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NCT05724199 (Rocatinlimab in Moderate-to-sever Atopic Dermatitis): BVCT ex-ante prediction vs. reported outcome

On 7 Dec 2024, BioinvestGPT's BVCT predicted technical success and commercial partial success for this trial. The 8 Mar 2025 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically significant and commercially maybe sufficient (inferior to upadacitinib).

Clinical Trial

NCTID
NCT05724199
Acronym
ROCKET-SHUTTLE
Drug Name
Rocatinlimab
Drug MoA
anti-OX40 inhibitor
Drug Modality
monoclonal antibody
Drug Class
First-In-Class
Therapeutic Area
Skin and Connective Tissue Diseases
Indication
Moderate-to-sever Atopic Dermatitis
Human Patients
746
Sponsor
Amgen
Phase
Phase 3

Prediction of , index 1860

Prospective Prediction
Prediction Index
1860
Prediction Date
Commercial Prediction
partial SUCCESS (commercially sufficient yet moderate additive clinical benefit in vIGA-AD/ EASI75 (higher dose); superior to dupilumab +TCS/TCI yet inferior to upadacitinib +TCS/TCI)
Technical Prediction
SUCCESS (statistically significant additive clinical benefit in vIGA-AD/EASI75 against placebo with positive dose-response relationship)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
91 days in advance
Readout Data Interpretation
rocatinlimab (low dose) achieved 30.4% placebo-adjusted EASI75 at week 24; inferior to dupilumab nearly 40% placebo-adjusted EASI75 at week 16 (see 10.1056/NEJMoa1610020); and inferior to upadacitinib’s nearly 60% placebo-adjusted EASI75 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 maybe sufficient (inferior to upadacitinib)
Prediction Classification
True Negative (TN)

ClinicalTrials.gov record

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

Official title
A Phase 3, Randomized, 24-week, Placebo-controlled, Double-blind Study to Assess the Efficacy, Safety, and Tolerability of Rocatinlimab (AMG 451) in Combination With Topical Corticosteroids and/or Topical Calcineurin Inhibitors in Adult Subjects With Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-SHUTTLE)
Phase
Phase 3
Status
Completed
Enrollment
746
Lead sponsor
Amgen
Conditions
Atopic Dermatitis
Interventions
DRUG: Rocatinlimab; OTHER: Placebo
Design
Randomized · Sequential · Double
Primary purpose
Treatment
Start
2023-02-21
Primary completion
2024-09-15
Completion
2024-12-04
Results first posted
2026-08-06
Primary outcomes
  • Number of Participants Who Achieved Validated Investigator's Global Assessment for AD (vIGA-AD) 1 Response With Presence of Only Barely Perceptible Erythema or vIGA-AD 0 Response (Revised Investigator's Global Assessment [rIGA] 0/1) at Week 24 (Baseline and Week 24)
  • Number of Participants Who Achieved ≥ 75% Reduction From Baseline in Eczema Area and Severity Index Score (EASI 75) at Week 24 (Baseline and Week 24)

NCT05724199 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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