BioinvestGPT

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NCT05509023 (Bempikibart in Atopic Dermatitis): 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 insignificant and commercially insufficient.

Clinical Trial

NCTID
NCT05509023
Acronym
SIGNAL-AD
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
Atopic Dermatitis
Human Patients
102
Sponsor
Q32 Bio
Phase
Phase 2

Prediction of , index 1715

Prospective Prediction
Prediction Index
1715
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient clinical benefit in EASI75 inferior to dupilumab)
Technical Prediction
FAILURE (statistically insignificant clinical benefit in EASI75 against placebo)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
118 days in advance
Readout Data Interpretation
bempikibart failed to achieve statistical significance in the primary efficacy endpoint EASI at week 14
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically insignificant and commercially insufficient
Prediction Classification
True Negative (TN)

ClinicalTrials.gov record

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

Official title
A Randomized, Double-Blind, Placebo-Controlled Phase 2a Proof-of-Concept Study Evaluating the Safety and Efficacy of ADX-914 in Subjects With Moderate to Severe Atopic Dermatitis
Phase
Phase 2
Status
Active not recruiting
Enrollment
102
Lead sponsor
Q32 Bio Inc.
Conditions
Atopic Dermatitis
Interventions
DRUG: ADX-914; DRUG: Placebo
Design
Randomized · Parallel · Triple
Primary purpose
Treatment
Start
2022-09-30
Primary completion
2024-12
Completion
2024-12
Primary outcomes
  • Part A only: Safety parameters including incidence of serious adverse events and adverse events of special interest (14 Weeks)
  • Part A and B: Mean percentage change from baseline in Eczema Area and Severity Index (EASI) score at Week 14 for ADX-914 vs placebo (14 Weeks)

NCT05509023 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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