BioinvestGPT

BioinvestGPT ApS · Research use only

NCT06118411 (Upadacitinib in Vitiligo): BVCT ex-ante prediction vs. reported outcome

On 24 Feb 2025, BioinvestGPT's BVCT predicted technical success and commercial success for this trial. The 29 Oct 2025 readout is classified on the dashboard as True Positive (TP), a correct prediction. Recorded clinical-benefit conclusion: statistically significant and commercially sufficient (no approved SoC for refractory vitiligo).

Clinical Trial

NCTID
NCT06118411
Acronym
Viti-Up
Drug Name
Upadacitinib
Drug MoA
pan-JAK inhibitor with higher efficacy against JAK1
Drug Modality
small molecule
Drug Class
Best-In-Class
Therapeutic Area
Skin and Connective Tissue Diseases
Indication
Vitiligo
Human Patients
614
Sponsor
AbbVie
Phase
Phase 3

Prediction of , index 1938

Prospective Prediction
Prediction Index
1938
Prediction Date
Commercial Prediction
SUCCESS (commercially sufficient clinical benefit F-VASI75/T-VASI50 for both upadacitinib monotherapy and upadacitinib + NB-UVB combotherapy moderately superior to ruxolitinib)
Technical Prediction
SUCCESS (statistically significant clinical benefit in F-VASI75/T-VASI50 for both upadacitinib monotherapy and upadacitinib + NB-UVB combotherapy compared with placebo)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
247 days in advance
Readout Data Interpretation
Upadacitinib 15mg achieved statistically significant 13.5%-15.6% placebo-adjusted T-VASI50 improvement at week 48(p<0.05); statistically significant 16.5%-19.3% placebo-adjusted F-VASI75 improvement at week 48 (p<0.05); and statistically significant 30.5%-35.4% placebo-adjusted F-VASI50 improvement at week 48 (p value undisclosed); no clinical data for ruxolitinib in refractory vitiligo available
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant and commercially sufficient (no approved SoC for refractory vitiligo)
Prediction Classification
True Positive (TP)

ClinicalTrials.gov record

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

Official title
A Phase 3, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Efficacy, Safety, and Tolerability of Upadacitinib in Adult and Adolescent Subjects With Non-Segmental Vitiligo Who Are Eligible for Systemic Therapy
Phase
Phase 3
Status
Active not recruiting
Enrollment
614
Lead sponsor
AbbVie
Conditions
Vitiligo
Interventions
DRUG: Upadacitinib; DRUG: Placebo; OTHER: NB-UVB (narrow-band ultraviolet B) Phototherapy
Design
Randomized · Sequential · Quadruple
Primary purpose
Treatment
Start
2023-12-19
Primary completion
2028-03
Completion
2028-03
Primary outcomes
  • Percentage of Participants Achieving Total Vitiligo Area Scoring Index (T-VASI) 50 (≥ 50% Improvement in T-VASI From Baseline) (Week 48)
  • Percentage of Participants Achieving Facial-Vitiligo Area Scoring Index (F-VASI) 75 (≥ 75% Improvement in F-VASI From Baseline) (Week 48)
  • Percentage of Participants Achieving T-VASI 75 (≥ 75% Improvement in T-VASI From Baseline) (Study 4 Week 28)
  • Number of Participants with Adverse Events (AEs) (Up to Approximately Week 175)

NCT06118411 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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