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CTRI Number  CTRI/2021/08/035804 [Registered on: 19/08/2021] Trial Registered Prospectively
Last Modified On: 06/11/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Biological 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A Phase 2, randomized, Clinical trial on Treatment of Moderate to Severely Active Systemic Lupus Erythematosus. 
Scientific Title of Study   A Phase 2 Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of VIB7734 for the Treatment of Moderate to Severely Active Systemic Lupus Erythematosus 
Trial Acronym  RECAST SLE 
Secondary IDs if Any  
Secondary ID  Identifier 
2020-005528-12  EudraCT 
NCT04925934  ClinicalTrials.gov 
VIB7734.P2.S1, Version 1.0, 21 December 2020  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name   
Designation   
Affiliation   
Address 




 
Phone    
Fax    
Email    
 
Details of Contact Person
Scientific Query  
Name  Rashmi Chitgupi 
Designation  Director Clinical Management 
Affiliation  PPD Pharmaceuticals Development India Private Limited 
Address  PPD Pharmaceuticals Development India Private Limited 101, A Wing,Fulcrum, Hiranandani Business Park Sahar Road, Andheri East

Mumbai
MAHARASHTRA
400099
India 
Phone  91-02266022900  
Fax  91-02266022999  
Email  Rashmi.Chitgupi@ppd.com  
 
Details of Contact Person
Public Query  
Name  Rashmi Chitgupi 
Designation  Director Clinical Management 
Affiliation  PPD Pharmaceuticals Development India Private Limited 
Address  PPD Pharmaceuticals Development India Private Limited 101, A Wing,Fulcrum, Hiranandani Business Park Sahar Road, Andheri East

Mumbai
MAHARASHTRA
400099
India 
Phone  91-02266022900  
Fax  91-02266022999  
Email  Rashmi.Chitgupi@ppd.com  
 
Source of Monetary or Material Support  
Viela Bio, Inc. One MedImmune Way, Gaithersburg, MD 20878 USA 
 
Primary Sponsor  
Name  Viela Bio Inc 
Address  One MedImmune Way, Gaithersburg, MD 20878 USA 
Type of Sponsor  Other [Pharmaceutical industry-global] 
 
Details of Secondary Sponsor  
Name  Address 
PPD PharmaceuticalDevelopment IndiaPrivate Limited  PPD Pharmaceutical Development India Private Limited. 101, AWing, Fulcrum, Hiranandani Business Park Sahar Road, AndheriEast, Mumbai 400099 India 
 
Countries of Recruitment     Argentina
Greece
India
Mexico
Poland
Russian Federation
Serbia
Spain
Taiwan
Ukraine
United States of America  
Sites of Study
Modification(s)  
No of Sites = 9  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Amit Sharma  Fortis Escorts Hospital  Clinical Research Department First Floor, Room number 4281 Near Neurology Observation Ward, Jawaharlal Nehru MargService Lane, Girdhar Marg, Malviya Nagar-302017, India
Jaipur
RAJASTHAN 		 91-9950123654

kotaamit@gmail.com 
Dr Dipti Chand  Government Medical College and Hospital  Medical College Square Road, Nagpur-440003, Maharashtra, India
Nagpur
MAHARASHTRA 		 91-9823257601

dachand.ngp@gmail.com 
Dr Samir Kumar  Indira Gandhi Institute of Medical Scineces  Department of General Medicine, Sheikhpura, Patna, Bihar-800014
Patna
BIHAR 		 91-9308332471

dr.samirkumar00@yahoo.com 
Dr Smruti Ramteke  Jasleen Hospital  First Floor, Research Room, Opposite Big Bazar, Panchsheel Square, Dhantoli -440012
Nagpur
MAHARASHTRA 		 9823514680

sramteke@rediffmail.com 
Dr Rama Krishnam Naidu Adapa  King George Hospital, Andhra Medical College  Clinical Research Room, Department of General Medicine, Rajendra Prasad Ward, Maharanipeta, Visakhapatnam-530002
Visakhapatnam
ANDHRA PRADESH 		 91-9885093386

rammky@yahoo.com 
Dr Sarath Chandra Mouli Veeravalli  Krishna Institute of Medical Sciences Limited  Department of Rheumatology and Clinical Immunology, Krishna Institute of Medical Sciences Limited, 1-8-31/1, Minister Road, Secunderabad-500003, Telangana, India
Hyderabad
TELANGANA 		 91-9866000685

sarath10@hotmail.com 
Dr Puja Srivastava  Panchshil Hospital  Second floor, Clinical Research Department, Near Sabarmati Police Station, Highway, Ramnagar, Sabarmati, Ahmedabad – 380005, Gujarat
Ahmadabad
GUJARAT 		 91-8155891234

dr.pujasrivastava@gmail.com 
Dr Vikram Haridas  Sushruta Multispeciality Hospital and Research Centre Private Limited  Research Room No 314, Third Floor,Old Building, P.B.Road, Vidyanagar, Hubballi – 580021, India
Dharwad
KARNATAKA 		 91-9343649883

drvikramharidas@gmail.com 
Dr Romi Kirankumar Shah  Unity Trauma Center and ICU (Unity Hospital)  Clinical Research Department, Basement, Nr. D.R. World, Opp Raghuvir Business Empire, Aai Mata Rd, Parvat Patiya -395010, India
Surat
GUJARAT 		 91-261-2607000

drromikshah@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 9  
Name of Committee  Approval Status 
Institutional Ethics Committee  Submittted/Under Review 
Institutional Ethics Committee Fortis Escorts Hospital  Approved 
Institutional Ethics Committee Indira Gandhi Institute of Medical Sciences  Approved 
Institutional Ethics committee King George Hospital  Approved 
Jasleen Ethics Committee  Approved 
KIMS Ethics Committee  Approved 
Panchshil Institutional Ethics Committee  Approved 
Sushruta Hospitals Ethics Committee  Approved 
Unity Hospital Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: D50-D89||Diseases of the blood and blood-forming organs and certain disorders involving the immune mechanism,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Placebo  Subcutaneous(ly),intravenously (IV) every 4 weeks (Q4W) 
Intervention  VIB7734   Receive VIB7734 200 mg Q4W SC, VIB7734 200 mg intravenously (IV), every 12 weeks (Q12W) SC, with an additional 200 mg intravenously (IV), SC dose at Week 4 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1 Age ≥ 18 years to ≤ 70 years.
2 Willing and able to understand and provide written informed consent.
3 Fulfill the 2019 European League Against Rheumatism/American College of Rheumatology Classification Criteria for SLE
4 Disease duration of at least 6 months.
5 Active SLE as indicated by presence of all the following:
a) SLEDAI-2K total score ≥ 6 at Screening, excluding fever, SLE headache, or organic brain syndrome.
b) SLEDAI-2K total score ≥ 4, excluding points attributable to any urine or laboratory results, immunologic measures, fever, SLE headache, or organic brain syndrome at Screening and Baseline (Day 1).
c) At least one of the following BILAG 2004 Index levels of disease at Screening:
BILAG A disease in ≥ 1 organ system
BILAG B disease in ≥ 2 organ systems d. PGA score ≥ 1 on a 0 to 3 visual analog scale (VAS) at Screening

Have at least one of the following at Screening per central lab:
i)ANA ≥ 1:80
ii)Anti-dsDNA antibodies elevated to above normal range as established by the central laboratory (ie, positive results)
iii)Anti-Smith antibodies elevated to above normal (ie, positive results)
1 Treatment with one or more disease-modifying anti-rheumatic drug (DMARD) or immunosuppressive medication: Any of the following medications each administered at conventional anti-rheumatic doses for treatment of SLE for at least 12 weeks before Screening (unless discontinued or dose adjusted for documented drug-related toxicity or size/weight), and at a stable dose (including route of administration) for a minimum of 8 weeks prior to Screening and maintained through Baseline (Day 1):
2 Treatment with OGC monotherapy (without the concomitant use of DMARDs or immunosuppressants):
Average daily dose of PO prednisone ≥ 10 mg but ≤ 40 mg (or prednisone equivalent) for a minimum of 4 weeks prior to Screening
 
 
ExclusionCriteria 
Details  1 Any condition that, in the opinion of the Investigator, would interfere with the evaluation of the IP or interpretation of participant safety or study results.
2 History of allergy, hypersensitivity reaction, or anaphylaxis to any component of the IP or a previous mAb or human Ig therapy.
3 Active LN or active severe or unstable neuropsychiatric SLE.
4 Current diagnosis of non-SLE vasculitis syndrome, mixed connective tissue disease, or rheumatic (overlap) syndrome.
5 Participation in another clinical study with an investigational drug within 4 weeks before Day 1.
6 Breastfeeding or pregnant women or women who intend to become pregnant anytime from signing the ICF through 6 months after receiving the last dose of IP.
7 Spontaneous or induced abortion, still or live birth, or pregnancy ≤ 4 weeks before Screening.
8 Known history of a primary immunodeficiency or an underlying condition such as known human immunodeficiency virus (HIV) infection.
9 Hepatitis B, Hepatitis C, active TB, any severe herpes infection, clinically active infection, or opportunistic infection.
10 History of clinically significant cardiac disease.
11 History of cancer within the past 5 years, except:
12 In situ carcinoma of the cervix and Cutaneous basal cell.
13 Receipt of a live-attenuated vaccine within 4 weeks before Day 1 Administration of inactivated (killed) vaccines is acceptable.
14 The use of immunosuppressants, biologics and DMARDS within the protocol defined washout periods 
 
Method of Generating Random Sequence   Stratified randomization 
Method of Concealment   Centralized 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
Proportion of Participants who achieve BICLA and OGC (oral glucocorticoid) reduction response at Week 48.
Participants will have BICLA (BILAG 2004 Index-Based Combined Lupus Assessment)
and oral glucocorticoid assessment at week 48. 		 Week 48 
 
Secondary Outcome  
Outcome  TimePoints 
Proportion of Participants with CLASI-A score ≥ 10 at Baseline (Day 1) who achieve ≥ 50% reduction from Baseline (Day 1) in CLASI-A score at Week 12.
Cutaneous Lupus Erythematosus Disease Area and Severity Index will be measured at week 12. The scoring consists of 2 parts: inflammatory activity of the disease and damage done by the disease. 		 Week 12 
Proportion of Participants achieving an SRI-4 response and an OGC dose ≤ 7.5 mg/day and ≤ Baseline (Day 1) dose of prednisone or equivalent at Week 48.
The SRI-4 (SLE Responder Index) is defined as meeting all criteria compared to baseline, (e.g. no worsening of symptoms). 		 Week 48 
Proportion of Participants at OGC dose ≥ 10 mg prednisone or equivalent at Baseline (Day 1) who achieve an OCG of ≤ 7.5 mg/day prednisone or equivalent at Week 36 through Week 48.
 		 Week 36 to week 48 
Proportion of Participants achieving LLDAS (Lupus Low Disease Activity State) at Week 48.
LLDAS is a composite measure of SLE disease activity that measures 5 criteria: SLEDAI-2K ≤ 4, with no activity in major organ systems, no new lupus disease activity, PGA ≤ 1 (scale 0 to 3), current prednisone (or equivalent) dose ≤ 7.5 mg daily, tolerated maintenance doses of immunosuppressive drugs and approved biological agents 		 Week 48 
 
Target Sample Size   Total Sample Size="195"
Sample Size from India="20" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   22/08/2021 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  28/05/2021 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Closed to Recruitment of Participants 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  
Data from Phase 2  studies with interferon (IFN)α-blocking agents and a plasmacytoid dendritic cell (pDC) antagonist have demonstrated improvement in systemic lupus erythematosus (SLE) or cutaneous lupus disease activity, supporting the rationale for blocking the IFN pathways and pDCs in patients with SLE. Given the lack of highly efficacious and safe treatments for active SLE and the significant impact of this disease on health-related quality of life, there is currently a significant unmet need for new targeted therapies. Based on its mechanism of action (binding to immunoglobulin-like transcript 7 on the surface of pDCs, thus inducing apoptosis and reduction in the number of pDCs), VIB7734 has the potential to decrease SLE disease activity. In addition, based on data currently available, VIB7734 presents an acceptable safety profile, and hence it is justified to evaluate its potential efficacy in patients with active SLE.

In this study, approximately 195 participants will be randomized in a ratio of 1:1:1 (65 participants per group) to receive VIB7734 200 mg Q4W SC, VIB7734 200 mg every 12 weeks (Q12W) SC, with an additional 200 mg SC dose at Week 4, or placebo. To maintain blinding, participants randomized to the VIB7734 200 mg Q12W SC dosing regimen will receive SC placebo injections on dosing visits outside the Q12W schedule. Randomization will be stratified by SLE Disease Activity Index 2000 (SLEDAI-2K) total score at Screening (≥ 10 or < 10) and prednisone or equivalent oral GC (OGC) dose at Baseline (Day 1) (≥ 10 mg or < 10 mg).
Adults aged ≥ 18 to ≤ 70 years who have moderate to severely active (recent flares or chronic active disease) SLE as defined by the SLE Disease Activity Index 2000 (SLEDAI-2K), British Isles Lupus Assessment Group (BILAG) 2004 Index, and Physician Global Assessment (PGA). Stabilization of the SLE treatment regimen in SLE participants prior to Baseline (Day 1) decreases the confounding of the study results by the SoC (ie, changes in disease activity post- Baseline [Day 1] are more likely to be attributable to the introduction of VIB7734, rather than a change in background therapy).
Rationale for study population: Severe central nervous system (CNS) lupus and LN may be less responsive to therapy than other manifestations or may require different treatment regimens (eg, cyclophosphamide, IV Ig, highdose mycophenolate) than typically used in extrarenal SLE. Therefore, these individuals will be excluded from participating in this study. Also, individuals with significantly impaired renal function are excluded since they may have advanced, fixed disease that will not be responsive to therapy, and furthermore, these individuals are at higher risk for AEs. A urine protein: creatinine ratio (UPCr) of up to 3 mg/mg is allowed. This limit is applied because higher levels of proteinuria increase the risk of AEs.

Outcomes: 
1.Primary Objectives : To evaluate the effect of VIB7734 compared to placebo in reducing SLE disease activity at Week 48 in participants treated with standard of care therapy.
Outcome measure : Proportion of participants achieving a BILAG 2004 Index-based Combined Lupus Assessment (BICLA) response and an oral glucocorticoid (OGC) dose ≤ 7.5 mg/day and ≤ Baseline (Day 1) dose of prednisone or equivalent at Week 48.

2. Secondary Objectives: 
a. To evaluate the effect of VIB7734 compared with placebo to reduce cutaneous disease activity at Week 12.
Outcome measure : Proportion of participants with Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI)-Activity (CLASI-A) score ≥ 10 at Baseline (Day 1) who achieve ≥ 50% reduction from Baseline (Day 1) in CLASI-A score at Week 12. 
b. To evaluate the effect of VIB7734 compared with placebo to reduce SLE disease activity at Week 48.
Outcome measure : Proportion of participants achieving a Systemic Lupus Responder Index (SRI)-4 response and an OGC dose ≤ 7.5 mg/day and ≤ Baseline (Day 1) dose of prednisone or equivalent at Week 48.
c. To evaluate the effect of VIB7734 compared with placebo on sustained OGC reduction from Week 36 to Week 48.
Outcome measure : Proportion of participants at OGC dose ≥ 10 mg prednisone or equivalent at Baseline (Day 1) who achieve OGC dose ≤ 7.5 mg/day prednisone or equivalent at Week 36 and maintained through Week 48.
d. To evaluate the effect of VIB7734 compared with placebo to achieve low disease activity at Week 48.
Outcome measure : Proportion of participants achieving Lupus Low Disease Activity State at Week 48.

 
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