doses and treatment regimen ..................................................................................... 31 
5.5.6 
Method of assigning treatment .................................................................................. 31 
5.5.7 
Blinding and procedures for breaking the blind .......................................................... 32 
5.5.8 
Treatment Compliance ................................................................................................ 32 
6 
STUDY PROCEDURES ...................................................................................................... 32 
6.1 
PARTICIPANT INFORMATION ....................................................................................................... 32 
6.2 
SCREENING VISIT (DAY -28 TO DAY -1) ........................................................................................ 32 
6.2.1 
Re-Screens ................................................................................................................... 33 

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6.3 
TREATMENT PERIOD ................................................................................................................. 33 
6.3.1 
Day 1 (Baseline) ........................................................................................................... 33 
6.3.2 
Week 4 and Week 8 ..................................................................................................... 34 
6.3.3 
Week 12 (End of Treatment) / Early Termination ....................................................... 35 
6.4 
WEEK 16 (FOLLOW UP) ............................................................................................................. 36 
7 
TRIAL ENDPOINTS........................................................................................................... 37 
7.1 
PRIMARY ENDPOINTS ................................................................................................................ 37 
7.2 
SECONDARY ENDPOINTS ............................................................................................................ 37 
7.2.1 
Safety Endpoints .......................................................................................................... 37 
7.2.2 
Efficacy Endpoints ....................................................................................................... 37 
7.3 
EXPLORATORY ENDPOINTS ......................................................................................................... 38 
8 
TRIAL MEASUREMENTS .................................................................................................. 38 
8.1 
PHARMACOKINETICS ................................................................................................................. 38 
8.2 
SAFETY AND TOLERABILITY .......................................................................................................... 38 
8.3 
EFFICACY ................................................................................................................................. 39 
8.4 
EXPLORATORY .......................................................................................................................... 41 
9 
STUDY OVERSIGHT ......................................................................................................... 42 
9.1 
DATA SAFETY MONITORING BOARD ............................................................................................ 42 
10 
ADVERSE EVENTS ........................................................................................................... 42 
10.1 
ADVERSE EVENT DEFINITIONS ..................................................................................................... 42 
10.2 
SERIOUS ADVERSE EVENTS ......................................................................................................... 43 
10.3 
ELICITING AND RECORDING OF ADVERSE EVENTS ........................................................................... 44 
10.4 
REPORTING SERIOUS ADVERSE EVENTS ........................................................................................ 44 
10.4.1 
Reporting to Sponsor ................................................................................................... 44 
10.4.2 
Reporting to Regulatory Authorities, Ethics Committees/Institutional Review Boards, 
and Investigators .......................................................................................................................... 45 
10.5 
FOLLOW-UP OF ADVERSE EVENTS AND SERIOUS ADVERSE EVENTS .................................................... 45 
10.6 
PREGNANCY REPORTING ............................................................................................................ 45 
11 
DATA MANAGEMENT ..................................................................................................... 45 
11.1 
DATA MANAGEMENT AND QUALITY CONTROL .............................................................................. 45 
12 
STATISTICAL ANALYSIS CONSIDERATIONS ....................................................................... 46 
12.1 
DETERMINATION OF SAMPLE SIZE ............................................................................................... 46 
12.2 
GENERAL METHODOLOGY .......................................................................................................... 46 
12.3 
ANALYSIS SETS ......................................................................................................................... 47 
12.4 
ANALYSES ................................................................................................................................ 47 
12.4.1 
Baseline Characteristics and Disposition ..................................................................... 47 
12.4.2 
Safety Analysis ............................................................................................................. 47 
12.4.3 
Pharmacokinetic Analysis ............................................................................................ 48 
12.4.4 
Efficacy Analysis .......................................................................................................... 50 
13 
TRIAL MANAGEMENT ..................................................................................................... 50 

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13.1 
CONTACTS ............................................................................................................................... 50 
13.2 
MONITORING .......................................................................................................................... 50 
13.3 
AUDITS AND INSPECTIONS .......................................................................................................... 51 
13.4 
TRAINING OF STAFF .................................................................................................................. 51 
13.5 
CHANGES TO THE PROTOCOL ...................................................................................................... 51 
13.6 
TRIAL AGREEMENTS .................................................................................................................. 52 
13.7 
TRIAL TIMETABLE AND TERMINATION .......................................................................................... 52 
13.8 
ETHICS REVIEW ........................................................................................................................ 52 
13.9 
ETHICAL CONDUCT OF THE STUDY ............................................................................................... 52 
13.10 
INSURANCE AND LIABILITY ..................................................................................................... 52 
13.11 
PARTICIPANT INFORMATION AND INFORMED CONSENT .............................................................. 53 
13.12 
DATA PROTECTION ............................................................................................................... 53 
13.13 
TRIAL REGISTRATION............................................................................................................. 53 
13.14 
RETENTION OF RECORDS ....................................................................................................... 53 
13.15 
PUBLICATION POLICY ............................................................................................................ 53 
14 
REFERENCES ................................................................................................................... 55 
 
Table 1:  Schedule of Assessments ........................................................................................................ 11 
Table 2:  FT011 Capsule Formulations .................................................................................................. 30 
Table 3:  Plasma PK Parameters ............................................................................................................ 49 
 
Figure 1:  Study Flow Diagram ............................................................................................................... 25 
 
 

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LIST OF ABBREVIATIONS 
Abbreviation 
Definition 
°C 
Degrees Celsius 
°F 
Degrees Fahrenheit 
µM 
Micromols 
ACR 
American College of Rheumatology 
AE 
Adverse event 
ALT 
alanine transaminase  
AST 
aspartate transaminase  
ATC 
Anatomical Therapeutic Chemical  
AUC 
Area under the curve 
BLQ 
Below limit of quantification 
BMI 
Body mass index 
CCL2 
c-c motif chemokine ligand 
CFR 
Code of Federal Regulations 
CKD 
Chronic Kidney Disease 
Cl/F 
Apparent clearance 
cmax 
Maximum concentration 
CNS 
Central nervous system 
CRA 
Clinical Research Associate 
CRF 
Case Report Form 
CRISS 
Composite Response Index in Diffuse Cutaneous Systemic Sclerosis  
CTCAE 
Common Terminology Criteria for Adverse Events 
CTGF 
Connective tissue growth factor 
CV 
Coefficient of variation 
CXCL4/8 
CXC-type chemokines 
DM 
Diabetes mellitus 
DN 
Diabetic nephropathy 
DSMB 
Data Safety Monitoring Board 
EC 
Ethics Committee 
ECG 
Electrocardiogram 
EDC 
Electronic Data Capture 
eGFR 
Estimated glomerular filtration rate  
EULAR 
European League Against Rheumatism  
FEV1 
Forced expiratory volume in 1 second 
FSGS 
Focal Segmental Glomerular Sclerosis 
FVC 
Forced Vital Capacity 
g 
gram 
GCP 
Good Clinical Practice 
GGT 
gamma-glutamyl transferase  
GMP 
Good Manufacturing Practice 
GFR 
glomerular filtration rate  
HAQ-DI 
Health Assessment Questionnaire - Disability Index 
hCav1.2 
L-type calcium channel  
HDPE 
High density polyethylene 
hERG 
Human ether-a-go-go 

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Abbreviation 
Definition 
hNav1.5 
sodium channel 
HPMC 
hydroxypropyl methylcellulose 
HRCT 
high resolution computed tomography  
IB 
Investigators Brochure 
ICAM 
Intercellular Adhesion Molecule 1 
ICH 
International Conference on Harmonisation 
ID 
Identification 
IL 
interleukin 
ILD 
Interstitial lung disease 
IMP 
Investigational medicinal product 
IRB 
Institutional Review Board 
IRT 
Interactive Response Technology 
ITT 
Intention to treat 
IV 
intravenous 
JAK 
Janus kinase 
kg 
Kilogram 
L 
litres 
LDH 
lactate dehydrogenase  
MCP-1 
Monocyte chemoattractant protein-1 
MedDRA 
Medical Dictionary of Regulatory Activities 
mg 
Milligram 
min 
Minute 
mITT 
modified intention to treat 
mL 
Millilitre 
mRSS 
modified Rodnan skin score  
NFκB 
nuclear factor kappa B 
ng 
nanogram 
NOAEL 
No observed adverse effect level 
PD 
Pharmacodynamic(s) 
PDGF 
Platelet derived growth factor 
PI 
Principal Investigator 
PICF 
Participant Information and Consent Form 
PK 
Pharmacokinetic(s) 
RNA 
Ribonucleic acid 
SAE 
Serious adverse event 
SAP 
Statistical analysis plan 
scRNA-seq 
Single cell RNA sequencing 
SCTC-DI 
Scleroderma Clinical Trials Consortium Damage Index  
SD 
Standard deviation 
SD rats 
Sprague Dawley rats 
SHAQ-DI 
Scleroderma Health Assessment Questionnaire- Disability Index 
SOP 
Standard Operating Procedure 
SRM 
Study Reference Manual 
SSc 
Systemic sclerosis 
STNx 
subtotal nephrectomy 

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Abbreviation 
Definition 
T1/2 
Half life 
TEAEs 
Treatment-emergent adverse events  
TGFβ 
transforming growth factor beta 
Tmax 
Time to maximum concentration 
TNFα 
tumour necrosing factor alpha 
ULN 
Upper limit of normal 
US 
United States 
VAS 
Visual Analogue Scale 
VEGF 
Vascular endothelial growth factor 
WHODD 
World Health Organisation Drug Dictionary 
WOCBP 
Women of child-bearing potential 

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3 
BACKGROUND AND RATIONALE 
Investigators should be familiar with the current FT011 Investigator’s Brochure (IB). 
3.1 
Scleroderma 
Systemic sclerosis (SSc) is a rare and complex autoimmune disease, characterised by vascular damage, 
chronic inflammation, and fibrosis of the skin and internal organs.  The current treatment 
recommendations include the use of immunosuppressants, such as methotrexate, mycophenolate 
mofetil, and cyclophosphamide, for managing the symptoms and preventing complications in SSc 
patients1.  However, these treatments have poor efficacy and are associated with significant side 
effects, such as organ toxicities and serious infections.  Nintedanib, a multiple tyrosine kinase inhibitor 
recently approved for the treatment of systemic sclerosis-associated interstitial lung disease (SSc-ILD), 
slowed the rate of decline in lung function in SSc-ILD2.  Since no clinical benefit of nintedanib was 
observed for other manifestations of the disease, there remains an unmet need for safe and effective 
treatments in early diffuse SSc patients. 
3.2 
FT011 
 
 
 
 
  
 
 
 
 
 
 
 
3.2.1 
FT011 for treatment of Scleroderma 
 
 
 
  
 
 
 
 
 
  
 
 
 
  
 
 
 
  
 
 
 
 
 

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3.3 
Nonclinical Studies with FT011 
A comprehensive nonclinical program supporting the development of FT011 includes in vitro and in 
vivo primary pharmacodynamic (PD) studies, safety pharmacology studies (central nervous system 
[CNS], respiratory, cardiovascular), in vitro and in vivo pharmacokinetic (PK) studies and repeat-dose 
toxicity studies. 
3.3.1 
Pharmacodynamics 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
  
 
 
 
 
 
 
3.3.2 
Toxicology 
 
 
 
 
 
 
 
 
 

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3.3.3 
Pharmacokinetics 
 
 
 
 
  
 
 
3.4 
Clinical Studies with FT011 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
3.5 
Study and Dose Justification 
 
 

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3.6 
Risk: Benefit Assessment 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 

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4 
STUDY OBJECTIVES 
The objectives of this study are to assess the PK, PD, and safety of FT011 in participants with diffuse 
SSc. 
Primary objective: 
• 
To assess the PK of oral FT011 in participants with diffuse SSc. 
Secondary objectives: 
• 
To assess the safety and tolerability of oral FT011 compared to placebo in participants with diffuse 
SSc. 
• 
To evaluate the short-term efficacy of oral FT011 compared to placebo in improving disease 
activity in participants with diffuse SSc. 
Exploratory objectives: 
• 
 
 
 
 
 
 
 
 
 
 

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5 
STUDY PLAN 
5.1 
Overall Trial Design 
This is a multi-centre, randomised, double blind, placebo-controlled study to assess the PK and PD 
effects and safety of FT011 in participants with diffuse systemic sclerosis. 
The targeted study population is patients with diffuse SSc with a disease duration of ≤10 years from 
onset of first non-Raynauds symptom, and a modified Rodnan Skin Score (mRSS) of 15 to 40 at the 
screening visit.  Patients meeting all eligibility criteria will have a baseline skin biopsy (2 x 3mm punch 
biopsies) taken before being randomised 1:1:1 to FT011 200mg, FT011 400mg, or placebo. 
Participants will take their investigational medicinal product (IMP) once a day for 3 months (12 weeks), 
in addition to their standard-of-care scleroderma medications.  They will return to the site for study 
visits at Weeks 4, 8, and 12.  Week 12 is the end of the study Treatment Period.  A final study follow-
up visit will be conducted one month after they complete treatment (Week 16). 
Visit procedures will include skin thickness assessments using the mRSS at every visit, and forced vital 
capacity (FVC), the Scleroderma Health Assessment Questionnaire- Disability Index (SHAQ-DI), and 
physician and patient global assessments at each visit during the Treatment Period.  A follow up skin 
biopsy will be taken at Week 12.  On Day 1 and at Week 12 participants will have serial PK samples 
collected out to 8 hours post-dose, and trough samples will be collected at each interim visit.  Other 
on-study visit assessments will include additional participant questionnaires, physical examinations, 
vital signs measurements, safety laboratory blood and urine tests, and electrocardiograms.  Adverse 
events and concomitant medications will be assessed and recorded at each study visit.  Additional 
blood samples will be collected at Day 1 and Week 12 for exploratory assessments. 
With the exception of methotrexate, which is excluded, participants should be maintained on their 
current SSc medications during the course of the Treatment Period unless they meet the following 
progression criteria; those who have a mRSS increase from Baseline of 5 or more may start 
immunosuppressive medications, or, if already taking these, have their immunosuppressive 
medications or doses changed. 
Safety rules are in place outlining actions to be taken based on liver function laboratory values.  In 
addition, a Data Safety Monitoring Board (DSMB) will review safety and PK data at agreed recruitment 
and progression milestones to provide independent oversight of participant safety. 
Figure 1, below, shows the study plan. 
 
 

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Figure 1:  Study Flow Diagram 
28 Day Screening 
Period
Eligibility 
assessments
FT011 200mg OD
FT011 400mg OD
Placebo OD
End of Study Visit
12 Week Treatment Period
Visits at Week 4, Week 8, Week 12
4 Week Follow Up Period
Randomis-
ation
 
5.2 
 Number of Participants 
It is planned that approximately 30 adults with diffuse SSc, aged 18 – 75 years inclusive, will be 
randomised.  Additional participants may be enrolled at the sponsor’s decision as replacement for 
dropouts. 
5.3 
Study Period/Duration of Participant Participation 
The duration of the study for each participant includes a Screening Period of up to 28 days, followed 
by a 12-week Treatment Period and a 4 week Follow Up Period.  Total study duration for each 
participant may be up to 20 weeks. 
It is anticipated that recruitment will take approximately 12 months.  The study period is expected to 
be across 2021 and 2022. 
The end of the trial is defined as the last protocol-specified data available from the last participant in 
the study. 
5.4 
Participant Selection and Withdrawal 
5.4.1 
Trial selection record 
Investigators must keep a record of participants who were considered for the study but were not 
enrolled. 
5.4.2 
Inclusion criteria 
Participants must meet all the following criteria: 
1. Provide written informed consent prior to any study procedures and who agree to adhere to all 
protocol requirements. 
2. Aged 18 to 75 years inclusive at the time of consent. 
3. Have a classification of systemic sclerosis, as defined by American College of Rheumatology (ACR) 
and European League Against Rheumatism (EULAR) criteria with disease duration ≤10 years from 
first non-Raynaud phenomenon manifestation. 
4. Have a diagnosis of diffuse cutaneous SSc defined as systemic sclerosis with skin thickening on the 
upper arms proximal to the elbows, on the upper legs proximal to the knees, or on the trunk. 
5. Have skin thickening in a body area suitable for repeat biopsy. 
6. Have a mRSS at Screening of ≥15 to ≤40. 

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7. FVC ≥50% of predicted at Screening. 
8. If on azathioprine, mycophenolate mofetil, or hydroxychloroquine, have been on a stable dose for 
at least 2 months prior to baseline. 
9. Participants must agree to use contraception according to protocol section 5.4.4. 
5.4.3 
Exclusion criteria 
Participants must not meet any of the following criteria: 
1. Pregnant or breast-feeding, or plan to become pregnant during the study. 
2. Have received any IMP within 30 days or 5 half-lives prior to randomisation (4 months if the 
previous drug was a new chemical entity), whichever is longer. 
3. Have known or suspected contraindications to the IMP. 
4. Have severe or unstable SSc or end-stage organ involvement as evidenced by: 
a. On an organ transplantation list or has received an organ transplant including autologous 
stem cell transplant. 
b. Renal crisis within 1 year prior to Baseline. 
5. Interstitial lung disease or pulmonary hypertension requiring constant oxygen therapy.  This 
excludes oxygen used to aid sleep or exercise. 
6. Gastrointestinal dysmotility requiring total parenteral nutrition or requiring hospitalisation within 
the 6 months prior to Baseline. 
7. Concomitant inflammatory myositis, rheumatoid arthritis, or systemic lupus erythematosus when 
definite classification criteria for those diseases are met (Bohan and Peter criteria for polymyositis 
and dermatomyositis) 
8. SSc-like illnesses related to exposures or ingestions 
9. The use of the following drugs within the specified periods: 
a. Methotrexate in the 2 weeks prior to Day 1 
b. Other anti-fibrotic agents including D-penicillamine or tyrosine kinase inhibitors (nilotinib, 
imatinib, dasatinib) in the month prior to Screening. 
c. Biologic drugs such as tumour necrosing factor (TNF) inhibitors, tocilizumab, or Janus 
kinase (JAK) inhibitors, in the 3 months prior to Screening. 
d. Rituximab in the 6 months prior to Screening. 
e. Cyclophosphamide oral or IV in the 3 months prior to Screening. 
f. Oral prednisolone >10 mg per day or IV steroids in the month prior to Screening. 
10. Have any malignancy not considered cured (except basal cell or squamous cell carcinoma of the 
skin, or carcinoma in situ of the cervix); a subject is considered cured if there has been no evidence 
of cancer recurrence for the 6 years prior to randomisation. 
11. Have aspartate transaminase (AST), alanine transaminase (ALT), gamma-glutamyl transferase 
(GGT), lactate dehydrogenase (LDH), or bilirubin values above the upper limit of normal (ULN) at 

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Screening or Baseline, or evidence of hepatic disease as determined by any one of the following: 
history of hepatic encephalopathy, history of oesophageal varices, or history of portacaval shunt. 
12. Estimated glomerular filtration rate (eGFR) <60mL/min, urinary albumin/creatinine ratio >30mg/g. 
13. Haemoglobin < 80 g/L, platelets < 90 x 109/L, or neutrophil count < 1.4 x 109/L 
14. Other than SSc, have any other medical condition or significant co-morbidities, clinically relevant 
social or psychiatric conditions, or any finding during Screening, which in the investigator’s opinion 
may put the subject at risk or interfere with the study objectives. 
5.4.4 
Contraception requirements 
The reproductive and development effects of FT011 have not been tested.  Therefore, as a precaution, 
female participants should avoid becoming pregnant and male participants should avoid fathering 
children or donating sperm, for the duration of the study and at least three months after their last 
dose of IMP.  If a participant becomes pregnant during the study, IMP must be stopped permanently, 
and the participant withdrawn from the study. 
There is no requirement to use contraception if the participant or their sole partner is permanently 
sterile, according to one of the following criteria: 
• 
A female who has undergone surgical sterilisation (e.g., hysterectomy, bilateral salpingectomy, or 
bilateral salpingo-oophorectomy). 
• 
A female who is postmenopausal, defined as one year without menses without an alternative 
medical cause. 
• 
A male who has had bilateral orchidectomy. 
All other participants must be advised to use (or ensure their partner uses) at least one method of 
highly effective contraception (i.e., methods with a failure rate of less than 1% per year when used 
consistently and correctly) for the entire study period and for 3 months after their last dose of IMP.  
Such methods include: 
• 
Combined (estrogen and progestogen containing) hormonal contraception associated with 
inhibition of ovulation (oral, intravaginal, or transdermal)  
• 
Progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, 
implantable) 
• 
Intrauterine device. 
• 
Intrauterine hormone-releasing system  
• 
bilateral tubal occlusion 
• 
vasectomised partner, provided that partner is the sole sexual partner of the female trial 
participant and that the vasectomised partner has received medical assessment of the surgical 
success 
• 
sexual abstinence defined as refraining from heterosexual intercourse, as the preferred and usual 
lifestyle of the subject. 
As potential interactions of FT011 with hormonal contraceptives have not been examined, male 
partners of WOCBP participants must also use a condom. 
Male participants with a partner who is a WOCBP must use a condom. 

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If a participant, or a male participant’s partner, does become pregnant during the period specified 
above, the participant will be asked to inform the investigator as soon as possible and consent to 
follow-up of the pregnancy outcome by Certa Therapeutics or designee. 
5.4.5 
Concomitant Medications and Treatments 
Methotrexate must not be taken within the 2 weeks prior to Day 1, or during the study. 
Participants should be maintained on their current SSc medications during the Treatment Period, 
unless they have a mRSS increase from Baseline of 5 or more.  In this case they may start 
immunosuppressive medications, or, if already taking those, have their immunosuppressive 
medications or doses changed. 
The following medications are exclusionary if taken during the specified pre-study period and should 
not be taken during the study treatment period. 
• 
Other anti-fibrotic agents including D-penicillamine or tyrosine kinase inhibitors (nilotinib, 
imatinib, dasatinib) in the month prior to Screening. 
• 
Biologic drugs such as TNF inhibitors, tocilizumab, or JAK inhibitors, in the 3 months prior to 
Screening. 
• 
Rituximab in the 6 months prior to Screening. 
• 
Cyclophosphamide oral or IV in the 3 months prior to Screening. 
• 
Oral prednisolone >10 mg per day or IV steroids in the month prior to Screening. 
 
 
 
 
If these medications are required to be used during the study Treatment Period, the investigator 
should discuss with the Medical Monitor whether the participant may remain on study or must be 
withdrawn. 
Any treatment or medication that is used, other than the IMP, must be noted in the source 
documentation and the Case Report Form (CRF).  This record should include the drug name, the dose 
and frequency, route of administration, the start and stop date of administration, and the indication. 
Medications or treatments taken in the 1 month prior to Baseline will be recorded on the prior 
medication CRF.  Any use of medications for the treatment of AE will be recorded on the concomitant 
medication CRF. 
5.4.6 
Study Restrictions 
There are no additional study restrictions. 
5.4.7 
Withdrawal of Participants from Study 
Participants can terminate their study participation at any time.  Participants who discontinue from 
the trial should always be asked about the reason(s) for their discontinuation and about the presence 
of any AEs. 
The Investigator or the Medical Monitor can exclude a participant from further taking part in the trial. 

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Possible reasons for discontinuing a participant may include: 
• 
Participant withdrawal of consent 
• 
Any unacceptable AEs, in the judgement of the Investigator 
• 
Participant’s non-compliance with the protocol 
• 
Certa Therapeutics terminates the study for financial or other reasons 
If a participant withdraws or is withdrawn, they should be encouraged to attend the follow up visit. 
5.4.8 
Stopping Rules / Discontinuation Criteria 
5.4.8.1 Individual Participant Stopping Rules 
Safety laboratory testing will be performed by a study central laboratory. 
If ALT or AST > 3 x ULN, the participant must have repeat testing conducted within 48 to 72 hours to 
confirm the values. 
If the elevation is confirmed as >3 x ULN, close observation that includes elicitation of a detailed history 
and performance of diagnostic laboratory studies to exclude other causes of acute liver injury must be 
conducted.  In addition, participants must have their liver chemistry (ALT, AST, ALP, international 
normalised ratio (INR) and total bilirubin) retested at least once weekly until levels normalise or return 
to baseline. 
In the event of confirmed laboratory results (i.e. confirmed on retest within 48 to 72 hours) meeting 
any of following criteria, IMP will be stopped permanently for that participant: 
• 
ALT or AST >8 x ULN 
• 
ALT or AST >5 x ULN for more than 2 weeks 
• 
ALT or AST >3 x ULN and either bilirubin >2 x ULN or INR >1.5 
• 
ALT or AST >3 x ULN with the appearance of fatigue, nausea, vomiting, right upper quadrant pain 
or tenderness, fever, rash, and/or eosinophilia (>5%). 
If serum creatinine is ≥ Grade 3 (based on the Common Terminology Criteria for Adverse Events 
(CTCAE)11), IMP will be stopped for that participant and they will be monitored until values return to 
Grade 1.  IMP may then be restarted but stopped permanently if there is a recurrence of serum 
creatinine levels ≥ Grade 3. 
All participants should attend the follow up visit 4 weeks after their last dose of IMP. 
5.4.8.2 Study Stopping Rules 
Recruitment will be halted and there will be an immediate review by the DSMB if any of the following 
conditions are met: 
• 
Three participants meet the same individual stopping rule. 
• 
Five participants meet any individual stopping rule. 
• 
There is any participant death assessed as related to IMP. 
The DSMB will review and recommend whether to continue recruitment and dosing, or to stop the 
study.  Participants who have not met any stopping rules may continue dosing while DSMB review is 
ongoing. 

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Additional stopping rules may be set by the DSMB. 
5.4.9 
 
Replacement of Participants 
Participants who are randomised but who withdraw prior to dosing will be replaced.  Additional 
participants may be enrolled into the study at the request of Certa Therapeutics to replace dropouts 
and ensure sufficient Week 12 PK samples are obtained for primary endpoint analysis.  Participants 
who withdraw due to AE will not be replaced. 
5.5 
Study Treatment 
5.5.1 
Description of the Investigational Medicinal Product 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
5.5.2 
Packaging and labelling 
The IMP will be presented in white high-density polyethylene (HDPE) bottles, containing 70 capsules 
per bottle. 
Labelling is in accordance with applicable requirements for each country participating in the clinical 
trial. 
5.5.3 
Investigational Medicinal Product handling and storage 
IMP must be stored at 15 to 30°C (59 to 86°F) and protected from light and humidity. 
Prior to dispensing, all IMP supplies must be stored in a secure area with access limited to authorised 
staff.  The Principal Investigator (PI) or designee will ensure that the IMP at site is safely stored in 
compliance with the storage requirements.  The PI is responsible for ensuring that the IMP is dispensed 
in accordance with the protocol and only to participants randomised in the study. 
Authorised study personnel will dispense the IMP according to the randomisation schedule. 
5.5.4 
Accountability of study supplies 
All material supplied is for use only in this clinical study and should not be used for any other purpose. 

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The PI or designee is responsible for IMP accountability, reconciliation, and record maintenance.  The 
PI or designated site staff must maintain IMP accountability records throughout the course of the study 
including records of the amount of IMP received, the identification of the participant for whom the 
drug was dispensed, and the date(s) and quantity of the drug dispensed. 
The IMP and records must be available for inspection by a study monitor during the study.  Drug 
supplies, including unused, partially used or empty bottles, will either be returned by the Investigator 
or designee to Certa Therapeutics or their agent, or destroyed on site if written approval to do so is 
given by Certa Therapeutics and appropriate facilities and procedures are available.  Records shall be 
maintained by the Investigator of any disposition of the IMP.  These records must show the 
identification and quantity of IMP disposed of, the method of destruction (taking into account the 
requirements of local law), and the person who disposed of the IMP.  Where IMP is destroyed on-site, 
a record of destruction shall be issued and submitted to Certa Therapeutics. 
At the end of the trial an overall drug accountability will be performed to reconcile the number of 
dispensed and used/lost/returned IMP. 
5.5.5 
Doses and treatment regimen 
Approximately 30 participants, who fulfil all the entry criteria, will be randomised in the study. 
Participants will be randomly assigned to one of the following treatment arms: 
• 
200mg oral FT011 once per day for 3 months. 
• 
400mg oral FT011 once per day for 3 months. 
• 
Oral placebo once per day for 3 months. 
One dose consists of two (2) capsules. 
Participants will be instructed to take two (2) capsules once per day during the treatment period.  
Capsules should be taken on an empty stomach with a small amount of still water, at approximately 
the same time each morning. 
A vomited dose must not be replaced.  A double dose (e.g., missed dose from previous day and dose 
for current day) must not be taken. 
At each visit, the time of administration of the previous dose of IMP, and the time the dose is taken at 
the study site, must be recorded. 
5.5.6 
Method of assigning treatment 
A unique identification (ID) code will be allocated to each participant who provides informed consent, 
so that participants can be identified without making assumptions about their subsequent eligibility 
for the trial. 
If a participant fails screening and is not randomised, or discontinues from the trial, that ID will not be 
reused. 
Participants who fail screening and are approved to be rescreened will be allocated a new ID. 
As this is a double blind, placebo-controlled study, site staff, subjects, Certa Therapeutics, and 
delegates will be blinded as to which treatment each participant receives. 
Participant eligibility will be established before randomisation.  On Day 1, eligible participants will be 
randomised using an Interactive Response Technology (IRT) system.  At each IMP dispensing visit, 

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participants will be allocated a bottle number by the IRT system.  The participant, site, sponsor, and 
monitoring personnel will be blind to whether the subject is receiving FT011 or placebo. 
5.5.7 
Blinding and procedures for breaking the blind 
The IRT system will provide the option for an investigator to break the blind.  Sites will be instructed 
to break the blind only in situations in which the investigator determines that adequate medical care 
cannot be provided to a participant without knowing the treatment assignment.  If a code break must 
occur, the investigator or designee should advise the study Medical Monitor as soon as possible.  
Details for contacting the Medical Monitor will be provided in the Study Reference Manual (SRM).  If 
the code is broken for a subject, the IRT system will immediately notify Certa Therapeutics or their 
delegate. 
If the blind has been broken, the investigator must document the date and the reason the blind was 
broken in the subject’s notes and CRF. 
5.5.8 
Treatment Compliance 
Participant compliance will be assessed at each study visit by capsule count.  Participants will be 
considered compliant if they take ±10% of scheduled doses.  Participants who are non-compliant 
should be reminded of the dosing requirements and advised that they may be withdrawn from the 
study if compliance does not improve. 
6 
STUDY PROCEDURES 
6.1 
Participant Information 
The Investigator must provide adequate information regarding the study conduct and obtain written 
informed consent from the participant before any tests or investigations outlined in the study protocol 
are carried out. 
Prior to any study procedure, the participant will be asked to provide informed consent.  The 
participant will be given time to read and understand the Participant Information and Consent Form 
(PICF) and have any questions answered.  They may wish to take the PICF and consider it further, or to 
discuss it with their family or their usual doctor before signing. 
The PICF must be personally signed and dated by both the Investigator obtaining consent, and the 
participant. 
6.2 
Screening Visit (Day -28 to Day -1) 
The purpose of the Screening visit is to confirm participant eligibility against inclusion and exclusion 
criteria. 
In this study, participant eligibility must be determined within the 28 days prior to Day 1.  Screening 
assessments may be conducted on different days during the Screening period if required due to timing, 
or participant availability. 
Potential participants will attend the in-clinic screening.  Once informed consent has been obtained, 
the following visit assessments and procedures will be performed: 
• 
Review eligibility criteria. 
• 
Record participant demographic data. 

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• 
Review and record medical history and current conditions, including SSc-specific signs and 
symptoms 
• 
Investigator assessment of the mRSS (see Section 8.3) 
• 
Physical examination, including weight and height (see Section 8.2). 
• 
Measurement of vital signs including blood pressure, heart rate, respiratory rate, and temperature 
(see Section 8.2). 
• 
Spirometry assessment of FVC and forced expiratory volume in 1 second (FEV1) (see Section 8.3) 
• 
12-lead ECG (see Section 8.2). 
• 
Safety laboratory tests including haematology, biochemistry, coagulation, and urinalysis, and 
serum pregnancy test for WOCBP (see Section 8.2).  
• 
Review and record current and past medications. 
6.2.1 
Re-Screens 
One repeat test of an individual screening assessment (e.g., laboratory test) is allowed, with prior 
approval from Certa Therapeutics or their designee.  If appropriate, and with prior approval from Certa 
Therapeutics or their designee, participants who fail screening may be completely re-screened once 
with a new ID. 
Eligible participants are to be randomised within 28 days of the Screening visit (first screening 
assessment).  Approval to randomise later than 28 days must be obtained from Certa Therapeutics or 
designee, and selected screening procedures may be required to be repeated first. 
6.3 
Treatment Period 
6.3.1 
Day 1 (Baseline) 
Participants who meet all the inclusion and none of the exclusion criteria will be scheduled to return 
to the site for their Day 1 visit.  This visit may be conducted over two consecutive days, as long as the 
dosing and PK samples are collected on the second day.  The dosing day visit should be conducted in 
the morning, and the participant should be fasted (except for water, which is allowed) for 
approximately 8 hours prior to the visit. 
At this visit the following will be performed: 
• 
Confirm participant continues to meet eligibility criteria. 
• 
Patient Global Assessment of disease severity (see Section 8.3). 
• 
Record any new medical events since Screening, including SSc-specific signs and symptoms. 
• 
Investigator assessment of the mRSS (see Section 8.3). 
• 
Completion of the Scleroderma Health Assessment Questionnaire- Disability Index (SHAQ-DI) (see 
Section 8.3). 
• 
Completion of the Scleroderma Clinical Trial Consortium Damage Index (SCTC-DI) (see Section 8.3). 
• 
Completion of the 5-D Itch Scale (see Section 8.3). 
• 
Symptom-directed physical examination (see Section 8.2). 

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• 
Weight. 
• 
Measurement of vital signs pre-dose including blood pressure, heart rate, respiratory rate, and 
temperature (see Section 8.2). 
• 
Spirometry assessment of FVC and FEV1 (see Section 8.3). 
• 
Physician Global Assessment of disease severity (see Section 8.3). 
• 
12-lead ECG (see Section 8.2). 
• 
Blood samples: 
o Pre-dose collection of blood samples for immune cell activation markers (see Section 8.4). 
o Pre-dose PK sample collected (see Section 8.1). 
o Pre-dose blood samples collected for cytokine and chemokine measurements (see Section 
8.4). 
o Safety laboratory tests including haematology, biochemistry, coagulation, and urinalysis, 
and serum pregnancy test for WOCBP (see Section 8.2). 
• 
Collect 2 x 3mm punch biopsy skin samples (see Section 8.4).  For operational reasons, biopsies 
may be collected during the screening period once participants have been confirmed as eligible, 
as long as they are collected pre-dose. 
• 
Review and record concomitant medications. 
Eligible participants will be randomised, dispensed IMP, and will take their first dose of IMP at the 
study site, with the time of administration recorded. 
• 
Participants will remain on site for PK blood samples to be collected at 1, 2, 3, 4, 5, 6, 7 and 8 hours 
post dose (see Section 8.1). 
• 
Vital signs to be recorded immediately prior to 8-hour post-dose PK sample. 
• 
Assess and record adverse events. 
At the end of the visit participants will be reminded to take 2 capsules once daily for the duration of 
the trial Treatment Period. 
6.3.2 
Week 4 and Week 8 
There is a ±3-day window on each visit. 
Participants should be contacted the day prior to their visit to remind them not to take their IMP on 
the morning of the visit until at site and instructed to do so by the study staff. 
This visit should be conducted in the morning, and the participant should be fasted (except for water, 
which is allowed) for approximately 8 hours prior to the visit. 
Participants will return to the site for the following assessments: 
• 
Patient Global Assessment of disease severity (see Section 8.3). 
• 
Record any SSc-specific signs and symptoms. 
• 
Investigator assessment of the mRSS (see Section 8.3). 

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• 
Completion of the SHAQ-DI (see Section 8.3). 
• 
Symptom-directed physical examination (see Section 8.2). 
• 
Weight. 
• 
Measurement of vital signs including blood pressure, heart rate, respiratory rate, and temperature 
(see Section 8.2). 
• 
Spirometry assessment of FVC and FEV1 (see Section 8.3). 
• 
Physician Global Assessment of disease severity (see Section 8.3). 
• 
12-lead ECG (see Section 8.2). 
• 
Blood samples: 
o Pre-dose PK sample collected (see Section 8.1). 
o Pre-dose blood samples collected for cytokine and chemokine measurements (see Section 
8.4). 
o Safety laboratory tests including haematology, biochemistry, coagulation, and urinalysis, 
and serum pregnancy test for WOCBP (see Section 8.2). 
• 
Participants will take their dose of IMP at the study site, with the time of administration and that 
of the previous dose recorded. 
• 
Review and record concomitant medications. 
• 
Assess and record adverse events. 
• 
Conduct IMP accountability and review compliance. 
• 
Dispense new IMP bottle 
6.3.3 
Week 12 (End of Treatment) / Early Termination 
There is a ±3-day window on this visit. 
Participants should be contacted the day prior to their visit to remind them not to take their IMP on 
the morning of the visit until at site and instructed to do so by the study staff. 
This visit should be conducted in the morning, and the participant should be fasted (except for water, 
which is allowed) for approximately 8 hours prior to the visit. 
At this visit the following will be performed: 
• 
Patient Global Assessment of disease severity (see Section 8.3). 
• 
Record any SSc-specific signs and symptoms. 
• 
Investigator assessment of the mRSS (see Section 8.3). 
• 
Completion of the SHAQ-DI (see Section 8.3). 
• 
Completion of the SCTC-DI (see Section 8.3). 
• 
Completion of the 5-D Itch Scale (see Section 8.3). 
• 
Symptom-directed physical examination (see Section 8.2). 

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• 
Weight. 
• 
Measurement of vital signs pre-dose including blood pressure, heart rate, respiratory rate, and 
temperature (see Section 8.2). 
• 
Spirometry assessment of FVC and FEV1 (see Section 8.3). 
• 
Physician Global Assessment of disease severity (see Section 8.3). 
• 
12-lead ECG (see Section 8.2). 
• 
Blood samples: 
o Pre-dose collection of blood samples for immune cell activation markers (see Section 8.4). 
o Pre-dose PK sample collected (see Section 8.1). 
o Pre-dose blood samples collected for cytokine and chemokine measurements (see Section 
8.4). 
o Safety laboratory tests including haematology, biochemistry, coagulation, and urinalysis, 
and serum pregnancy test for WOCBP (see Section 8.2). 
• 
Collect 2 x 3mm punch biopsy skin samples (see Section 8.4). 
• 
Review and record concomitant medications. 
• 
Participants will take their dose of IMP at the study site, with the time of administration and that 
of the previous dose recorded. 
o Participants will remain on site for PK blood samples to be collected at 1, 2, 3, 4, 5, 6, 7 
and 8 hours post dose (see Section 8.1). 
o Collection of blood samples for immune cell activation markers at 4 hours post dose (see 
Section 8.4). 
o Vital signs to be recorded immediately prior to 8-hour post-dose PK sample. 
• 
Assess and record adverse events. 
• 
Conduct IMP accountability and review compliance. 
This is the end of the Treatment Period.  The participant will not receive any IMP after this visit. 
This visit should also be conducted as the final treatment visit in the case of early withdrawal/early 
termination of a participant. 
6.4 
Week 16 (Follow up) 
There is a +1-week window on this visit.  At this visit the following will be performed: 
• 
Record any SSc-specific signs and symptoms. 
• 
Investigator assessment of the mRSS (see Section 8.3). 
• 
Symptom-directed physical examination (see Section 8.2). 
• 
Weight. 
• 
Measurement of vital signs including blood pressure, heart rate, respiratory rate, and temperature 
(see Section 8.2). 

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• 
12-lead ECG (see Section 8.2). 
• 
Safety laboratory tests including haematology, biochemistry, coagulation, and urinalysis, and 
serum pregnancy test for WOCBP (see Section 8.2). 
• 
Review and record concomitant medications. 
• 
Assess and record adverse events. 
This is the final study visit. 
7 
TRIAL ENDPOINTS 
7.1 
Primary Endpoints 
• 
FT011 cmax, tmax, and AUC in plasma after a single dose and after 12-weeks of treatment. 
• 
Measurement of steady state FT011 levels in plasma. 
Additional calculations may be performed, and metabolites may also be measured. 
7.2 
Secondary Endpoints 
7.2.1 
Safety Endpoints 
Safety will be assessed by: 
• 
Treatment emergent adverse events from first dose of study drug to End of Study. 
• 
Physical examination. 
• 
Vital signs (blood pressure, heart rate, respiratory rate, and temperature). 
• 
12-lead ECG. 
• 
Safety laboratory results (haematology, biochemistry, coagulation, and urinalysis). 
• 
Use of concomitant medications. 
7.2.2 
Efficacy Endpoints 
• 
Change in mRSS from Baseline at each visit. 
• 
Change in percent predicted FVC from Baseline to Week 4, Week 8, and Week 12. 
• 
Change in HAQ-DI Score from Baseline to Week 4, Week 8, and Week 12. 
• 
Change in Patient Global Assessment Score from Baseline to Week 4, Week 8, and Week 12. 
• 
Change in Physician Global Assessment Score from Baseline to Week 4, Week 8, and Week 12. 
• 
The proportion of patients showing an improvement (defined as ACR Composite Response Index 
in Diffuse Cutaneous Systemic Sclerosis (CRISS) score predicted probability of ≥0.60) at Week 12. 
• 
Change in the Scleroderma Clinical Trials Consortium Damage Index (SCTC-DI) score from Baseline 
to Week 12. 
• 
Change in the 5-D Itch Scale from Baseline to Week 12. 

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7.3 
Exploratory Endpoints 
 
 
 
 
 
 
 
 
 
 
 
8 
TRIAL MEASUREMENTS 
8.1 
Pharmacokinetics 
Details of the laboratory and sample collection, processing, storage, and shipment are described in the 
Laboratory Manual. 
Blood samples for plasma PK analyses will be collected at the following time points: 
• 
Day 1:  within 30 minutes prior to IMP administration, and at 1, 2, 3, 4, 5, 6, 7 and 8 hours post 
dose. 
• 
Week 4:  within 30 minutes prior to IMP administration. 
• 
Week 8:  within 30 minutes prior to IMP administration. 
• 
Week 12:  within 30 minutes prior to IMP administration, and at 1, 2, 3, 4, 5, 6, 7 and 8 hours post 
dose. 
A window of ± 10 minutes is allowed for all time points.  Collections outside of these windows will be 
recorded as protocol deviations.  Actual collection time must be recorded. 
At each visit, the time of administration of the previous dose of IMP, and the time the dose is taken at 
the study site, must be recorded. 
The PK samples will be shipped to a central laboratory for determination of the pharmacokinetics of 
FT011. 
Metabolites may also be measured.  Remaining samples will be stored for up to 10 years and may be 
used for additional research into FT011 or relevant indication biomarkers. 
8.2 
Safety and tolerability 
Safety will be assessed by recording of AEs, laboratory parameters, vital signs, physical examination, 
and 12-lead ECG.  Where multiple procedures are scheduled for the same nominal time point, safety 
blood samples should be taken after all other procedures have been performed. 
• 
The physical examination will include the following: examination of general appearance, skin, 
head, neck (including thyroid), eyes, ears, nose, throat, heart, lungs, abdomen, lymph nodes, 
extremities, and nervous system.  Height will be recorded at screening only.  A symptom directed 
physical examination will be conducted at post-screening visits, based on signs and symptoms the 
patient has experienced or reported. 

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• 
Vital sign measurements should be taken after the participant has rested in a supine position for 
at least 5 minutes and include blood pressure (systolic and diastolic), heart rate (beats/minute), 
respiratory rate, and body temperature.  The same arm (preferably the nondominant arm) and the 
appropriate size cuff should be used for each blood pressure measurement. 
o At the Day 1 and Week 12 visits, vital signs are to be recorded pre-dose and just prior to 
the 8-hour post dose PK sample. 
• 
12-lead ECGs will be performed.  Participants should be in a resting supine position for 10 minutes 
prior to ECG collection.  The Investigator (or a qualified observer at the investigational site) will 
interpret the ECG using one of the following categories: within normal limits, abnormal but not 
clinically significant, or abnormal and clinically significant.  The heart rate from the ECG machine 
should not be used as part of the vital sign measurements. 
• 
Blood and urine samples will be taken throughout the course of the study.  On-study collections 
should be fasted.  Details of the laboratory and sample collection, processing, storage, and 
shipment are described in the Laboratory Manual.  The following specific tests will be performed 
at the study central laboratory: 
o Haematology: Haemoglobin, haematocrit, red blood cell count, red cell distribution width, 
mean corpuscular volume, mean corpuscular haemoglobin, mean corpuscular 
haemoglobin concentration, white blood cell count with differential, and platelet count. 
o Coagulation:  Activated partial thromboplastin time, prothrombin time, international 
normalised ratio, fibrinogen. 
o 
Serum Chemistry: Sodium, potassium, magnesium, bicarbonate, phosphate, calcium, urea, 
urate, serum albumin, total protein, gamma-glutamyl transferase, alanine transaminase, 
aspartate transaminase, direct bilirubin, alkaline phosphatase, glucose, cholesterol, 
triglycerides, high-density lipoprotein, low-density lipoprotein, creatine phosphokinase, 
lactate dehydrogenase, and creatinine.  The central laboratory will calculate and report 
the eGFR value. 
o Urinalysis: Mid-stream urine microscopy, culture and sensitivities, urinary albumin: 
creatinine ratio (ACR) 
o Serum pregnancy test:  for women of childbearing potential. 
• 
Participants will be questioned at each visit from Day 1 about any AEs they may have experienced 
since the previous visit.  See Section 10.3 for further details on recording AEs. 
• 
Participants will be questioned at each visit about any concomitant medications they may have 
taken since the previous visit.  This will assist in identifying AEs. 
8.3 
Efficacy 
• 
The mRSS is a validated physical evaluation of patient's skin thickness rated by clinical palpation 
using a 0-3 scale (0 = normal skin; 1 = mild thickness; 2 = moderate thickness; 3 = severe thickness 
with inability to pinch the skin into a fold for each of 17 surface anatomic areas of the body: face, 
anterior chest, abdomen, and, with right and left sides of the body separately evaluated, the 
fingers, forearms, upper arms, thighs, lower legs, dorsum of hands and feet. Individual values are 
summed and defined as the total skin score.  Total score is 0 to 51 with higher scores indicating 
worse symptomology.  Minimally clinically significant difference in MRSS is 3-5 points.12 

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• 
Percent predicted FVC is calculated using equations incorporating age, gender, and race.  It is 
calculated as (FVC Observed / FVC predicted) x 100, where FVC predicted is calculated relative to 
a reference population.  Forced expiratory manoeuvres will be performed at least in triplicate with 
the minimal requirement that three manoeuvres are "acceptable" and that two of these 
manoeuvres meet end-of-test and repeatability criteria for FVC and FEV1. 
• 
The SHAQ-DI consists of 20 questions referring to eight component sets consisting of 
dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities.  Each item is scored 
on a 4-point scale from 0 to 3: 0 = Without any difficulty; 1 = With some difficulty; 2 = With much 
difficulty; 3 = Unable to do.  The eight scores of the eight sections are summed and divided by 8.  
If one section is not completed by a subject, the summed score is divided by 7.  The total score 
indicates the patient's self-assessed level of disability - higher scores indicate worse 
symptomology.  This outcome measure represents the change in mean score from baseline.  A 
negative change from baseline indicates improvement.  The Scleroderma HAQ (SHAQ) includes an 
additional five scleroderma‐specific visual analogue scales (VAS), addressing overall disease 
activity, Raynaud's phenomenon, finger ulcers, breathing, and intestinal problems.  A composite 
VAS score is not created nor are the individual VAS scores incorporated into the HAQ DI score. 
• 
The Patient's Global Assessment represents the patient's overall assessment of current SSc status 
on a 100-mm horizontal VAS, ranging from 0 on the extreme left end of the scale indicating 
"extremely poor health", and 100 on the extreme right end indicating "excellent health". 
• 
The Physician's Global Assessment is to be completed based on examination and overall 
assessment of the patient.  The physician's assessment of the patient's SSc status will be scored on 
a 100-mm horizontal VAS, ranging from 0 on the extreme left end of the scale indicating "no 
disease activity" (symptom free), and 100 on the extreme right end indicating "worst imaginable 
disease activity". 
• 
The ACR CRISS was developed using expert consensus and data driven approaches for use in clinical 
trials.13,14  The exponential algorithm determines the predicted probability of improvement from 
baseline, incorporating change in the mRSS, FVC percent predicted, physician and patient global 
assessments, and HAQ-DI.  The outcome is a continuous variable between 0.0 and 1.0 (0 - 100%).  
A higher score indicates greater improvement. 
The application of CRISS algorithm in a randomised clinical trial is a 2-step process. 
In the first step, participants will be clinically evaluated to determine whether the participant has 
improved or not. A participant is considered not improved and is assigned a probability score of 
improving equal to 0.0, irrespective of improvement on other core items, if he/she develops:  
1. New scleroderma renal crisis. 
2. Decline in FVC % predicted ≥15% (relative), confirmed by another FVC % within a month, 
high resolution computed tomography (HRCT) to confirm interstitial lung disease (if previous 
HRCT did not show interstitial lung disease) and FVC % predicted below 80% predicted 
(attributable to SSc). 
3. New onset of left ventricular failure (defined as ejection fraction ≤45%) or new onset of 
pulmonary arterial hypertension requiring treatment (attributable to SSc). 

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If the participant is determined to exhibit improvement in the first step (i.e., not assigned a 0.0), 
the second step involves computing the predicted probability of improving (a score between 0.0 
and 1.0, inclusive) using the equation: 
 
where ΔMRSS indicates the change in mRSS from baseline to the visit, ΔFVC denotes the change in 
FVC % predicted from baseline to the visit, ΔPt-glob indicates the change in patient global 
assessment, ΔMD-glob denotes the change in physician global assessment, and ΔHAQ-DI is the 
change in HAQ-DI.  Note that all changes are absolute changes. 
Participants for which the predicted probability is greater or equal to 0.60 are considered 
improved, while participants for which the predicted probability is below 0.60 are considered not 
improved. 
• 
The SCTC-DI is a 23-item composite damage index to quantify organ damage in systemic sclerosis. 
• 
The 5-D itch scale is a validated brief multidimensional questionnaire designed to be useful as an 
outcome measure in clinical trials. The five dimensions are degree, duration, direction, disability, 
and distribution. 
8.4 
Exploratory 
 
 
 
 
 
 
 
 
 
   
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 

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9 
STUDY OVERSIGHT 
9.1 
Data Safety Monitoring Board 
An independent DSMB will be established prior to recruitment start, with appropriate charter that 
defines its roles and responsibilities.  The DSMB will monitor accruing trial safety results and PK data 
at intervals throughout the study.  The main purpose of the DSMB will be to protect the interests of 
the participants included in the trial. 
The charter will specify the intervals for formal DSMB meetings. 
The DSMB will convey to Certa Therapeutics their recommendations as to whether the trial may 
continue as planned or if the trial should be modified or stopped.  The final decision on whether the 
study should be modified or stopped will be the responsibility of Certa Therapeutics.  Any decision to 
modify or stop will be communicated to investigators and regulatory authorities (RA) by Certa 
Therapeutics (or their representatives).  The DSMB may also report PK data in a blinded fashion. 
The DSMB will also review any serious adverse events (SAE) that occur during the study. 
Certa Therapeutics may also decide to cease enrolment at any time if unfavourable safety data lead to 
the conclusion that the benefit-risk assessment for the trial is no longer positive. 
10 ADVERSE EVENTS 
The definitions of AEs and SAEs are given below.  It is extremely important that all staff involved in the 
trial are familiar with the content of this section.  The PI is responsible for ensuring this. 
AEs and SAEs will be captured from the time of the first dose of IMP through to the final study visit. 
10.1 Adverse Event Definitions 
An AE is defined as any untoward medical occurrence in a participant or clinical investigation 
participant administered a pharmaceutical product and which does not necessarily have a causal 
relationship with this treatment.  An AE can therefore be any unfavourable and unintended sign 
(including an abnormal laboratory finding), symptom, or disease temporally associated with the use of 
a medicinal (investigational) product whether or not related to the medicinal (investigational) product. 
Laboratory reference ranges are defined by upper or lower limits of parameters of the respective 
laboratory.  The Investigator should ensure that each parameter out of the normal range is assessed 
for clinical significance and potential for being an AE.  It is at the discretion of the Investigator to 
document any change in laboratory result as an AE if he considers the change to be clinically significant, 
even if the absolute value is within the alert limit or reference range. 
The participant must be instructed to inform the Investigator about all AEs and these must be 
documented in the participant records and CRF together with their intensity: 
• 
Severe are those AEs which make normal daily routine impossible. 
• 
Moderate AEs impact the normal daily routine. 
• 
Mild AEs do not impact normal daily routine. 
An AE that is assessed as severe should not be confused with a SAE.  Severity is a category utilised for 
rating the intensity of an event, and both AEs and SAEs can be assessed as severe.  An event is defined 
as ‘serious’ when it meets one of the pre-defined outcomes as described in Section 10.2. 

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The Investigator must assign causality to each adverse event in relation to IMP based on the following 
scale: 
• 
Not related:  AE for which there is evidence of another explanation, e.g. the adverse event is 
obviously explained by the participant’s disease(s), is in accordance with the known effect of a 
concomitant medication, or has occurred prior to first administration of FT011. 
• 
Unlikely related:  AE with a time relationship to FT011 administration that makes a relationship 
improbable (but not impossible), and disease or other drugs provide plausible explanations. 
• 
Possibly related:  AE with a reasonable time relationship to FT011 administration, but which could 
also be explained by disease or other drugs.  Information on FT011 withdrawal may be lacking or 
unclear. 
• 
Probably related:  AE with reasonable time relationship to FT011 administration that is unlikely to 
be attributed to disease or other drugs.  Response to FT011 withdrawal is clinically reasonable.  
Rechallenge is not required. 
• 
Definitely related:  AE with plausible time relationship to FT011 administration which cannot be 
explained by disease or other drugs.  Response to FT011 withdrawal is plausible 
(pharmacologically, 
pathologically), 
and 
event 
is 
definitive 
pharmacologically 
or 
phenomenologically (i.e. an objective and specific medical disorder or a recognised 
pharmacological phenomenon).  Rechallenge, if performed/necessary, is satisfactory. 
All AEs must be documented by the Investigator, regardless of causality. 
If an AE leads to premature discontinuation of the study, the appropriate pages of the CRF must be 
completed. 
Expected AEs are defined in the IB reference safety information.  At this stage of development there 
are no expected AEs defined for FT011. 
10.2 Serious Adverse Events 
An AE shall be classified as serious if it: 
• 
Results in death. 
• 
Is life-threatening. 
Life threatening in the definition of serious refers to an event in which the participant was at risk 
of death at the time of the event, it does not refer to an event which hypothetically might have 
caused death if it were more severe. 
• 
Requires inpatient hospitalisation or prolongation of existing hospitalisation. 
Hospitalisation is defined as inpatient admission or care regardless of duration. 
Out-patient treatment in an emergency room is not in itself an SAE, although the reasons for it 
may be (e.g. bronchospasm, laryngeal oedema).  Elective surgery, hospitalisation for social reasons 
(with no causing AE), or hospital admissions and/or surgical operations planned before or during 
this study are not considered AEs if the illness or disease existed before the participant was 
enrolled in the study, provided that it did not deteriorate in an unexpected way during the study. 
• 
Results in persistent or significant disability/incapacity. 

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• 
Is a congenital anomaly/birth defect. 
• 
Is an important medical event. 
This includes events that may not be immediately life-threatening or result in death or 
hospitalisation but may jeopardise the participant or may require intervention to prevent one of 
the other outcomes listed above. 
10.3 Eliciting and Recording of Adverse Events 
At every study visit, participants must be asked a standard, non-directed question, such as, “How have 
you been feeling since your last visit?” to elicit any medically related changes in their well-being.  They 
may also be asked if they have been hospitalised, had any accidents, used any new medications, or 
changed concomitant medication regimens (including prescription drugs, over-the-counter 
medications, vitamins, herbal products, and minerals).  Responses must be documented in the source 
documents. 
In addition to patient observations, AEs must be documented for any clinically significant diagnosis 
resulting from abnormal laboratory test values, physical examination findings, or ECG abnormalities, 
or from other documents that are relevant to participant safety. 
AEs will be captured from the time of first IMP dose, until the final study visit.  Conditions occurring 
prior to the first dose of IMP will be recorded as medical history.  SAEs judged to be possibly related to 
FT011 occurring to a study participant after the SAE reporting period will be reported to the sponsor if 
the Investigator becomes aware of them. 
It is preferable that AEs are reported as diagnoses if one can be made, rather than individual signs and 
symptoms. The AE description, start and stop dates, intensity, causality, and outcome must be 
recorded, as well as any actions taken. 
Unless a diagnosis is made, or signs and symptoms are present, abnormal laboratory values, physical 
examination findings, abnormal vital signs, or ECG abnormalities, should only be reported as AEs if they 
cause the participant to discontinue from the trial, the investigator feels it is clinically significant, or 
they meet a criterion for a SAE. 
10.4 Reporting Serious Adverse Events 
10.4.1 Reporting to Sponsor 
Investigators and other site personnel must report SAEs on a SAE form to Certa Therapeutics or their 
designee within 24 hours of becoming aware of the SAE, regardless of causality.  Information regarding 
SAEs will be entered in to the electronic CRF, confirmed by a physician from the study site, and 
transmitted within 24 hours.  If the electronic CRF is inaccessible, SAE reports (paper form) should be 
submitted by email to 
within the same timelines. 
Follow-up information on SAEs must also be reported by the investigational site within the same time 
frame.  If a non-serious AE becomes serious, this and other relevant follow-up information must also 
be provided within 24 hours. 
All SAEs will be recorded in the participant records and the CRF. 

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10.4.2 Reporting to Regulatory Authorities, Ethics Committees/Institutional Review Boards, and 
Investigators 
Certa Therapeutics or their designee will report SAEs, AEs that are both serious and unexpected and 
are considered to be related to the administered product (suspected unexpected serious adverse 
reactions [SUSARs]), and Safety Issues to RAs in accordance with applicable laws and regulations. 
The investigator must comply with any applicable site-specific requirements related to the reporting 
of SAEs (and in particular deaths) involving his/her subjects to the EC/IRB that approved the trial.  In 
accordance with ICH GCP guidelines, the sponsor will inform the investigator of ‘findings that could 
adversely affect the safety of subjects, impact the conduct of the trial, or alter the EC’s/IRB’s 
approval/favourable opinion to continue the trial.’  In particular and in line with respective regulations, 
the sponsor will inform the investigator SUSARs.  The investigator should retain copies of safety reports 
in the Investigator Site File (ISF). 
When specifically required by regulations and guidelines, the sponsor will provide appropriate safety 
reports directly to the concerned lead EC/IRB and will maintain records of these notifications.  When 
direct reporting by the sponsor is not clearly defined by national or site-specific regulations, the 
investigator will be responsible for notifying the relevant EC/IRB of any safety reports as required, 
within the period specific by the EC/IRB, and of filing copies of all related correspondence in the ISF. 
10.5 Follow-up of Adverse Events and Serious Adverse Events 
All AEs and all SAEs must be followed by the Investigator until resolution, until the AE stabilises or is 
recognised as a permanent condition by the Investigator, or until the participant is lost to follow up, 
whichever comes first.  Follow-up investigations may be necessary according to the Investigator’s 
medical judgement. 
10.6 Pregnancy Reporting 
If a participant or their partner becomes pregnant, they will be asked to consent to follow up of the 
pregnancy and outcome.  Pregnancy will be recorded on a pregnancy notification form. 
Certa Therapeutics or designee will follow-up on the outcome of the pregnancy and the health status 
of the neonate, including after study completion. 
11 DATA MANAGEMENT 
11.1 Data Management and Quality Control 
A 21 CFR Part 11 compliant Electronic Data Capture (EDC) system will be used to capture data for all 
patients entered in the study.  Data collection and entry into the CRF will be completed by authorised 
study site personnel designated by the Investigator.  Appropriate training will be completed with the 
Investigator and all authorised study site personnel prior to the study being initiated and any data 
being entered into the CRF for any study participants. 
All data must be entered in English.  The CRFs should always reflect the latest observations on the 
participants participating in the trial; therefore, the CRFs are to be completed as soon as possible after 
the participant’s visit.  The Investigator must verify that all data entries in the CRFs are accurate and 
correct.  If some assessments are not done, or if certain information is not available or not applicable 
or unknown, this should be indicated in the CRF.  The PI (or designee) will be required to sign off on 
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The study monitor/Clinical Research Associate (CRA) will review the CRFs and evaluate them for 
completeness and consistency and compare them to the source documents to ensure that there are 
no discrepancies between critical data.  All entries, corrections and alterations are to be made by the 
responsible Investigator or designee.  The CRA cannot enter data into the CRFs.  If corrections are 
needed, the CRA or Data Manager will query the site. 
The CRF is essentially a data entry form and should not constitute the original, or source document, 
unless otherwise specified.  Source documents are all documents used or obtained by the Investigator 
or trial site that relate to the participant’s medical history, that verify the existence of the participant, 
the inclusion and exclusion criteria and all records covering the participant’s participation in the study.  
They include, but are not limited to, laboratory reports, pharmacy dispensing records, hospital records, 
participant files, etc. 
The Investigator is responsible for maintaining source documents.  These will be made available for 
inspection by the CRA at each monitoring visit. 
12 STATISTICAL ANALYSIS CONSIDERATIONS 
A Statistical Analysis Plan (SAP) will be written and approved prior to database lock.  The SAP (as an 
extension of the protocol) will detail the implementation of all the planned statistical analyses in 
accordance with the principal features stated in the protocol.  Methodology described in the SAP will 
take precedence over the protocol.  Any deviations from the analyses described in the SAP will be 
presented in the final clinical study report. 
12.1 Determination of Sample Size  
The sample size for this study is sized based on practical considerations and a formal sample size 
calculation was not performed.  A total of approximately 30 participants, 10 per treatment group, will 
be randomised and treated.  The sample size is considered sufficient to assess the study objectives. 
12.2 General Methodology 
Results will be presented by treatment group, for the pooled FT011 group and overall. 
In general, data will be summarised using descriptive statistics (number of observations, mean, 
median, standard deviation [SD], minimum and maximum) or frequency counts and percentages, as 
appropriate to the type of data.  The coefficient of variation (CV), geometric mean and geometric CV 
will also be presented for the PK tables. 
Confidence intervals will be reported where appropriate.  If not mentioned otherwise, all statistical 
tests will be performed with a type I two-sided error rate of 5%. 
Baseline will be defined as the last available, valid, non-missing assessment prior to the first study drug 
administration. 
Only data from protocol scheduled visits/time points will be included in the summary tables.  Data 
from unscheduled visits/time points will be included in the figures (where appropriate) and data 
listings. 
Medical history and adverse event terms will be coded by Medical Dictionary for Regulatory Activities 
(MedDRA) codes and prior and concomitant medications by the World Health Organisation Drug 
Dictionary (WHO-DD) Anatomical Therapeutic Chemical (ATC) classification codes.  The specific 
dictionary versions will be documented in the SAP and in the outputs. 

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The software (and version) used to perform the statistical and PK analyses will be documented in the 
SAP. 
12.3 Analysis Sets 
The following analysis sets will be defined: 
Intention-to-Treat (ITT) Set:  The ITT set is defined as all participants who were randomised.  
Participants in this set will be analysed based on the treatment that they were randomised to. 
Safety Set:  The safety set is defined as all participants who were randomised and received at least one 
dose of study medication.  Participants in this set will be analysed based on the actual treatment that 
they received.  All safety analyses will be based on the safety set. 
Modified Intention-to-Treat (mITT) Set:  The mITT set is defined as all randomised participants who 
received at least one dose of study medication and who have post-baseline efficacy data for at least 
one of the efficacy outcome measures.  All efficacy analyses will be based on the mITT set.  Participants 
in this set will be analysed based on the treatment that they were randomised to. 
PK Set:  The PK set is defined as all participants included in the safety set who have sufficient 
concentrations to allow for the calculation of at least one PK parameter.  Participants who experience 
any adverse events or have protocol deviations that could affect the PK profiles may be excluded from 
the PK set at the pharmacokineticist’s discretion.  All PK analyses will be based on the PK set.  
Participants in this set will be analysed based on the actual treatment that they received. 
12.4 Analyses 
12.4.1 Baseline Characteristics and Disposition 
Participant enrolment and disposition will be summarised by treatment group and will include the total 
number of participants randomised into the study and in included into each of the defined analysis 
sets.  The number of participants who prematurely discontinuing from the study, along with the reason 
for early discontinuation will also be summarised. 
Demographic and other baseline characteristics data recorded at screening and prior to dosing will be 
summarised, by randomised treatment group. 
All analyses will be based on the ITT set. 
12.4.2 Safety Analysis 
All safety analyses will be based on the safety set. 
12.4.2.1 Adverse Events 
AEs will be grouped by MedDRA system organ class and preferred term and summarised, by treatment 
group.  The summary tables will present the number and percentage of total participants and number 
of events, by system organ class and by preferred term. 
For the summaries of AEs, participants who experience the same AE (in terms of the MedDRA preferred 
term) more than once will only be counted once for that event in the number of participants but all 
occurrences of the same event will be counted in the number of events. 
All AE summaries will be restricted to treatment emergent AEs only.  Treatment emergent AEs are 
defined as AEs which commence on or after the first study drug administration. 

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Drug-related SAEs and treatment emergent AE (TEAEs) leading to early study withdrawal will also be 
summarised. 
Separate summaries will be produced based on severity and relationship to study drug categories. 
All adverse events data will be listed. 
12.4.2.2 Duration of Exposure and Compliance 
Exposure and compliance data will be summarised and listed. 
12.4.2.3 Laboratory Results 
Laboratory data will be summarised and listed by treatment group and visit.  Actual values and the 
changes from baseline will be presented.  In addition, ‘shift from baseline’ tables will also be presented 
showing the changes in the reference range classifications (normal, low, high) over time. 
Dipstick urinalysis results evaluation (normal or, abnormal not clinically significant or abnormal 
clinically significant) will be summarised by treatment group and visit using frequency tabulations. 
Abnormal laboratory values (including clinical significance as assessed by the Investigator) will be 
flagged in the listings. 
12.4.2.4 Vital Signs and Physical Examination 
Vital signs will be summarised and listed by treatment group and visit.  Actual values and the changes 
from baseline will be presented. 
Physical examination findings will only be listed. 
12.4.2.5 12-lead ECG Results 
ECG measurement will be summarised and listed by treatment group and visit.  Actual values and the 
changes from baseline will be presented. 
In addition, a frequency tabulation of overall ECG interpretation (normal or, abnormal not clinically 
significant or abnormal clinically significant) will be summarised by treatment group and visit using 
frequency tabulations. 
12.4.2.6 Prior and Concomitant Medications 
Prior and concomitant medications will be grouped by the WHO-DD ATC classification Level 2 term and 
by preferred drug name. 
Prior medications are those medications that were stopped prior to the first study drug administration.  
Concomitant medications are medications that are taken at least once after the first study drug 
administration.  Medications stopping on the same day as the first study drug administration will be 
considered as concomitant medications. 
12.4.3 Pharmacokinetic Analysis 
The analysis of the plasma FT011 PK concentrations and parameters data will be based on the PK set. 
Results will be presented by visit (Day 1 and Week 12) and treatment group. 

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12.4.3.1 Pharmacokinetic Concentrations 
Plasma FT011 concentrations data will be summarised by visit and nominal collection time points using 
descriptive statistics including the number of concentrations below the limit of quantification (BLQ), 
CV, geometric mean, and geometric CV. 
Results reported as BLQ will be treated as zero for the calculation of the summary statistics, and as 
missing for the calculation of the geometric statistics. 
Spaghetti plots of the individual plasma FT011 concentrations vs. actual time profiles (relative to the 
dose at the visit) will be presented on linear and log-linear scales.  Plots will be presented by treatment 
group and visit.  BLQ concentrations will be set to 0 in the linear plots and will be treated as missing in 
the log-linear plots. 
Mean concentration profiles (± SD bars) vs. nominal time curves will be presented by visit on linear 
and log-linear scales.  All treatment groups will be presented in the same plot. 
All plasma FT011 concentration data will be listed, and the listing will include the calculated elapsed 
time since the study drug administration at the specific visit and the time deviations between the 
actual and planned sample collection times. 
12.4.3.2 Pharmacokinetic Parameters 
Two sets of plasma FT011 PK parameters will be calculated based the concentrations collected after 
the single dose on Day 1 and based on the concentrations collected after the last dose at Week 12. 
Plasma PK parameters will be calculated using a non-compartmental approach based on the observed 
concentration-time profiles.  Actual sampling times relative to the dose at the visit will be used in all 
PK calculations.  The handling of BLQ values in the parameter calculations will be described in the SAP. 
The plasma PK parameters shown in Table 3 will be calculated (data permitting) from the 
concentration-time profiles and additional parameters may be added at the discretion of the 
pharmacokineticist 
Table 3:  Plasma PK Parameters 
PK Parameter 
Method 
cmax  
Maximum observed concentration. 
tmax  
Time to reach maximum concentration. 
AUC0-8 
Area under the plasma concentration-time curve from the time of the dose 
administration to the time of the 8-hour post-dose concentration 
calculated by the linear up log down trapezoidal method. 
AUClast 
Area under the concentration-time curve from the time of the dose 
administration to the time of the last measurable concentration calculated 
by the linear up log down trapezoidal method. 
 
The plasma PK parameter results will be summarised by treatment group and visit using summary 
statistics and the geometric statistics described for the PK concentrations.  Results will also be 
presented graphically using box-and-whiskers plots. 

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All plasma PK parameter results will be listed. 
12.4.4 Efficacy Analysis  
All efficacy analyses will be based on the mITT set. 
Whilst no formal hypothesis testing is planned, exploratory analyses may be performed to assess the 
treatment effect of FT011 on the efficacy outcomes.  Full details of any inferential analyses will be 
provided in the SAP. 
The handling of missing data and adjustments for multiplicity will be described in the SAP. 
All collected and derived results will be presented in the data listings. 
12.4.4.1 Continuous Endpoints 
The actual results and the change from baseline values at each post-baseline visit will be summarised 
by treatment group using descriptive statistics. 
The mean change from baseline values (±SD) over time will also be presented graphically. 
The change from baseline values will be compared between the FT011 and placebo groups using a 
mixed model repeated measures model with the baseline value a covariate, treatment group as fixed 
effect, the interaction effect between study visit and treatment group, and subject as random effect 
with an unstructured covariance assumption.  Parameter estimates will be calculated using restricted 
maximum likelihood methods, and the Kenward-Rogers method will be used to calculate the degrees 
of freedom. 
The least squares means, estimated treatment differences (compared to placebo) and the 
corresponding confidence intervals and p-values at each visit will be presented. 
The numeric CRISS scores be analysed using a Wilcoxon test. 
12.4.4.2 Binary Endpoints 
Binary endpoints will be summarised using counts, percentages, and odds ratios (compared to 
placebo).  The proportions between each FT011 group and the placebo group will be compared using 
a Cochran-Mantel-Haenszel test. 
12.4.4.3 Categorical Endpoints 
Categorical endpoints will be summarised using counts and percentages. 
13 TRIAL MANAGEMENT 
13.1 Contacts 
Details of investigators, study sites, Medical Monitors, CRAs, Certa Therapeutics and designee contacts 
can be found in the SRM. 
13.2 Monitoring 
Study monitoring will be performed in accordance with applicable regulations, International 
Conference on Harmonisation (ICH) Good Clinical Practice (GCP), and Certa Therapeutics and designee 
Standard Operating Procedures (SOPs). 

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Before the start of the trial, a representative of Certa Therapeutics or designee will contact the 
investigational site to ensure facilities are adequate and discuss responsibilities with the site staff with 
regards to following the protocol and regulatory and ethical requirements. 
During the trial, a CRA from Certa Therapeutics or its designee will regularly visit the site to monitor 
and confirm protocol, regulatory and ethical adherence, confirm data accuracy and provide 
information and support as needed. 
In agreement with Certa Therapeutics and the PI, monitoring activities may take place remotely.  The 
conduct of remote monitoring visits should not replace the conduct of on-site visits entirely.  If on-site 
monitoring visits are no longer possible, the use of central and remote monitoring programs will be 
used to maintain oversight of clinical sites. 
The PI agrees to allow the CRA direct access to all relevant documents, including electronic medical 
records, and to allocate his time and the time of his staff to the CRA to discuss findings and any relevant 
issues. 
Site staff will be provided with CRA and back up contact details in the event they have queries or 
require assistance. 
13.3 Audits and Inspections 
An audit is a systematic and independent examination of trial related activities and documents to 
determine whether the evaluated trial related activities were conducted, and the data were recorded, 
analysed, and accurately reported according to the protocol, Certa Therapeutics SOPs and those of 
Certa Therapeutics designees, GCP, and applicable regulatory requirements. 
Authorised representatives of Certa Therapeutics, its designee, a RA, or the EC may visit the centre to 
perform audits or inspections.  The investigator should contact Certa Therapeutics or designee 
immediately if they are contacted by a RA about an inspection at their centre.  If an audit or inspection 
occurs, the PI and institution agree to allow the auditor/inspector direct access to all relevant 
documents and allocate their time and the time of their staff to the auditor/inspector to discuss 
findings and any relevant issues. 
13.4 Training of Staff 
Each individual involved in conducting a trial should be qualified by education, training, and experience 
to perform his or her respective tasks. 
Site staff may be trained for this study at meetings and initiation and study visits by Certa Therapeutics, 
or their designees. 
The PI will maintain records of all individuals involved in the trial at their site.  The PI will ensure that 
appropriate training relevant to the trial is given to all these staff, and that they will receive any new 
information relevant to the performance of this trial in a timely manner. 
13.5 Changes to the Protocol 
Trial procedures will not be changed without the agreement of Certa Therapeutics. 
If it is necessary for the trial protocol to be amended, the amendment or a new version of the trial 
protocol must be notified to or approved by the relevant RA if applicable, and by the site’s EC/IRB 
before implementation at the site, unless the safety of participants is involved.  Local requirements 
must be followed. 

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If a protocol amendment requires a change to the PICF, approval of the revised PICF by Certa 
Therapeutics or their designee and by the EC/IRB and RA if applicable is required before the revised 
form can be used. 
Certa Therapeutics or their designee will distribute amendments and new versions of the protocol to 
the PI and to the appropriate RAs as required.  The PI will be responsible for submitting to their EC/IRB. 
13.6 Trial Agreements 
The PI and institution must comply with all the terms, conditions, and obligations of the trial agreement 
for this trial.  In the event of any inconsistency between this protocol and the trial agreement, the trial 
agreement shall prevail. 
13.7 Trial Timetable and Termination 
The planned start date for this trial is first quarter 2021, and the proposed completion data is third 
quarter 2022. 
Certa Therapeutics reserves the right to terminate the trial at any stage for any reason including 
commercial considerations. 
13.8 Ethics Review 
The protocol and the PICF will be submitted for approval to the appropriate EC/IRB and RA if applicable 
and must be approved or given a favourable opinion in writing as appropriate.  In addition, the EC/IRB 
must approve any other written information to be provided to participants, including advertising used 
to recruit participants for the trial.  The investigator must submit written EC/IRB approval to Certa 
Therapeutics or designee before they can enrol any participant into the trial. 
Any amendment to the protocol will be sent to the EC/IRB and RA if applicable.  No deviations from or 
changes to the protocol will be implemented without documented approval from the EC and RA (if 
required) of an amendment, except where necessary to eliminate an immediate hazard(s) to trial 
participant, or when the change(s) involves only logistical or administrative aspects of the trial. 
The deviations from or changes to the protocol which were implemented to eliminate an immediate 
hazard to the trial participant and the proposed amendment, if appropriate, should be submitted to 
the EC/IRB and RA for review and approval as soon as possible after the event. 
The PI must submit progress reports to the EC/IRB according to local regulations and guidelines.  The 
PI must also provide the EC/IRB with any reports of SAEs from the trial site in accordance with their 
EC’s/IRB’s requirements and timelines. 
13.9 Ethical Conduct of the Study 
The trial will be performed in accordance with the ethical principles in the Guidelines of the World 
Medical Association's Declaration of Helsinki in its current revised edition, ICH GCP (E6 R2) and 
applicable regulatory requirements. 
13.10 Insurance and Liability 
Certa Therapeutics has appropriate liability insurance cover in accordance with all local legal 
requirements.  Further details of this and financial arrangements are specified in the agreement with 
the trial site. 

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13.11 Participant Information and Informed Consent 
The PI will ensure that the participant is given full and adequate oral and written information about 
the nature, purpose, possible risks, and potential benefits of the trial.  Participants must also be 
notified that they are free to discontinue from the trial at any time.  The participant should be given 
the opportunity to ask questions and should be allowed time to consider the information provided. 
The participant’s signed and dated informed consent must be obtained before conducting any 
procedure specifically for the trial.  The site investigator must store the original, signed PICF.  A copy 
of the signed and dated PICF must be given to the participant. 
13.12 Data Protection 
The PICF will explain that trial data will be stored in a computer database, maintaining confidentiality 
in accordance with national data legislation.  Participants in this database will be identified by 
participant ID only.  The PICF will also explain that for data verification purposes, authorised 
representatives of Certa Therapeutics, RA, ECs/IRBs, or sites may require direct access to parts of the 
hospital or practice records relevant to the trial, including participant medical history. 
13.13 Trial Registration 
Prior to commencing recruitment, a description of this clinical trial will be available on a publicly 
accessible registry such as www.clinicaltrials.gov.  This website will not include information that can 
identify individual participants. 
13.14 Retention of Records 
The PI is responsible for the retention or archiving of the trial records for their site.  Trial records include 
the participant files as well as the source data, the ISF, pharmacy records, and other study documents. 
The PI will maintain all study records according to ICH-GCP and applicable regulatory requirement(s).  
Records will be retained for at least 2 years after the last marketing application submission or 2 years 
after formal discontinuation of the clinical development of the IMP.  However, these documents should 
be retained for a longer period if required by the applicable local regulatory requirements or by an 
agreement with Certa Therapeutics.  It is the responsibility of Certa Therapeutics to inform the 
PI/institution as to when these documents no longer need to be retained.  Records may not be 
destroyed without prior written consent from Certa Therapeutics. 
If the PI leaves the site or withdraws from the responsibility of keeping the study records, custody must 
be transferred to a person willing to accept the responsibility.  The Sponsor must be notified in writing 
if a custodial change occurs. 
13.15 Publication Policy 
By signing the study protocol, the investigator agrees with the use of results of the study for the 
purposes of national and international regulatory submissions, registration, publication, and 
information for medical and pharmaceutical professionals.  If necessary, the authorities will be notified 
of the investigator's name, address, qualifications, and extent of involvement. 
An investigator shall not publish any data related to this study (poster, abstract, paper, slide 
presentation, etc.) without having consulted with Certa Therapeutics in advance.  The objectives, the 
content and the results of the present clinical trial should be considered confidential.  All data and 
results are the exclusive property of Certa Therapeutics. 

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Except for legal reasons, the Investigators will not reveal the result of the study to a third party without 
a mutual agreement about the analysis and interpretation of the data with Certa Therapeutics. 

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