A Study of Nemolizumab for the Treatment of Adults With Systemic Sclerosis
ConditionSystemic Sclerosis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorGalderma R&D
About this trial
The main purpose of the study is to investigate the efficacy on cutaneous thickness and the safety of Nemolizumab in adult patients with systemic sclerosis after a 52-week treatment period and to select the optimal dose for this target population.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Participant must be 18 years of age or older, at the time of signing the Informed Consent Form.
Classification of systemic sclerosis (SSc) as defined by the 2013 American College of Rheumatology [ACR]/European League Against Rheumatism [EULAR] criteria.
Modified Rodnan Skin Score.
Diffuse cutaneous systemic sclerosis (DcSSc) participants and modified Rodnan Skin Score (mRSS) of greater than equal to (>=)12 and less than (<)30 at both screening and baseline
Disqualifiers
Anti-centromere antibody positive at screening for participants with LcSSc.
Anti-RNA polymerase 3 antibody positive for participants with a disease duration >18months.
Creatinine clearance <30 milli liter per minute [ml/min] (calculated by Cockcroft-Gault formula).
Positive serology results (hepatitis B surface antigen [HBsAg] or hepatitis B core antibody [HbcAb], hepatitis C [HCV] antibody with positive confirmatory test for hepatitis C virus [HCV] antibody with positive HCV RNA, or human immunodeficiency virus [HIV] antibody).
Trial design
Design model
Parallel
Treatments tested in this trial
Nemolizumab
DrugSubcutaneous Injection
Placebo
DrugSubcutaneous Injection
Treatment groups
162 Participants
are divided into 3 treatment groupsGroup A: Nemolizumab Dose 1Experimental treatment 1 intervention
Group B: Nemolizumab Dose 2Experimental treatment 1 intervention
Group C: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change From Baseline (BL) in Modified Rodnan Skin Score (mRSS) at Week 52
mRSS is the assessment of skin involvement includes semiquantitative estimation of skin thickness, pliability (hardness), and fixation to underlying structures (tethering).Cutaneous thickness is assessed in 17 body surface areas using a 0-3 scale, where mRSS of score 0="normal" with fine wrinkles but no skin thickness; score 1="mild" skin thickness; score 2= "moderate" skin thickness with difficulty in making skin folds and no wrinkles; and score 3="severe" skin thickness with inability to make skin folds between 2 examining fingers. Where higher score indicating more severe disease.
Time frame
Baseline, at Week 52Secondary outcomes
1
Change From Baseline in Forced Vital Capacity (FVC) at Week 52
FVC will be assessed with the Flow screen spirometer.
Time frame
Baseline, at Week 522
Proportion of Responders to the Treatment Based on the Revised Composite Response Index in Systemic Sclerosis (rCRISS) at Week 52
Responders are defined as participants who meet all the following criteria: Improvement in 2 out of the 5 rCRISS components \>=5% absolute increase from BL in ppFVC (percent predicted forced vital capacity), \>=25% relative decrease from BL in mRSS, Health Assessment Questionnaire Disability Index (HAQ-DI), PGA (Patient's Global Assessment), CGA(Clinician/Physician's Global Assessment) score. Worsening in no more than 1 rCRISS component \>=5% absolute decrease from BL in ppFVC, \>=25% relative increase from BL in mRSS, HAQ-DI, PGA, CGA score. No significant SSc-related event.
Time frame
At Week 523
Change From Baseline in mRSS at Weeks 8, 12, 24, 28, 36, 44, 52
mRSS is the assessment of skin involvement includes semiquantitative estimation of skin thickness, pliability (hardness), and fixation to underlying structures (tethering).Cutaneous thickness is assessed in 17 body surface areas using a 0-3 scale, where mRSS of score 0="normal" with fine wrinkles but no skin thickness; score 1="mild" skin thickness; score 2= "moderate" skin thickness with difficulty in making skin folds and no wrinkles; and score 3="severe" skin thickness with inability to make skin folds between 2 examining fingers. Where higher score indicating more severe disease.
Time frame
Baseline, at Week 8, 12, 24, 28, 36, 44, 524
Percent change from Baseline in mRSS at Week 52
mRSS is the assessment of skin involvement includes semiquantitative estimation of skin thickness, pliability (hardness), and fixation to underlying structures (tethering).Cutaneous thickness is assessed in 17 body surface areas using a 0-3 scale, where mRSS of score 0="normal" with fine wrinkles but no skin thickness; score 1="mild" skin thickness; score 2= "moderate" skin thickness with difficulty in making skin folds and no wrinkles; and score 3="severe" skin thickness with inability to make skin folds between 2 examining fingers. Where higher score indicating more severe disease.
Time frame
Baseline, at Week 52Sponsors and contacts
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Source ClinicalTrials.gov