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NCT05651711 (Rocatinlimab in Atopic Dermatitis): BVCT ex-ante prediction vs. reported outcome

On 10 Aug 2024, BioinvestGPT's BVCT predicted technical success and commercial success for this trial. The 24 Sep 2024 readout is classified on the dashboard as True Positive (TP), a correct prediction. Recorded clinical-benefit conclusion: statistically significant and commercially maybe sufficient.

Clinical Trial

NCTID
NCT05651711
Acronym
ROCKET-Horizon
Drug Name
Rocatinlimab
Drug MoA
anti-OX40 mAb inhibitor
Drug Modality
monoclonal antibody
Drug Class
First-In-Class
Therapeutic Area
Skin and Connective Tissue Diseases
Indication
Atopic Dermatitis
Human Patients
726
Sponsor
Amgen
Phase
Phase 3

Prediction of , index 1445

Prospective Prediction
Prediction Index
1445
Prediction Date
Commercial Prediction
SUCCESS (commercially sufficient clinical benefit in EASI75; superior to dupilumab/lebrikizumab; non-superior-and-non-inferior to amlitelimab; yet inferior to upadacitinib)
Technical Prediction
SUCCESS (statistically significant clinical benefit in EASI75 against placebo)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
45 days in advance
Readout Data Interpretation
rocatinlimab achieved 19.1% 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 10.1016/S0140-6736(21)00588-2).
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant and commercially maybe sufficient
Prediction Classification
True Positive (TP)

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) Monotherapy in Adult Subjects With Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-Horizon)
Phase
Phase 3
Status
Completed
Enrollment
726
Lead sponsor
Amgen
Conditions
Atopic Dermatitis
Interventions
DRUG: Rocatinlimab; OTHER: Placebo
Design
Randomized · Parallel · Double
Primary purpose
Treatment
Start
2022-12-14
Primary completion
2024-06-05
Completion
2024-08-27
Results first posted
2026-06-26
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)

NCT05651711 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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