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NCT02684097 · ClinicalTrials.gov registry record · Phase 2
A Pilot Study of Tralokinumab in Subjects With Moderate to Severe Alopecia Areata
A Phase 2 study, sponsored by Emma Guttman.
- Completed
- Registry status
- Phase 2
- Development phase
- 22
- Enrollment target
NCT02684097: Completed Phase 2 study, sponsored by Emma Guttman.
NCT02684097 is a Phase 2 study that has completed, run by Emma Guttman. The registered enrollment target is 22 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02684097, a Phase 2 study, has completed, sponsored by Emma Guttman.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 22 participants
- Enrollment target
Study Summary
The purpose of this study is to assess whether tralokinumab can be a helpful treatment for alopecia areata. This is a randomized, double-blind, placebo-controlled pilot study of a total of 30 subjects with moderate to severe alopecia areata involving 30-100% of the scalp. Expected is 50% of these subjects to have concomitant alopecia areata (AA) and atopic dermatitis (AD). Subjects with AA alone (15 subjects) will be randomized (2:1) to either receive tralokinumab or placebo via subcutaneous injection every 2 weeks for 24 weeks. Subjects with concomitant alopecia areata and atopic dermatitis (15 subjects) will be randomized separately in a 2:1 ratio to receive tralokinumab or placebo via subcutaneous injection every 2 weeks for 24 weeks.
Primary Outcome
Change from baseline in cellular, and molecular markers in skin biopsies after treatment. Gene expression changes in Th2/IL-13, "T22"/IL-22, S100A7 and S100A8, Th1/IFN-gamma, and Th17/IL-17A jointly correlated assessed as change at week 24 compared to baseline of the biomarkers combined z-score expression. Th2/IL-13, T22/IL-22, S100A7 and S100A8, Th1/IFN-gamma, and Th17/IL-17A biomarkers was computed as following. The combined score was obtained by mean z-score expression of all biomarkers, wher
Interventions
- DRUG Placebo
- DRUG Tralokinumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2016-01 |
| Est. Completion | 2017-11-28 |
| Phase | Phase 2 |
What the finished NCT02684097 record still lists
NCT02684097 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (83% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02684097 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02684097 about?
NCT02684097 is a clinical study titled "A Pilot Study of Tralokinumab in Subjects With Moderate to Severe Alopecia Areata". The purpose of this study is to assess whether tralokinumab can be a helpful treatment for alopecia areata. This is a randomized, double-blind, placebo-controlled pilot study of a total of 30 subjects with moderate to severe alopecia areata involving 30-100% of the scalp. Expected is 50% of these su...
What is the current status of trial NCT02684097?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 22 participants. The study started on 2016-01. Estimated completion is 2017-11-28.
What interventions are being tested in trial NCT02684097?
The interventions under investigation include: Placebo (DRUG), Tralokinumab (DRUG).
Who is sponsoring clinical trial NCT02684097?
This trial is sponsored by Emma Guttman, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02684097's enrollment target sits among peer trials
22 1790th of 2000 higher than 207 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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