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NCT05849922 (Brivekimig in Hidradenitis Suppurativa): 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 17 Sep 2025 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically significant and commercially maybe sufficient.

Clinical Trial

NCTID
NCT05849922
Acronym
HS OBTAIN
Drug Name
Brivekimig (SAR442970)
Drug MoA
bispecific antibody that inhibits both TNFalpha and OX40L
Drug Modality
bispecific antibody
Drug Class
First-In-Class
Therapeutic Area
Immune System Diseases
Indication
Hidradenitis Suppurativa
Human Patients
86
Sponsor
Sanofi
Phase
Phase 2

Prediction of , index 1856

Prospective Prediction
Prediction Index
1856
Prediction Date
Commercial Prediction
partial SUCCESS (commercially sufficient yet moderate clinical benefit in HiSCR50 score superior to adalimumab/povorcitinib yet non-superior to sonelokimab/bimekizumab/secukinumab)
Technical Prediction
SUCCESS (statistically significant clinical benefit in HiSCR50 score against placebo)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
284 days in advance
Readout Data Interpretation
Brivekimig has achieved 30% placebo-adjusted HiSCR50 and 22% placebo-adjusted HiSCR90; superior to 24% placebo-adjusted HiSCR50 (10.1056/NEJMoa1504370) and 15% placebo-adjusted HiSCR90 achieved by adalimumab (10.1001/jamadermatol.2021.2905); yet non-superior to 24% placebo-adjusted HiSCR50 (10.1016/S0140-6736(24)00101-6) and 32% placebo-adjusted HiSCR90 achieved by bimekizumab (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
Prediction Classification
True Negative (TN)

ClinicalTrials.gov record

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

Official title
A Randomized, Double-blind, Placebo-controlled, Proof-of-concept Study Assessing the Efficacy and Safety of an Anti-TNF-OX40L NANOBODY® Molecule, SAR442970, in Participants With Moderate to Severe Hidradenitis Suppurativa
Phase
Phase 2
Status
Completed
Enrollment
86
Lead sponsor
Sanofi
Conditions
Hidradenitis Suppurativa
Interventions
DRUG: SAR442970; DRUG: Placebo
Design
Randomized · Parallel · Quadruple
Primary purpose
Treatment
Start
2023-06-06
Primary completion
2024-08-22
Completion
2025-01-09
Results first posted
2026-01-29
Primary outcomes
  • Period A (DB Period): Percentage of Biologic and Small Molecule Immunosuppressive-Naïve Participants Who Achieved Hidradenitis Suppurativa Clinical Response (HiSCR50) at Week 16 (Week 16)

NCT05849922 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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