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NCT06655896 · ClinicalTrials.gov registry record · Phase 2
Phase 2 Study Evaluating Rapcabtagene Autoleucel in Participants With Diffuse Cutaneous Systemic Sclerosis
A Phase 2 study of Scleroderma, Diffuse, sponsored by Novartis Pharmaceuticals.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 96
- Enrollment target
- 20
- Study locations
NCT06655896: Recruiting Phase 2 study of Scleroderma, Diffuse, sponsored by Novartis Pharmaceuticals.
NCT06655896 is a Phase 2 study of Scleroderma, Diffuse that is actively recruiting participants, run by Novartis Pharmaceuticals. The registered enrollment target is 96 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (28% lower). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06655896, a Phase 2 study of Scleroderma, Diffuse, is actively recruiting participants, sponsored by Novartis Pharmaceuticals.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 96 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to evaluate the efficacy, safety and tolerability of rapcabtagene autoleucel (administered once following lymphodepletion) in participants with severe refractory diffuse cutaneous systemic sclerosis relative to rituximab.
Primary Outcome
To demonstrate the superiority of rapcabtagene autoleucel as a single infusion compared to rituximab, with respect to the proportion of participants achieving a Revised Composite Response Index in Systemic Sclerosis 50 (rCRISS50) response at Week 52. This response is assessed across 5 assessment domains: (1) modified Rodnan Skin Score (mRSS), (2) Health Assessment Questionnaire Disability Index (HAQ-DI), (3) patient global assessment (PGA), (4) physician global assessment (PhGA) and (5) percent
Conditions Studied
Interventions
- BIOLOGICAL rapcabtagene autoleucel
- BIOLOGICAL rituximab
Study Locations (20)
California
- UCLA - Los Angeles
- UCSF - San Francisco
- UCSF - San Francisco
- Sutter Health Network - San Pablo
Other
- Novartis Investigative Site - Graz
- Novartis Investigative Site - Vienna
- Novartis Investigative Site - Olomouc
New South Wales
- Novartis Investigative Site - Camperdown
- Novartis Investigative Site - Darlinghurst
Florida
- FL Medical Clinic Orlando Health - Zephyrhills
Illinois
- Northwestern University - Chicago
Iowa
- University Of Iowa - Iowa City
Massachusetts
- Boston Medical Center - Boston
Michigan
- Michigan Med University of Michigan - Ann Arbor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 96 participants |
| Start Date | 2024-10-29 |
| Est. Completion | 2032-08-30 |
| Phase | Phase 2 |
What NCT06655896 shows while recruiting
NCT06655896 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 96 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (28% lower).
The record links to 1 condition, with Scleroderma, Diffuse appearing as the primary indexed condition, and to 2 interventions - of which rapcabtagene autoleucel is the first listed.
NCT06655896 names 20 study sites across 14 states, led by California, Other, New South Wales.
Frequently Asked Questions
What is clinical trial NCT06655896 about?
NCT06655896 is a clinical study titled "Phase 2 Study Evaluating Rapcabtagene Autoleucel in Participants With Diffuse Cutaneous Systemic Sclerosis". The purpose of this study is to evaluate the efficacy, safety and tolerability of rapcabtagene autoleucel (administered once following lymphodepletion) in participants with severe refractory diffuse cutaneous systemic sclerosis relative to rituximab.
What is the current status of trial NCT06655896?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 96 participants. The study started on 2024-10-29. Estimated completion is 2032-08-30.
What conditions does trial NCT06655896 study?
This clinical trial studies the following conditions: Scleroderma, Diffuse.
What interventions are being tested in trial NCT06655896?
The interventions under investigation include: rapcabtagene autoleucel (BIOLOGICAL), rituximab (BIOLOGICAL).
Who is sponsoring clinical trial NCT06655896?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06655896 being conducted?
This trial has 20 study locations across California, Florida, Illinois, Iowa, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Scleroderma, Diffuse
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 NCT06655896's enrollment target sits among peer trials
96 747th of 2000 higher than 1,243 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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