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NCT03222492 · ClinicalTrials.gov registry record · Phase 1
Brentuximab Vedotin for Systemic Sclerosis
A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 17
- Enrollment target
NCT03222492: Completed Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT03222492 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 17 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (72% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03222492, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 17 participants
- Enrollment target
Study Summary
There is significant unmet need for effective treatment options for Diffuse Cutaneous Systemic Sclerosis (dcSSc). The present study will be a dose-escalation safety trial of brentuximab vedotin, a drug-antibody conjugate approved for the treatment of lymphoma and targeted to the protein CD30 molecule expressed on activated immune cells There is evidence for CD30 involvement in SSc. This study represents the first step in determining safety and tolerability of brentuximab vedotin in SSc.
Primary Outcome
Adverse events were graded using the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0, except for the grading of liver chemistry abnormalities. The scale ranges from grade 1 through 5, with grade 1 being the least severe and grade 5 being the most severe. Liver chemistry abnormalities were graded, from 1 through 4 (with 1 being least severe and 4 being most severe) relative to the upper limit of normal (ULN) with different g
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL Brentuximab Vedotin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2017-09-20 |
| Est. Completion | 2023-04-10 |
| Phase | Phase 1 |
What the finished NCT03222492 record still lists
NCT03222492 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (72% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03222492 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03222492 about?
NCT03222492 is a clinical study titled "Brentuximab Vedotin for Systemic Sclerosis". There is significant unmet need for effective treatment options for Diffuse Cutaneous Systemic Sclerosis (dcSSc). The present study will be a dose-escalation safety trial of brentuximab vedotin, a drug-antibody conjugate approved for the treatment of lymphoma and targeted to the protein CD30 molecul...
What is the current status of trial NCT03222492?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 17 participants. The study started on 2017-09-20. Estimated completion is 2023-04-10.
What interventions are being tested in trial NCT03222492?
The interventions under investigation include: Placebo (BIOLOGICAL), Brentuximab Vedotin (BIOLOGICAL).
Who is sponsoring clinical trial NCT03222492?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03222492's enrollment target sits among peer trials
17 1785th of 2000 higher than 215 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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