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NCT06619990 (XmAb942 in Ulcerative Colitis): BVCT ex-ante prediction vs. reported outcome

On 22 Jan 2025, BioinvestGPT's BVCT predicted technical success and commercial failure for this trial. The 29 Apr 2025 readout is classified on the dashboard as True Positive (TP), a correct prediction. Recorded clinical-benefit conclusion: statistically significant (tolerability) and commercially TBD.

Clinical Trial

NCTID
NCT06619990
Drug Name
XmAb942
Drug MoA
anti-TL1A inhibitor
Drug Modality
monoclonal antibody
Drug Class
Best-In-Class
Therapeutic Area
Immune System Diseases
Indication
Ulcerative Colitis
Human Patients
300
Sponsor
Xencor
Phase
Phase 1 Phase 2

Prediction of , index 1827

Prospective Prediction
Prediction Index
1827
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient clinical benefit in MMS inferior to PRA023/TEV574)
Technical Prediction
SUCCESS (statistically significant yet moderate clinical benefit in MMS compared with placebo)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
97 days in advance
Readout Data Interpretation
XmAb942 achieved a half-life estimate of greater than 71 days and sufficient tolerability
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant (tolerability) and commercially TBD
Prediction Classification
True Positive (TP)

ClinicalTrials.gov record

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

Official title
A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study in Healthy Participants Followed by a Randomized, Double-Blind, Placebo-Controlled Phase 2 Study in Participants With Moderate-To-Severe Active Ulcerative Colitis.
Phase
Phase 1, Phase 2
Status
Recruiting
Enrollment
270
Lead sponsor
Xencor, Inc.
Conditions
Ulcerative Colitis (UC)
Interventions
BIOLOGICAL: XmAb942; DRUG: Placebo
Design
Randomized · Parallel · Double
Primary purpose
Treatment
Start
2024-10-10
Primary completion
2027-12
Completion
2030-05
Primary outcomes
  • Incidence, nature, and severity of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) of XmAb942 in healthy volunteers (Part A) (20 weeks)
  • Incidence, nature, and severity of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) of XmAb942 in healthy volunteers (Part B) (28 weeks)
  • Clinical remission based on modified mayo score (MMS), defined as MMS ≤ 2 with Mayo endoscopic score (MES) of 1, rectal bleeding subscore (RBS) of 0, and stool frequency subscore (SFS) of 0-1. (12 weeks)

NCT06619990 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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