Clinical trial NCT02407041
Conditions: Psoriasis
Sponsor: Galectin Therapeutics Inc.
Start date: 2015-09-01; Completion date: 2018-03-01
Enrollment: 5 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Study GT-030 is a phase 2a, single-center, open-label study of subjects with moderate to severe plaque psoriasis

Detailed description:
The overall objective is to establish the safety and efficacy of GR-MD-02 in patients with moderate to severe plaque psoriasis.

Primary objective:

The objective is to evaluate the number of patients with moderate to severe plaque psoriasis who have 75% improvement in Psoriasis Activity Severity Index (PASI-75) following 12 weeks of therapy with GR-MD-02

Secondary objectives:

* To determine the PASI-50 and PASI-100 scores in patients with moderate to severe plaque psoriasis following the first 12 weeks of therapy with GR-MD-02
* To determine the PASI-50, PASI-75, and PASI-100 scores in patients with moderate to severe plaque psoriasis following an additional 12 weeks of therapy (total 24 weeks) with GR-MD-02
* To determine the durability of response to therapy in responders over a one year period following the end of therapy
* To determine whether there is any change in disease status of patients who also have psoriatic arthritis
* To determine the incidence of adverse events and vital sign and laboratory abnormalities during study treatment

Arms: arm 1: active arm
Interventions: intervention 1: GR-MD-02
Intervention descriptions: intervention 1: IV infusion

Protocol documents:
Prot_SAP_000.pdf: 
CLINICAL STUDY PROTOCOL 
GT-030 
 
 
 
A Single-Center, Open-Label Phase 2a Clinical Trial to Evaluate 
the Safety and Efficacy of GR-MD-02 for the Treatment of 
Patients with Moderate to Severe Plaque Psoriasis 


Study GT-030 
 
Sponsor: 
Galectin Therapeutics Inc. 
4960 Peachtree Industrial Blvd., Suite 240 
Norcross, GA 30071 
Sponsor Contact: 
Peter G. Traber, MD 
Chief Medical Officer, CEO 
Telephone: (713) 540-9776 
Project Manager: 
Adam E. Allgood, Pharm.D., R.Ph. 
Telephone: (470) 299-4725 
Medical Monitor: 
Peter G. Traber, MD 
Chief Medical Officer 
Telephone: (713) 540-9776 
Protocol Contributor 
 
 
 
 
Version of Protocol:  
Peter G. Traber, MD 
Chief Medical Officer 
Galectin Therapeutics 
4960 Peachtree Industrial Blvd., Suite 240  
Norcross, GA 30071 
Protocol Version 5.0 
Date of Protocol:  
Original: March 26, 2015 
 
Amendment 1: July 16, 2015 
Amendment 2: August 20, 2015 
Amendment 3: September 18, 2015 
Amendment 4: March 14, 2016 
 
 
CONFIDENTIAL  
All financial and nonfinancial support for this study will be provided by Galectin 
Therapeutics Inc. The concepts and information contained in this document or generated 
during the study are considered proprietary and may not be disclosed in whole or in part 
without the expressed, written consent of Galectin Therapeutics Inc. 
The study will be conducted according to the International Conference on Harmonisation 
harmonised tripartite guideline E6(R1): Good Clinical Practice. 
 








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Table of Contents 
Table of Contents ....................................................................................................................... 6 
Protocol Synopsis..................................................................................................................... 10 
List of Abbreviations................................................................................................................ 15 
1 
Introduction ...................................................................................................................... 17 
2 
Study Objectives ............................................................................................................... 20 
2.1 
Primary Objective(s) ............................................................................................... 20 
2.2 
Secondary Objective(s) ........................................................................................... 20 
3 
Investigational Plan .......................................................................................................... 21 
3.1 
Study Design ........................................................................................................... 21 
3.1.1 
Rationale of Study Design ....................................................................... 22 
4 
Subject Selection and Withdrawal Criteria ...................................................................... 23 
4.1 
Selection of Study Population ................................................................................. 23 
4.1.1 
Inclusion Criteria ..................................................................................... 23 
4.1.2 
Exclusion Criteria .................................................................................... 23 
4.2 
Withdrawal of Subjects From the Study ................................................................. 25 
4.2.1 
Reasons for Withdrawal/Discontinuation ................................................ 25 
4.2.2 
Handling of Withdrawals ......................................................................... 26 
4.2.3 
Replacements ........................................................................................... 26 
5 
Study Treatments .............................................................................................................. 27 
5.1 
Method of Assigning Subjects to Treatment Groups .............................................. 27 
5.2 
Treatments Administered ........................................................................................ 27 
5.3 
Identity of Investigational Product.......................................................................... 28 
5.4 
Management of Clinical Supplies ........................................................................... 28 
5.4.1 
Study Drug Packaging and Storage ......................................................... 28 
5.4.2 
Test Article Accountability ...................................................................... 29 
5.4.3 
Other Supplies.......................................................................................... 30 
5.5 
Overdose Management ........................................................................................... 30 
5.5.1 
Treatment of Overdose ............................................................................ 31 
5.5.2 
Medication Errors .................................................................................... 31 
5.5.3 
Treatment of Medication Errors ............................................................... 31 
5.6 
Misuse for Illegal Purposes ..................................................................................... 31 
5.7 
Treatment Compliance ............................................................................................ 31 


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5.8 
Prior and Concomitant Therapy .............................................................................. 31 
5.8.1 
Prohibited Concomitant Medication (Drugs and Therapies) ................... 32 
6 
Study Assessments and Procedures .................................................................................. 33 
6.1 
Schedule of Events .................................................................................................. 33 
6.2 
Efficacy Assessments .............................................................................................. 35 
6.3 
Safety [Tolerability] Assessments ........................................................................... 35 
6.3.1 
Adverse Events ........................................................................................ 35 
6.3.1.1 
Definitions of Adverse Events ................................................................. 35 
6.3.1.2 
Eliciting and Documenting Adverse Events ............................................ 36 
6.3.1.3 
Reporting Adverse Events ....................................................................... 36 
6.3.1.4 
Assessment of Severity ............................................................................ 37 
6.3.1.5 
Assessment of Causality .......................................................................... 38 
6.3.1.6 
Follow-Up of Subjects Reporting Adverse Events .................................. 38 
6.4 
Pregnancy ................................................................................................................ 38 
6.5 
Laboratory Analyses ............................................................................................... 39 
6.6 
Sample Collections ................................................................................................. 39 
7 
Statistical and Analytical Plan .......................................................................................... 40 
7.1 
Primary Efficacy Endpoints .................................................................................... 40 
7.2 
Secondary Efficacy Endpoints ................................................................................ 40 
7.3 
[Other or Exploratory] Efficacy Endpoints ............................................................. 40 
7.4 
Sample Size Calculations ........................................................................................ 40 
7.5 
Analysis Sets ........................................................................................................... 40 
7.6 
Description of Subgroups to be Analyzed .............................................................. 41 
7.7 
Statistical Analysis Methodology ........................................................................... 41 
7.7.1 
Analysis of Primary Efficacy Endpoint ................................................... 41 
7.7.2 
Analysis of Secondary Efficacy Endpoint ............................................... 41 
7.7.3 
Analyses of [Other or Exploratory] Efficacy Endpoint ........................... 41 
7.7.4 
Safety Analyses ........................................................................................ 41 
7.7.5 
Data Management .................................................................................... 42 
8 
Ethics ................................................................................................................................ 43 
8.1 
Independent Ethics Committee or Institutional Review Board .............................. 43 
8.2 
Ethical Conduct of the Study .................................................................................. 43 
8.3 
Subject Information and Consent............................................................................ 43 
9 
Investigator’s Obligations ................................................................................................ 45 


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9.1 
Confidentiality ........................................................................................................ 45 
9.2 
Financial Disclosure and Obligations ..................................................................... 45 
9.3 
Investigator Documentation .................................................................................... 45 
9.4 
Study Conduct ......................................................................................................... 46 
9.5 
Adherence to Protocol............................................................................................. 46 
9.6 
Adverse Events and Study Report Requirements ................................................... 46 
9.7 
Investigator’s Final Report ..................................................................................... 47 
9.8 
Records Retention ................................................................................................... 47 
9.9 
Publications ............................................................................................................. 47 
10 Study Management ........................................................................................................... 48 
10.1 Monitoring .............................................................................................................. 48 
10.1.1 
Monitoring of the Study ........................................................................... 48 
10.1.2 
Inspection of Records .............................................................................. 48 
10.2 Management of Protocol Amendments and Deviations.......................................... 48 
10.2.1 
Modification of the Protocol .................................................................... 48 
10.2.2 
Protocol Deviations.................................................................................. 49 
10.3 Study Termination ................................................................................................... 49 
10.4 Final Report ............................................................................................................ 49 
11 Reference List................................................................................................................... 51 
1.  
Yang RY, Rabinovich GA, Liu FT. Galectins: structure, function and therapeutic 
potential. Expert Rev Mol Med 2008;10:e17. ................................................. 51 
2.  
Traber PG, Zomer E. Therapy of experimental NASH and fibrosis with galectin 
inhibitors. PLoS One 2013;8(12):e83481. ...................................................... 51 
3.  
Traber PG, Chou H, Zomer E, Hong F, Klyosov A, Fiel MI, et al. Regression of 
fibrosis and reversal of cirrhosis in rats by galectin inhibitors in 
thioacetamide-induced liver disease. PLoS One 2013;8(10):e75361. ............ 51 
4.  
Chen HY, Lo C-H, Li C-S, Hsu DK, Liu FT. Galectins and cutaneous immunity. 
Dermatologica Sinica 2012;30:121-127. ......................................................... 51 
5.  
Lacina L, Plzakova Z, Smetana K, Jr., Stork J, Kaltner H, Andre S. 
Glycophenotype of psoriatic skin. Folia Biol (Praha) 2006;52(1-2):10-15. ... 51 
6.  
Schon MP. Animal models of psoriasis: a critical appraisal. Exp Dermatol 2008 
Aug;17(8):703-712. ......................................................................................... 51 
12 Protocol Amendments ...................................................................................................... 52 
12.1 Amendment 1 .......................................................................................................... 52 
12.2 Amendment 2 .......................................................................................................... 54 


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12.3 Amendment 3 .......................................................................................................... 54 
12.4 Amendment 4 .......................................................................................................... 55 
 


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Protocol Synopsis 
Protocol Number: 
GT-030 
 
Title: 
 
A Single-Center, Open-Label Phase 2a Clinical Trial to Evaluate 
the Safety and Efficacy of GR-MD-02 for the Treatment of 
Patients with Moderate to Severe Plaque Psoriasis 
Sponsor: 
Galectin Therapeutics Inc. 
4960 Peachtree Industrial Blvd., Suite 240 
Norcross, GA 30071 
 
Study Phase: 
Phase 2 
 
Study Sites: 
Single study site at Brooke Army Medical Center, Fort Sam 
Houston, TX 
 
Indication: 
Moderate to Severe Plaque Psoriasis 
 
Rationale: 
The overall objective of this exploratory Phase 2 study is to 
establish the safety and efficacy of GR-MD-02 in subjects with 
moderate to severe plaque psoriasis. 
The rationale for this objective is the observation that a subject 
who received GR-MD-02 at a dose of 4 mg/kg for four doses 
over a 6-week period in a Phase 1 clinical trial in patients with 
NASH with advanced fibrosis, reported a complete response of 
her plaque psoriasis that was durable for at least 11 months. 
 


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Objectives: 
The overall objective is to establish the safety and efficacy of 
GR-MD-02 in patients with moderate to severe plaque psoriasis. 
  
Primary objective: 
The objective is to evaluate the number of patients with 
moderate to severe plaque psoriasis who have 75% improvement 
in Psoriasis Activity Severity Index (PASI-75) following the 
first 12 weeks of therapy with GR-MD-02   
 
Secondary objectives:  
• To determine the PASI-50 and PASI-100 scores in 
patients with moderate to severe plaque psoriasis 
following the first 12 weeks of therapy with GR-MD-02 
• To determine the PASI-50, PASI-75, and PASI-100 
scores in patients with moderate to severe plaque 
psoriasis following an additional 12 weeks of therapy 
(total 24 weeks) with GR-MD-02 
• To determine the durability of response to therapy in 
responders over a six-month period following the end of 
therapy 
• To determine whether there is any change in disease 
status of patients who also have psoriatic arthritis 
• To determine the incidence of adverse events and vital 
sign and laboratory abnormalities during study treatment 
 
Subject Population: 
Main Inclusion Criteria: Subjects will be entered into the study 
if they have biopsy proven psoriasis and active moderate to 
severe plaque psoriasis with PASI ≥ 12 and at least 10% of body 
area affected.  
 
Additional Inclusion and Exclusion Criteria are outlined in the 
main protocol.  
 


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Study Design: 
Study GT-030 is a phase 2a, single-center, open-label study of 
subjects with moderate to severe plaque psoriasis. All subjects 
are required to have signed Institutional Review Board (IRB) or 
Ethics Committee (EC)-approved informed consent prior to 
undergoing any study specific procedures. 
After screening of the subject by the principal investigator for 
inclusion and exclusion criteria, the patient will have a skin 
punch biopsy to confirm the diagnosis of plaque psoriasis, 
unless one has been done previously.  Ten (10) subjects who 
have a PASI (Psoriasis Activity and Severity Index) of ≥ 12 and 
at least 10% of skin affected will be enrolled in the trial.   
Subjects will be administered GR-MD-02 intravenously in a 
dose of 8 mg/kg lean body weight every other week over 6 
months for a total of 13 doses.  During the treatment phase of the 
trial, all subjects in the study will attend study visits according to 
a schedule of visits for study administration and monitoring. 
Study assessments performed prior to each drug infusion will 
include vital signs, limited physical examination, and assessment 
of adverse events and concomitant medications.  Additionally, 
body weight will be assessed at the first infusion, an ECG will 
be performed at the third infusion, clinical laboratory tests and 
urinalysis will be performed at the fourth, seventh, and tenth 
infusions, and a urine pregnancy test will be performed monthly. 
Patients will be called one week following each infusion to 
assess for adverse events. Prior to the first infusion (at baseline 
visit), before the 4th,  7th, and 10th infusions, before the final 
infusion, and 30 days following the final infusion, PASI will be 
evaluated in the patient and full body integument photos will be 
taken by the Principal Investigator or his co-investigator.  
All subjects are to attend a final study visit 30 days after the last 
dose (or at the time of early discontinuation) to evaluate safety. 
During this visit, in addition to PASI and integument 
photography, a final complete physical exam, ECG, clinical 
laboratory tests, urinalysis, and urine pregnancy test will be 
performed, vital signs and weight will be measured, and adverse 
events, if applicable, evaluated. Subjects will have follow up 
visits at 9 and 12 months after their initial infusion to evaluate 
disease activity and PASI.   
 


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Estimated Study 
Duration: 
Subjects will remain on study therapy for a total of twenty-four 
(24) weeks and receive 13 total drug doses unless intolerable 
side effects develop, or the subject is withdrawn from study 
participation. Subjects may be discontinued at the discretion of 
the investigator. 
 
Efficacy Assessments: 
The primary endpoint will be PASI-75, or a 75% improvement 
from baseline (day 1, prior to first infusion) in PASI score as 
assessed at the day 84 (week 12) visit. 
 
The secondary endpoints that will be evaluated include:  
• PASI-75, or a 75% improvement from baseline (day 1, 
prior to first infusion) in PASI score as assessed at 
protocol day 42, day 126, day 168, and 30 day follow up 
visits. 
• PASI-50, or a 50% improvement from baseline (day 1, 
prior to first infusion) in PASI score as assessed at 
protocol day 42, day 84, day 126, day 168, and 30 day 
follow up visits. 
• PASI-100, or a 100% improvement from baseline (day 1, 
prior to first infusion) in PASI score as assessed at 
protocol day 42, day 84, day 126, day 168, and 30 day 
follow up visits. 
• Durability of response as assessed by PASI-50, 75 and 
100 at 9 and 12 months after the initial infusion.  
 
Safety Assessments: 
Safety Endpoints: 
• 
Incidence of adverse events during study treatment 
• 
Emergent physical examination abnormalities 
• 
Laboratory parameter abnormalities 


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Study Drug, Dosage, 
and Route of 
Administration: 
GR-MD-02 (galactoarabino-rhamnogalacturonate) is provided as 
an aqueous solution and is dissolved at a concentration of 30 
mg/ml in 7 mM phosphate buffered saline, pH 6.5, and provided 
in single use 10 mL vials. 
Subjects will receive GR-MD-02 in a dose of 8 mg/kg lean body 
weight (up to a maximum of 800 mg total). The study drug will 
be diluted in 100 ml of normal saline and infused intravenously 
over 30 min. The study drug will be administered every other 
week for 24 weeks for a total of 13 doses. No dose modification 
for GR-MD-02 is allowed.  
Phase I data from another trial using GR-MD-02 at the same 
dose as in this protocol has been submitted to the FDA which 
demonstrated no clinically meaningful adverse effects from the 
infusion of this medicine. 
Lean body mass (LBM) will be used for dosing because GR MD 
02 is distributed primarily in the blood compartment. LBM will 
be estimated from height and weight measurements using 
formulas (Janmahasatian, et al. Quantification of lean 
bodyweight. Clin Pharmacokinet 2005; 44: 1051-1065): 
• Males:  LBM = 9270 X TBW / (6680 + 216 X BMI) 
• Females: LBM = 9270 X TBW / (8780 + 244 X BMI) 
Where TBW (total body weight) is in kg and BMI is mass 
(kg)/height (m)2. 
 
Sample Size: 
10 subjects will be enrolled in this exploratory study.  
 
Statistical Methods: 
Formal statistical analysis was not used to evaluate sample size 
in this study.  A positive study will be considered a PASI-75 in ≥ 
5 out of the 10 patients.  
 
Date of Protocol: 
March 14, 2016 


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March 14, 2016 
 
 
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List of Abbreviations 
Abbreviation 
Definition 
AE 
adverse event 
ALT 
alanine aminotransferase 
ANOVA 
analysis of variance 
AP 
alkaline phosphatase 
AST 
aspartate aminotransferase 
AUC0-inf 
area under the concentration-time curve from zero up to an infinite time 
AUC0-t 
area under the concentration-time curve from zero up to a definite time 
BMI 
body mass index 
BUN 
blood urea nitrogen 
CFR 
Code of Federal Regulations 
CI 
confidence interval 
Cmax 
observed maximum plasma or serum concentration after administration 
CMH 
Cochran-Mantel-Haenszel 
CRF 
case report form 
CV 
curriculum vitae 
ECG 
Electrocardiogram 
eCRF 
electronic case report form 
FAS 
full-analysis set 
FDA 
Food and Drug Administration 
GCP 
Good Clinical Practice 
GERD 
gastroesophageal reflux disease 
GGT 
gamma-glutamyltransferase 
GI 
Gastrointestinal 
HBsAg 
hepatitis B surface antigen 
Hct 
Hematocrit 
Hgb 
Hemoglobin 
HIV 
human immunodeficiency virus 
ICF 
informed consent form 
ICH 
International Conference on Harmonisation 
IEC 
independent ethics committee 
IND 
investigational new drug 
IRB 
institutional review board 
ITT 
intent to treat 


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March 14, 2016 
 
 
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Abbreviation 
Definition 
IVRS 
interactive voice response system 
LDH 
lactate dehydrogenase 
LLN 
lower limit of normal 
LOCF 
last observation carried forward 
MedDRA 
Medical Dictionary for Regulatory Activities 
NDA 
new drug application 
NSAID 
nonsteroidal anti-inflammatory drug 
OTC 
PASI 
over-the-counter 
Psoriasis Activity and Severity Index 
PD 
Pharmacodynamic 
PK 
Pharmacokinetic 
PP 
per protocol 
PPS 
per-protocol set 
PSA 
prostate-specific antigen 
RBC 
red blood cell 
SAE 
serious adverse event 
TDD 
total daily dose 
TEAE 
treatment-emergent adverse event 
Tmax 
time to reach the observed maximum (peak) concentration 
ULN 
upper limit of normal 
VAS 
visual analogue scale 
WBC 
white blood cell 


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1 
Introduction 
This clinical trial includes subjects with moderate to advanced plaque psoriasis. The reason 
for this focus is an observed clinical effect on psoriasis found in a phase 1 clinical trial for 
another indication, as will be described below.   
GR-MD-02 is a complex carbohydrate drug that is delivered by intravenous infusion, which 
binds to galectin molecules, predominantly galectin-3, and inhibits their function. Galectin-3 
is a galactose binding protein that has functions in the regulation of both adaptive and innate 
immunity as well as in tissue repair/fibrosis, and angiogenesis (1). In experimental models, 
galectin-3, as well as other galectin proteins, appear to have roles in a number of 
inflammatory, fibrotic, and neoplastic diseases. Experiments performed in animal models has 
shown that GR-MD-02 is able to reduce the inflammation in steatohepatitis (2) and to reduce 
and reverse liver fibrosis in both steatohepatitis and in a toxic model of liver fibrosis (3).   
As a result of these preclinical findings in steatohepatitis and liver fibrosis, a Phase 1 clinical 
trial was conducted to characterize the safety, tolerability and dose-limiting toxicities (DLTs) 
for GR-MD-02 when administered intravenously to subjects with biopsy-proven NASH and 
advanced liver fibrosis. This trial was designed as an ascending dose cohort study which 
showed that doses of GR-MD-02 of 2 mg/kg, 4 mg/kg, and 8 mg/kg lean body weight given 
as single and multiple infusions (four total) over 6 weeks was safe and well tolerated. Results 
and pharmacokinetics are described in the Investigator brochure.   
Thirty (30) patients total, 20 receiving active drug and 10 receiving placebo, completed the 
Phase 1 clinical trial.  Of these patients, 4 were found to have a previous diagnosis of 
psoriasis and all four of these were in the active group as shown in the table below.  
Subject # 
Randomization # 
GR-MD-02 dose 
Psoriasis 
Onset of Pso 
1152-005 
201 
4 mg/kg 
Yes 
2010 
1143-001 
108 
2 mg/kg 
Yes 
2010 
1143-003 
205 
4 mg/kg 
Yes 
1991 
1151-006 
203 
4 mg/kg 
Yes 
2014 
 
Subject #1152-005 was found by the Principle Investigator to have a marked improvement in 
her psoriasis and she was further questioned about her response by the Principal Investigator 
of this proposed study, Dr. Simon Ritchie, a board-certified dermatologist.  The subject was a 
46 year old woman who reported 4-6 years of psoriasis that affected the front and back of 


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Page 18 
both arms, completely involving her elbows. She described that her elbows looked like 
“elephant knees” with thick, grey and scaling skin.  In addition, she reported raised, “angry 
looking”, erythematous skin associated with pain and pruritus. The rough skin caught on her 
clothes and she only wore long sleeves because of embarrassment. From the time of its first 
appearance, the psoriasis severity waxed and waned but was always present. The only 
therapy she used was topical steroid preparations. During the Phase 1 clinical trial, she began 
to see improvements after the third infusion, and following the fourth infusion she reported 
that her psoriasis was “completely gone” and her skin was “normal”.  Her skin remained 
normal 11 months after the final infusion of study drug. She is convinced that the 
improvement in her psoriasis is related to study drug.   
After hearing about this incident case, information was gathered on the other three patients in 
the trial with psoriasis.  Patient #1143-001 had a history of relatively mild psoriasis with 
infrequent flares that was well-controlled with a clobetasol topical preparation. She notes that 
there was probably was some improvement after receiving study drug because she has now 
no longer requires the steroid preparation.  Subject 1143-003 had moderate to severe 
psoriasis and had no improvement on study drug, but represents a complicated case.  
Immediately prior to being enrolled in the Phase 1 study, Stelara (a biologic for psoriasis) had 
been discontinued and he had a flare of his psoriasis. Subject #1152-005 did not have a 
definitive diagnosis of psoriasis and his only symptom was dandruff which was not changed 
by therapy. 
These serendipitous findings in a subject with psoriasis in the Phase 1 clinical trial led to this 
proposed exploratory phase 2 trial. Psoriasis is a common, chronic, relapsing/remitting, 
immune-mediated skin disease characterized by red, scaly patches, papules, and plaques, 
which usually itch. The disease affects 2–4% of the general population and may vary in 
severity from minor localized patches to complete body coverage. There are multiple 
therapies available for psoriasis including topical corticosteroid preparations, phototherapy, 
non-biological systemic treatments (methotrexate, cyclosporine, and retinoids), and biologics 
that interrupt the immune process involved in psoriasis, but are also associated with a small 
increase in the risk for infection. In addition to the currently marketed biologics (etanercept, 
adalimumab, infliximab, and ustekinumab), there are novel products in development such as 
Eli Lilly's ixekizumab, Amgen's brodalumab, Novartis’ secukinumab, Merck's MK-3222, 
Pfizer's Xeljanz (tofacitinib), Celgene's apremilast, and Biocon's Alzumab (itolizumab).  
While dermatologists agree that the current biologics have revolutionized the psoriasis 
landscape, there is a need for therapies that can provide long-lasting effects, without side 
effects or an increased risk of comorbidities. It is in this regard that we wish to explore the 


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Page 19 
use of GR-MD-02. This anti-galectin agent could add to the therapeutic armamentarium if 
the following conditions are met: 1) Efficacy as good or better at improving disease as 
current biologics; 2) Potential for remission of disease would be desirable since other 
biologicals do not induce long term remission; 3) Minimal adverse effects including 
infection; and 4) Lower cost than current biologicals. 
In addition to the observation of improvement in a patient in the Phase 1 clinical trial, there 
are other biological reasons why GR-MD-02 might be effective in psoriasis.  A number of 
galectin proteins are expressed in skin and are involved in cutaneous immunity and a number 
of skin disorders including atopic dermatitis, contact dermatitis, and psoriasis (4). While it 
appears there may be different, and sometimes opposite effects, of various galectin proteins, 
galectin-3 is markedly up-regulated in the capillary epithelia of psoriatic dermis (4, 5). This 
finding has led to the suggestion that galectin-3 may be involved in capillary changes in the 
psoriatic dermis and inflammatory cell recruitment (5).  
What about testing in animal models of psoriasis? While animal models may provide some 
insight into various mechanisms of cutaneous inflammation, no models appear to recapitulate 
the complex nature of the human disease state (6).  Therefore, because of the scientific data 
that suggests galectin-3 may have a role in psoriasis, the anti-inflammatory effect of GR-
MD-02 in other pre-clinical models, and the marked effect in one patient in the Phase 1 trial, 
we feel that it is most relevant to perform a small, open label exploratory study in subjects 
with moderate to severe plaque psoriasis.   
GR-MD-02 (galactoarabino-rhamnogalacturonate) represents a new class of drug that acts 
through binding to galectin proteins.  GR-MD-02 is a complex carbohydrate molecule 
derived from a natural plant compound which has an average molecular weight of 54.8 KDa. 
Galectin-3 protein binds to terminal galactose residues on glycoproteins, thereby acting to 
modulate the function of those glycoproteins in various cellular processes including 
signaling, cell-cell interactions, and cell-matrix interactions. Single and multiple dose 
toxicology studies for up to 3 months in rats and monkeys and the safety results of the Phase 
1 clinical trial (GT-020) do not predict significant clinical adverse events, as summarized in 
the Investigator Brochure. There are no known adverse class effects of galectin inhibitors. 
The route of administration is intravenous infusion and the dose chosen is the top dose from 
Phase 1 clinical trial given once every other week over three months for a total of 7 doses.   


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2 
Study Objectives 
2.1 
Primary Objective(s) 
The primary objective of this study is to evaluate the number of patients with moderate to 
severe plaque psoriasis who have 75% improvement in Psoriasis Activity Severity Index 
(PASI-75) following the first 12 weeks of therapy with GR-MD-02. 
2.2 
Secondary Objective(s) 
The secondary objectives of this study are: 
• To determine the PASI-50 and PASI-100 scores in patients with moderate to severe 
plaque psoriasis following the first 12 weeks of therapy with GR-MD-02 
• To determine the PASI-50, PASI-75, and PASI-100 scores in patients with moderate 
to severe plaque psoriasis following an additional 12 weeks of therapy (total 24 
weeks) with GR-MD-02 
• To determine the durability of response to therapy in responders over a six-month 
period following the end of therapy 
• To determine the incidence of adverse events and vital sign and laboratory 
abnormalities during study treatment 
 


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3 
Investigational Plan 
3.1 
Study Design 
Study GT-030 is a phase 2a, single center, single group, non-controlled, non-blinded, open 
label study of subjects with moderate to severe plaque psoriasis. Below is a graphical 
representation of the study design. All subjects are required to have signed Institutional 
Review Board (IRB) or Ethics Committee (EC)-approved informed consent prior to 
undergoing any study specific procedures. 
 
 
After screening of the subject by the principal investigator for inclusion and exclusion 
criteria, the patient will have a skin punch biopsy to confirm the diagnosis of plaque 
psoriasis, unless one has been done previously. Ten (10) subjects who have a PASI (Psoriasis 
Activity and Severity Index) of ≥ 12 or at least 10% of skin affected will be enrolled in the 
trial.   
Subjects will be administered GR-MD-02 intravenously in a dose of 8 mg/kg lean body 
weight every other week over 6 months for a total of 13 doses.  During the treatment phase of 
the trial, all subjects in the study will attend study visits according to a schedule of visits for 
study administration and monitoring (see Section 6.1). Study assessments performed prior to 
each drug infusion will include vital signs, limited physical examination, and assessment of 
adverse events and concomitant medications.  Additionally, body weight will be assessed at 
the first infusion, an ECG will be performed at the third infusion, clinical laboratory tests and 
urinalysis will be performed at the fourth, seventh, and tenth infusions, and a urine pregnancy 
test will be performed monthly. Patients will be called one week following each infusion to 
assess for adverse events.  


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Prior to the first infusion (at baseline), before the 4th, 7th, and 10th infusions, before the final 
infusion, and 30 days following the final infusion, PASI will be evaluated in the patient and 
full body integument photos will be taken by the Principal Investigator or his co-investigator.  
All subjects are to attend a final study visit 30 days after the last dose (or at the time of early 
discontinuation) to evaluate safety. During this visit, in addition to PASI and integument 
photography, a final complete physical exam, ECG, clinical laboratory tests, urinalysis, and 
urine pregnancy test will be performed, vital signs and weight will be measured, and adverse 
events, if applicable, evaluated. Subjects will have follow up visits 9 and 12 months after 
their initial infusion to evaluate disease activity and PASI.   
3.1.1 Rationale of Study Design  
The overall objective of this exploratory Phase 2 study is to establish the safety and efficacy 
of GR-MD-02 in subjects with moderate to severe plaque psoriasis. The design is a 
straightforward, exploratory phase 2a study to evaluate drug effect in an open-label design.  
The rationale for this objective is the observation that a subject who received GR-MD-02 at a 
dose of 4 mg/kg for four doses over a 6-week period in a Phase 1 clinical trial in patients 
with NASH with advanced fibrosis, reported a complete response of her plaque psoriasis that 
was durable for at least 11 months. The design is appropriate to determine whether to 
progress this treatment to a larger, dose ranging phase 2 clinical trial. 


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4 
Subject Selection and Withdrawal Criteria 
4.1 
Selection of Study Population 
Approximately 10 subjects will be enrolled at 1 site in the United States, Brooke Army 
Medical Center, Fort Sam Houston, TX. Subjects will be assigned to study treatment only if 
they meet all of the inclusion criteria and none of the exclusion criteria. 
Deviations from the inclusion and exclusion criteria are not allowed because they can 
potentially jeopardize the scientific integrity of the study, regulatory acceptability, or subject 
safety. Therefore, adherence to the criteria as specified in the protocol is essential. 
4.1.1 Inclusion Criteria 
Each subject must meet all of the following criteria to be enrolled in this study: 
1. Is capable of understanding the written informed consent, provides signed and 
witnessed written informed consent, and agrees to comply with protocol requirements. 
2. Is between the ages of 18 and 75 years. 
3. Has biopsy proven psoriasis and active moderate to severe plaque psoriasis with a 
PASI of ≥ 12 and at least 10% of involved body surface area.   
4. The patient is not pregnant and must have a negative pregnancy test prior to start of 
the study. Post-menopausal women must have been amenorrheic for at least 12 months 
to be considered of non-child-bearing potential.  
5. Sexually active men or women of childbearing potential must agree to use effective 
means of contraception throughout their participation in this study and for 90 days 
after discontinuation of study medication. 
6. Lactating females must agree to discontinue nursing before the start of study treatment 
and refrain from nursing until 90 days after discontinuation of study medication. 
7. Male subjects must refrain from sperm donation throughout the study period and for a 
period of 90 days following the last dose of study drug. 
4.1.2 
Exclusion Criteria 
Subjects meeting any of the following criteria will be excluded from the study: 


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1. Any medical illness that is not stable on therapy 
2. Use of any biologic medication for psoriasis within 6 months  
3. Use of non-biological systemic therapy to include: methotrexate, oral retinoids, 
phototherapy/PUVA, cyclosporine, or any other cytotoxic or immunosuppressive 
medication within 4 weeks of start of study 
4. Topical treatment that is likely to impact signs and symptoms of psoriasis, in the 
opinion of the Principal Investigator, within 2 weeks of the start of study 
5. Prior exposure to GR-MD-02 
6. Known positivity for Human Immunodeficiency Virus (HIV) infection  
7. Any patient who had major surgery within 8 weeks of Day 1, significant traumatic 
injury, or anticipation of need for major surgical procedure during the study. 
8. Has a history of alcohol/drug abuse. 
9. Any patient who has clinically significant and uncontrolled cardiovascular disease 
(e.g., uncontrolled hypertension, myocardial infarction, unstable angina), New York 
Heart Association (NYHA) Grade II or greater congestive heart failure, serious cardiac 
arrhythmia requiring medication, or Grade II or greater peripheral vascular disease 
within 12 months prior to Day 1. 
10. Any patient with concurrent infection including diagnoses of fever of unknown origin 
(FUO) (subjects must be afebrile at the start of therapy). 
11. History of  malignant disease with a recurrence of that disease within 5 years of 
follow-up except for those that have been curatively treated including basal or 
squamous cell carcinoma of the skin and in situ carcinoma of the cervix 
12. Participation in an investigational new drug (IND) trial in the 30 days before 
randomization.  
13. Clinically significant medical or psychiatric condition considered a high risk for 
participation in an investigational study. 
14. Has donated or lost a significant volume (>450 mL) of blood or plasma within 30 days 
of the study. 
15. Failure to give informed consent 
16. Subjects with known allergies to the study drug or any of its excipients.  


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17. Is an employee or family member of the investigator or study site personnel. 
4.2 
Withdrawal of Subjects From the Study 
The duration of the study is defined for each subject as the date signed written informed 
consent is provided through the last follow-up visit at 12 months from their initial infusion.  
4.2.1 Reasons for Withdrawal/Discontinuation 
Subjects may withdraw from the study at any time and for any reason without prejudice to 
their future medical care by the investigator or at the study site. Every effort should be made 
to keep subjects in the study. The reasons for subjects not completing the study will be 
recorded. A subject may be withdrawn from the study for any of the following reasons: 
1. Does not meet the protocol inclusion or exclusion criteria. 
2. Noncompliance with the protocol. 
3. A serious or intolerable adverse event(s) (AE[s]) that in the investigator’s opinion 
requires withdrawal from the study.  
4. Laboratory safety assessments that reveal clinically significant hematological or 
biochemical changes from the baseline values. 
5. Symptoms or an intercurrent illness not consistent with the protocol requirements or 
that justifies withdrawal. 
6. Lost to follow-up. 
7. Other (e.g., pregnancy, development of contraindications of use of study drug). 
8. The subject withdraws consent or the investigator or sponsor decide to discontinue the 
subject’s participation in the study. 
The investigator will also withdraw a subject if Galectin Therapeutics terminates the study by 
withdrawal of study drug. Upon occurrence of a serious or intolerable AE, the investigator 
will confer with Galectin Therapeutics. If a subject is discontinued because of an AE, the 
event will be followed until it is resolved. Any subject may withdraw his or her consent at 
any time. 


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4.2.2 Handling of Withdrawals 
Subjects are free to withdraw from the study or study treatment at any time upon request. 
Subject participation in the study may be stopped at any time at the discretion of the 
investigator or at the request of the sponsor. 
Subjects who discontinue study treatment or active participation in the study will no longer 
receive study drug. When a subject withdraws from the study, the reason(s) for withdrawal 
shall be recorded by the investigator on the relevant page of the case report form (CRF). 
Whenever possible, all subjects who discontinue study treatment or withdraw from the study 
prematurely will undergo all end-of-study assessments. Subjects who fail to return for final 
assessments will be contacted by the site in an attempt to have them comply with the 
protocol. This contact will consist of 2 documented phone calls followed by 1 registered 
letter. 
It is vital to obtain follow-up data on any subject withdrawn because of an AE or serious AE 
(SAE). In every case, efforts must be made to undertake protocol-specified, safety, follow-up 
procedures. 
4.2.3 Replacements 
If subjects discontinue the study before completion of the 24 week treatment phase, they may 
be replaced by new subjects. 


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5 
Study Treatments 
5.1 
Method of Assigning Subjects to Treatment Groups 
This is a single-group, unblended, open-label study. 
5.2 
Treatments Administered 
GR-MD-02 for Injection is supplied in a sterile aqueous solution of phosphate buffered saline 
at a concentration of 30 mg/ml GR-MD-02 and should be diluted to the target dose in normal 
saline and administered intravenously over a period of 60 minutes. The product is expected to 
be stable at pH 4.0 to pH 7.5.  
Phase I data from another trial using GR-MD-02 at the same dose as in this protocol has been 
submitted to the FDA which demonstrated no clinically meaningful adverse effects from the 
infusion of this medicine. 
GR-MD-02 solution will be supplied in 10 mL vials with the following composition to the 
clinical study site (Table 1). 
Table 1 
Composition of GR-MD-02 Concentrate 
Ingredient 
Concentration 
GR-MD-02 
300 mg 
USP Sodium Chloride 
82 mg 
USP Disodium Phosphate Heptahydrate 
14.4 mg 
USP Monosodium Phosphate Monohydrate 
2.4 mg 
USP Sterile Water for Injection 
to 10 mL 
 
The 10 mL vials of GR-MD-02 for Injection (30 mg/mL) are to be stored under refrigerated 
conditions at 2°C to 8°C until preparation of the drug infusion solution. To prepare the final 
infusion solution for administration, the GR-MD-02 can be diluted in sterile normal saline as 
required to achieve the target dose. Instructions on dosing preparation are provided in the 
pharmacy manual. 
Once the infusion solutions are prepared, they may be stored at controlled room temperature 
and should be administered within 24 hours of preparation. Infusions should be administered 


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intravenously over a period of 60 minutes. Frequency of administration should be once every 
2 weeks (bi-weekly). 
  
5.3 
Identity of Investigational Product 
GR-MD-02 (galactoarabino-rhamnogalaturonate) is a soluble and physiologically compatible 
polysaccharide composed of alternating α-(1,2)-L-rhamnosyl-α-(1,4)-D-galacturonosyl 
backbone with side branches composed of mainly galactose and arabinose oligosaccharides. 
GR-MD-02 will be administered as an intravenous (IV) infusion through a peripheral vein 
over a period of 60 minutes.  
GR-MD-02 solution for injection is a clear, light yellow-tan solution, and will be supplied in 
10 mL sterile vials at a concentration of 30 mg/mL of phosphate buffered saline.  
Detailed instructions for the preparation and administration of the GR-MD-02 by slow IV 
drip over a period of 60 minutes will be provided in the Pharmacy Manual. The pharmacist 
will be unblinded to treatment assignment and will prepare the GR-MD-02.  
Lean body mass (LBM) will be used for dosing because it is anticipated that many subjects 
will be obese and GR-MD-02 is distributed primarily in the blood compartment. Lean body 
mass will be estimated from height and weight measurements using formulas that have been 
well-validated in obese individuals: 
• 
Males:  LBM = 9270 X TBW (total body weight) / (6680 + 216 X BMI) 
• 
Females:  LBM = 9270 X TBW / (8780 + 244 X BMI) 
Where TBW is in kg and BMI is mass (kg)/height (m)2. Tables of LBM values for a range of 
heights and weights will be provided to the pharmacies participating in the study as a check 
on calculations. 
5.4 
Management of Clinical Supplies 
5.4.1 Study Drug Packaging and Storage 
Galectin Therapeutics Inc. will provide IMP to the sites. The following drug supplies will be 
used in the study: 
• 
GR-MD-02, supplied as 10 mL sterile vials 


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GR-MD-02 for Injection (30 mg/mL) in 10 mL vials are manufactured by Catalent Pharma 
Solutions, Woodstock, Illinois, and packaged and labeled for the clinical study by Catalent 
Pharma Solutions, Philadelphia, Pennsylvania. 
The GR-MD-02 for Injection (30 mg/mL) vials are to be stored under refrigerated conditions 
at 2°C to 8°C until preparation of the drug infusion solution. To prepare the final infusion 
solution for administration, the GR-MD-02 can be diluted in sterile normal saline as required 
to achieve the target dose. Instructions on dosing preparation are provided in the pharmacy 
manual.  
Once the infusion solutions are prepared, they may be stored at controlled room temperature 
and should be administered within 24 hours of preparation. Infusions should be administered 
intravenously over a period of 60 minutes. Frequency of administration should be once every 
2 weeks (bi-weekly). 
All medication provided to the study site will be prepared, packaged, and labeled by the 
Sponsor according to Standard Operating Procedures (SOPs), Good Manufacturing Practice 
guidelines, International Conference on Harmonization Good Clinical Practice guidelines 
(ICH GCP), and applicable local laws/regulations.  
5.4.2 Test Article Accountability 
The investigator will maintain accurate records of receipt of all test articles, including dates 
of receipt. In addition, accurate records will be kept regarding when and how much test 
article is dispensed and used by each subject in the study. Reasons for departure from the 
expected dispensing regimen must also be recorded. At the completion of the study, to satisfy 
regulatory requirements regarding drug accountability, all study drug will be reconciled and 
retained or destroyed according to applicable regulations. 
Current ICH GCP Guidelines require the Investigator to ensure that study drug deliveries 
from the Sponsor are received by a responsible person (e.g., pharmacist), and: 
• That such deliveries are recorded. 
• That study drug is handled and stored safely and properly. 
• That study drug is only dispensed to study subjects in accordance with the protocol. 
• That any unused, including expired, study drug is returned to the Sponsor or designee. 


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Drug inventory and accountability records for the study drugs will be kept by the 
Investigator/ pharmacist. Study drug accountability throughout the study must be 
documented. The following guidelines are therefore pertinent: 
The Investigator agrees not to supply study drugs to any persons except the subjects in this 
study. 
The Investigator/pharmacist will keep the study drugs in a pharmacy or other locked and 
secure storage facility under controlled storage conditions, accessible only to those 
authorized by the Investigator to dispense these test drugs. 
A study drug inventory will be maintained by the Investigator/pharmacist. The inventory will 
include details of material received and a clear record of when they were dispensed and to 
which subject. At the conclusion or termination of this study, the Investigator/pharmacist 
agrees to conduct a final drug supply inventory and to record the results of this inventory on 
the Drug Accountability Record. It must be possible to reconcile delivery records with those 
of used and returned study drug. Any discrepancies must be accounted for. Appropriate 
forms of deliveries and returns must be signed by the person responsible. 
Used and unused study drug must be returned to the Sponsor designated drug destruction 
facility after drug accountability has been conducted by the Sponsor or representative. With 
prior approval from the Sponsor and only if required by site operating procedures, used study 
may be destroyed at the study center according to standard institutional procedures after drug 
accountability has been conducted by the Sponsor or representative. A copy of the standard 
institutional procedure for destroying investigational drugs will be provided to the Sponsor or 
designee upon request. Unused study drug must be returned to the Sponsor or designee at the 
end of the study or upon expiration. 
5.4.3 Other Supplies 
Intravenous tubing with a filter will be supplied to the site for drug administration.  
5.5 
Overdose Management 
There are no known or expected overdose signs or symptoms associated with GR-MD-02. An 
overdose is any dose of study treatment given to a subject or taken by a subject that exceeds 
the dose described in the protocol. Any overdose, with or without associated AEs, must be 
promptly reported to Galectin Therapeutics Inc. Chief Medical Officer. Overdoses without 


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signs or symptoms do not need to be recorded as AEs; in case of any AEs associated with the 
overdose, these should be reported on relevant CRF. 
5.5.1 Treatment of Overdose 
There are no specific treatments for overdose. Patient should have a plasma sample drawn for 
drug levels and observed for 24 hours.   
5.5.2 Medication Errors 
If there is a medication error in route of administration, such as oral, there are no medical 
consequences.  This should be reported to Galectin Therapeutics Inc.  
5.5.3 Treatment of Medication Errors 
No specific treatments are indicated. 
5.6 
Misuse for Illegal Purposes 
There are no CNS effects of GR-MD-02 and no abuse potential.  
5.7 
Treatment Compliance 
Subject compliance will be determined by observation of drug infusion in clinic. 
5.8 
Prior and Concomitant Therapy  
Use of all concomitant medications will be recorded in the subject’s CRF. The minimum 
requirement is that drug name and the dates of administration are to be recorded. This will 
include all prescription drugs, herbal products, vitamins, minerals, and OTC medications. 
Any changes in concomitant medications also will be recorded in the subject’s CRF. 
Any concomitant medication deemed necessary for the welfare of the subject during the 
study may be given at the discretion of the investigator. However, it is the responsibility of 
the investigator to ensure that details regarding the medication are recorded in full in the 
CRF. 


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5.8.1 Prohibited Concomitant Medication (Drugs 
and Therapies) 
Topical treatments likely to impact signs and symptoms of psoriasis or biological or non-
biological systemic therapy including acitretin, methotrexate, cyclosporine, phototherapy, or 
any other cytotoxic or immunosuppressive medication.  
 


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6 
Study Assessments and Procedures 
Before performing any study procedures, all potential subjects will sign an informed consent 
form (ICF). Subjects will have the opportunity to have any questions answered before 
signing the ICF. The investigator must address all questions raised by the subject. The 
investigator will also sign the ICF. 
6.1 
Schedule of Events  
The overall schedule of events is outlined in Table 6-1, below. 


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Table 6–1  Schedule of Events 
Procedure 
Base 
line 
Day 
1 
Day
14 
Day 
28 
Day
42 
Day 
56 
Day 
70 
Day 
84 
Day 
98 
Day 
112 
Day 
126 
Day 
140 
Day 
154 
Day 
168 
30 day 
Follow-up 
Month 
94 
Month 
124 
Visit Window (days) 
–28 
+1 
±2 
±2 
±2 
±2 
±2 
±2 
±2 
±2 
±2 
±2 
±2 
±2 
±7 
± 7 
± 7 
Informed consent 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Medical history 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
X 
X 
12-lead electrocardiogram 
X 
 
 
X 
 
 
 
 
 
 
 
 
 
 
X 
 
 
Serum pregnancy test 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Skin punch biopsy1 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Urine pregnancy test 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
X 
 
 
Physical examination2 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
 
Vital sign measurements 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
 
Clinical laboratory tests3 
X 
 
 
 
X 
 
 
X 
 
 
X 
 
 
 
X 
 
 
Urinalysis 
X 
 
 
 
X 
 
 
X 
 
 
X 
 
 
 
X 
 
 
Drug administration 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
 
 
PASI 
X 
 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
X 
X 
X 
Integument Photography 
X 
 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
X 
X 
X 
Monitor AEs & Con Meds  
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
 
Call patient for AE check 
one week after infusion 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
 
 
Abbreviations: PASI (psoriasis activity and severity index); AE (Adverse Event); Con Med (Concomitant Medications); PE (Physical Examination) 
1 Perform skin punch biopsy to confirm the diagnosis of plaque psoriasis, unless one has been done previously. 
2 Complete PE at Baseline, at 1st and last infusion visits, and 30-day follow-up visits; limited PE at each interim infusion visit. 
3 Clinical laboratory tests include chemistry panel, CBC, platelet count, reticulocyte count, prothrombin time and partial thromboplastin time. 
4 Following the first infusion (i.e., Day 1)  
 


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6.2 
Efficacy Assessments 
Efficacy will be primarily assessed using the Psoriasis Area and Severity Index (PASI) as 
described in the table below.  
 
6.3 
Safety [Tolerability] Assessments 
Safety will be determined using evaluation of vital signs and laboratory test as well as 
documenting AEs during the course of the trial.  
6.3.1 Adverse Events 
6.3.1.1 
Definitions of Adverse Events 
The investigator is responsible for reporting all AEs that are observed or reported during the 
study, regardless of their relationship to study drug or their clinical significance. 
An AE is defined as any untoward medical occurrence in a subject enrolled into this study 
regardless of its causal relationship to study drug. Subjects will be instructed to contact the 
investigator at any time after randomization if any symptoms develop. 


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A treatment-emergent AE (TEAE) is defined as any event not present before exposure to 
study drug or any event already present that worsens in either intensity or frequency after 
exposure to study drug. 
An SAE is defined as any event that results in death, is immediately life threatening, requires 
inpatient hospitalization or prolongation of existing hospitalization, results in persistent or 
significant disability/incapacity, or is a congenital anomaly/birth defect. Important medical 
events that may not result in death, be life threatening, or require hospitalization may be 
considered SAEs when, based upon appropriate medical judgment, they may jeopardize the 
subject or may require medical or surgical intervention to prevent one of the outcomes listed 
in this definition. Examples of such medical events include allergic bronchospasm requiring 
intensive treatment in an emergency room or at home, blood dyscrasias or convulsions that 
do not result in inpatient hospitalization, or the development of drug dependency or drug 
abuse. 
6.3.1.2 
Eliciting and Documenting Adverse Events 
Adverse events will be assessed beginning at enrollment (date of signed informed consent) 
and up to 30 days after the last dose of study drug. 
Serious AEs that occur more than 30 days after the last dose of study drug need not be 
reported unless the investigator considers them related to study drug. 
At every study visit, subjects will be asked a standard nonleading question to elicit any 
medically related changes in their well-being. They will also be asked if they have been 
hospitalized, had any accidents, used any new medications, or changed concomitant 
medication regimens (both prescription and OTC medications). 
In addition to subject observations, AEs will be documented from any data collected on the 
AE page of the eCRF (e.g., laboratory values, physical examination findings, 
electrocardiogram [ECG] changes) or identified from review of other documents (e.g., 
subject diaries) that are relevant to subject safety. 
6.3.1.3 
Reporting Adverse Events 
All AEs reported or observed during the study will be recorded on the AE page of the CRF. 
Information to be collected includes drug treatment, dose, event term, time of onset, 
investigator-specified assessment of severity and relationship to study drug, time of 
resolution of the event, seriousness, any required treatment or evaluations, and outcome. 


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Adverse events resulting from concurrent illnesses, reactions to concurrent illnesses, 
reactions to concurrent medications, or progression of disease states must also be reported. 
All AEs will be followed to adequate resolution. The Medical Dictionary for Regulatory 
Activities (MedDRA) will be used to code all AEs.  
Any medical condition that is present at the time that the subject is screened but does not 
deteriorate should not be reported as an AE. However, if it deteriorates at any time during the 
study, it should be recorded as an AE. 
Any AE that meets SAE criteria (Section 6.3.1.1) must be reported to Galectin Therapeutics 
Inc. immediately (i.e., within 24 hours) after the time site personnel first learn about the 
event. The following contact information is to be used for SAE reporting: 
 
Office of the Chief Medical Officer, Dr. Peter G. Traber 
Galectin Therapeutics Inc., 4960 Peachtree Industrial Blvd, Suite 240, Norcross, 
GA 30071 
 
SAE Hotline: 713 540-9776 
 
SAE Fax line: 770 864-1327 
6.3.1.4 
Assessment of Severity 
The severity, or intensity, of an AE refers to the extent to which an AE affects the subject’s 
daily activities. The intensity of the AE will be rated as mild, moderate, or severe using the 
following criteria: 
Mild: 
These events require minimal or no treatment and do not interfere with the 
subject’s daily activities. 
 
Moderate: 
These events result in a low level of inconvenience or concern with the 
therapeutic measures. Moderate events may cause some interference with 
normal functioning. 
 
Severe: 
These events interrupt a subject’s usual daily activity and may require systemic 
drug therapy or other treatment. Severe events are usually incapacitating. 
 
Changes in the severity of an AE should be documented to allow an assessment of the 
duration of the event at each level of intensity to be performed. Adverse events characterized 
as intermittent do not require documentation of onset and duration of each episode. 


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6.3.1.5 
Assessment of Causality 
The investigator’s assessment of an AE’s relationship to study drug is part of the 
documentation process, but it is not a factor in determining what is or is not reported in the 
study. If there is any doubt as to whether a clinical observation is an AE, the event should be 
reported. 
The relationship or association of the test article in causing or contributing to the AE will be 
characterized using the following classification and criteria: 
Unrelated: 
This relationship suggests that there is no association between the study drug 
and the reported event. 
 
Possible: 
This relationship suggests that treatment with the study drug caused or 
contributed to the AE, i.e., the event follows a reasonable temporal sequence 
from the time of drug administration or follows a known response pattern to the 
study drug, but could also have been produced by other factors. 
 
Probable: 
This relationship suggests that a reasonable temporal sequence of the event 
with drug administration exists and, based upon the known pharmacological 
action of the drug, known or previously reported adverse reactions to the drug 
or class of drugs, or judgment based on the investigator’s clinical experience, 
the association of the event with the study drug seems likely. The event 
disappears or decreases on cessation or reduction of the dose of study drug. 
 
Definite: 
This relationship suggests that a definite causal relationship exists between drug 
administration and the AE, and other conditions (concurrent illness, 
progression/expression of disease state, or concurrent medication reaction) do 
not appear to explain the event. The event reappears or worsens if the study 
drug is re-administered. 
 
6.3.1.6 
Follow-Up of Subjects Reporting Adverse Events 
All AEs must be reported in detail on the appropriate page of the CRF and followed to 
satisfactory resolution, until the investigator deems the event to be chronic or not clinically 
significant, or until the subject is considered to be stable. 
6.4 
Pregnancy 
Pregnancy is not regarded as an AE unless there is a suspicion that an investigational product 
may have interfered with the effectiveness of a contraceptive medication. Any pregnancy that 


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occurs during study participation must be reported. To ensure subject safety, each pregnancy 
must be reported to Galectin Therapeutics Inc. within 2 weeks of learning of its occurrence. 
The pregnancy must be followed-up to determine outcome (including spontaneous 
miscarriage, elective termination, normal birth, or congenital abnormality) and status of 
mother and child, even if the subject was discontinued from the study. Pregnancy 
complications and elective terminations for medical reasons must be reported as an AE or 
SAE. Spontaneous miscarriages must be reported as an SAE. 
Any SAE occurring in association with a pregnancy, brought to the investigator’s attention 
after the subject has completed the study, and considered by the investigator as possibly 
related to the study treatment, must be promptly reported to Galectin Therapeutics Inc. 
6.5 
Laboratory Analyses 
Safety laboratory tests will include hematology (CBC with differential, platelet count, and 
reticulocyte count), clinical chemistry panel, coagulation tests (PT and PTT), and urinalysis. 
Any abnormal laboratory test results or other safety assessments (e.g., vital sign 
measurements), including those that worsen from baseline, felt to be clinically significant in 
the medical and scientific judgment of the investigator are to be recorded as AEs or SAEs. 
However, any clinically significant safety assessments that are associated with the underlying 
disease, unless judged by the investigator to be more severe than expected for the subject’s 
condition, are not to be reported as AEs or SAEs. 
6.6 
Sample Collections 
Sample collections for safety labs as indicated in table 6-1 will be analyzed at the Brooke 
Army Medical Center under prevailing protocols.   


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7 
Statistical and Analytical Plan 
7.1 
Primary Efficacy Endpoints 
The primary endpoint will be PASI-75, or a 75% improvement from baseline (day 1, prior to 
first infusion) in PASI score as assessed at the day 84 (week 12) visit. 
7.2 
Secondary Efficacy Endpoints 
The secondary endpoints that will be evaluated include:  
• PASI-75, or a 75% improvement from baseline (day 1, prior to first infusion) in PASI 
score as assessed at protocol day 42, day 126, day 168, and 30 day follow up visits. 
• PASI-50, or a 50% improvement from baseline (day 1, prior to first infusion) in PASI 
score as assessed at protocol day 42, day 84, day 126, day 168, and 30 day follow up 
visits. 
• PASI-100, or a 100% improvement from baseline (day 1, prior to first infusion) in 
PASI score as assessed at protocol day 42, day 84, day 126, day 168, and 30 day 
follow up visits. 
• Durability of response as assessed by PASI-50, 75 and 100 at 9 and 12 months from 
initial infusion.  
7.3 
[Other or Exploratory] Efficacy Endpoints 
Principal investigator assessment of psoriatic arthritis, if present. 
7.4 
Sample Size Calculations 
Formal sample size calculations were not done for this exploratory study.  A total of 10 
subjects (male or female) will be enrolled in the study. This number was chosen to determine 
whether ≥ 50% of subjects would achieve the primary endpoint which would make the 
therapy in a similar range as other biological therapies for moderate to severe plaque 
psoriasis.   
7.5 
Analysis Sets 
The following analysis sets will be used in the statistical analyses. 
Full-analysis set (FAS): The FAS will consist of all participants who were assigned to receive 
study drug. The FAS can also be called the intent-to-treat [ITT] set. 
Per-protocol set (PPS): The PPS will consist of all FAS participants who fulfill all 
inclusion/exclusion criteria, have at least 75% compliance with study treatment, have not 


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taken any prohibited medication and have no significant protocol deviations. All analyses 
using the PPS will group participants according to treatment actually received. 
Safety set: The safety set will consist of all participants who received any study drug. All 
analyses using the safety set will group participants according to treatment actually received. 
The PPS set will be used as the primary efficacy analysis set. 
7.6 
Description of Subgroups to be Analyzed 
No subgroup analyses are planned. 
7.7 
Statistical Analysis Methodology 
No formal significance testing will be performed. 
7.7.1 Analysis of Primary Efficacy Endpoint 
The primary efficacy endpoint will be considered reached if ≥ 50% of subjects meet the 
primary endpoint.  
7.7.2 Analysis of Secondary Efficacy Endpoint 
The secondary efficacy endpoints will be considered reached if ≥ 50% of subjects meet the 
secondary endpoint.  
7.7.3 Analyses of [Other or Exploratory] Efficacy 
Endpoint 
No statistical analysis.  
7.7.4 Safety Analyses 
Clinical AEs will be displayed by SOC in the data listings for each subject, with summary 
tabulations by SOC for each treatment group, using MedDRA coding. Absolute laboratory 
values, changes in laboratory values from Baseline, and graded laboratory abnormalities will 
be displayed for each subject and treatment group.  
The proportions of active-dosed subjects experiencing clinical AEs and laboratory 
abnormalities (overall, and of given types) will be tabulated. The group displays and 
comparisons for safety results will utilize descriptive statistics. Vital sign data will be 


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similarly displayed by treatment, using descriptive statistics, and any post-Screen changes in 
physical examination findings will be summarized in tabular form, by subject and by Data 
Quality Assurance. 
Patient compliance will be assured by records of infusion dates and times.   
7.7.5 Data Management 
As part of the responsibilities assumed by participating in the study, the investigator agrees to 
maintain adequate case histories for the subjects treated as part of the research under this 
protocol. The investigator agrees to maintain accurate CRFs and source documentation as 
part of the case histories.  
The study site will supply the CRF. All CRFs should be completed legibly in black ink or 
typed. The CRFs may not be completed in pencil. 
All CRF information is to be filled in. If an item is not available or is not applicable, this fact 
should be indicated. Blank spaces should not be present unless otherwise directed. A 
correction should be made by striking through the incorrect entry with a single line and the 
corrected information should be entered adjacent to the deleted item. The correction must be 
initialed and dated by the person making the correction. 
Each completed CRF must be reviewed, signed, and dated by the investigator in a timely 
manner. The completed CRF will be collected by clinical monitors as soon as practical after 
completion. One copy will remain at the site in the investigator’s files. 


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8 
Ethics 
8.1 
Independent Ethics Committee or Institutional Review Board 
Federal regulations and the International Conference on Harmonisation (ICH) guidelines 
require that approval be obtained from an IRB/IEC before participation of human subjects in 
research studies. Before study onset, the protocol, informed consent, advertisements to be 
used for the recruitment of study subjects, and any other written information regarding this 
study to be provided to the subject or the subject’s legal guardian must be approved by the 
IRB/IEC. Documentation of all IRB/IEC approvals and of the IRB/IEC compliance with ICH 
harmonised tripartite guideline E6(R1): Good Clinical Practice (GCP) will be maintained by 
the site and will be available for review by the sponsor or its designee. 
All IRB/IEC approvals should be signed by the IRB/IEC chairman or designee and must 
identify the IRB/IEC name and address, the clinical protocol by title or protocol number or 
both, and the date approval or a favorable opinion was granted. 
The investigator is responsible for providing written summaries of the progress and status of 
the study at intervals not exceeding 1 year or otherwise specified by the IRB/IEC. The 
investigator must promptly supply the sponsor or its designee, the IRB/IEC, and, where 
applicable, the institution, with written reports on any changes significantly affecting the 
conduct of the study or increasing the risk to subjects. 
8.2 
Ethical Conduct of the Study 
The study will be performed in accordance with the ethical principles that have their origin in 
the Declaration of Helsinki, ICH Good Clinical Practice, and all applicable regulations. 
8.3 
Subject Information and Consent 
A written informed consent in compliance with US Title 21 Code of Federal Regulations 
(CFR) Part 50 shall be obtained from each subject before entering the study or performing 
any unusual or nonroutine procedure that involves risk to the subject. An informed consent 
template may be provided by the sponsor to investigative sites. If any institution-specific 
modifications to study-related procedures are proposed or made by the site, the consent 
should be reviewed by the sponsor or its designee or both before IRB/IEC submission. Once 
reviewed, the consent will be submitted by the investigator to his or her IRB/IEC for review 
and approval before the start of the study. If the ICF is revised during the course of the study, 
all active participating subjects must sign the revised form. 


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Before recruitment and enrollment, each prospective subject or his or her legal guardian will 
be given a full explanation of the study and be allowed to read the approved ICF. Once the 
investigator is assured that the subject/legal guardian understands the implications of 
participating in the study, the subject/legal guardian will be asked to give consent to 
participate in the study by signing the ICF. 
The investigator shall retain the signed original ICF(s) and give a copy of the signed original 
form to the subject or legal guardian. 
The following administrative items are meant to guide the investigator in the conduct of the 
study but may be subject to change based on industry and government standard operating 
procedures, working practice documents, or guidelines. Changes will be reported to the IRB/ 
IEC but will not result in protocol amendments. 


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9 
Investigator’s Obligations 
9.1 
Confidentiality 
All laboratory specimens, evaluation forms, reports, and other records will be identified in a 
manner designed to maintain subject confidentiality. All records will be kept in a secure 
storage area with limited access. Clinical information will not be released without the written 
permission of the subject (or the subject’s legal guardian), except as necessary for monitoring 
and auditing by the sponsor, its designee, the Food and Drug Administration (FDA), or the 
IRB/IEC. 
The investigator and all employees and coworkers involved with this study may not disclose 
or use for any purpose other than performance of the study any data, record, or other 
unpublished, confidential information disclosed to those individuals for the purpose of the 
study. Prior written agreement from the sponsor or its designee must be obtained for the 
disclosure of any said confidential information to other parties. 
9.2 
Financial Disclosure and Obligations 
Investigators are required to provide financial disclosure information to allow the sponsor to 
submit the complete and accurate certification or disclosure statements required under 21 
CFR 54. In addition, the investigator must provide to the sponsor a commitment to promptly 
update this information if any relevant changes occur during the course of the investigation 
and for 1 year following the completion of the study. 
Neither the sponsor nor PPD is financially responsible for further testing or treatment of any 
medical condition that may be detected during the screening process. In addition, in the 
absence of specific arrangements, neither the sponsor nor PPD is financially responsible for 
further treatment of the subject’s disease. 
9.3 
Investigator Documentation 
Prior to beginning the study, the investigator will be asked to comply with ICH E6(R1) 8.2 
and Title 21 of the CFR by providing the following essential documents, including but not 
limited to: 
• 
IRB/IEC approval 
• 
Original investigator-signed investigator agreement page of the protocol 


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• 
Form FDA 1572, fully executed, and all updates on a new fully executed Form 
FDA 1572 
• 
Curriculum vitae (CV) for the investigator and each subinvestigator listed on 
Form FDA 1572 
• 
Financial disclosure information to allow the sponsor to submit complete and 
accurate certification or disclosure statements required under 21 CFR 54. In 
addition, the investigators must provide to the sponsor a commitment to 
promptly update this information if any relevant changes occur during the 
course of the investigation and for 1 year after the completion of the study. 
• 
IRB/IEC-approved informed consent, samples of site advertisements for 
recruitment for this study, and any other written information regarding this 
study that is to be provided to the subject or legal guardian, and 
• 
Laboratory certifications and normal ranges for any local laboratories used by 
the site, in accordance with 42 CFR 493 
9.4 
Study Conduct 
The investigator agrees that the study will be conducted according to the principles of ICH 
E6(R1). The investigator will conduct all aspects of this study in accordance with all 
national, state, and local laws or regulations. Study information from this protocol will be 
posted on publicly available clinical trial registers before enrollment of subjects begins. 
9.5 
Adherence to Protocol 
The investigator agrees to conduct the study as outlined in this protocol in accordance with 
ICH E6(R1) and all applicable guidelines and regulations. 
9.6 
Adverse Events and Study Report Requirements 
By participating in this study the investigator agrees to submit reports of SAEs according to 
the time line and method outlined in the protocol. In addition, the investigator agrees to 
submit annual reports to the study site IRB/IEC as appropriate. 


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9.7 
Investigator’s Final Report 
Upon completion of the study, the investigator, where applicable, should inform the 
institution; the investigator/institution should provide the IRB/IEC with a summary of the 
study’s outcome and the sponsor and regulatory authority(ies) with any reports required. 
9.8 
Records Retention 
Essential documents should be retained until at least 2 years after the last approval of a 
marketing application in an ICH region and until there are no pending or contemplated 
marketing applications in an ICH region or at least 2 years have elapsed since the formal 
discontinuation of clinical development of the investigational product. These documents 
should be retained for a longer period, however, if required by the applicable regulatory 
requirements or by an agreement with the sponsor. It is the responsibility of the sponsor to 
inform the investigator/institution as to when these documents no longer need to be retained. 
9.9 
Publications 
After completion of the study, the data may be considered for reporting at a scientific 
meeting or for publication in a scientific journal. In these cases, the sponsor will be 
responsible for these activities and will work with the Galectin Therapeutics Inc. to 
determine how the manuscript is written and edited, the number and order of authors, the 
publication to which it will be submitted, and other related issues. The sponsor has final 
approval authority over all such issues. 
Data are the property of the sponsor and cannot be published without prior authorization 
from the sponsor, but data and publication thereof will not be unduly withheld. 


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10 Study Management 
10.1 Monitoring 
10.1.1 Monitoring of the Study 
The clinical monitor, as a representative of the sponsor, has the obligation to follow the study 
closely. In doing so, the monitor will visit the investigator and study site at periodic intervals, 
in addition to maintaining necessary telephone and letter contact. The monitor will maintain 
current personal knowledge of the study through observation, review of study records and 
source documentation, and discussion of the conduct of the study with the investigator and 
personnel. 
All aspects of the study will be carefully monitored, by the sponsor or its designee, for 
compliance with applicable government regulation with respect to current GCP and current 
standard operating procedures. 
10.1.2 Inspection of Records 
Investigators and institutions involved in the study will permit study-related monitoring, 
audits, IRB/IEC review, and regulatory inspections by providing direct access to all study 
records. In the event of an audit, the investigator agrees to allow the sponsor, representatives 
of the sponsor, or a regulatory agency (e.g., FDA or other regulatory agency) access to all 
study records. 
The investigator should promptly notify the sponsor and Galectin Therapeutics Inc. of any 
audits scheduled by any regulatory authorities and promptly forward copies of any audit 
reports received to the sponsor. 
10.2 Management of Protocol Amendments and Deviations 
10.2.1 Modification of the Protocol 
Any changes in this research activity, except those necessary to remove an apparent, 
immediate hazard to the subject, must be reviewed and approved by the sponsor and Galectin 
Therapeutics Inc. Amendments to the protocol must be submitted in writing to the 
investigator’s IRB/IEC for approval before subjects can be enrolled into an amended 
protocol. 


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10.2.2 Protocol Deviations 
The investigator or designee must document and explain in the subject’s source 
documentation any deviation from the approved protocol. The investigator may implement a 
deviation from, or a change of, the protocol to eliminate an immediate hazard to study 
subjects without prior IRB/IEC approval. As soon as possible after such an occurrence, the 
implemented deviation or change, the reasons for it, and any proposed protocol amendments 
should be submitted to the IRB/IEC for review and approval, to the sponsor for agreement, 
and to the regulatory authorities, if required. 
A deviation from the protocol is an unintended or unanticipated departure from the 
procedures or processes approved by the sponsor and the IRB/IEC and agreed to by the 
investigator. A significant deviation occurs when there is nonadherence to the protocol by the 
subject or investigator that results in a significant, additional risk to the subject. Significant 
deviations can include nonadherence to inclusion or exclusion criteria, enrollment of the 
subject without prior sponsor approval, or nonadherence to FDA regulations or ICH GCP 
guidelines, and will lead to the subject being withdrawn from the study (Section 4.2). 
Protocol deviations will be documented by the clinical monitor throughout the course of 
monitoring visits. Principal investigators will be notified in writing by the monitor of 
deviations. The IRB/IEC should be notified of all protocol deviations in a timely manner. 
10.3 Study Termination 
Although Dr. Simon Ritchie has every intention of completing the study, Dr. Richie reserves 
the right to discontinue the study at any time for clinical or administrative reasons. 
The end of the study is defined as the date on which the last subject completes the last visit 
(includes follow-up visit). 
10.4 Final Report 
Whether the study is completed or prematurely terminated, the sponsor will ensure that the 
clinical study reports are prepared and provided to the regulatory agency(ies) as required by 
the applicable regulatory requirement(s). The sponsor will also ensure that the clinical study 
reports in marketing applications meet the standards of the ICH harmonised tripartite 
guideline E3: Structure and content of clinical study reports. 
Where required by applicable regulatory requirements, an investigator signatory will be 
identified for the approval of the clinical study report. The investigator will be provided 


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reasonable access to statistical tables, figures, and relevant reports and will have the 
opportunity to review the complete study results. 
Upon completion of the clinical study report, the sponsor will provide the investigator with 
the full summary of the study results. The investigator is encouraged to share the summary 
results with the study subjects, as appropriate. The study results will be posted on publicly 
available clinical trial registers. 


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11 Reference List 
 
1. Yang RY, Rabinovich GA, Liu FT. Galectins: structure, function and therapeutic potential. 
Expert Rev Mol Med 2008;10:e17. 
2. Traber PG, Zomer E. Therapy of experimental NASH and fibrosis with galectin inhibitors. 
PLoS One 2013;8(12):e83481. 
3. Traber PG, Chou H, Zomer E, Hong F, Klyosov A, Fiel MI, et al. Regression of fibrosis 
and reversal of cirrhosis in rats by galectin inhibitors in thioacetamide-induced liver disease. 
PLoS One 2013;8(10):e75361. 
4. Chen HY, Lo C-H, Li C-S, Hsu DK, Liu FT. Galectins and cutaneous immunity. 
Dermatologica Sinica 2012;30:121-127. 
5. Lacina L, Plzakova Z, Smetana K, Jr., Stork J, Kaltner H, Andre S. Glycophenotype of 
psoriatic skin. Folia Biol (Praha) 2006;52(1-2):10-15. 
6. Schon MP. Animal models of psoriasis: a critical appraisal. Exp Dermatol 2008 
Aug;17(8):703-712. 


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12 Protocol Amendments 
This section provides a summary of significant changes implemented via protocol 
amendment to the previous version of the protocol. Minor changes that do not affect the 
material substance or intent of the original protocol, such as correction of 
grammatical/typographical errors, minor wording/editorial revisions, date revisions, format 
changes, etc. are not described in the Description of Changes Table. 
12.1 Amendment 1 
Location of Change 
Description of Change and Rationale (if needed) 
• Cover Page 
Changed Project Manager from Rex Horton to Adam Allgood 
• Protocol Synopsis 
• 4.1.1. Inclusion 
Criteria 
BSA > 5% and PASI >6 increased to BSA > 10% and PASI >12. 
Rationale: FDA recommended that Inclusion Criteria be revised to 
define a moderate to severe population suitable for treatment with a 
systemic investigational agent. 
• Protocol Synopsis 
• 5.2 Treatments 
Administered 
Added the following sentence: “Phase I data from another trial 
using GR-MD-02 at the same dose as in this protocol has been 
submitted to the FDA which demonstrated no clinically meaningful 
adverse effects from the infusion of this medicine.” 
Rationale: IRB requested additional wording to the protocol 
reflecting upon the safety of dosing and justification of 
dosing/schedule. 
• Protocol Synopsis 
• 3.1 Study Design 
• 6.1 Schedule of 
Events 
Added ECG to day 28 visit and 30-day follow-up visit.  
Rationale: FDA requested additional ECGs at early steady state 
(agreed at 1 month) and at the end of the trial. 
• 3.1 Study Design 
• 6.1 Schedule of 
Events 
Added phone call to patient one week following each infusion to 
assess for adverse events.  
Rationale: FDA request. 
• 4.1.2 Exclusion 
Criteria 
• 5.8.1. Prohibited 
Concomitant 
Medication 
Removed exclusion of drugs with a narrow therapeutic window 
metabolized by CYP3A4, including fast acting opioids (alfentanil 
and fentanyl), immunosuppressive drugs (cyclosporine, sirolimus, 
and tacrolimus), some cardiovascular agents (ergotamine, quinidine 
and dihydroergotamine), and select psychotropic agents (pimozide).  
Rationale: Results of GT-029 Drug-Drug Interaction Study 
performed to evaluate CYP3A4 enzyme activity utilizing 


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Location of Change 
Description of Change and Rationale (if needed) 
midazolam confirmed that there were no drug-drug interactions and 
no serious adverse events or drug-related adverse events. As agreed 
with FDA, upon successful completion of this study, the exclusion 
of drugs with a narrow therapeutic index metabolized by CYP3A4 
can be removed from the protocol. 
• 5.8.1. Prohibited 
Concomitant 
Medication 
Added biological or non-biological systemic therapy including 
acitretin, methotrexate, cyclosporine, phototherapy, or any other 
cytotoxic or immunosuppressive medication. 
Rationale: To be consistent with the Exclusion Criteria whereby 
these therapies/medications are excluded within 6 months of the 
start of the study. If taken concomitantly during the study, these 
therapies/medications may also confound the study outcome 
measures. 
• Protocol Synopsis 
• 3.1 Study Design 
• 6.1 Schedule of 
Events 
Added urine pregnancy test to the Day 28, 56, 82, and 30-day 
follow-up visits. 
Rationale: In addition to the baseline serum pregnancy test, FDA 
requested that a pregnancy test be added monthly during treatment. 
• 6.1 Schedule of 
Events 
Revised table (including adding a footnote) to clarify that complete 
Physical Exams will be performed at Baseline, Day 1, Day 82 and 
at 30-day follow-up visits and limited Physical Exams will be 
performed at the other visits. 
• 6.6. Sample 
Collections 
Removed requirement that samples be drawn after an 8 hour fast. 
Rationale: Fasting not required, per Principal Investigator. 
 
 
 
 
 
 
 
 
 


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12.2 Amendment 2 
Location of Change 
Description of Change and Rationale (if needed) 
• 4.1.2 Exclusion 
Criteria 
 
Reduced the washout period for the use of non-biological systemic 
therapy from 6 months to 4 weeks. 
Added exclusion criterion for topical treatment that is likely to 
impact signs and symptoms of psoriasis, in the opinion of the 
Principal Investigator, within 2 weeks of the start of study. 
Added criterion to exclude patients with prior exposure to GR-MD-
02. 
Rationale: Principal Investigator request. 
• 5.8.1 Prohibited 
Concomitant 
Medication 
 
Added topical treatments likely to impact signs and symptoms of 
psoriasis. 
Rationale: To be consistent with the Exclusion Criteria whereby 
these therapies/medications are excluded within 2 weeks of the start 
of the study. If taken concomitantly during the study, these 
therapies/medications may also confound the study outcome 
measures. 
 
12.3 Amendment 3 
Location of Change 
Description of Change and Rationale (if needed) 
• 6.1 Schedule of 
Events 
Removed baseline chest X-ray. 
Rationale: IRB request. 
 


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12.4 Amendment 4 
The purpose of this amendment is to extend the original 12 week treatment period for an 
additional 12 weeks. Open-label results from the first 3 subjects at 6 weeks show an apparent 
pharmacodynamic effect. The rationale for extending the treatment period in this exploratory 
study is to give the study drug more time to maximize its therapeutic effect to better inform 
potential future phase 2 studies, where it will be important to know a priori how long to treat. 
Location of Change 
Description of Change and Rationale (if needed) 
• Protocol Synopsis 
(Objectives) 
• Study Objectives 
(Section 2) 
 
Revised the Primary objective statement to reflect that the primary 
objective will be evaluation of the number of patients who have 
achieved PASI-75 following the first 12 weeks of therapy. 
Revised the first Secondary objective statement to reflect that the 
PASI-50 and PASI-100 scores will be determined following the first 
12 weeks of therapy.  
Added a secondary objective to determine the PASI-50, 75, and 100 
scores following the additional 12 weeks of therapy. 
• Protocol Synopsis 
(Efficacy Assessments) 
• Statistical and 
Analytical Plan 
(Section 7) 
Revised the Primary Efficacy endpoint to reflect that PASI-75 will 
be assessed at the day 84 (week 12) visit. 
Revised the Secondary Objectives to reflect that PASI-50, 75, and 
100 will also be assessed during the additional 12 weeks of therapy, 
i.e., at day 126 and day 168. 
• Protocol Synopsis  
• Study Design 
(Section 3.1) 
Increased study drug administration period from over a 3 month 
period to over a 6 month period, resulting in an increase in total 
doses from 7 to 13. 
Included urinalysis, clinical laboratory, full body integument 
photography, and PASI assessments during the additional 12 weeks 
of therapy, i.e., at the 7th and 10th infusion visits. 
Revised the study design pictorial schematic to reflect the 
additional 12 weeks of therapy. 
• Schedule of Events 
(Section 6.1) 
Revised the Schedule of Events table to reflect the additional 12 
weeks of therapy and associated assessments.