Effectiveness and Safety of SAR156597 in Treating Diffuse Systemic Sclerosis

• Register: ClinicalTrials.gov
• Last refreshed on: 21 March 2022
• Main ID: NCT02921971
• Date of registration: 30/09/2016
• Prospective Registration: Yes
• Primary sponsor: Sanofi
• Public title: Effectiveness and Safety of SAR156597 in Treating Diffuse Systemic Sclerosis
• Scientific 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
• Date of first enrolment: December 21, 2016
• Target sample size: 97
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02921971
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

Argentina, Austria, Belgium, Estonia, France, Germany, Italy, Mexico, Poland, Romania, Russian Federation, Ukraine, United Kingdom, United States

Contacts

• Name: Clinical Sciences & Operations
• Affiliation: Sanofi

Key inclusion & exclusion criteria

Inclusion criteria :

- 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.

Exclusion criteria:

- 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.

- 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Systemic Sclerosis

Intervention(s)

Drug: Placebo

Drug: SAR156597

Primary Outcome(s)

Change From Baseline in Modified Rodnan Skin Score to Week 24 [Time Frame: Baseline, Week 24]

Secondary Outcome(s)

Change From Baseline in Mean Observed Diffusing Lung Capacity for Carbon Monoxide (DLco) to Week 24 [Time Frame: Baseline, Week 24]

Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score to Week 24 [Time Frame: Baseline, Week 24]

Change From Baseline in Mean Observed Forced Vital Capacity (FVC) Level to Week 24 [Time Frame: Baseline, Week 24]

Secondary ID(s)

U1111-1179-4690

ACT14604

2016-001028-80

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 02/02/2022
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02921971