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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
162
Subcutaneous Injection
Subcutaneous Injection
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 52
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 52
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 52
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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Baseline, at Week 8, 12, 24, 28, 36, 44, 52
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 52
Change from Baseline in Percent Predicted FVC (ppFVC) at Week 52
FVC will be assessed with the Flow screen spirometer.
Time frame: Baseline, at Week 52
Percent Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 52
HAQ-DI is a participant-reported questionnaire and sensitive to change in disease activity (cutaneous and visceral involvement and with changes in physiological parameters over time).Each question is rated on a 0 to 3 scale (0 = without difficulty; 3 = unable to do), and additional points can be added if aids or devices (i.e., cane, walker) are needed for specific activities. An increased score indicated worse functionality.
Time frame: Baseline, at Week 52
Percent Change From Baseline in Patient's Global Assessment (PGA) Score at Week 52
The participant's global impression of health Numeric Rating Scale 0-10 (NRS) will be self-administered by the participant. 0 represents excellent and 10 represents extremely poor.
Time frame: Baseline, at Week 52
Percent Change From Baseline in Clinician's Global Assessment (CGA) Score at Week 52
The clinician global impression of health Numeric Rating Scale 0-10 (NRS) will be filled out by the participant's clinician after all other study procedures have been completed. 0 represents excellent and 10 represents extremely poor.
Time frame: Baseline, at Week 52
Incidence and Severity of TEAEs, Treatment-Emergent SAEs, Treatment-Emergent AEs of Special Interest (AESIs), Significant SSc-Related TEAEs, TEAEs Leading to Investigational Product Discontinuation and Study Discontinuation.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. A Serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose, meets one or more of the criteria listed: Results in death, life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, congenital anomaly/birth defect, Other serious (important medical events).
Time frame: From baseline of study intervention to 12 weeks after last dose (52 weeks)
Incidence of Abnormal Vital Signs
Change from BL in pulse rate, blood pressure, respiration rate, and body temperature will be assessed by visit and treatment group including participants with treatment emergent changes.
Time frame: From baseline of study intervention to 12 weeks after last dose (52 weeks)
Incidence of Abnormal Laboratory Parameters
Change from BL in hematology, clinical chemistry, and lipid variables will be assessed by visit and treatment group including participants with treatment-emergent changes.
Time frame: From baseline of study intervention to 12 weeks after last dose (52 weeks)
Incidence of Abnormal Electrocardiogram (ECG) Findings
Observed values of heart rate, QRS duration, PR interval, RR interval and QT interval will be summarized by visit and treatment group including participants with clinically significant abnormal results.
Time frame: From baseline of study intervention to 12 weeks after last dose (52 weeks)
Incidence of Abnormal Weight Change
Change from BL in weight (kilograms) will be assessed by visit and treatment and medically significant changes will be recorded as adverse events.
Time frame: From baseline of study intervention to 12 weeks after last dose (52 weeks)