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NCT06154252 · ClinicalTrials.gov registry record · Phase 2
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
A Phase 2 study of Dermatomyositis and Juvenile Dermatomyositis, sponsored by Cabaletta Bio.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 74
- Enrollment target
- 20
- Study locations
NCT06154252: Recruiting Phase 2 study of Dermatomyositis and Juvenile Dermatomyositis, sponsored by Cabaletta Bio.
NCT06154252 is a Phase 2 study of Dermatomyositis and Juvenile Dermatomyositis that is actively recruiting participants, run by Cabaletta Bio. The registered enrollment target is 74 participants, below the 481-participant average among 19 other Dermatomyositis trials with a reported enrollment target (85% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06154252, a Phase 2 study of Dermatomyositis and Juvenile Dermatomyositis, is actively recruiting participants, sponsored by Cabaletta Bio.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 74 participants
- Enrollment target
- 20
- Study locations
Study Summary
RESET-Myositis: Open-Label Study to Evaluate the Safety and Efficacy of CABA-201 in Subjects with Active Idiopathic Inflammatory Myopathy or Juvenile Idiopathic Inflammatory Myopathy
Primary Outcome
Incidence and severity of AEs
Conditions Studied
Interventions
- BIOLOGICAL CABA-201 following preconditioning with fludarabine and cyclophosphamide
Study Locations (20)
Illinois
- Ann & Robert H. Lurie Children's Hospital of Chicago - Accepting Young Adult and Juvenile Patients - Chicago
- Northwestern Memorial Hospital - Accepting Adult Patients - Chicago
- The University of Chicago Medical Center - Accepting Adult and Juvenile Patients - Chicago
New York
- Hospital for Special Surgery - Accepting Adult and Juvenile Patients - New York
- Memorial Sloan Kettering Cancer Center - Accepting Adult and Juvenile Patients - New York
- Children's Hospital at Montefiore - Accepting Young Adult and Juvenile Patients - The Bronx
California
- University of California Irvine - Accepting Adult Patients - Orange
- University of California, San Francisco Benioff Children's Hospital - Accepting Young Adult and Juvenile Patients - San Francisco
Florida
- Mayo Clinic Florida - Accepting Adult Patients - Jacksonville
- Johns Hopkins All Children's Hospital - Accepting Juvenile Patients - St. Petersburg
Georgia
- Children's Healthcare of Atlanta - Accepting Juvenile Patients - Atlanta
- Emory University - Accepting Adult Patients - Atlanta
North Carolina
- University of North Carolina at Chapel Hill - Accepting Adult Patients - Chapel Hill
- Duke University Medical Center - Accepting Young Adults and Juvenile Patients - Durham
Colorado
- Children's Hospital Colorado - Accepting Juvenile Patients - Aurora
Kansas
- University of Kansas Medical Center - Accepting Adult Patients - Kansas City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 74 participants |
| Start Date | 2023-12-20 |
| Est. Completion | 2028-07 |
| Phase | Phase 2 |
What NCT06154252 shows while recruiting
NCT06154252 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 74 participants, a relatively small participant target, below the 481-participant average among 19 other Dermatomyositis trials with a reported enrollment target (85% lower).
The record links to 8 conditions, with Dermatomyositis appearing as the primary indexed condition, and to 1 intervention - of which CABA-201 following preconditioning with fludarabine and cyclophosphamide is the first listed.
NCT06154252 names 20 study sites across 12 states, led by Illinois, New York, California.
Frequently Asked Questions
What is clinical trial NCT06154252 about?
NCT06154252 is a clinical study titled "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". RESET-Myositis: Open-Label Study to Evaluate the Safety and Efficacy of CABA-201 in Subjects with Active Idiopathic Inflammatory Myopathy or Juvenile Idiopathic Inflammatory Myopathy
What is the current status of trial NCT06154252?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 74 participants. The study started on 2023-12-20. Estimated completion is 2028-07.
What conditions does trial NCT06154252 study?
This clinical trial studies the following conditions: Dermatomyositis, Juvenile Dermatomyositis, Idiopathic Inflammatory Myopathy, Anti-Synthetase Syndrome, Immune-Mediated Necrotizing Myopathy.
What interventions are being tested in trial NCT06154252?
The interventions under investigation include: CABA-201 following preconditioning with fludarabine and cyclophosphamide (BIOLOGICAL).
Who is sponsoring clinical trial NCT06154252?
This trial is sponsored by Cabaletta Bio, which has 6 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06154252 being conducted?
This trial has 20 study locations across California, Colorado, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Dermatomyositis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06154252's enrollment target sits among peer trials
74 11th of 19 higher than 9 of 19 other Dermatomyositis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Dermatomyositis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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