A Phase 2a, Double-blind, Placebo-Controlled Study of RSLV-132 in Subjects With Systemic Lupus Erythematosus (SLE)
Phase: PHASE2
Conditions: Systemic Lupus Erythematosus
Sponsor: Resolve Therapeutics

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RSLV-132 
PROTOCOL 132-03 
 
 
 
A PHASE 2A, DOUBLE-BLIND, PLACEBO-
CONTROLLED STUDY OF RSLV-132 IN SUBJECTS 
WITH SYSTEMIC LUPUS ERYTHEMATOSUS 
 
 
 
RESOLVE THERAPEUTICS, LLC 
454 N. 34TH STREET 
SEATTLE, WASHINGTON 98103 
 

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Protocol Title: 
A Phase 2a, Double-Blind, Placebo-Controlled Study of 
RSLV-132 in Subjects With Systemic Lupus Erythematosus 
Protocol Number: 
132-03 
Investigational Product: 
RSLV-132 
IND Number: 
117593 
Current Version: 
5.0 
Prior Version: 
4.0 
Date of Publication: 
27 April 2017 
Sponsor: 
Resolve Therapeutics, LLC 
454 N. 34th Street 
Seattle, WA, 98103 
(208) 727-7010 (Office Telephone No.) 
(206) 545-2897 (Office Facsimile No.) 
 
Sponsor Contact: 
James Posada, PhD 
454 N. 34th Street 
Seattle, WA, 98103 
jp@resolvebio.com 
(208) 727-7010 (Cell) 
 
Medical Monitor 
Emergency Sponsor Contact 
Dan Burge, MD 
454 N. 34th Street 
Seattle, WA, 98103 
dan@burgeconsulting.com 
(425) 802-3359 (Cell) 
 
Investigators: 
Multicenter Study: Investigator information on file at 
Resolve Therapeutics. 
Clinical Laboratories: 
Resolve Therapeutics Laboratories 
454 N. 34th Street 
Seattle, WA 98103 
 
 
ICON Development Solutions, LLC 
8282 Halsey Road 
Whitesboro, NY  13492 
 
 
Q2 Solutions 
5927 South Miami Blvd., Suite 100 
Morrisville, NC  27560 

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Myriad RBM, Inc. 
3300 Duval Rd. 
Austin, TX  78759 
 
University of Washington Medical Center 
Clinical Immunology Lab, Room NW275 
1959 NE Pacific 
Seattle, WA  98195 
 
Sponsor Approval: 
 
 
 
 
 
James Posada, PhD 
Chief Executive Officer 
 

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1 
PROTOCOL SYNOPSIS 
Name of Sponsor: 
Resolve Therapeutics, LLC 
Name of Investigational Product: 
RSLV-132 
Name of Active Ingredient: 
RNase-IgG Fc 
Number and Title of Study:  
Protocol 132-03: A Phase 2a, Double-Blind, Placebo-Controlled Study of RSLV-132 in 
subjects with Systemic Lupus Erythematosus (SLE) 
Phase of development:   
2a 
Study period:  
Patient participation duration: 28 days of screening followed by 22 weeks of treatment and 8 
weeks of follow up (approximately 34 weeks total). 
 
Planned study conduct duration: approximately 24 months total (from enrollment of first 
subject to completion of follow-up for last patient). 
Objectives:  
• assess the impact of 13 IV infusions of RSLV-132 on cutaneous lupus disease activity 
using the CLASI activity score. 
• assess improvement in disease activity using SLEDAI-2K, BILAG-2004 and PGA; 
• evaluate the immunogenicity of RSLV-132 in subjects with SLE; 
• assess improvement in tender or swollen joint count; 
• assess improvement in patient reported outcomes using the FACIT-Fatigue scale; 
• assess the ability of subjects to reduce oral steroids at Day 169; 
• evaluate the safety and tolerability of 22 weeks of RSLV-132 exposure; 
• assess the proportion of subjects achieving a 50% improvement in CLASI activity 
score 
• assess the following exploratory endpoints 
o evaluate the impact of RSLV-132 treatment on gene expression profile; 
o evaluate the impact of RSLV-132 treatment on autoantibody and complement 
profiles; 
o evaluate the impact of RSLV-132 on serum protein levels; 
o assess the impact of RSLV-132 on the CLASI damage score 
 

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Study design: 
This is a multi-center, double-blind, placebo-controlled study to evaluate the impact of 13 
intravenous infusions of RSLV-132 in approximately 50 patients with SLE. Each of the 
approximately 50 subjects will be randomized 2:1 (active:placebo) and will receive 13 
infusions of 10 mg/kg of RSLV-132 or placebo as follows on days: 
 
• 1, 8, 15, 29, 43, 57, 71, 85, 99, 113, 127, 141, and 155 
 
Potential subjects will be screened to assess their eligibility to enter the study within 28 days 
prior to study entry (i.e., prior to Baseline visit).  Following Baseline evaluations on Day 1, 
subjects will receive their first infusion of RSLV-132 or placebo.  Subjects will return to the 
research unit for follow-up visits as described in Appendix A.   
Dose selection rationale:  The dose level was chosen based on safety and tolerability data from 
Protocol 132-02 (multiple ascending dose study in SLE patients).   
RSLV-132 shall be prepared for each subject from individual stock vials provided by Sponsor.  
Details of dilution, dose preparation, and administration instructions will be provided in the 
Study Drug Reference Manual. The dose for each individual shall be based on the subject’s 
body weight. 
Number of subjects (planned):  
It is anticipated that approximately 50 subjects will be enrolled in the study 
Number of Study Centers (planned):  
Approximately 15-20 study sites in the United States, Canada and Europe will be involved in 
the study. 
Diagnosis and main criteria for inclusion:  
Subjects with SLE, including cutaneous manifestations of SLE and a CLASI score ≥ 10, and 
positive serology (increased levels of one or more of the following: Ro-52/60, La, Sm, 
SmRNP, U1 RNP A/68) at Screening will be eligible for the study. 
Inclusion Criteria: 
Subjects who meet the following criteria may be included in the study: 
1. diagnosis of SLE meeting four of the eleven criteria in the 1997 Update of the 1982 
American College of Rheumatology Revised Criteria and a history of active SLE 
including cutaneous involvement at Screening; 
2. SLE with cutaneous manifestations and a CLASI activity score of ≥10 at Screening; 
3. elevated levels of any one of the following autoantibodies: 
• Ro-52/60, La, Sm, SmRNP, U1 RNP A/68 (local or central laboratory); 
4. no change in medications for the treatment of SLE for the previous 30 days prior to 
Baseline; 
5. able to communicate and able to provide valid, written informed consent; 
6. ages 18 to 70, inclusive; 

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7. minimum weight of 45 kg; 
8. Female participants shall be either of non-child-bearing potential (permanently 
sterilized by tubal occlusion, hysterectomy, or bilateral salpingectomy), or menopausal 
(more than one year since last menstrual cycle and confirmed by blood FSH levels ≥ 
22 mIU/mL) OR practicing highly effective contraception (e.g., oral, injectable, 
implantable or transdermal contraceptives, a non-hormonal intrauterine device [IUD] 
with spermicide; female condom with spermicide; contraceptive sponge with 
spermicide; an intravaginal system, a diaphragm with spermicide; cervical cap with 
spermicide; a male sexual partner who agrees to use a male condom with spermicide; a 
sterile sexual partner) for at least 2 months prior to dosing and until 110 days following 
the End of Study.  
9. Male participants must agree to use a male condom with spermicide from the first dose 
until 90 days after the last dose.  Male participants must also agree not to donate sperm 
from the first dose until 90 days after the last dose. 
Exclusion Criteria: 
The following will exclude potential subjects from the study: 
1. severe, active CNS involvement at Screening; 
2. severe renal involvement at Screening (urine protein/creatinine ratio of >200 
mg/mmol, or an estimated creatinine clearance of <30 mL/min); 
3. use of cyclophosphamide within 3 months of the Baseline visit; 
4. use of rituximab within 6 months of the Baseline visit; 
5. use of belimumab within 3 months of the Baseline visit; 
6. use of background medications within 1 month of Baseline in excess of: 
i. 
mycophenolate mofetil > 3 g/day; 
ii. 
azathioprine > 200 mg/day; 
iii. 
methotrexate > 25 mg/week; 
iv. 
hydroxychloroquine > 400 mg/day; 
v. 
prednisone (or equivalent) > 15 mg/day; 
7. use of an intravenous steroid “pulse” within 2 months of Baseline; 
8. use of an intramuscular steroid injection within 1 month of Baseline; 
9. change in SLE medications within 1 month of Baseline; 
10. the presence of a clinically significant infection in the judgement of the Investigator 
within seven days prior to the receipt of the first dose of study drug; 
11. positive viral load test for hepatitis B, C, or HIV at Screening; 
12. participation in another clinical trial with receipt of an investigational product within 3 
months or 5 half- lives, of last administration (whichever is longer) from Baseline; 
13. positive pregnancy test at Screening or at Baseline; 
14. female subjects currently breast feeding at Baseline; 
15. inability or unwillingness to comply with protocol-specified procedures which, in the 
opinion of the Investigator, would make the subject unsuitable for study participation. 

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CRITERIA FOR EVALUATION: 
Clinical measures: 
• CLASI (both activity and damage scores) 
• SLEDAI-2K 
• BILAG-2004 
• PGA 
• Tender and swollen joint count 
Pharmacodynamics: 
• Gene expression profiling of peripheral blood mononuclear cells (PBMCs) 
• Analysis of serum proteins 
• Autoantibody profiling 
Patient reported outcomes: 
• FACIT-Fatigue patient reported fatigue index  
Evaluations by Day: 
Screening Procedures 
• informed consent; 
• evaluation of inclusion/exclusion criteria; 
• complete medical and medication history; 
• demographic data; 
• weight and height; 
• physical examinations; 
• vital signs; 
• clinical laboratory evaluations (Chem-20, CBC, and UA); 
• viral load tests for hepatitis B, C, and HIV; 
• serum pregnancy test; 
• measurement of cutaneous disease activity (CLASI); 
• Photographs of cutaneous disease activity; 
• autoantibody profile (Ro-52/60, La, Sm, SmRNP, U1 RNP A/68) (local or central 
laboratory); 
• FSH (when required to confirm menopause in female subjects) 
Baseline Procedures 
• confirmation of inclusion/exclusion criteria; 
• interim medical and medication history; 
• physical examination; 
• vital signs; 
• adverse event baseline assessment; 

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• measurement of cutaneous disease activity (CLASI); 
• photographs of cutaneous manifestations of lupus; 
• measurement of SLE activity (SLEDAI-2K, BILAG-2004, PGA);  
• tender and swollen joint count; 
• patient reported outcome, FACIT fatigue index; 
• serum for study drug concentration; 
• clinical laboratory evaluations (Chem-20, CBC, and UA); 
• whole blood for measurement of gene expression; 
• serum for protein analysis; 
• serum for measurement of RNase activity; 
• evaluation of autoantibody profile (dsDNA, Ro-52/60, La, Sm, SmRNP, U1 RNP 
A/68) from local or central laboratory; 
• serum for complement analysis, C3 and C4; 
• assessment of antibodies to RSLV-132; 
• urine pregnancy test; 
• study drug administration. 
Additional Procedures   
The following procedures will be performed at various visits during the study.  A total of 
twelve post-baseline visits will occur; once weekly for two weeks, then every two weeks for 
20 weeks, plus an end of study visit 8 weeks after visit 13: 
• physical exam; 
• vital signs; 
• adverse event assessment; 
• medication history; 
• measurement of cutaneous disease activity (CLASI); 
• measurement of SLE activity (SLEDAI-2K, BILAG-2004, PGA); 
• tender and swollen joint count; 
• FACIT-fatigue index patient reported outcome;  
• photographs of cutaneous manifestations of lupus; 
• serum sample for study drug concentration; 
• serum sample for measurement of RNase activity; 
• serum for protein analysis; 
• whole blood for gene expression profile; 
• serum sample for autoantibody profile (dsDNA, Sm, Ro-52/60, La, SmRNP, U1 RNP 
A/68) from local or central laboratory; 
• serum for complement analysis, C3 and C4; 
• clinical laboratory evaluations (Chem-20, CBC, and UA); 

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• serum sample for assessment of antibodies to RSLV-132; 
• pregnancy test; 
• study drug administration. 
 

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2 
TABLE OF CONTENTS 
1 
PROTOCOL SYNOPSIS ............................................................................................ 4 
2 
TABLE OF CONTENTS .......................................................................................... 10 
2.1 
List of Tables ............................................................................................................... 12 
2.2 
List of Abbreviations and Definitions of Terms .......................................................... 12 
3 
INTRODUCTION...................................................................................................... 14 
3.1 
Systemic Lupus Erythematosus, Immune Complexes, Human Safety Data with 
RSLV-132 .................................................................................................................... 14 
3.2 
RSLV-132 .................................................................................................................... 15 
3.3 
Study Rationale ............................................................................................................ 16 
3.4 
RSLV-132 Human Safety Data ................................................................................... 16 
3.4.1 
Study 132-01 – Single Ascending Dose Study Summary: .......................................... 17 
3.4.2 
Study 132-02 Multiple Ascending Dose Study Summary: Safety............................... 17 
4 
TRIAL OBJECTIVES AND PURPOSE ................................................................. 18 
4.1 
Primary Objective ........................................................................................................ 18 
4.2 
Secondary Objectives................................................................................................... 18 
4.3 
Exploratory Measures .................................................................................................. 18 
5 
INVESTIGATIONAL PLAN ................................................................................... 19 
5.1 
Overall Study Design and Plan .................................................................................... 19 
5.2 
Number of Subjects and Centers .................................................................................. 19 
5.3 
Estimated Study Duration ............................................................................................ 19 
6 
SELECTION AND WITHDRAWAL OF SUBJECTS .......................................... 20 
6.1 
Subject Inclusion Criteria ............................................................................................ 20 
6.2 
CLASI Score Entry Criteria – Adjudication ................................................................ 20 
6.3 
Subject Exclusion Criteria ........................................................................................... 20 
6.4 
Subject Withdrawal Criteria ........................................................................................ 21 
6.5 
Women of Child-Bearing Potential ............................................................................. 21 
7 
TREATMENT OF SUBJECTS ................................................................................ 23 
7.1 
Description of Study Drug ........................................................................................... 23 
7.2 
Treatment Compliance ................................................................................................. 23 
7.3 
Concomitant Medications ............................................................................................ 23 
7.4 
Steroid Tapering........................................................................................................... 23 
7.5 
Treatment of Flares ...................................................................................................... 24 
7.6 
Randomization and Blinding ....................................................................................... 24 
8 
STUDY DRUG MATERIALS AND MANAGEMENT ......................................... 25 
8.1 
Study Drug ................................................................................................................... 25 
8.2 
Placebo ......................................................................................................................... 25 
8.3 
Study Drug Packaging, Labeling, Storage, Shipping, and Preparation ....................... 25 
8.4 
Study Drug Administration .......................................................................................... 25 
8.5 
Study Drug Accountability .......................................................................................... 26 
8.6 
Study Drug Handling and Disposal ............................................................................. 26 
9 
ASSESSMENT OF SAFETY .................................................................................... 27 

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9.1 
Adverse Event Definition ............................................................................................ 27 
9.2 
Serious Adverse Event Definitions .............................................................................. 28 
9.3 
Adverse Event Reporting ............................................................................................. 28 
9.4 
Serious Adverse Event Reporting Requirements ......................................................... 28 
9.5 
Non-Serious Adverse Event Reporting Requirements ................................................ 29 
9.6 
Adverse Event Follow Up ............................................................................................ 29 
9.7 
Severity Assessment .................................................................................................... 29 
9.8 
Causality Assessment................................................................................................... 29 
9.9 
Abnormal Test Findings .............................................................................................. 29 
9.10 
Hospitalization ............................................................................................................. 30 
10 
ASSESSMENT OF PHARMACOKINETICS ........................................................ 31 
10.1 
Measurement of RSLV-132 Drug Levels .................................................................... 31 
10.2 
Pharmacokinetic Analysis ............................................................................................ 31 
11 
STATISTICS .............................................................................................................. 32 
11.1 
Subject Population for Efficacy/Activity Analysis ...................................................... 32 
11.2 
Analysis of the Primary Objective ............................................................................... 32 
11.3 
Analysis of the Secondary Objectives ......................................................................... 32 
11.4 
Exploratory Analysis ................................................................................................... 32 
11.5 
Subject Population for Safety Analysis ....................................................................... 32 
11.6 
Sample Size .................................................................................................................. 33 
12 
STUDY PROCEDURES ........................................................................................... 34 
12.1 
Evaluations ................................................................................................................... 34 
12.2 
Screening Procedures ................................................................................................... 34 
12.3 
Baseline (Day 1) Procedures ........................................................................................ 35 
12.4 
Procedures on Days 8, 15, 43, 71, 99, 127, and 155 .................................................... 35 
12.5 
Procedures on Days 29, 57, 85, 113, 141, and 169/End of Treatment (EOT) ............. 35 
12.6 
End of Study Day 215 Evaluations .............................................................................. 36 
12.7 
Vital Signs .................................................................................................................... 36 
12.8 
Medical/Medication History ........................................................................................ 36 
12.9 
CLASI Clinical Assessment ........................................................................................ 37 
12.10 
SLEDAI-2K, BILAG-2004, PGA, and Tender and Swollen Joint Count Clinical 
Assessments ................................................................................................................. 37 
12.11 
Study Drug Concentration ........................................................................................... 37 
12.12 
Gene Expression Analysis ........................................................................................... 37 
12.13 
Protein Analysis ........................................................................................................... 37 
12.14 
Anti-Drug Antibodies .................................................................................................. 37 
12.15 
RNase Activity Assessments ....................................................................................... 37 
12.16 
Autoantibody Profile .................................................................................................... 38 
13 
DIRECT ACCESS TO SOURCE DATA/DOCUMENTS ..................................... 39 
13.1 
Study Monitoring ......................................................................................................... 39 
13.2 
Audits and Inspections ................................................................................................. 39 
13.3 
Institutional Review Board .......................................................................................... 39 
14 
ETHICS ...................................................................................................................... 41 
14.1 
Ethical Conduct of the Study ....................................................................................... 41 

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14.2 
Written Informed Consent ........................................................................................... 41 
14.3 
Disclosure .................................................................................................................... 41 
15 
DATA HANDLING AND RECORDKEEPING ..................................................... 42 
15.1 
Inspection of Records .................................................................................................. 42 
16 
REFERENCES ........................................................................................................... 43 
17 
APPENDICES ............................................................................................................ 46 
17.1 
Appendix A:  Study Procedures ................................................................................... 46 
17.2 
Appendix B: Clinical Laboratory Evaluations ............................................................. 48 
17.3 
Appendix C: Investigator Protocol Agreement Page ................................................... 49 
17.4 
Appendix D:  ACR SLE Classification Criteria .......................................................... 50 
17.5 
Appendix E:  Summary of Changes............................................................................. 52 
 
2.1 
List of Tables 
Table 1: 
Abbreviations and specialist terms 
12 
Table 2: 
Study Drug 
25 
2.2 
List of Abbreviations and Definitions of Terms 
The following abbreviations and specialist terms are used in this study protocol. 
Table 1: Abbreviations and specialist terms 
Abbreviation or 
specialist term 
Explanation 
ACR 
American College of Rheumatology 
ADA 
anti-drug antibodies 
AE 
adverse event/experience 
ALT 
alanine aminotransferase (alanine transaminase) 
ANA 
anti-nuclear antibody 
AST 
aspartate aminotransferase (aspartate transaminase) 
BILAG 
British isles lupus activity group 
cSFI 
classic (SELENA)-SLEDAI flare index 
CBC 
complete blood count (hematology clinical laboratory evaluations) 
CFR 
code of federal regulations 
Chem-20 
chemistry panel of 20 analytes 
CLASI 
cutaneous lupus erythematosus disease area and severity index 
CNS 
central nervous system 
CRA 
clinical research associate 
CRF 
case report form 
CRO 
clinical research organization 
DNase 
deoxyribonuclease 
ELISA 
enzyme-linked immunosorbent assay 
ESR 
erythrocyte sedimentation rate 

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Abbreviation or 
specialist term 
Explanation 
FDA 
food and drug administration 
FSH 
Follicle-stimulating Hormone 
GCP 
good clinical practice 
HBs Ag 
hepatitis B surface antigen 
HCV 
hepatitis C virus 
HIV 
human immunodeficiency virus 
IC 
Immune complex 
ICF 
informed consent form 
ICH 
international committee on harmonization 
IFN 
interferon 
IgG 
immunoglobulin G 
IgM 
immunoglobulin M 
IL-1 RA 
Interleukin-1 receptor antagonist 
IRB 
institutional review board 
ISM 
interferon signature metric (score) 
IUD 
intrauterine device 
IV 
intravenous 
MTD 
maximum tolerated dose 
OCS 
Oral Corticosteroids 
PCR 
polymerase chain reaction 
pDC 
plasmacytoid dendritic cells 
PGA 
physician’s global assessment 
PK 
pharmacokinetic 
PMN 
polymorphonuclear (cells) 
RNA 
ribonucleic Acid 
SAE 
serious adverse event/experience 
SELENA 
safety of estrogens in lupus erythematosus national assessment 
SLE 
systemic lupus erythematosus 
SLEDAI 
Systemic Lupus Erythematosus Disease Activity Index SELENA 
Modification 
TLR 
toll-like receptor 
UA 
urinalysis 
ULN 
upper limit of normal 
 

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3 
INTRODUCTION 
3.1 
Systemic Lupus Erythematosus, Immune Complexes, Human Safety Data with 
RSLV-132 
Systemic Lupus Erythematosus (SLE) is a heterogeneous autoimmune disorder affecting many 
tissues and organs including skin, kidney and brain [22].   Despite wide inter-patient diversity 
with respect to clinical manifestations, a common characteristic of SLE patients is the presence 
of circulating autoantibodies directed against nuclear antigens [24, 19].  The presence of these 
autoantibodies signifies that host immune tolerance has been compromised.  The physiological 
cause underlying the loss of tolerance is unclear, but current theories include that SLE patients’ 
cells are predisposed to undergo capricious apoptosis or that host mechanisms involved in 
clearance of apoptotic cells/debris are impaired [27, 16].  In either scenario, the extracellular 
accumulation of nuclear-associated antigens, including nucleic acid-containing complexes, elicits 
B-cells to produce antibodies that recognize these normally sequestered components as foreign 
antigens.  As a result, immune tolerance is broken 
When complexed with their respective antigens, SLE patient autoantibodies form immune 
complexes (ICs) which can promote activation of immune cells in vitro.  For example, ICs 
formed following incubation of SLE patient sera with necrotic and/or apoptotic cell extracts (a 
source of nuclear antigens), are effective agonists for activating plasmacytoid dendritic cells 
(pDCs) to produce type 1 interferon (IFN) [5].  Circulating ICs recovered from SLE patients are 
also capable of eliciting IFN-α output from pDCs in culture, though lower abundance of the 
endogenous complexes relative to the quantities formed following addition of exogenous 
antigens promotes smaller quantities of cytokine production [1, 8].  ICs also are capable of 
stimulating B-cells resulting in NF-κB activation and proliferation [15, 6].  Moreover, SLE 
patient ICs have been reported to activate human polymorphonuclear (PMN) cell activities 
including chemotaxis, the oxidative burst response, and netosis [17, 7].   In addition to effects on 
immune cells, ICs can deposit within tissues (e.g. kidney, blood vessels) where their physical 
accumulation and associated inflammation appear to disrupt normal homeostatic function [21, 3].  
Overall, ICs are positioned at the apex of an effector cascade which instigates and drives SLE 
disease pathology.   
Many common SLE patient autoantibodies are directed against nucleic acids or to proteins that 
bind to non-coding RNAs.  Importantly, recent studies have established that nucleic acids 
associated with SLE patient ICs are capable of activating Toll-like receptors (TLRs) [12, 18, 14, 
4, 13].  Although TLRs are thought to operate as key elements of the innate immune system by 
recognizing pathogen-associated molecular components, it is now clear that host nucleic acids 
also can activate specific family members including TLR7, TLR8, and TLR9 [26].   Cells 
expressing these receptors do so without distributing them to the cell surface; rather, TLRs 7/8/9 
are sequestered within endosomes [26].  This positioning is postulated to minimize interaction 
with host nucleic acids.  However, when present within an IC, nucleic acid antigens are actively 
internalized into cells via receptor-mediated endocytosis.  Effector Fc, complement, and B-cell 
receptors all may facilitate entry of nucleic acid containing ICs into endosomes [18, 14].  Once 
internalized, the nucleic acid cargo is positioned to bind to and activate resident endosomal 
TLRs.  Activated TLRs, in turn, promote type 1 IFN from pDCs, activate PMNs, and promote B-

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cell proliferation and autoantibody production.  Thus, the nucleic acid-containing antigens are 
envisioned to contribute to multiple aspects of SLE disease pathophysiology. 
Evidence of the importance of TLR-induced signaling to autoimmunity is further suggested by a 
mouse transgenic line engineered to overexpresses TLR7 [9].  Overexpression of this receptor is 
associated with development of spontaneous autoimmunity.  A substantial increase in TLR7 
expression is associated with enhanced mortality, an increase in circulating anti-DNA antibodies, 
and dendritic cell dysregulation [9].  Given that the transgenic mice do not require an exogenous 
agonist to promote the autoimmune phenotype, these findings suggest that elevation of the 
receptor’s steady state expression is sufficient to tilt the homeostatic balance from a state where 
immune tolerance is maintained to one where tolerance is broken.  Since TLR7 is known to 
recognize RNA-containing ligands [11], the spontaneous development of autoimmunity in the 
TLR7 transgenic animals suggests that endogenous RNAs are contributing to the 
pathophysiological response.   Importantly, when the TLR7 receptor transgenic mice are crossed 
with a mouse line over expressing bovine RNase under control of a serum albumin promoter, the 
double transgenic descendants demonstrate increased survival, reduced activation of T and B 
lymphocytes, and reduced hepatic inflammation [25].  Thus, the addition of a secreted 
ribonuclease to the system appears to attenuate the heightened state of autoimmunity, 
presumably by degradation of the endogenous TLR7 ligands. 
Evidence also exists in humans suggesting that TLRs and nucleases impact SLE.  A mutation 
within the promoter of the TLR7 gene is reported to enhance TLR7 expression and to be a risk 
factor for development of SLE [23].  In addition, polymorphisms within TLRs 7/8/9 have been 
linked to SLE patients [10].  Likewise, mutations resulting in loss of DNase1 or DNase1L3 each 
have been reported as predisposing to the development of SLE [28, 2]. Moreover, genetic 
association studies have established a link between the 3’-5’ exonuclease Trex1 and SLE [20].   
Therefore, in both mice and humans the balance between the levels of endogenous nucleic acid-
containing ligands and expression of the nucleic acid-sensing TLRs appears key in regulating 
cellular immune responses and autoimmunity. 
3.2 
RSLV-132 
RSLV-132 is a novel therapeutic being developed for the treatment of SLE.  This fully human 
biologic (Figure 1) consists of RNase1 (also known as pancreatic RNase) fused to the N-
terminus of the Fc segment of IgG1.  The attachment of the Fc segment is intended to extend the 
circulatory half-life of the RNase and by so doing reduce the frequency of administration.  
RSLV-132 is intended to utilize the RNase to break down RNA containing immune complexes, 
thereby reducing the activation of TLRs, decreasing the production of type 1 IFN and decreasing 
the proliferation of B-cells and autoantibody production.   

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Figure 1: Schematic of RSLV-132 
 
3.3 
Study Rationale 
Chronic systemic inflammation is the hallmark of SLE.  There is a preponderance of scientific 
and clinical evidence that supports the concept that RNA associated with autoantibodies 
specifically delivered to immune system cells triggers multiple inflammatory pathways.  
Many investigative drugs either currently or previously tested in lupus are designed to inhibit key 
inflammatory cytokines such as Interferon-α, Interferon-γ, or B-cell targets such as CD-20, or 
CD22.  All of these targets lie downstream of the initial triggering event and may be only one of 
the pathways involved in SLE inflammation.   
RNA-containing immune complexes circulating in SLE patient blood are specifically delivered 
to Fc receptor-bearing cells and internalized resulting in the activation of TLRs and the 
activation of myriad downstream inflammatory pathways.  RSLV-132 is an enzymatically active 
RNase with a long circulating half-life that is designed to digest the RNA contained in these 
immune complexes and thereby render the immune complexes biologically inert.  The 
therapeutic hypothesis is that over time depleting the blood of RNA immune complexes will 
decrease the activation of multiple pro-inflammatory cascades and thereby decrease the overall 
SLE inflammation. 
3.4 
RSLV-132 Human Safety Data 
Two safety studies in humans have been conducted to date with RSLV-132; a single ascending 
dose study in 32 healthy volunteers, and a multiple ascending dose study in 32 subjects with 
systemic lupus erythematosus. 
 

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3.4.1 
Study 132-01 – Single Ascending Dose Study Summary: 
This first-in-man study was a double-blind, placebo-controlled study conducted in healthy 
volunteers in a phase one unit to assess the safety and tolerability of a single, escalating IV dose 
of RSLV-132 (0.3 mg/kg – 10.0 mg/kg).  There we no SAEs, or drug discontinuations due to an 
AE.  The drug was well tolerated at all doses tested and an MTD was not reached.  The serum 
half-life of the drug was measured to be approximately 16 days.  None of the subjects in the 
study were positive for anti RSLV-132 antibodies.  
3.4.2 
Study 132-02 Multiple Ascending Dose Study Summary: Safety 
This was a multi-center, double-blind, placebo-controlled study with successive escalating 
cohorts to assess the safety and tolerability of repeated IV doses (0.3 mg/kg – 10.0 mg.kg) of 
RSLV-132 in SLE subjects with inactive or mild disease.  The MTD was not reached at the 
highest dose of RSLV-132 tested.  Repeated administration of RSLV-132 doses was generally 
well tolerated by the subjects in this study. Across all dose cohorts, AEs were observed at the 
same overall incidence in RSLV 132 subjects as placebo subjects (6/8 subjects [75%] versus 
18/24 subjects [75%]). The incidence of AEs and the average number of events per subject did 
not increase with increasing dose level. The most frequently reported AEs in the RSLV 132 arm 
were headache, nausea, and upper respiratory tract infection, each of which occurred in 5 
subjects (20.8%). The majority of AEs in this study were Grade 1 in severity; 13 subjects (10 
RSLV-132 and 3 placebo subjects) experienced Grade 2 AEs, and one subject in Cohort 1 of the 
RSLV-132 arm experienced a Grade 3 AE of acute cholecystitis (this event was also reported as 
the only SAE in the study). No Grade 4 or Grade 5 events occurred. Adverse events judged to be 
related to blinded study drug were reported for 38% of placebo subjects and 29% of RSLV 132 
subjects. No dose related trends were observed for any adverse event. No deaths due to AEs 
occurred. All subjects had at least one out-of-range chemistry, hematology, or urinalysis value, 
but no values were considered clinically significant in RSLV-132 subjects. No dose-dependent 
trends were observed in the incidence of out-of-range values and no concerning patterns of 
laboratory abnormalities were detected. No notable differences between treatment groups and no 
trends over the course of the study were observed in vital signs or physical findings. No 
clinically significant ECG abnormalities were reported during the study. No confirmed positive 
anti-RSLV-132 antibodies were detected in any of the subjects in this 113-day study. 

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4 
TRIAL OBJECTIVES AND PURPOSE 
The present study is designed as a proof-of-concept study to demonstrate clinical activity of 
RSLV-132 in a cohort of SLE subjects with active cutaneous manifestations of SLE.  Evidence 
of clinical activity is sought in a smaller, more homogeneous subset of lupus subjects prior to 
embarking on a larger phase 2 dose ranging study. 
4.1 
Primary Objective 
• assess the impact of 13 IV infusions of RSLV-132 on cutaneous lupus disease activity 
using the CLASI activity score comparing Baseline with Day 85 and Day 169 among the 
drug-treated and placebo groups. 
4.2 
Secondary Objectives 
At Days 85 and 169: 
• assess disease activity using SLEDAI-2K, BILAG-2004 and PGA; 
• evaluate the immunogenicity of RSLV-132 in subjects with SLE; 
• assess improvement in tender or swollen joint count; 
• assess improvement in patient reported outcomes using the FACIT-Fatigue scale; 
• assess the proportion of subjects achieving a 50% improvement in CLASI activity score 
At Day 169: 
• assess the ability of subjects to reduce oral steroids at Day 169 relative to Day 85; 
• evaluate the safety and tolerability of 22 weeks of RSLV-132 exposure; 
4.3 
Exploratory Measures 
• evaluate the impact of RSLV-132 treatment on gene expression profile; 
• evaluate the impact of RSLV-132 treatment on autoantibody and complement profiles; 
• evaluate the impact of RSLV-132 on serum protein levels; 
• assess the impact of RSLV-132 on the CLASI damage score 

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5 
INVESTIGATIONAL PLAN 
5.1 
Overall Study Design and Plan 
This is a multi-center, double-blind, placebo-controlled study of approximately fifty subjects 
with SLE.  Potential subjects will be screened to assess their eligibility to enter the study within 
twenty-eight days prior to study entry (i.e., prior to Baseline visit). 
Subjects will be evaluated during screening for evidence of active, evaluable cutaneous 
manifestations of SLE which will be measured by the investigator using the CLASI score and 
documented using photography.  The photographs will be adjudicated by a dermatologist with 
expertise in the use of the CLASI tool in SLE clinical trials in order to confirm the subject meets 
the CLASI entry criteria. 
Following Baseline evaluations on Day 1, subjects will receive their first intravenous infusion of 
RSLV-132.   Subjects will return to the research unit for additional visits as described in 
Appendix A.   
The subjects will be randomized 2:1 (active:placebo) to receive IV administrations of 10 mg/kg 
of study drug or placebo as follows on days: 
• 1, 8, 15, 29, 43, 57, 71, 85, 99, 113, 127, 141, and 155 
5.2 
Number of Subjects and Centers 
Approximately 50 subjects will be enrolled at approximately 15-20 clinical centers in the United 
States, Canada and Europe. 
5.3 
Estimated Study Duration 
Each subject will be screened within twenty-eight days of admission to the study center 
(Baseline visit).  The duration of the study from Baseline visit to End of Study visit, excluding 
the screening period is approximately 30 weeks for each subject. 

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6 
SELECTION AND WITHDRAWAL OF SUBJECTS 
Subjects who meet all of the inclusion criteria and none of the exclusion criteria will be eligible 
to be enrolled into the study. 
6.1 
Subject Inclusion Criteria 
Subjects who meet the following criteria may be included in the study: 
1. diagnosis of SLE by meeting four of the eleven ACR criteria described in the 1997 
update of the 1982 SLE criteria (see Appendix D) including cutaneous involvement at 
Screening; 
2. cutaneous manifestations of SLE and a CLASI activity score of ≥10 at Screening; 
3. elevated levels of any one of the following autoantibodies (local or central laboratory): 
• Ro-52/60, La, Sm, SmRNP, U1 RNP A/68; 
4. no changes to SLE medications in the 30 days prior to Baseline; 
5. able to communicate and able to provide valid, written informed consent; 
6. ages 18 to 70 inclusive; 
7. minimum weight of 45 kg;  
8. Female participants shall be either of non-child-bearing potential (permanently sterilized 
by tubal occlusion, hysterectomy, or bilateral salpingectomy, or menopausal more than 
one year since last menstrual cycle and confirmed by ensuring blood FSH levels ≥ 22 
mIU/mL);  OR practicing highly effective contraception (e.g., oral, implantable, 
transdermal or injectable contraceptives, a non-hormonal intrauterine device [IUD] with 
spermicide; female condom with spermicide; contraceptive sponge with spermicide; 
intravaginal system, diaphragm with spermicide; cervical cap with spermicide; a male 
sexual partner who agrees to use a male condom with spermicide; a sterile sexual partner) 
for at least 2 months prior to dosing and until 110 days following the End of Study.  
9. Male participants must agree to use a male condom with spermicide from the first dose 
until 90 days after the last dose. Male participants must agree not to donate sperm from 
the first dose until 90 days after the last dose. 
6.2 
CLASI Score Entry Criteria – Adjudication 
Prior to being enrolled in the study, each patient’s cutaneous SLE disease activity measure and 
photographs of the cutaneous areas of disease involvement will be submitted to and reviewed by 
an adjudicator.  The adjudicator is a dermatologist with extensive experience in reviewing 
cutaneous clinical data from SLE subjects in a clinical trial setting.  The adjudicator will review 
the photographs of the cutaneous disease to confirm the subject meets the entry criteria and is 
eligible for the study.  
6.3 
Subject Exclusion Criteria 
The following will exclude potential subjects from the study: 
1. severe, active CNS involvement at Screening; 

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2. severe renal involvement (urine protein/creatinine ratio of >200 mg/mmol, or an 
estimated creatinine clearance of <30 mL/min) at Screening; 
3. use of cyclophosphamide within 3 months of Baseline; 
4. use of background medications within 1 month of Baseline in excess of: 
a. mycophenolate mofetil > 3 g/day; 
b. azathioprine > 200 mg/day; 
c. methotrexate > 25 mg/week; 
d. hydroxychloroquine > 400 mg/day; 
e. prednisone (or equivalent) > 15 mg/day; 
5. use of an intravenous corticosteroid “pulse” within 2 months of Baseline; 
6. use of an intramuscular steroid injection within 1 month of Baseline; 
7. use of rituximab within 6 months of Baseline; 
8. use of belimumab within 3 months of Baseline; 
9. acute infection or history of acute infection within seven days prior to Baseline; 
10. positive viral load test for hepatitis B, C or HIV at Screening; 
11. receipt of an investigational product within 3 months of Baseline or five half-lives 
(whichever is longer); 
12. positive pregnancy test at Screening or at Baseline; 
13. female subjects currently breast feeding at Baseline; 
14. inability or unwillingness to comply with study restrictions, return for follow up 
appointments, or other considerations, in the opinion of the Investigator, which would 
make the candidate unsuitable for study participation. 
6.4 
Subject Withdrawal Criteria 
Subjects will be informed that they are free to withdraw from the study at any time and for any 
reason. The Investigator may remove a subject from investigational treatment if, in the 
Investigator's opinion, it is not in the best interest of the subject to continue. Notification of 
discontinuation of investigational treatment will be made immediately to the Sponsor. In case of 
premature discontinuation of investigational treatment, efforts will be made to perform all End of 
Treatment (EOT) assessments and an End of Study (EOS) visit outlined in (Appendix A). 
 
If a subject wishes to withdraw from the study, the site staff should confirm whether the subject 
is agreeable to continue the assessments without the investigational treatment or if they wish no 
further involvement in the study. In the latter case no further study-related evaluations will be 
performed and no additional data will be collected.   
The date and the reason for discontinuation of investigational treatment or withdrawal from the 
study will be recorded on the subject’s Case Report Form (CRF). Subjects that withdraw after 
receiving study drug will not be replaced. 
6.5 
Women of Child-Bearing Potential 
As women of ages 18 to 70 years old are eligible to enroll in this study, all women will be 
considered to be of child-bearing potential unless: 

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• the subject has undergone a surgical sterilization procedure (e.g. bilateral oophorectomy, 
hysterectomy, or tubal ligation); 
• the subject is greater than 12 months past her last menstrual cycle and menopause is 
confirmed by ensuring blood FSH levels ≥ 22 mIU/mL 
Pregnancy tests will be performed at Screening, Baseline, and End of Study visits for women of 
childbearing potential. 

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7 
TREATMENT OF SUBJECTS 
7.1 
Description of Study Drug 
RSLV-132 is a novel therapeutic candidate.  This fully human biologic consists of RNase1 (also 
known as pancreatic RNase) fused to the N-terminus of the Fc portion of IgG1.   The attachment 
of the Fc domain is intended to extend the serum half-life of the RNase and reduce the frequency 
of administration.  RSLV-132 is provided in single-use vials for dilution for intravenous 
infusion.  Two lots of drug have been used in the study; lot 1-FIN-1778 which was provided at 
9.5 mg/mL, and lot 1-FIN-2899 which was provided at 10.0 mg/mL. 
7.2 
Treatment Compliance 
Study drug will be administered at the clinical site by trained study staff according to the Study 
Drug Reference Manual provided by the Sponsor. 
7.3 
Concomitant Medications 
Subjects entering the study who had no changes to their SLE medications in the previous 30 days 
prior to the Baseline visit shall remain on the background medications at the same doses 
throughout the study.  With the exception of decreases in OCS, no changes in lupus medications 
shall be permitted during the study, including the addition of topical steroids or topical 
tacrolimus, except for the rescue of a lupus flare. 
7.4 
Steroid Tapering 
One of the objectives of the study is to evaluate the potential steroid sparing effects of RSLV-
132.  Steroid doses should remain stable through Day 85.  Thereafter, Investigators shall 
decrease the use of oral corticosteroids beginning on Day 85 using the guidance below.  No 
further steroid decreases should occur from Day 141 through Day 169. 
• Subjects receiving >7.5 mg of prednisone or equivalent daily AND demonstrating a 
clinical improvement in the cutaneous manifestations of lupus as measured by a decrease 
in the CLASI activity by 50% compared with Baseline shall decrease oral corticosteroids 
as follows: 
o Decrease prednisone (or equivalent) by 2.5 mg/day  
o If the prednisone dose (or equivalent) remains greater than 7.5 mg/day AND 
cutaneous disease activity remains improved (CLASI activity score decreased by 
50% compared with baseline) AND prednisone has been stable for 2 weeks, 
reduce prednisone by an additional 2.5 mg; repeat after 2 more weeks.   
o If prednisone reduced to 7.5 mg, see below,  
o If after a decrease in prednisone, the CLASI is no longer decreased (compared to 
baseline) by 50%, the investigator may increase the prednisone to the previous 
daily dose (not to exceed the baseline dose) 
• Subjects receiving ≤7.5 mg/of prednisone or equivalent daily AND demonstrating 
clinical improvement in the cutaneous manifestations of lupus as measured by a decrease 

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in the CLASI activity score by 50% compared with baseline, the investigator may, at 
his/her discretion, decrease prednisone by no greater than 2.5 mg/day every other week. 
7.5 
Treatment of Flares 
Investigators should treat lupus flares as they deem appropriate with the minimum amount of 
corticosteroid necessary and should return the subject to baseline steroid dose as quickly as 
medically reasonable.  Should a subject require more than steroids for a lupus flare, investigators 
should treat as necessary and notify the medical monitor. 
7.6 
Randomization and Blinding 
This will be a double-blind, placebo-controlled study. As such, except for the specifically 
designated unblinded study site pharmacist, the investigator, sponsor, and remaining study site 
clinical staff will be blinded as to treatment.  Ongoing drug accountability will be monitored by 
an unblinded monitor. 
Except in a medical emergency, the investigator or designee and blinded study site clinical staff 
will remain blinded during the conduct of the study and until such time that all discrepancies in 
the clinical database are resolved (i.e., at the time of the database lock). The date/initials and 
reason for the investigator and/or clinical staff removing the study blind will be documented. 

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8 
STUDY DRUG MATERIALS AND MANAGEMENT 
8.1 
Study Drug 
RSLV-132 is presented as a single-use, preservative-free vial of sterile solution concentrate for 
dilution for intravenous infusion at a strength of either 9.5 mg/mL or 10.0 mg/mL.  The 
formulation buffer contains 10 mM sodium citrate pH 6.0, 220 mM trehalose and 50 mM L-
arginine. All excipients meet multiple compendia requirements and are not of animal origin. 
The Sponsor, or designee, will provide the investigator with adequate quantities of the study 
drugs (see Table 2). 
Table 2: Study Drug 
Study Drug 
RSLV-132 
Forma 
Sterile injectable solution for intravenous administration packaged in a 
single-use vial.  RSLV-132 will be diluted in saline for infusion. 
Strength 
 Lot 1-FIN-1778, 9.5 mg/mL 
 
Lot 1-FIN-2899, 10.0 mg/mL 
a  
Specific ingredients/purity will be identified on the Certificate of Analysis (or equivalent) that is supplied with the study 
drug. The lot numbers for each concentration of the study drugs will be provided to the clinical site by the 
supplier/manufacturer and will be on vial labels. 
8.2 
Placebo 
Placebo will be sterile saline for infusion and will be provided by each site and prepared by the 
unblinded pharmacist.  
8.3 
Study Drug Packaging, Labeling, Storage, Shipping, and Preparation 
The study drug will be provided to the sites in single use vials, clearly labeled with drug name 
and lot number.  Study drug will be stored at <-20°C under secure conditions and protected from 
light. Prior to administration to the subject, individual dosing solutions will be prepared from a 
vial as detailed in the Study Drug Reference Manual.   Details of study drug packaging, labeling, 
storage, shipping, and preparation, including preparation of matching placebo doses, will 
likewise be provided in the Study Drug Reference Manual.  
8.4 
Study Drug Administration 
RSLV-132 or placebo will be administered intravenously at 10 mg/kg at baseline, then weekly 
for two weeks and then once every 2 weeks for the next 20 weeks (13 administrations) to 
subjects with SLE. The preparation of the study drug and rate of infusion will be provided in the 
Study Drug Reference Manual. For each dose, the date, actual infusion rate, start and stop time 
of infusion will be recorded in the source documents and transcribed into the CRFs. 

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8.5 
Study Drug Accountability 
The unblinded pharmacist will maintain an accurate record of the receipt of the Investigational 
Product as shipped by the Sponsor (or designee), including the date received. In addition, an 
accurate drug disposition record will be kept, specifying the amount dispensed to each subject 
and the date of dispensation.  
8.6 
Study Drug Handling and Disposal 
At the completion of the study, all unused drug supplies will be destroyed by the sites after final 
accountability and reconciliation with the dispensing log. 

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9 
ASSESSMENT OF SAFETY 
Safety of the treatment will be compared between the two groups by assessing adverse events 
and laboratory results as well as any physical findings that have changed from baseline. 
All patients who have received any infusion with either RSLV-132 or placebo will be included in 
the overall analysis of safety. All data relating to safety will be listed and summarized by 
treatment group using descriptive statistics. The change from baseline for each of the vital signs 
parameters will also be computed and included in individual patient listings and descriptive 
summaries.  
Deaths that occur during the study and the proportion of subjects discontinuing the study due to 
adverse events will as well be summarized by treatment group. 
All adverse events will be coded and tabulated by MedDRA System Organ Class (SOC) and 
preferred term (PT) and presented in descending frequency. Adverse events will also be 
tabulated by severity and relationship to the study medication. Serious adverse events will be 
summarized separately. 
9.1 
Adverse Event Definition 
An adverse event (AE) is any untoward medical occurrence in a subject administered a 
pharmaceutical product that does not necessarily have a causal relationship with this treatment. 
Adverse events may be reported by the subject, discovered by Investigator questioning, or 
detected through PE, a laboratory test requiring further attention, or other means. 
Adverse events can therefore be any unfavorable or unintended sign, symptom or disease 
temporally associated with the use of an investigational medicinal product, whether or not 
considered related to the investigational medicinal product. Adverse events include: 
• Any sign, medical diagnosis or symptom 
• Any new undesirable medical experience or unfavorable and unintended worsening of an 
existing condition that occurs during or after treatment, whether or not considered related 
to study drug 
• Abnormal laboratory results that have associated symptoms or findings, require specific 
treatment, or require a change in subject management.   
Whenever possible, the Investigator should group signs or symptoms that constitute a single 
diagnosis under a single event term. For example, cough, rhinitis and sneezing might be grouped 
together as “upper respiratory tract infection”. If possible, abnormal laboratory results that meet 
the definition of an AE (that warrant management, investigation or treatment) should be reported 
as a clinical diagnosis rather than the abnormal value itself (e.g., “anemia” rather than “decreased 
blood count”).  Adverse events will be graded according to the Rheumatology CTC (Woodworth 
et al., J. Rheumatology 2007; 34(6): 1401-1414). 

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9.2 
Serious Adverse Event Definitions 
An AE is classified as serious if it meets any of the following criteria: 
• Results in death 
• Is life-threatening 
o This definition implies that the subject, in the view of the Investigator, was at 
immediate risk of death at the time of the event. It does not include an event that, 
had it occurred in a more severe form, might have caused death. 
• Requires in-patient hospitalization or prolongs an existing hospitalization 
o Hospitalizations for surgeries planned before study entry, for social reasons, or for 
normal disease management procedures (including treatment adjustment) are not 
to be considered SAEs according to this criterion. 
• Results in persistent or significant disability and/or incapacity 
• Results in an adverse outcome in a child or fetus of a patient exposed to the study 
treatment regimen before conception of during pregnancy. 
• Otherwise considered medically important in the judgment of a health care professional. 
Medical and scientific judgment should determine whether an AE is classified as an SAE 
in many situations. Medically important conditions that may not result in death, not be 
life-threatening, nor require hospitalization, may be considered SAEs when they may 
jeopardize the subject or may require intervention to prevent one of the outcomes listed 
above. Examples of such events are allergic bronchospasm requiring intensive treatment 
in an emergency room, blood dyscrasias or convulsions that do not result in in-patient 
hospitalization. 
9.3 
Adverse Event Reporting 
All AEs, both serious and non-serious, will be recorded on the AE CRF at each visit from the 
time the subject receives the first dose of study medication until the End of Study visit.   
9.4 
Serious Adverse Event Reporting Requirements 
SAEs will be reported to Resolve on the SAE report form within 24 hours of awareness of the 
event by the investigator.   
In the event that the investigator does not become aware of the occurrence of a SAE 
immediately, the investigator is to report the event within 24 hours of his/her first awareness of 
the SAE. 
Any SAE occurring any time after the reporting period must be promptly reported if a causal 
relationship to investigational product is suspected.   
The initial report should include as much relevant information as possible but at a minimum 
should include subject Number, date of event onset, event term/description of event, 
investigator’s assessment of relationship to study drug. 

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For all SAEs, the investigator is obligated to pursue and provide information to Resolve or its 
designee in accordance with the timeframes for reporting specified above.  In addition, an 
investigator may be requested by Resolve to obtain specific additional follow-up information in 
an expedited fashion.  This information may be more detailed than that captured on the AE case 
report form.  In general, this will include a description of the AE in sufficient detail to allow for a 
complete medical assessment of the case and independent determination of possible causality.  
Information on other possible causes of the event, such as concomitant medications and illnesses 
must be provided.  All new information including final outcome should be submitted as soon as 
possible. 
9.5 
Non-Serious Adverse Event Reporting Requirements 
Non-serious AEs are to be reported on the AE CRFs, which are to be submitted as outlined in the 
study guidelines. 
9.6 
Adverse Event Follow Up 
For adverse events with a causal relationship to the investigational product, follow-up by the 
investigator is required until the event or its sequelae resolve, stabilize or are explained.  
9.7 
Severity Assessment 
As required on the AE case report forms, the investigator will assess the severity of an event 
according to the Rheumatology CTC (Woodworth et al., J. Rheumatology 2007; 34(6): 1401-
1414). 
9.8 
Causality Assessment 
The investigator’s assessment of causality must be provided for all AEs (serious and non-
serious).  Causality is determined as not related, possibly related, or definitely related according 
to the following definitions: 
• Not related: The event can be readily attributed to other factors such as the subject’s 
clinical state, environmental factors, or other concomitant medications or therapies 
administered. 
• Possibly Related: Follows a reasonable temporal sequence from administration and is 
unlikely to be attributed to the subject's clinical state or environmental factors or other 
therapies administered. 
• Definitely related:  Clear-cut temporal association with study drug administration with 
improvement on cessation of study drug AND cannot be readily attributed to other 
factors such as the subject’s clinical state, environmental factors, or other concomitant 
medications or therapies administered. 
9.9 
Abnormal Test Findings 
When laboratory results are outside the normal range, a decision regarding whether the result is 
of clinical significance or not shall be made by the Investigator and shall be based, in part, upon 

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the nature and degree of the observed abnormality. Abnormal evaluations may be repeated, to 
rule out lab error. 
The criteria for determining whether an abnormal objective test finding should be reported as an 
AE are as follows:  
• Test result is associated with accompanying symptoms, and/or; 
• Test result requires additional diagnostic testing or medical/surgical intervention, and/or; 
• Test result is considered to be an AE by the investigator or Sponsor. 
An abnormal test result, in the absence of any of the above conditions, does not constitute an AE. 
Any abnormal test result that is determined to be an error does not require reporting as an AE. 
9.10 
Hospitalization 
AEs reported from the clinical study associated with subject hospitalization or prolongation of 
subject hospitalization, are considered serious. 
Hospitalization or prolongation of hospitalization in the absence of a precipitating, clinical AE is 
not an SAE.  Examples include: 
• Admission for treatment of a preexisting condition not associated with the development 
of a new AE or with a worsening of the preexisting condition (e.g., for work-up of 
persistent pre-treatment lab abnormality); 
• Social admission (e.g., subject has no place to sleep); 
• Administrative admission (e.g., for yearly physical exam); 
• Protocol-specified admission during a clinical study (e.g., for a procedure required by the 
study protocol); 
• Pre-planned or optional admission not associated with a precipitating clinical AE. 

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10 
ASSESSMENT OF PHARMACOKINETICS 
10.1 
Measurement of RSLV-132 Drug Levels 
RSLV-132 drug levels in subject serum samples will be quantitated by two different assays; a 
validated ELISA assay that directly measures RSLV-132 (ICON Laboratories), and a catalytic 
activity assay that measures the RNase enzyme activity of RSLV-132 (Resolve Therapeutics, 
LLC). 
10.2 
Pharmacokinetic Analysis 
Pharmacokinetic (PK) parameters will be calculated for each subject, whenever possible, based 
on the serum concentrations of RSLV-132. 

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11 
STATISTICS 
A statistical analysis plan will be prepared after completion of the final protocol and will be 
finalized before database lock. The statistical analysis plan will include more details on the 
statistical analysis and presentation of the data.  The fundamentals of the analysis are listed 
below.  Data will be analyzed and reported by subject’s sex and gender.  
11.1 
Subject Population for Efficacy/Activity Analysis 
The efficacy/activity analysis set will include all subjects randomized and that receive at least 
one dose of study drug. 
11.2 
Analysis of the Primary Objective 
The primary objective is a comparison of the mean improvement (from Baseline to Day 85; or 
Baseline to Day 169 in CLASI Activity scores of those in the efficacy analysis set receiving 
RSLV-132 and those receiving placebo. 
11.3 
Analysis of the Secondary Objectives 
The following secondary objectives will be compared between the two treatment arms: 
• The immunogenicity of RSLV-132 as measured by the presence of RSLV-132 antibodies 
• Improvements (from Baseline to Day 85 and Day 169) in the SLEDAI-2K, PGA, and 
BILAG-2004 scores  
• Improvement (from Baseline to Day 85 and Day 169) in the FACIT-Fatigue scale  
• Improvements (from Baseline to Day 85 and Day 169) in tender or swollen joint count 
• Reduction in oral steroids at Day 169 relative to Day 85 
• The proportion of subjects achieving a 50% improvement in CLASI activity score 
11.4 
Exploratory Analysis 
Differences between the gene expression profiles, autoantibody and complement profiles, and 
serum protein levels will be compared between the two treatment arms.  A comparison will be 
made of the mean improvement (from Baseline to Day 85; or Baseline to Day 169 in CLASI 
damage scores of those randomized to be treated with RSLV-132 and those randomized to 
receive placebo. 
11.5 
Subject Population for Safety Analysis 
The safety of RSLV-132 will be compared between the two arms using the following safety 
parameters:  adverse events, previous and concomitant medications, previous and concomitant 
diseases and laboratory data. The safety population will include all patients who received any 
treatment with either RSLV-132 or placebo. Randomized patients that receive the incorrect 
therapy from that intended will be summarized in the group according to the therapy actually 
received. Patients who are not randomized but who receive treatment or placebo will also be 
included in the safety population and summarized according to the therapy actually received. In 

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the unlikely event of a patient commencing one study therapy and crossing over to the other, the 
data for that patient will be included in summaries and analyses with the original group. 
11.6 
Sample Size 
The sample size chosen for this study was based upon precedent set by other studies of similar 
nature and was not based on power calculations. 

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12 
STUDY PROCEDURES 
12.1 
Evaluations 
Evaluations are summarized in Appendix A. During the course of the study approximately 295 
mL of blood will be drawn.  A central laboratory will perform all evaluations with the following 
exceptions: 
• anti-drug antibody evaluations will be performed by ICON. 
• autoantibody assessments will be performed by the University of Washington Clinical 
Laboratory. 
• measurement of drug concentration by will be performed by ICON. 
• measurement of RNase enzyme activity will be conducted by Resolve Therapeutics. 
• serum protein analysis will be conducted by Myriad RBM. 
• blood-cell gene expression analysis will be performed by Q2 Solutions. 
• Each site will perform a urine pregnancy test on females at the baseline visit only 
Every attempt will be made to perform evaluations on the scheduled day and time, as 
appropriate. If evaluations cannot be performed on the day of the scheduled visit a window of ± 
3 days may be applied for visit Days 8 through 155 and ±5 days for Day 169 and Day 215. In the 
event visit windows are utilized the minimum interval between administrations of RSLV-132 
should be 10 calendar days. 
All scheduled study visits should occur on the specified number of days after Baseline, even if a 
preceding visit occurred off-schedule.  
12.2 
Screening Procedures 
The following Screening procedures will be performed for all potential subjects at a visit 
conducted within 28 days of study entry (prior to Baseline): 
• informed consent; 
• assess inclusion/exclusion criteria; 
• demographic data; 
• weight, and height; 
• viral load for hepatitis-B and C and HIV (Appendix B); 
• physical examination; 
• pregnancy test (serum); 
• medical and medication history; 
• vital signs (temperature, respiratory rate, blood pressure and pulse); 
• clinical laboratory evaluations (including Chem-20, CBC, and UA), laboratory 
evaluations may be repeated if abnormal; 
• measurement of cutaneous SLE activity (CLASI); 
• photographs of cutaneous SLE lesions for adjudication (if CLASI ≥10); 
• evaluation of autoantibody profile (Ro-52/60, La, Sm, SmRNP, U1 RNP A/68) local or 
central laboratory. 

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12.3 
Baseline (Day 1) Procedures 
Prior to study drug administration (pre-dose procedures): 
• the inclusion/exclusion criteria will be re-evaluated (CLASI score and concomitant 
medications only); 
• directed physical examination; 
• pregnancy test (urine); 
• AE Assessment; 
• interim medical/medication history; 
• vital signs (temperature, respiratory rate, blood pressure and pulse); 
• clinical laboratory evaluations (Chem-20, CBC, and UA); 
• measurement of SLE disease activity (CLASI, SLEDAI-2K, BILAG-2004, PGA); 
• tender and swollen joint count 
• photographs of cutaneous SLE lesions; 
• FACIT Index (subject completes form); 
• serum sample for study drug concentration;  
• serum for protein analysis; 
• serum sample for measurement of RNase activity; 
• whole blood for gene expression profile; 
• serum sample for autoantibody profile (Ro-52/60, La, Sm, SmRNP, U1 RNP A/68, 
dsDNA) C3 and C4 (local or central laboratory); 
• serum for assessment of antibodies to RSLV-132; 
• after completion of above assessments: 
o study drug administration 
12.4 
Procedures on Days 8, 15, 43, 71, 99, 127, and 155 
Prior to study drug administration (pre-dose procedures): 
• adverse event assessment; 
• interim medication history; 
• vital signs (temperature, respiratory rate, blood pressure and pulse); 
• serum for assessment of anti-RSLV-132 antibodies (Day 15 only) 
• measurement of cutaneous disease activity (CLASI) – (Days 99, 127 and 155 only); 
• after completion of above assessments: 
o study drug administration 
12.5 
Procedures on Days 29, 57, 85, 113, 141, and 169/End of Treatment (EOT) 
Prior to study drug administration (pre-dose procedures): 
• directed physical examination; 
• adverse event assessment; 
• interim medication history; 
• vital signs (temperature, respiratory rate, blood pressure and pulse); 

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• Chem-20, CBC, UA; 
• measurement of SLE activity (SLEDAI-2K, BILAG-2004, PGA); 
• measurement of cutaneous disease activity (CLASI); 
• tender and swollen joint count; 
• photographs of cutaneous disease activity (Days 85 and 169 only); 
• FACIT fatigue index (subject completes form) (Days 85 and 169 only); 
• serum for study drug concentration (Days 29, 85, and 169 only); 
• serum for protein analysis (Day 85 and 169 only); 
• serum for RNase activity (Days 29, 85, and 169 only); 
• whole blood for gene expression profile (Days 29, 85, and 169 only); 
• serum for autoantibody profile (Ro-52/60, La, Sm, SmRNP, U1 RNP A/68, dsDNA) C3 
and C4 (local or central laboratory); 
• serum for assessment of anti-RSLV-132 antibodies (Days 29 and 85 only); 
• after completion of above assessments: 
o study drug administration (except Day 169) 
12.6 
End of Study Day 215 Evaluations 
The following procedures will be performed on Day 215: 
• directed physical examination; 
• pregnancy test (serum). 
• adverse event assessment; 
• interim medication history; 
• vital signs (including temperature, respiratory rate, and seated blood pressure and pulse); 
• clinical laboratory evaluations (Chem-20, CBC, and UA); 
• serum for study drug concentration; 
• serum for measurement of RNase activity; 
• whole blood for gene expression profile; 
• serum for assessment of antibodies to RSLV-132; 
12.7 
Vital Signs 
Vital signs (including temperature, respiratory rate, and seated blood pressure and pulse) will be 
obtained. Blood pressure and pulse will be measured after the subject has been seated for at least 
five minutes. 
12.8 
Medical/Medication History 
Subjects arriving at the clinical unit for the Screening visit will have a complete medical history 
performed including the current and past medications the subject has been using.  At subsequent 
visits to the clinic only an interim medical/medication history shall be performed to determine 
what changes to the subject’s symptoms and medications have taken place since the last visit.  

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12.9 
CLASI Clinical Assessment 
A CLASI assessment shall be performed for each subject at scheduled visits to determine the 
SLE disease activity for each subject at the visit.  The assessment will include determination of 
both the CLASI Activity Score and the CLASI Damage Score.  The assessment shall be 
performed by a qualified, licensed rheumatologist that has completed training provided by the 
Lupus Foundation of America (LFA) on the use of the instrument. 
12.10 
SLEDAI-2K, BILAG-2004, PGA, and Tender and Swollen Joint Count Clinical 
Assessments 
SLEDAI-2K, PGA, BILAG-2004, and tender and swollen joint count assessments shall be 
performed for each subject at scheduled visits to determine the SLE disease activity for each 
subject at the visit.  The above mentioned clinical assessments shall be performed by a qualified, 
licensed rheumatologist that has experience in performing such assessments and has participated 
in clinical trials in which such measurements were performed. 
12.11 
Study Drug Concentration 
Serum samples will be analyzed using a validated, competitive ELISA assay to determine the 
serum concentration of study drug at selected visits during the study. 
12.12 
Gene Expression Analysis 
RNA will be extracted from whole blood to measure the expression level of genes that are 
related to inflammatory pathways though to be involved in SLE.  Samples will be obtained at 
selected visits during the study from Baseline to the End of Study visit. 
12.13 
Protein Analysis 
Serum samples will be obtained at various visits during the study to analyze the level of 
circulating serum proteins.  The protein analysis will measure protein levels related to the 
inflammatory process.  The analysis will be carried out using a multiplexed immunoassay.   
12.14 
Anti-Drug Antibodies 
Serum will be analyzed by ICON for the presence of anti-RSLV 132 antibodies using a validated 
immunoassay. Each positive serum sample will be evaluated for ADA specificity by repeating 
the immunoassay in the presence of an excess of RSLV-132. Confirmed positive, specific serum 
samples will be titered by serial dilution and a numerical titer will be assigned. 
12.15 
RNase Activity Assessments 
RNase activity will be determined by Resolve Therapeutics using a qualified analytical 
procedure.  Serum samples for RNase activity will be collected, processed, stored and shipped 
according to instructions provided in a separate study manual.  Samples will be obtained 
periodically during the study from Baseline to the End of Study visit. 

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12.16 
Autoantibody Profile 
Serum samples will be analyzed using validated methods.  The analysis shall provide values for 
the following autoantibodies and indicate if the result is positive, equivocal, or negative using the 
validated assay range for the testing laboratory: Ro-52/60, La, Sm, SmRNP, U1 RNP A/68, and 
dsDNA. 

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13 
DIRECT ACCESS TO SOURCE DATA/DOCUMENTS 
The Investigator(s) will permit trial-related monitoring, audits, IRB review, and regulatory 
inspection(s) by providing direct access to source data/documents. 
13.1 
Study Monitoring 
Blinded Study Monitors will be responsible for monitoring this clinical trial. The Study Monitors 
will monitor the study conduct, proper CRF and source documentation completion.  To this end, 
the Study Monitors will visit the study site at suitable intervals and be in frequent contact 
through verbal and written communication. It is essential that the Study Monitors have access to 
all documents (related to the study and the individual participants) at each monitoring visit. In 
turn, the Study Monitors will adhere to all requirements for subject confidentiality as outlined in 
the Informed Consent Form (ICF). The investigator and investigator’s staff will be expected to 
cooperate with the Study Monitors, to be available during a portion of the monitoring visit to 
answer questions, and to provide any missing information.   
An unblinded monitor will periodically visit each site to evaluate drug compliance and 
accountability but will not be involved in the monitoring of any clinical data. 
13.2 
Audits and Inspections 
A Quality Assurance representative from Resolve or a clinical research organization may 
conduct audits at the study site(s). Audits will include, but are not limited to, drug supply, 
presence of required documents, the informed consent process, laboratory specimen processing, 
and comparison of CRFs with source documents. The Investigator agrees to cooperate with 
audits conducted at a reasonable time and in a reasonable manner. 
Regulatory authorities may also audit the Investigator during or after the study. The Investigator 
should contact Resolve Therapeutics immediately if this occurs, and must fully cooperate with 
the audits conducted at a reasonable time in a reasonable manner. 
The Investigator is required to make all study documentation promptly available for inspection, 
review or audit at the study site upon request by sponsor, its representatives, or any appropriate 
regulatory agencies. 
13.3 
Institutional Review Board 
In accordance with 21 CFR 56, the protocol, advertisement, and ICF will be reviewed and 
approved by the IRB. The Sponsor will supply relevant material for the investigator to submit to 
the IRB for the protocol’s review and approval. Verification of the IRB unconditional approval 
of the protocol and the written ICF statement will be transmitted to the investigator. 
The IRB will be informed by the investigator of subsequent protocol amendments and of serious 
and unexpected AEs. Approval for protocol amendments will be transmitted in writing to the 
investigator. If requested, the investigator will permit audits by the IRB and regulatory 
inspections by providing direct access to source data/documents. 

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The investigator will provide the IRB with progress reports at appropriate intervals (not to 
exceed one year) and a Study Progress Report following the completion, termination, or 
discontinuation of the investigator’s participation in the study. 

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14 
ETHICS 
14.1 
Ethical Conduct of the Study 
The study procedures outlined in this protocol will be conducted in accordance with the U.S. 
Code of Federal Regulations governing Protection of Human Subjects (21 CFR 50), Financial 
Disclosure by Clinical Investigators (21 CFR 54), Institutional Review Boards (21 CFR 56), 
Investigational New Drug Application (21 CFR 312), and Applications for FDA Approval to 
Market a New Drug (21 CFR 314), as appropriate. As such, these sections of U.S. Title 21 CFR, 
along with the applicable International Conference on Harmonization (ICH) Guidelines, are 
commonly known as Good Clinical Practices, which are consistent with the Declaration of 
Helsinki. 
14.2 
Written Informed Consent 
Written informed consent for the study will be obtained from all subjects before protocol specific 
procedures are carried out. The ICF generated by the IRB will be approved (along with the 
protocol) by the IRB and will be acceptable to the Sponsor. 
The investigator (or designee) will explain the nature of the study and the action of the test 
product. The subjects will be informed that participation is voluntary and that they can withdraw 
from the study at any time. In accordance with 21 CFR 50, the informed consent process shall be 
documented by the use of a written ICF approved by the IRB and will be signed by the subject 
prior to protocol-specific procedures being performed.  The subject will be given a copy of the 
signed consent, and the original will be maintained with the subject’s records. 
14.3 
Disclosure 
All information provided regarding the study, as well as all information collected/documented 
during the course of the study, will be regarded as confidential. The investigator agrees not to 
disclose such information in any way without prior written permission from the Sponsor. 
Any publication of the results, either in part or in total (articles in journals or newspapers, oral 
presentations, abstracts, etc.) by the Investigator(s) or their representative(s), shall require prior 
notification and review, within a reasonable time frame, by the Sponsor, and cannot be made in 
violation of the Sponsor’s confidentiality restrictions or to the detriment of the Sponsor’s 
intellectual property rights. 

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15 
DATA HANDLING AND RECORDKEEPING 
There will be no alterations in the protocol without agreement between the Sponsor and the 
investigator.  There will be no alterations in the protocol affecting subject safety without the 
express written approval of the Sponsor, investigator, and the IRB.   
Investigators are required to prepare and maintain adequate and accurate case histories that 
record all observations and other data pertinent to the investigation on each individual 
administered the investigational drug or employed as a control in the investigation. Case histories 
include the case report forms and supporting data including, for example, signed and dated 
consent forms and medical records including, for example, progress notes of the physician, the 
individual's hospital chart(s), and the nurses' notes. The case history for each individual shall 
document that informed consent was obtained prior to participation in the study 
The results from screening and data collected during the study will be recorded in the subject’s 
CRF (either paper or electronic CRF). To maintain confidentiality, the subjects/patients will be 
identified only by numbers and/or initials.  The completed CRFs will be transferred to the 
Sponsor or designee. Copies of each CRF will be retained by the Investigator. All source 
documents, records, and reports will be retained by the study site in accordance with 21 CFR 
312.62(c).  Data handling and record keeping are further described in the Data Management 
Plan. 
15.1 
Inspection of Records 
All primary data, or copies thereof (e.g., laboratory records, CRFs, data sheets, correspondence, 
photographs, drug accountability records, and computer records), which are a result of the 
original observations and activities of the study and are necessary for the reconstruction and 
evaluation of any study report, will be retained in the study site archives for a period of 2 years 
following the date a marketing application is approved for the drug for the indication for which it 
is being investigated; or, if no application is to be filed or if the application is not approved for 
such indication, until 2 years after the investigation is discontinued and FDA is notified. 

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16 
REFERENCES 
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antibodies in circulating immune complexes in SLE.  Lupus 21:586-595. 
2. Al-Mayouf, S.M., Sunker, A., Abdwani, R., Al  Abrawi, S., Almurshedi, F., Alhashmi, N., 
Al Sonbul, A., Sewairi, W., Qari, A., Abdallah, E., Al-Owain, M., Al Motywee, S., Al-
Rayes, H., Hashem, M., Khalak, H, Al-Jebali, L., and Alkuraya, F.  2011.  Loss-of-function 
variant in DNASE1L3 causes a familial form of systemic lupus erythematosus.  Nat. Gen. 
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3. Arbuckle, M.R., McClain, M.T., Rubertone, M.V., Scofield, R.H., Dennis, G.J., James, J.A., 
and Harley, J.B.  2003.  Development of autoantibodies before the clinical onset of systemic 
lupus erythematosus.  N. Engl. J. Med. 349:1526-1533. 
4. Barrat, F.J., Meeker, T., Gregorio, J., Chan, J.H., Uematsu, S., Akira, S., Chang, B., 
Duramad, O., Coffman, R.L.  2005.  Nucleic acids of mammalian origin can act as 
endogenous ligands for Toll-like receptors and may promote systemic lupus erythematosus.  
J. Exp. Med. 202:1131-1139. 
5. Bave, U., Alm, G.V., and Ronnblom, L. 2000.  The combination of apoptotic U937 cells and 
lupus IgG is a potent IFN-inducer.  J. Immunol. 165:3519-3526. 
6. Busconi, L., Bauer, J.W., Tumang, J.R., Laws, A., Perkins-Mesires, K., Tabor, A.S., Lau, C., 
Corley, R.B., Rothstein, T.L., Lund, F.E., Behrens, T.W., and Marshak-Rothstein, A.  2007.  
Functional outcome of B cell activation by chromatin immune complex engagement of the B 
cell receptor and TLR9.  J. Immunol. 179:7397-7405. 
7. Chen, K., Nishi, H., Travers, R., Tsuboi, N., Martinod, K, Wagner, D.D., Stan, R., Croce, K., 
and Mayadas, T.N.  2012.  Endocytosis of soluble immune complexes leads to their clearance 
by FcRIIIB but induces neutrophil extracellular traps via FcRIIA in vivo.  Blood 120:4421-
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8. Chiang, E.Y., Yu, X., and Grogan, J.L.  2011.  Immune complex-mediated cell activation 
from systemic lupus erythematosus and rheumatoid arthritis patients elaborate different 
requirements for IRAK1/4 kinase across human cell types.  J. Immunol. 186:1279-1288. 
9. Deane, J.A., Pisitkun, P., Barrett, R.S., Feigenbaum, L., Town, T., Ward, J.M., Flavell, R.A. 
and Bolland, S.  2007.  Control of Toll-like receptor 7 expression is essential to restrict 
autoimmunity and dendritic cell proliferation.  Immunity 27:801-810. 
10. dos Santos, B.P., Valverde, J.V., Rohr, P., Monticielo, O.A., Brenol, J.C.T., Xavier, R.M., 
and Chies, J.A.B.  2012.  TLR7/8/9 polymorphisms and their associations in systemic lupus 
erythematosus patients from Southern Brazil.  Lupus 21:302-309. 
11. Gantier, M.P., Tong, S., Behlke, M.A., Xu, D., Phipps, S., Foster, P.S., and Williams, B.R. 
2008.  TLR7 is involved in sequence-specific sensing of single-stranded RNAs in human 
macrophages.  J. Immunol. 180:2117-21124. 
12. Hoffman RW, Gazitt T, Foecking MF, et al. U1 RNA induces innate immunity signaling. 
Arth & Rheum. 2004;50:2891-2896. 
13. Kelly-Scumpia, K.M., Nacionales, D.C., Scumpia, P.O., Weinstein, J.S., Narain, S., 
Moldawer, L.L., Satoh, M., and Reeves, W.H.  2007.  In vivo adjuvant activity of the RNA 
component of the smRNP lupus autoantigen.  Arth. & Rheum. 56:3379-3386. 
14. Lau, C.M., Broughton, C., Tabor, A.S., Akira, S., Flavell, R.A., Mamula, M.J., Christensen, 
S.R., Shlomchik, M.J., Viglianti, G.A., Rifkin, I.R., and Marshak-Rothstein, A.  2005.  RNA-

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associated autoantigens activate B cells by combined B cell antigen/Toll-like receptor 7 
engagement.  J. Exp. Med. 202:1171-1177. 
15. Leadbetter, E.A., Rifkin, I.R., Hohlbaum, A.M., Beaudette, B.C., Shlomchik, M.J., and 
Marshak-Rothstein, A.  2002.  Chromatin-IgG complexes activate B-cells by dual 
engagement of IgM and Toll-like receptors.  Nature 416:603-607. 
16. Liu, Z. and Davidson, A.  2012.  Taming lupus – a new understanding of pathogenesis is 
leading to clinical advances.  Nat. Med. 18:871-882. 
17. Lood, C., Allhorn, M., Lood, R., Gullstrand, B., Olin, A.I., Ronnblom, L., Truedsson, L., 
Colling, M., and Bengtsson, A.A.  2012.  IgG glycan hydrolysis by endoglycosidase S 
diminishes the proinflammatory properties of immune complexes from patients with 
systemic lupus erythematosus.  Arth. & Rheum. 64:2698-2706. 
18. Means, T.K., Latz, E., Hayashi, F., Murali, M.R., Golenbock, D.T., and Luster, A.D. 2005.  
Human lupus autoantibody-DNA complexes activate DCs through cooperation of CD32 and 
TLR9.  J. Clin. Invest. 115:407-417. 
19. Moder, K.G., Wener, M.H., Weisman, M.H., Ishimori, M.L., Wallace, D.J., Buckeridge, D., 
and Homburger, H.A.   2007.  Measurement of antinuclear antibodies by multiplex 
immunoassay: a prospective multicenter clinical evaluation.  J. Rheumat. 34:978-986. 
20. Namjou, B., Kothari, P.H., Kelly, K.A., Glenn, S.B., Ojwang, J.O., Adler, A., Alarcon-
Riquelme, M.E., Gallant, C.J., Boackle, S.A., Criswell, L.A., Kimberly, R.P., Brown, E., 
Edberg, J., Stevens, A.M., Jacob, C.O., Tsao, B.P., Gilkeson, G.S., Kamen, D.L., Merrill, 
J.T., Petri, M., Goldman, R.R., Vila, L.M., Anaya, J.-M., Niewold, T.B., Martin, J., Pons-
Estel, B.A., Sabio, J.M., Callejas, J.L., Vyse, T.J., Bae, S.-C., Perrino, F.W., Breedman, B.I., 
Scofield, R.H., Moser, K.L., Gaffney, P.M., James, J.A., Langefeld, C.D., Kaufman, K.M., 
Harley, J.B., and Atkinson, J.P.  2011. Evaluation of the TREX1 gene in a large multi-
ancestral lupus cohort.  Genes Immun. 12:270-279. 
21. Nowling, T.K. and Gilkeson, G.S.  2011.  Mechanisms of tissue injury in lupus nephritis.  
Arth. Res. & Ther. 13:250. 
22. O’Neill, S. and Cervera, R. 2010.  Systemic lupus erythematosus.  Best Pract. Res. Clin. 
Rheumatol. 24:841-855. 
23. Shen, N., Fu, Q., Deng, Y., Qian, X., Zhao, J., Kaufman, K.M., Wu, Y.L., Yu, C.Y., Tang, 
Y., Chen, J.-Y., Wanling, Y., Wong, M., Kawaska, A., Tsuchlya, N., Sumida, T., 
Kawaguchi, Y., Howe, H.S., Mok, M.Y., Band, S.-Y., Liu, F.-L., Chang, D.-M., Takasaki, 
Y., Hashimoto, H., Harley, J.B., Guthridge, J.M., Grossman, J.M., Cantor, R.M., Song, 
Y.W., Bae, S.-C., Chen, S., Hahn, B.H., Lau, Y.L., and Tsao, B.P.  2010.  Sex-specific 
association of X-linked Toll-like receptor 7 (TLR7) with male systemic lupus erythematosus.  
Proc. Natl. Acad. Sci. 107:15838-15843. 
24. Solomon, D.H., Kavanaugh, A.J., and Schur, P.H.  2002. American College of 
Rheumatology Ad Hoc Committee on Immunologic Testing Guidelines.  Evidenced-based 
guidelines for the use of immunologic tests: antinuclear antibody testing.  Arthritis Rheum. 
2002. 47:434-444. 
25. Sun, X., Wiedeman, A., Agrawal, N., Teal, T.H., Tanaka, L., Hudkins, K.L., Alpers, C.E., 
Bolland, S., Buechler, M., Hamerman, J., Ledbetter, J.A., Liggitt, D., and Elkon, K.B.  2013.  
Increased RNase expression reduces inflammation and prolongs survival in TLR7 transgenic 
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26. Theofilopoulos, A.N., Gonzalez-Quintial, R., Lawson, B.R., Koh, Y.T., Stern, M.E., Kono, 
D.H., Beutler, B., and Baccala, R.  2010.  Sensors of the innate immune system: their link to 
rheumatic diseases.  Nat.  Rev. Rheum. 6:146-156. 
27. Tsokos, G.C. 2011.  Systemic Lupus Erythematosus.  N. Eng. J. Med. 365:2110-2121. 
28. Yasutomo, K., Horiuchi, T., Kagami, S., Tsukamoto, H., Hashimura, C., Urushihara, M., and 
Kuroda, Y.  2001.  Mutation of DNASE1 in people with systemic lupus erythematosus.  Nat. 
Gen. 28:313-314 
 

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17 
APPENDICES 
17.1 
Appendix A:  Study Procedures 
Study Procedures 
Screen 
(-28 to 
-1) 
Baseline 
Day 1 
Day 
8 
Day 
15 
Day 
29 
Day 
43 
Day 
57 
Day 
71 
Day 
85 
Day 
99 
Day 
113 
Day 
127 
Day 
141 
Day 
155 
Day 
169 
(EOT) 
Day 
215 
(EOS) 
Acceptable Visit 
Window (days) 
 
 
+ 3 
+ 3 
+ 3 
+ 3 
+ 3 
+ 3 
+ 3 
+ 3 
+ 3 
+ 3 
+ 3 
+ 3 
+ 5 
+ 5 
Informed Consent 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Inclusion/exclusion  
X 
Xa 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Demographics 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Weight, height 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Hepatitis, HIV tests 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Physical exam 
X 
Xb 
 
 
Xb 
 
Xb 
 
Xb 
 
Xb 
 
Xb 
 
Xb 
Xb 
Pregnancy tests 
Xc 
Xd 
 
 
 
 
 
 
 
 
 
 
 
 
 
Xc 
AE assessment 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Medical/medication 
history 
X 
Xe 
Xe 
Xe 
Xe 
Xe 
Xe 
Xe 
Xe 
Xe 
Xe 
Xe 
Xe 
Xe 
Xe 
Xe 
Vital signs 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Chem-20, CBC, 
UA 
X 
X 
 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
X 
SLEDAI, BILAG, 
PGA, joint count 
 
X 
 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
CLASI 
X 
X 
 
 
X 
 
X 
 
X 
X 
X 
X 
X 
X 
X 
 
Photographs of 
cutaneous disease 
X 
X 
 
 
 
 
 
 
X 
 
 
 
 
 
X 
 

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Study Procedures 
Screen 
(-28 to 
-1) 
Baseline 
Day 1 
Day 
8 
Day 
15 
Day 
29 
Day 
43 
Day 
57 
Day 
71 
Day 
85 
Day 
99 
Day 
113 
Day 
127 
Day 
141 
Day 
155 
Day 
169 
(EOT) 
Day 
215 
(EOS) 
Acceptable Visit 
Window (days) 
 
 
+ 3 
+ 3 
+ 3 
+ 3 
+ 3 
+ 3 
+ 3 
+ 3 
+ 3 
+ 3 
+ 3 
+ 3 
+ 5 
+ 5 
FACIT index 
 
X 
 
 
 
 
 
 
X 
 
 
 
 
 
X 
 
Serum for study 
drug concentration 
 
X 
 
 
X 
 
 
 
X 
 
 
 
 
 
X 
X 
Serum for protein 
analysis 
 
X 
 
 
 
 
 
 
X 
 
 
 
 
 
X 
 
Serum for RNase 
activity 
 
X 
 
 
X 
 
 
 
X 
 
 
 
 
 
X 
X 
Whole blood for 
gene expression 
 
X 
 
 
X 
 
 
 
X 
 
 
 
 
 
X 
X 
Serum for 
autoantibody, C3, 
C4 profile 
X 
X 
 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
Serum for ADA 
 
X 
 
X 
X 
 
 
 
X 
 
 
 
 
 
 
X 
Study Drug 
administration 
 
Xf 
X 
Xf 
Xf 
Xf 
Xf 
Xf 
Xf 
Xf 
Xf 
Xf 
Xf 
Xf 
 
 
a 
CLASI activity and damage score and confirm no changes in SLE medications only 
b 
directed physical exam 
c 
serum pregnancy test for women of childbearing potential (7.4) 
d 
urine pregnancy test for women of childbearing potential (7.4) 
e 
interim medical/medication history only 
f 
RSLV-132 or placebo shall be administered according to the infusion rate and time set forth in the Study Drug Reference Manual 
 
 

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 Protocol 132-03 
 
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17.2 
Appendix B: Clinical Laboratory Evaluations 
Chemistry (Chem-20): 
Hematology (CBC): 
Other Tests: 
Albumin 
Alkaline Phosphatase 
ALT 
AST 
Bicarbonate 
BUN 
Calcium 
Chloride 
Cholesterol 
Creatinine 
GGT 
Glucose 
Lactate dehydrogenase 
Phosphate 
Potassium 
Sodium 
Total Bilirubin 
Total Protein 
Triglycerides 
Uric acid 
Hematocrit 
Hemoglobin 
Mean corpuscular 
hemoglobin 
Mean corpuscular 
hemoglobin concentration 
Mean corpuscular volume 
Platelet count 
Red blood cell count 
White blood cell count 
White blood cell differential 
(Percent and Absolute): 
Basophils 
Eosinophils 
Lymphocytes 
Monocytes 
Neutrophils 
Bands 
Hepatitis B, and C HIV 
Pregnancy Test (serum and 
urine qualitative) 
RNase activity 
Study drug concentration 
Serum protein analysis 
Anti-RSLV-132 antibodies 
Autoantibody profile 
C3 and C4 
Gene expression  
FSH 
Complete Urinalysis (UA): 
 
 
pH and Specific Gravity 
Bilirubin 
Glucose 
Ketones 
Leukocytes 
Nitrite 
Occult blood 
Protein (Albumin/Creatinine) 
Urobilinogen 
Microscopic (RBC, WBC) 
 
 
 

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17.3 
Appendix C: Investigator Protocol Agreement Page 
By signing, I confirm that my staff and I have read and understand this protocol, and agree to 
comply with the conduct and terms of this study. My staff and I have agreed to abide by the 
following responsibilities: 
• To conduct the study in compliance with Sponsor agreements, this protocol, any future 
amendments, any conditions of the governing reviewing EC/IRB or regulatory agency, 
and with any other study conduct procedures implemented by Resolve Therapeutics. 
• To supervise all testing involving human subjects. 
• To abide by FDA regulations, Good Clinical Practices (GCP), and all applicable regional 
regulations.  
• Ensure that the requirements for obtaining informed consent from each study participant 
or their legal representative are met. 
• To report any Serious Adverse Events to Resolve Therapeutics in a timely manner as 
required by the protocol. 
• To report any Serious Adverse Events to the IRB in a timely manner. 
• To report Non-Serious Adverse Events as required by the protocol. 
• To assure access by Resolve Therapeutics representatives to original source documents. 
• To maintain confidentiality and assure security of Resolve Therapeutics confidential 
documents that include but are not limited to: the protocol, case report forms, 
Investigator’s Brochure, final study documents, manuscript drafts, unpublished data, 
sponsor correspondence, etc. 
• To cooperate fully with any study related GCP audit as performed by the sponsor’s 
quality assurance group. 
• To cooperate fully with any regulatory agency audit. 
 
Principal Investigator (printed name): 
 
 
 
 
 
 
 
 
 
 
 
Principal Investigator (signature): 
 
 
 
 
 
 
 
 
Date Signed (mm/dd/yyyy) 
 
 
 

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 Protocol 132-03 
 
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Version 5 27 April 2017  
Page 50 of 52 
17.4 
Appendix D:  ACR SLE Classification Criteria 
1997 Update of the 1982 American College of Rheumatology revised criteria for classification of 
systemic lupus erythematosus 
1. Malar Rash 
Fixed erythema, flat or raised, over the malar eminences, tending to spare 
the nasolabial folds 
2. Discoid rash 
Erythematous raised patches with adherent keratotic scaling and follicular 
plugging; atrophic scarring may occur in older lesions 
3. Photosensitivity 
Skin rash as a result of unusual reaction to sunlight, by patient history or 
physician observation 
4. Oral ulcers 
Oral or nasopharyngeal ulceration, usually painless, observed by physician 
5. Nonerosive arthritis 
Involving 2 or more peripheral joints, characterized by tenderness, swelling, 
or effusion 
6. Pleuritis or pericarditis 
1. Pleuritis--convincing history of pleuritic pain or rubbing heard by a 
physician or evidence of pleural effusion 
 
OR 
2. Pericarditis--documented by electrocardigram or rub or evidence of 
pericardial effusion 
7. Renal disorder 
1. Persistent proteinuria > 0.5 grams per day or > than 3+ if quantitation 
not performed 
 
OR 
2. Cellular casts--may be red cell, hemoglobin, granular, tubular, or 
mixed 
8. Neurologic disorder 
3. Seizures--in the absence of offending drugs or known metabolic 
derangements; e.g., uremia, ketoacidosis, or electrolyte imbalance 
 
OR 
4. Psychosis--in the absence of offending drugs or known metabolic 
derangements, e.g., uremia, ketoacidosis, or electrolyte imbalance 
9. Hematologic disorder 
1. Hemolytic anemia--with reticulocytosis 
OR 
2. Leukopenia--< 4,000/mm3 on ≥ 2 occasions 
OR 
3. Lyphopenia--< 1,500/ mm3 on ≥ 2 occasions 
OR 
4. Thrombocytopenia--<100,000/ mm3 in the absence of offending drugs 

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 Protocol 132-03 
 
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Version 5 27 April 2017  
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10. Immunologic disorder 
1. Anti-DNA: antibody to native DNA in abnormal titer 
OR 
2. Anti-Sm: presence of antibody to Sm nuclear antigen 
OR 
3. Positive finding of antiphospholipid antibodies on: 
1. an abnormal serum level of IgG or IgM anticardiolipin antibodies, 
2. a positive test result for lupus anticoagulant using a standard 
method, or 
3. a false-positive test result for at least 6 months confirmed by 
Treponema pallidum immobilization or fluorescent treponemal 
antibody absorption test 
11. Positive antinuclear antibody 
An abnormal titer of antinuclear antibody by immunofluorescence or an 
equivalent assay at any point in time and in the absence of drugs 
 

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 Protocol 132-03 
 
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Version 5 27 April 2017  
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17.5 
Appendix E:  Summary of Changes 
 
From Version 4.0 to Version 5.0 
Overall 
1. Clarified that there are two lot numbers and concentrations of study 
drug. 
2. Clarified which assessments should be performed for subjects that 
discontinue early from the study. 
3. Clarified that all AEs, both serious and non-serious, will be recorded on 
the AE CRF at each visit from the time the subject receives the first 
dose of study medication until the End of Study visit.   
Section 
Details of Changes 
Title Page 
• Updated Version, Prior Version, Date of Publication  
• Updated version number and date to footer 
6.4 
Updated section to clarify that efforts will be made to perform all End of 
Treatment (EOT) assessments and an End of Study (EOS) visit outlined in 
(Appendix A). 
7.1 
Clarified RSLV-132 is provided in single-use vials for dilution for 
intravenous infusion.  Two lots of drug have been used in the study; lot 1-
FIN-1778 which was provided at 9.5 mg/mL, and lot 1-FIN-2899 which 
was provided at 10.0 mg/mL. 
8.1 
Clarified RSLV-132 is presented as a single-use, preservative-free vial of 
sterile solution concentrate for dilution for intravenous infusion at a 
strength of either 9.5 mg/mL or 10.0 mg/mL. 
 
Table 2: 
Added Lot 1-FIN-1778, 9.5 mg/mL and Lot 1-FIN-2899, 10.0 mg/mL 
 
Footnote:  
Clarified the lot numbers for each concentration of the study drugs will be 
provided to the clinical site by the supplier/manufacturer and will be on vial 
labels. 
9.3 
Clarified all AEs, both serious and non-serious, will be recorded on the AE 
CRF at each visit from the time the subject receives the first dose of study 
medication until the End of Study visit. 
17.5 
Appendix E 
Updated table with summary of changes.