Trial · NCT05869955
Registered outcomes22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 22
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of participants with treatment-emergent adverse events (AEs) in each indication. | Up to 2 years after CC-97540 infusion | |
| Primary | Number of participants with serious AEs (SAEs) in each indication. | Up to 2 years after CC-97540 infusion | |
| Primary | Number of participants with AEs of special interest (AESI) in each indication. | Up to 2 years after CC-97540 infusion | |
| Primary | Number of participants with laboratory abnormalities in each indication. | Up to 2 years after CC-97540 infusion | |
| Primary | Number of participants with Dose Limiting Toxicities (DLT) in each indication. | Up to 2 years after CC-97540 infusion | |
| Primary | Recommended Phase 2 Dose (RP2D) of CC-97540 in each indication. | Up to 2 years after CC-97540 infusion | |
| Secondary | Proportion of participants achieving definition of remission in SLE (DORIS) remission | At week 24 | SLE Cohort |
| Secondary | Proportion of participants achieving Lupus Low Disease Activity State (LLDAS) | At week 24 | SLE Cohort |
| Secondary | Change in proteinuria measured by urine protein creatinine ratio (UPCR) | At week 24 | SLE Cohort |
| Secondary | Change in Health Assessment Questionnaire - Disability Index (HAQ-DI) | At week 24 | |
| Secondary | Proportion of participants achieving Myositis Response Criteria (MRC) Total Improvement Score (TIS) Major Response | At Week 24 | IIM Cohort |
| Secondary | Change in the Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) | At Week 24 | Only Dermatomyositis (DM) participants in the IIM Cohort |
| Secondary | Proportion of participants with ILD with no worsening of pulmonary function including forced expiratory volume (FEV1) (> 10%), forced vital capacity (FVC) (> 10%), and diffusing capacity of the lung for carbon monoxide (DLCO) (> 15%) | At Week 24 | IIM Cohort |
| Secondary | Proportion of participants achieving a minimal clinically important difference (MCID) of 24% change from baseline of the modified Rodnan Skin Score (mRSS) | At Week 24 | SSc Cohort |
| Secondary | Participants with an improvement from baseline of the Revised Composite Response Index in Systemic Sclerosis (CRISS) | At Week 24 | SSc Cohort |
| Secondary | The worsening of pulmonary function including FVC (>10% absolute), DLCO (>15% absolute decline) in participants with interstitial lung disease (ILD) | At Week 24 | SSc Cohort |
| Secondary | Proportion of participants achieving low Disease Activity Score-28 Joint C-Reactive Protein (DAS28-CRP) | At week 24 | RA cohort |
| Secondary | Proportion of participants achieving simplified disease activity index (SDAI) remission | At week 24 | RA cohort |
| Secondary | Proportion of participants with ILD with no worsening of pulmonary function including FVC (> 10%) | At week 24 | RA cohort |
| Secondary | Maximum observed blood concentration (Cmax) | Up to 2 years |
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/NCT05869955/registered