BioinvestGPT ApS · Research use only

NCT06345404 (Soquelitinib in atopic dermatitis): BVCT ex-ante prediction vs. reported outcome

On 10 Nov 2024, BioinvestGPT's BVCT predicted technical success and commercial partial success for this trial. The 8 May 2025 readout is classified on the dashboard as True Positive (TP), a correct prediction. Recorded clinical-benefit conclusion: statistically significant and commercially sufficient (non-inferior to upadacitinib).

Clinical Trial

Drug Name
Soquelitinib
Drug MoA
anti-ITK inhibitor
Drug Modality
small molecule
Drug Class
First-In-Class
Therapeutic Area
Skin and Connective Tissue Diseases
Indication
atopic dermatitis
Human Patients
64
Sponsor
Corvus Pharmaceuticals
Phase
Phase 1

Prediction of , index 1797

Prospective Prediction
Prediction Index
1797
Prediction Date
Commercial Prediction
partial SUCCESS (commercially maybe sufficient clinical benefit in EASI75 superior to adalimumab and non-inferior to upadacitinib)
Technical Prediction
SUCCESS (statistically significant clinical benefit in EASI75 against placebo)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
179 days in advance
Readout Data Interpretation
soquelitinib achieved 63% placebo-adjusted EASI75 at week 4; superior to dupilumab nearly 40% placebo-adjusted EASI75 at week 16 (see add'l link below); and non-inferior to upadacitinib’s nearly 60% placebo-adjusted EASI75 at week 24 (see 10.1016/S0140-6736(21)00588-2)
Press Release
Additional Readout Data
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant and commercially sufficient (non-inferior to upadacitinib)
Prediction Classification
True Positive (TP)

ClinicalTrials.gov record

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

Official title
A Phase 1, Randomized, Blinded, Placebo-controlled, Dose Escalation and Expansion Study to Investigate the Safety, Tolerability, and Preliminary Efficacy of ITK Inhibitor Soquelitinib in Participants With Moderate to Severe Atopic Dermatitis
Phase
Phase 1
Status
Completed
Enrollment
82
Lead sponsor
Corvus Pharmaceuticals, Inc.
Conditions
Atopic Dermatitis
Interventions
DRUG: Soquelitinib; DRUG: Placebo
Design
Randomized · Sequential · Quadruple
Primary purpose
Treatment
Start
2024-04-16
Primary completion
2026-01-28
Completion
2026-02-24
Primary outcomes
  • Incidence of adverse events, changes in laboratory values, vital signs, and electrocardiograms (Up to 30 days after last intervention administration)

NCT06345404 on ClinicalTrials.gov

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