BioinvestGPT

BioinvestGPT ApS · Research use only

NCT05198310 (KPL-404 in Rheumatoid Arthritis): BVCT ex-ante prediction vs. reported outcome

On 26 Nov 2023, BioinvestGPT's BVCT predicted technical failure and commercial failure for this trial. The 2 Apr 2024 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically insignificant and commercially insufficient.

Clinical Trial

NCTID
NCT05198310
Drug Name
KPL-404
Drug MoA
anti-CD40 mAb inhibitor
Drug Modality
monoclonal antibody (mAb)
Drug Class
First-In-Class
Therapeutic Area
Immune System Diseases
Indication
Rheumatoid Arthritis
Human Patients
145
Sponsor
Kiniksa Pharmaceuticals
Phase
Phase 2

Prediction of , index 1345

Prospective Prediction
Prediction Index
1345
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient clinical benefit)
Technical Prediction
FAILURE (statistically insignificant clinical benefit)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
128 days in advance
Readout Data Interpretation
DAS28-CRP primary endpoint not met for cohort 3 and cohort 4.
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically insignificant 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 2, Multicenter, Randomized, Double-blind, Placebo Controlled Study to Assess the Safety, Pharmacokinetics, and Efficacy of KPL-404 in Subjects With Moderate to Severe Active Rheumatoid Arthritis With Inadequate Response or Intolerance to at Least One Biologic Disease-modifying Anti-rheumatic Drug or a Janus Kinase Inhibitor
Phase
Phase 2
Status
Completed
Enrollment
145
Lead sponsor
Kiniksa Pharmaceuticals, Ltd.
Conditions
Arthritis, Rheumatoid
Interventions
DRUG: KPL-404; DRUG: Placebo
Design
Randomized · Sequential · Quadruple
Primary purpose
Treatment
Start
2021-12-14
Primary completion
2024-02-08
Completion
2024-05-06
Results first posted
2025-07-22
Primary outcomes
  • Cohorts 1 and 2: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) (From first dose of study drug to 24 weeks)
  • Cohorts 1 and 2: Maximum Serum Concentration (Cmax) (Days 1 (Dose 1) and 57 (Dose 4))
  • Cohorts 1 and 2: Area Under the Serum Concentration-time Curve From Time of Administration to the End of the Dosing Interval, (AUCtau) (Days 1 (Dose 1) and 57 (Dose 4))
  • Cohort 3 and 4: Change From Baseline in Disease Activity Score of 28 Joints Using C-reactive Protein (DAS28-CRP) at Week 12 (Baseline, Week 12)

NCT05198310 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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