BioinvestGPT ApS · Research use only

NCT06340360 (Rezpegaldesleukin in severe-to-very-severe alopecia areata): BVCT ex-ante prediction vs. reported outcome

On 3 Nov 2024, BioinvestGPT's BVCT predicted technical failure and commercial failure for this trial. The 16 Dec 2025 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically significant and commercially insufficient.

Clinical Trial

Acronym
REZOLVE-AA
Drug Name
Rezpegaldesleukin
Drug MoA
IL-2 conjugate
Drug Modality
biologic
Drug Class
First-In-Class
Therapeutic Area
Skin and Connective Tissue Diseases
Indication
severe-to-very-severe alopecia areata
Human Patients
94
Sponsor
Nektar Therapeutics
Phase
Phase 2

Prediction of , index 1821

Prospective Prediction
Prediction Index
1821
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient clinical benefit in SALT inferior to baricitinib)
Technical Prediction
FAILURE (statistically insignificant clinical benefit in SALT against placebo)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
408 days in advance
Readout Data Interpretation
rezpegaldesleukin failed to achieve statistically significant improvement in SALT score at week 36 compared with placebo (p=0.186), which is inferior to baricitinib that achieved 28% placebo-adjusted SALT20 response at week 24 (see add'l link below)
Press Release
Additional Readout Data
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant and commercially insufficient
Prediction Classification
True Negative (TN)

ClinicalTrials.gov record

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

Official title
A Phase 2b, Randomized, Double-Blind, Parallel Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Rezpegaldesleukin in the Treatment of Severe to Very Severe Alopecia Areata in Adult Patients (Rezolve AA)
Phase
Phase 2
Status
Completed
Enrollment
94
Lead sponsor
Nektar Therapeutics
Conditions
Alopecia Areata
Interventions
DRUG: Rezpegaldesleukin; DRUG: Placebo
Design
Randomized · Parallel · Quadruple
Primary purpose
Treatment
Start
2024-04-02
Primary completion
2025-11-26
Completion
2026-08-20
Primary outcomes
  • Percent change from baseline in Severity of Alopecia Tool (SALT) score at Week 36 (Baseline and Week 36)

NCT06340360 on ClinicalTrials.gov

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