Trial · NCT07220252
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 18 of 18
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Part A: Area Under the Curve From Week 0 to 24 (AUC0-W24) of Ublituximab | Predose and multiple timepoints up to Week 24 | |
| Primary | Part A: Maximum Observed Concentration (Cmax) of Ublituximab | Day 1 and Day 15 | |
| Primary | Part A: Participant B Cell Counts | Up to Week 24 | |
| Primary | Part B: Annualized Relapse Rate (ARR) | Up to 96 weeks | |
| Primary | Part C: Annualized Relapse Rate (ARR) | Up to 168 weeks | |
| Secondary | Part A, B and C: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Part A: Up to Week 24; Part B: Up to 96 weeks; Part C: Up to 168 weeks | |
| Secondary | Part A, B and C: Number of Participants With Change in Columbia-Suicide Severity Rating Scale (C-SSRS ) | Part A: Up to Week 24; Part B: Up to 96 weeks; Part C: Up to 168 weeks | |
| Secondary | Part A: Serum Concentrations of Ublituximab | Up to Week 24 | |
| Secondary | Part A and B: Percentage of Participants with Treatment-emergent Anti-drug Antibodies (ADAs) to Ublituximab | Part A: Up to Week 24; Part B: Up to 96 weeks | |
| Secondary | Part A and B: Number of Gadolinium Enhancing (Gd-enhancing) T1 Lesions per Magnetic Resonance Imaging (MRI) Scan | Part A: Up to Week 24; Part B: Up to 96 weeks | |
| Secondary | Part A and B: Number of New and/or enlarging T2 Hyperintense Lesions (NELs) per MRI Scan | Part A: Up to Week 24; Part B: Up to 96 weeks | |
| Secondary | Past A: Annualized Relapse Rate | Up to Week 24 | |
| Secondary | Part A and C: Change From Baseline in Expanded Disability Status Scale (EDSS) Score | Part A: Baseline, up to Week 24; Part C: Baseline, up to 168 weeks | |
| Secondary | Part B: Pharmacokinetics (PK) Serum Concentration of Ublituximab | Up to Week 96 | |
| Secondary | Part B: Percentage of Participants with CD19+ B cell counts ≤10 cells/uL | Up to 96 weeks | |
| Secondary | Part B: Annualized Relapse Rate ARR | Up to Week 96 | |
| Secondary | Part C: Time to Confirmed Disability Progression (CDP) | Up to Week 24 | |
| Secondary | Part C: Time to Confirmed Disability Improvement (CDI) | Up to Week 24 |
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
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT07220252/registered