Effectiveness and Safety of SAR156597 in Treating Diffuse Systemic Sclerosis

NCT02921971 | Completed Phase 2 Results DMC FDA Drug

• 3 other identifiers: ACT146042016-001028-80U1111-1179-4690
• Study Type: interventional
• Target: 97
• Locations: 13 countries
• Sites: 44

Brief Summary

Primary Objective: To evaluate, in comparison with placebo, the efficacy of SAR156597 administered subcutaneously for 24 weeks on skin fibrosis in participants with diffuse cutaneous systemic sclerosis (dcSSc). Secondary Objectives:

• To evaluate the efficacy of SAR156597 compared to placebo on physical/functional disability in participants with dcSSc.
• To evaluate the efficacy of SAR156597 compared to placebo on respiratory function of participants with dcSSc.
• To evaluate the safety profile of SAR156597 compared to placebo in participants with dcSSc.
• To evaluate the potential for immunogenicity (anti-drug antibodies response) of SAR156597 in participants with dcSSc.
• To evaluate the pharmacokinetics (trough plasma concentrations) of SAR156597 administered subcutaneously for 24 weeks.

Conditions

Systemic Sclerosis

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Modified Rodnan Skin Score to Week 24

  mRSS, an accepted clinical measure of the skin thickness (fibrosis). Investigator physicians or qualified medical personnel assessed the thickening of skin in 17 skin sites including fingers, hands, forearms, arms, feet, legs and thighs, face, chest and abdomen. Each skin site was rated on a 0-3 scale; where 0 = normal skin, 1 = mild thickness, 2 = moderate thickness and 3 = severe thickness. Total mRSS ranged from 0 (no thickening) to 51 (severe thickening in all 17 areas), where higher score indicated more severity of skin thickening/worst outcome.

  Baseline, Week 24

Secondary Outcomes (3)

• Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score to Week 24

  Baseline, Week 24

• Change From Baseline in Mean Observed Forced Vital Capacity (FVC) Level to Week 24

  Baseline, Week 24

• Change From Baseline in Mean Observed Diffusing Lung Capacity for Carbon Monoxide (DLco) to Week 24

  Baseline, Week 24

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo (for SAR156597), single subcutaneous (SC) injection once in a week (QW) up to Week 24.

Drug: Placebo

SAR156597

EXPERIMENTAL

SAR156597 200 milligram (mg), single SC injection QW up to Week 24.

Drug: SAR156597

Interventions

SAR156597 DRUG

Pharmaceutical form: Solution Route of administration: Subcutaneous

Also known as: Romilkimab

SAR156597

Placebo DRUG

Pharmaceutical form: Solution Route of administration: Subcutaneous

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Systemic Sclerosis (SSc) according to the American College of Rheumatology/The European League against Rheumatism (ACR/EULAR) 2013 criteria.
• Diffused cutaneous form of SSc according to Leroy's criteria.
• Able and willing to sign the written informed consent form with comprehension of its contents and complied with the requirements of the study protocol.

You may not qualify if:

• Aged less than (\<) 18 years of age.
• Disease duration for greater than (\>) 36 months from time of first non-Raynaud's phenomenon manifestation.
• Modified Rodnan Skin Score \<10 or \>35 at screening and baseline visits.
• History of vasculitis, active or in remission.
• Diagnosis of connective tissue diseases (other than SSc) or overlap syndrome (eg, polymyositis/scleroderma).
• Positive Human Immunodeficiency Virus (HIV) serology or a known history of HIV infection, active or in remission.
• Abnormal hepatitis B and/or hepatitis C tests indicative of active or chronic infection:
• Abnormal Hepatitis B tests: Positive hepatitis B surface antigen (HBsAg) OR positive total hepatitis B core antibody (HBcAb) with negative hepatitis B surface antibody (HBsAb) OR positive total HBcAb with positive HBsAb and presence of hepatitis B virus deoxyribonucleic acid.
• Abnormal Hepatitis C tests: Positive anti-hepatitis C virus antibody (HCV Ab) and positive HCV ribonucleic acid.
• Positive or 2 confirmed indeterminate Quantiferon-tuberculosis Gold tests at screening (regardless of prior treatment status).
• Serious infection (eg, pneumonia, pyelonephritis) within 4 weeks of screening, infection requiring hospitalization or intravenous antibiotics within 4 weeks of screening or chronic bacterial infection (eg, osteomyelitis).
• History of anaphylaxis to any biologic therapy.
• Evidence of any clinically significant, severe or unstable, acute or chronically progressive, uncontrolled infection or medical condition (eg, cerebral, cardiac, pulmonary, renal, hepatic, gastrointestinal or neurologic other than SSc or SSc-interstitial lung disease) or previous, active or pending surgical disorder, or any condition that may affect participant safety in the judgment of the Investigator.
• At screening, the percent (%) predicted forced vital capacity was less than or equal to (\<=75) % and % predicted carbon monoxide diffusing lung capacity after hemoglobin correction is \<=40%.
• History of heart failure (including acutely decompensated in the setting of preserved ejection fraction), left ventricular ejection fraction \<= 45%, coronary artery disease, angina, myocardial infarction, ischemic cardiomyopathy and/or hypertrophic cardiomyopathy.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (44)

Investigational Site Number 8400006

San Francisco, California, 94143, United States

Location

Investigational Site Number 8400005

Washington D.C., District of Columbia, 20007, United States

Location

Investigational Site Number 8400002

Cleveland, Ohio, 44195, United States

Location

Investigational Site Number 8400007

Houston, Texas, 77030, United States

Location

Investigational Site Number 0320003

Buenos Aires, C1015ABO, Argentina

Location

Investigational Site Number 0320002

Caba, C1181ACH, Argentina

Location

Investigational Site Number 0320005

Capital Federal, C1280AEB, Argentina

Location

Investigational Site Number 0320001

San Miguel de Tucumán, T4000AXL, Argentina

Location

Investigational Site Number 0560001

Ghent, 9000, Belgium

Location

Investigational Site Number 0560002

Leuven, 3000, Belgium

Location

Investigational Site Number 2330001

Tallinn, 13419, Estonia

Location

Investigational Site Number 2500003

Montpellier, 34295, France

Location

Investigational Site Number 2500004

Paris, 75014, France

Location

Investigational Site Number 2500002

Strasbourg, 67098, France

Location

Investigational Site Number 2760003

Bad Nauheim, 61231, Germany

Location

Investigational Site Number 2760001

Berlin, 10117, Germany

Location

Investigational Site Number 2760002

Cologne, 50937, Germany

Location

Investigational Site Number 2760004

Ulm, 89081, Germany

Location

Investigational Site Number 3800004

Genova, 16132, Italy

Location

Investigational Site Number 3800001

Milan, 20122, Italy

Location

Investigational Site Number 3800005

Milan, 20122, Italy

Location

Investigational Site Number 3800006

Orbassano, 10043, Italy

Location

Investigational Site Number 4840001

Chihuahua City, 31000, Mexico

Location

Investigational Site Number 4840005

Guadalajara, 44160, Mexico

Location

Investigational Site Number 4840002

Guadalajara, 44690, Mexico

Location

Investigational Site Number 4840003

Monterrey, 64460, Mexico

Location

Investigational Site Number 6160001

Poznan, 61-397, Poland

Location

Investigational Site Number 6160002

Warsaw, 02-691, Poland

Location

Investigational Site Number 6160003

Wroclaw, 52-416, Poland

Location

Investigational Site Number 6420003

Bucharest, 011172, Romania

Location

Investigational Site Number 6420004

Bucharest, 011172, Romania

Location

Investigational Site Number 6420005

Bucharest, 020475, Romania

Location

Investigational Site Number 6420001

Cluj-Napoca, 400006, Romania

Location

Investigational Site Number 6420002

Târgu Mureş, 540142, Romania

Location

Investigational Site Number 6430002

Kemerovo, 650000, Russia

Location

Investigational Site Number 6430005

Moscow, 115404, Russia

Location

Investigational Site Number 6430001

Moscow, 115522, Russia

Location

Investigational Site Number 6430004

Moscow, 125284, Russia

Location

Investigational Site Number 6430003

Ufa, 450005, Russia

Location

Investigational Site Number 8040001

Kyiv, 02125, Ukraine

Location

Investigational Site Number 8040002

Kyiv, 03151, Ukraine

Location

Investigational Site Number 8040004

Kyiv, 04050, Ukraine

Location

Investigational Site Number 8040003

Kyiv, 04070, Ukraine

Location

Investigational Site Number 8260001

London, United Kingdom

Location

Related Publications (1)

• Allanore Y, Wung P, Soubrane C, Esperet C, Marrache F, Bejuit R, Lahmar A, Khanna D, Denton CP; Investigators. A randomised, double-blind, placebo-controlled, 24-week, phase II, proof-of-concept study of romilkimab (SAR156597) in early diffuse cutaneous systemic sclerosis. Ann Rheum Dis. 2020 Dec;79(12):1600-1607. doi: 10.1136/annrheumdis-2020-218447. Epub 2020 Sep 22.

  PMID: 32963047 DERIVED

MeSH Terms

Conditions

Scleroderma, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Results Point of Contact

• Title: Trial Transparency Team
• Organization: Sanofi

Contact-US@sanofi.com

800-633-1610

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2016
• First Posted: October 3, 2016
• Study Start: December 21, 2016
• Primary Completion: January 14, 2019
• Study Completion: April 1, 2019
• Last Updated: March 21, 2022
• Results First Posted: February 2, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will share

Locations

RO (5); UA (4); US (4); RU (5); GB (1); IT (4); DE (4); ES (1); BE (2); AR (4); ME (4); FR (3); PL (3)