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NCT06018428 (Bempikibart in Severe Alopecia Areata): BVCT ex-ante prediction vs. reported outcome

On 14 Aug 2024, BioinvestGPT's BVCT predicted technical failure and commercial failure for this trial. The 10 Dec 2024 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically probably significant and commercially probably insufficient.

Clinical Trial

NCTID
NCT06018428
Acronym
SIGNAL-AA
Drug Name
Bempikibart (ADX-914)
Drug MoA
anti-IL7Ralpha mAb inhibitor
Drug Modality
monoclonal antibody
Drug Class
First-In-Class
Therapeutic Area
Skin and Connective Tissue Diseases
Indication
Severe Alopecia Areata
Human Patients
40
Sponsor
Q32 Bio
Phase
Phase 2

Prediction of , index 1716

Prospective Prediction
Prediction Index
1716
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient clinical benefit in SALT score inferior to baricitinib)
Technical Prediction
FAILURE (statistically insignificant clinical benefit in SALT score against placebo)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
118 days in advance
Readout Data Interpretation
bempikibart probably failed to achieve statistical significance in the primary efficacy endpoint SALT score at week 24 (16% vs 2% placebo with a p=0.045 after excluding three placebo patients)
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically probably significant and commercially probably insufficient
Prediction Classification
True Negative (TN)

ClinicalTrials.gov record

ClinicalTrials.gov record, retrieved 2026-09-24. Third-party data.

Official title
A Phase 2a, Randomized, Double-blind, Placebo-Controlled, Proof-of-Concept Trial With Part B and Open-label Extension of Bempikibart (ADX-914) for the Treatment of Severe Alopecia Areata (SIGNAL-AA)
Phase
Phase 2
Status
Active not recruiting
Enrollment
75
Lead sponsor
Q32 Bio Inc.
Conditions
Alopecia Areata
Interventions
DRUG: bempikibart (ADX-914)
Design
Single group · None
Primary purpose
Treatment
Start
2023-09-12
Primary completion
2026-06
Completion
2026-09
Primary outcomes
  • Part A: Mean relative percent change in SALT score (24 Weeks)
  • Part B: Mean percent change from baseline in SALT score (36 weeks)

NCT06018428 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

How to read these records: evidence · methodology · all trials