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NCT06585202 (ATI-2138 in Moderate to Severe Atopic Dermatitis): BVCT ex-ante prediction vs. reported outcome

On 10 Nov 2024, BioinvestGPT's BVCT predicted technical success and commercial success for this trial. The 29 Jul 2025 readout is classified on the dashboard as True Positive (TP), a correct prediction. Recorded clinical-benefit conclusion: statistically significant and commercially probably sufficient.

Clinical Trial

NCTID
NCT06585202
Drug Name
ATI-2138
Drug MoA
oral anti-ITK and anti-JAK3 dual inhibitor
Drug Modality
small molecule
Drug Class
First-In-Class
Therapeutic Area
Skin and Connective Tissue Diseases
Indication
Moderate to Severe Atopic Dermatitis
Human Patients
14
Sponsor
Aclaris Therapeutics
Phase
Phase 2

Prediction of , index 1844

Prospective Prediction
Prediction Index
1844
Prediction Date
Commercial Prediction
SUCCESS (commercially sufficient clinical benefit in EASI75 superior to dupilumab and superior to upadacitinib)
Technical Prediction
SUCCESS (statistically significant clinical benefit in EASI75 against placebo)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
261 days in advance
Readout Data Interpretation
ATI2138 achieved 77.1% mean EASI score improvement at week 12 (p<0.001); superior to dupilumab’s 67.5% mean EASI score improvement at week 12 (see add'l link below); and superior to upadacitinib’s 69.2% mean EASI score improvement at week 12-16 (see DOI-10.1016/j.ad.2024.10.067)
Press Release
Additional Readout Data
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant and commercially probably sufficient
Prediction Classification
True Positive (TP)

ClinicalTrials.gov record

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

Official title
A Phase 2a Open-label Study to Investigate the Safety, Tolerability, Pharmacokinetics, Efficacy, and Pharmacodynamics of ATI-2138 Administered Over 12 Weeks in Participants With Moderate to Severe Atopic Dermatitis
Phase
Phase 2
Status
Completed
Enrollment
14
Lead sponsor
Aclaris Therapeutics, Inc.
Conditions
Atopic Dermatitis
Interventions
DRUG: ATI-2138
Design
Single group · None
Primary purpose
Treatment
Start
2024-08-19
Primary completion
2025-03-13
Completion
2025-03-31
Primary outcomes
  • Incidence and severity of treatment emergent adverse events (TEAEs) (From baseline up to two weeks after treatment (Day 98))

NCT06585202 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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