Trial · NCT06154252
RESET-Myositis: An Open-Label Study to Evaluate the Safety and Efficacy of CABA-201 in Subjects With Active Idiopathic Inflammatory Myopathy or Juvenile Idiopathic Inflammatory Myopathy
NCT06154252, Phase 2, Phase 3, Recruiting, Cabaletta Bio
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. RESET-Myositis: An Open-Label Study to Evaluate the Safety and Efficacy of CABA-201 in Subjects With Active Idiopathic Inflammatory Myopathy or Juvenile Idiopathic Inflammatory Myopathy. Trials, record NCT06154252. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06154252
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- RESET-Myositis: An Open-Label Study to Evaluate the Safety and Efficacy of CABA-201 in Subjects With Active Idiopathic Inflammatory Myopathy or Juvenile Idiopathic Inflammatory Myopathy
- NCT number
- NCT06154252
- Status
- Recruiting
- Phases
- Phase 2, Phase 3
- Enrollment
- 74 participants, estimated
- Lead sponsor
- Cabaletta Bio
- Conditions
Idiopathic Inflammatory Myopathy, Dermatomyositis, Anti-Synthetase Syndrome, Immune-Mediated Necrotizing Myopathy, Juvenile Dermatomyositis, Juvenile Polymyositis, Juvenile Idiopathic Inflammatory Myopathy (JIIM), Juvenile Myositis
- Interventions
- CABA-201 following preconditioning with fludarabine and cyclophosphamide
- First posted
- 2023-12-04
- Last updated
- 2026-10-15
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Phase 1/2: Incidence and severity of adverse events (AEs) | Up to 28 days after CABA-201 infusion | Incidence and severity of AEs |
| Primary | Phase 2b Sub-study 1: Proportion of DM & ASyS subjects achieving at least a moderate Total Improvement Score (TIS) without any immunomodulatory medications and no or low dose of steroids | Within 16 weeks | ≥40 on the TIS, a composite measure ranging from 0 to 100, derived from six Core Set Measures, with higher scores indicating greater clinical improvement |
| Primary | Phase 2b Sub-study 2: Proportion of subjects with IMNM achieving at least a minimal TIS without any immunomodulatory medications and no or low dose of steroids | Within 24 weeks | ≥20 on the TIS, a composite measure ranging from 0 to 100, derived from six Core Set Measures, with higher scores indicating greater clinical improvement |
| Secondary | Incidence of adverse events and laboratory abnormalities | Up to 156 weeks (Phase 1/2) and through 52 weeks (Sub-study 1 and 2) | Incidence and severity of AEs, including changes in laboratory values and vital signs |
| Secondary | Pharmacodynamics (PD) | Up to 156 weeks (Phase 1/2) and through 52 weeks (Sub-study 1 and 2) | Levels of B cells in the blood |
| Secondary | Pharmacokinetics (PK) | Up to 156 weeks (Phase 1/2) and through 52 weeks (Sub-study 1 and 2) | Levels of CABA-201-positive T cells in the blood |
| Secondary | Change in disease-related biomarkers of muscle inflammation | Up to 156 weeks (Phase 1/2) | Levels of muscle enzymes (CK, LDH, AST, ALT, and aldolase) in serum |
| Secondary | Change in autoantibody-related biomarkers | Up to 156 weeks (Phase 1/2) | Levels of autoantibodies from the Myositis-Specific Autoantibody Panel (e.g., MDA-5, Jo-1, and HMGCR) in the serum |
| Secondary | Proportion of DM subjects achieving at least a moderate TIS without any immunomodulatory medications and no or low dose of steroids | Week 16 (Sub-study 1) | ≥40 on the TIS, a composite measure ranging from 0 to 100, derived from six Core Set Measures, with higher scores indicating greater clinical improvement |
| Secondary | Mean change from baseline on the MMT-8 in subjects with DM and ASyS without any immunomodulatory medications and no or low dose of steroids | Week 16 (Sub-study 1) | MMT-8 measures muscle strength on a scale ranging from 0 to 150 points, where higher scores reflect greater muscle strength |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 39245937 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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 trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06154252
GET https://conductscience.org/api/trials/v1/NCT06154252/registered