Trial · NCT07047690
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline (BL) in Modified Rodnan Skin Score (mRSS) at Week 52 | Baseline, 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. |
| Secondary | Change From Baseline in Forced Vital Capacity (FVC) at Week 52 | Baseline, at Week 52 | FVC will be assessed with the Flow screen spirometer. |
| Secondary | Proportion of Responders to the Treatment Based on the Revised Composite Response Index in Systemic Sclerosis (rCRISS) at Week 52 | 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. |
| Secondary | Change From Baseline in mRSS at Weeks 8, 12, 24, 28, 36, 44, 52 | Baseline, at Week 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. |
| Secondary | Percent change from Baseline in mRSS at Week 52 | Baseline, 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. |
| Secondary | Change from Baseline in Percent Predicted FVC (ppFVC) at Week 52 | Baseline, at Week 52 | FVC will be assessed with the Flow screen spirometer. |
| Secondary | Percent Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 52 | Baseline, 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. |
| Secondary | Percent Change From Baseline in Patient's Global Assessment (PGA) Score at Week 52 | Baseline, 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. |
| Secondary | Percent Change From Baseline in Clinician's Global Assessment (CGA) Score at Week 52 | Baseline, 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. |
| Secondary | 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. | From baseline of study intervention to 12 weeks after last dose (52 weeks) | 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). |
| Secondary | Incidence of Abnormal Vital Signs | From baseline of study intervention to 12 weeks after last dose (52 weeks) | 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. |
| Secondary | Incidence of Abnormal Laboratory Parameters | From baseline of study intervention to 12 weeks after last dose (52 weeks) | Change from BL in hematology, clinical chemistry, and lipid variables will be assessed by visit and treatment group including participants with treatment-emergent changes. |
| Secondary | Incidence of Abnormal Electrocardiogram (ECG) Findings | From baseline of study intervention to 12 weeks after last dose (52 weeks) | 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. |
| Secondary | Incidence of Abnormal Weight Change | From baseline of study intervention to 12 weeks after last dose (52 weeks) | Change from BL in weight (kilograms) will be assessed by visit and treatment and medically significant changes will be recorded as adverse events. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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