Trial · NCT06141473
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 17 of 17
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Annualized relapse rate (ARR) during the study period assessed by protocol defined adjudicated relapses | Until Week 156 | ARR during the study period assessed by protocol-defined adjudicated relapses. This endpoint will be analyzed in the ITT population of each study using a negative binomial model with the total number of adjudicated relapses per participant occurring during the observation period as the response variable and with terms for treatment group, Gd-enhancing T1 lesions at baseline (presence, absence), EDSS strata (\<4, ≥4), and geographical region (US, non-US). |
| Secondary | Time to onset of composite confirmed disability worsening (cCDW) | Until Week 156 | confirmed over 6 months as assessed by the composite of: * increase from the baseline expanded disability status scale (EDSS) score of ≥1.5 points when the baseline is 0, or ≥1.0 point when the baseline is 0.5 to 5.0, or ≥0.5 point when the baseline is ≥5.5, OR * increase of ≥20% from the baseline time in the 9-hole peg test (9HPT), OR * increase of ≥20% from the baseline time in the Timed 25-foot walk (T25FW) test |
| Secondary | Time to onset of cCDW, confirmed over 3 months | Until Week 156 | |
| Secondary | Time to onset of individual components of the composite, confirmed over 3-months or 6-months | Until Week 156 | |
| Secondary | Time to onset of confirmed disability improvement (CDI) | Until Week 156 | defined as decrease from baseline EDSS score of ≥1.0 or ≥ 0.5 points when the baseline is ≥2 to ≤5.5 or \>5.5 points, respectively, confirmed over 6 months. No improvement possible for 0 to 1.5 points |
| Secondary | Progression independent of relapse activity defined as the time to onset of 6-month cCDW | Until Week 156 | defined by either no prior relapse or an onset more than 90 days after the start date of the last adjudicated relapse |
| Secondary | Total number of new and/or enlarging T2 hyperintense lesions as detected by MRI | Until Week 156 | defined as the sum of the individual number of new and/or enlarging T2 lesions at all scheduled visits starting after baseline up to and including the EOS visit |
| Secondary | Total number of new Gd-enhancing T1hyperintense lesions per scan as detected by MRI | Until Week 156 | defined as the sum of the individual number of new Gd enhancing T1-hyperintense lesions at all scheduled visits starting after baseline up to and including the EOS visit divided by the number of scans |
| Secondary | Percent change in brain volume loss as detected by brain MRI scans at the EOS compared to Month 6 | From Week 24 to Week 156 | |
| Secondary | Change in cognitive function at the EOS compared to baseline as assessed by the symbol digit modalities test (SDMT) | From baseline to Week 156 | |
| Secondary | Change from baseline in multiple sclerosis impact scale 29 version 2 (MSIS-29v2) questionnaire scores over time | From baseline to Week 156 | |
| Secondary | Change from baseline in patient reported outcome measurement information system (PROMIS) Fatigue MS-8 over time | Until Week 156 | |
| Secondary | Number of participants with adverse events, SAEs, AEs leading to permanent study intervention discontinuation, AESIs and safety scales during the study period | Until Week 168 | |
| Secondary | Number of participants with potentially clinically significant abnormality (PCSAs) in laboratory tests, ECG and vital signs during the study period | Until Week 168 | 12-lead ECG (electrocardiogram) will be obtained using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QTc intervals. |
| Secondary | Number of participants with antidrug (ADAs) over time | Until Week 156 | |
| Secondary | Change from baseline in plasma neurofilament light chain (NfL) levels over time | Until Week 144 | |
| Secondary | Frexalimab plasma concentration over time | Until Week 144 |
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.
For software
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GET https://conductscience.org/api/trials/v1/NCT06141473/registered