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Systemic SclerosisPhase 2NCT02921971

Effectiveness and Safety of SAR156597 in Treating Diffuse Systemic Sclerosis

A Phase 2 study testing SAR156597 in people with Systemic Sclerosis, run by Sanofi at 44 sites in 13 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Systemic Sclerosis
What is being tested?
SAR156597
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
97 participants
Where
44 sitesin 13 countries
Study dates
21 Dec 2016to 1 Apr 2019
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 35Show fewer
  • 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.
  • Any prior history of malignancy or active malignancy, including lymphoproliferative diseases (except successfully-treated carcinoma in-situ of the cervix, non-metastatic squamous cell carcinoma or basal cell carcinoma of the skin) within 5 years prior to baseline.
  • Ischemic electrocardiogram (ECG) changes (except those not supported by the findings of a left heart catheterization performed in the last year) and/or other clinically significant ECG findings. (All abnormal ECG finding were reviewed and confirmed by a local cardiologist).
  • High dose steroids (>10 mg/day prednisolone equivalent); or change in steroid dose within 4 weeks prior to randomization (or baseline visit); or expected changes during the course of the study.
  • Previous treatment with rituximab within 12 months prior to screening.
  • Previous treatment with bone marrow transplantation, total lymphoid irradiation or ablative ultra-high dose cyclophosphamide.
  • Treatment with high dose immunosuppressive drug (eg, cyclophosphamide >1 mg/kilogram (kg) oral/day or >750 mg intravenous (IV)/month; azathioprine >100 mg/day; methotrexate >15 mg/week; mycophenolate mofetil >2 gram (g)/day) within 3 months of screening or change in dose within 4 weeks prior to randomization (or baseline visit); or expected changes in dose during the course of the study.
  • Treatment with etanercept, cyclosporine A, IV immunoglobulin, rapamycin, D-penicillamine, tyrosine kinase inhibitors within 4 weeks of screening or antithymocyte globulin within 6 months of screening.
  • Treatment with infliximab, certolizumab, golimumab, abatacept, or adalimumab, tocilizumab within 8 weeks of screening or anakinra within 1 week of screening.
  • Treatment with any investigational drug within 1 month of screening, or 5 half-lives, if known (whichever was longer).
  • Abnormal laboratory tests at screening:
  • Alanine transaminase or aspartate transaminase >2 times upper limit of normal range;
  • Hemoglobin <11 g/100 milliliter (mL) for male and <10 g/100 mL for female;
  • Neutrophils <1500/mm^3 (except <1000/mm^3 for those of African descent);
  • Platelets <100 000/mm^3;
  • Creatinine greater than or equal to (>=)150 micromole/Liter (mcgmol/L).
  • Current history of substance and/or alcohol abuse.
  • Any condition or circumstance that would preclude the participant from following and completing protocol requirements, in the opinion of the Investigator.
  • Pregnant or breastfeeding woman.
  • Women who were of childbearing potential not protected by highly-effective contraceptive method(s) of birth control, and/or who were unwilling or unable to be tested for pregnancy.
  • The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Trial locations and contacts

44 sites in 13 countries.

44 sites in 13 countries

Romania5 sites

  • Investigational Site Number 6420003

    Bucharest, 011172

  • Investigational Site Number 6420004

    Bucharest, 011172

  • Investigational Site Number 6420005

    Bucharest, 020475

  • Investigational Site Number 6420001

    Cluj-Napoca, 400006

  • Investigational Site Number 6420002

    Târgu Mureş, 540142

Other trials in Romania

Russia5 sites

  • Investigational Site Number 6430002

    Kemerovo, 650000

  • Investigational Site Number 6430005

    Moscow, 115404

  • Investigational Site Number 6430001

    Moscow, 115522

  • Investigational Site Number 6430004

    Moscow, 125284

  • Investigational Site Number 6430003

    Ufa, 450005

Other trials in Russia

United States4 sites

  • Investigational Site Number 8400002

    Cleveland, Ohio, 44195

  • Investigational Site Number 8400007

    Houston, Texas, 77030

  • Investigational Site Number 8400006

    San Francisco, California, 94143

  • Investigational Site Number 8400005

    Washington D.C., District of Columbia, 20007

Other trials in United States

Argentina4 sites

  • Investigational Site Number 0320003

    Buenos Aires, C1015ABO

  • Investigational Site Number 0320002

    Caba, C1181ACH

  • Investigational Site Number 0320005

    Capital Federal, C1280AEB

  • Investigational Site Number 0320001

    San Miguel de Tucumán, T4000AXL

Other trials in Argentina

Germany4 sites

  • Investigational Site Number 2760003

    Bad Nauheim, 61231

  • Investigational Site Number 2760001

    Berlin, 10117

  • Investigational Site Number 2760002

    Cologne, 50937

  • Investigational Site Number 2760004

    Ulm, 89081

Other trials in Germany

Italy4 sites

  • Investigational Site Number 3800004

    Genova, 16132

  • Investigational Site Number 3800001

    Milan, 20122

  • Investigational Site Number 3800005

    Milan, 20122

  • Investigational Site Number 3800006

    Orbassano, 10043

Other trials in Italy

Mexico4 sites

  • Investigational Site Number 4840001

    Chihuahua City, 31000

  • Investigational Site Number 4840005

    Guadalajara, 44160

  • Investigational Site Number 4840002

    Guadalajara, 44690

  • Investigational Site Number 4840003

    Monterrey, 64460

Other trials in Mexico

Ukraine4 sites

  • Investigational Site Number 8040001

    Kyiv, 02125

  • Investigational Site Number 8040002

    Kyiv, 03151

  • Investigational Site Number 8040004

    Kyiv, 04050

  • Investigational Site Number 8040003

    Kyiv, 04070

Other trials in Ukraine

France3 sites

  • Investigational Site Number 2500003

    Montpellier, 34295

  • Investigational Site Number 2500004

    Paris, 75014

  • Investigational Site Number 2500002

    Strasbourg, 67098

Other trials in France

Poland3 sites

  • Investigational Site Number 6160001

    Poznan, 61-397

  • Investigational Site Number 6160002

    Warsaw, 02-691

  • Investigational Site Number 6160003

    Wroclaw, 52-416

Other trials in Poland

Belgium2 sites

  • Investigational Site Number 0560001

    Ghent, 9000

  • Investigational Site Number 0560002

    Leuven, 3000

Other trials in Belgium

Estonia1 site

  • Investigational Site Number 2330001

    Tallinn, 13419

Other trials in Estonia

United Kingdom1 site

  • Investigational Site Number 8260001

    London

Other trials in United Kingdom

About this study

Official title: Efficacy and Safety of SAR156597 in the Treatment of Diffuse Cutaneous Systemic Sclerosis (dcSSc): A Randomized, Double-blind, Placebo-controlled, 24-week, Proof of Concept Study

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).

Read more

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.
Read the detailed description

The total study duration per participant was 39 weeks; consisting of a 4-week screening, a 24-week of study treatment period, and an 11-week follow-up with no study drug treatment.

Being tested
SAR156597, Placebo
Medical subject headings
Scleroderma, Systemic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SAR156597Drug

    Also called Romilkimab

    Pharmaceutical form: Solution Route of administration: Subcutaneous

  • PlaceboDrug

    Pharmaceutical form: Solution Route of administration: Subcutaneous

Study groups in NCT02921971
Study groupRoleWhat they receive
PlaceboPlacebo comparatorPlacebo (for SAR156597), single subcutaneous (SC) injection once in a week (QW) up to Week 24.
Receives: Drug: Placebo
SAR156597ExperimentalSAR156597 200 milligram (mg), single SC injection QW up to Week 24.
Receives: Drug: SAR156597

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline, Week 24

Secondary outcomes (3)

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

    HAQ-DI assessed the degree of difficulty participants experienced in 8 daily living activity domains during past week: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and common daily activities. Each activity category consisted of 2-3 items. For each items, level of difficulty was scored from 0-3 (0=no difficulty, 1=some difficulty, 2=much difficulty, 3=unable to do). Overall HAQ-DI score was computed as the sum of domain scores divided by the number of domains answered, providing a score from 0 (no difficulty) to 3 (maximum difficulty), where higher score indicated greater disability.

    Measured: Baseline, Week 24

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

    FVC was the total amount of air (in liters) exhaled from the lungs during the lung function test measured by spirometer which assessed the change in lung function related to the disease status of an underlying ILD. Change from Baseline was calculated by subtracting Baseline value from Week 24 value.

    Measured: Baseline, Week 24

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

    DLco is a measurement of the ability of the lungs to transfer gases from the air to the blood. Participant breathe in (inhale) air containing a very small, harmless amount of a tracer gas, such as carbon monoxide. Participant hold the breath for 10 seconds, then rapidly blow it out (exhale). The exhaled gas was tested to determine amount of the tracer gas absorbed during the breath.

    Measured: Baseline, Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Oct 2016 (estimated)
  2. Study start21 Dec 2016
  3. Primary completion14 Jan 2019
  4. Study completion1 Apr 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
97 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02921971
Sponsor's protocol ID
ACT14604
Other IDs
2016-001028-80, U1111-1179-4690, 2016
Status last verified
Mar 2022
First submitted
30 Sep 2016
Last updated
21 Mar 2022
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Publications

  • 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.

    PubMed 32963047

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SAR156597 in people with Systemic Sclerosis, run by Sanofi at 44 sites in 13 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 35 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 44 sites in Romania, Russia, United States, Argentina, Germany and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Feb 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Modified Rodnan Skin Score to Week 24 (time frame: Baseline, Week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02921971, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2022.

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