BioinvestGPT ApS · Research use only

NCT05785715 (ABBV-113 in Moderate to Severe Ulcerative Colitis): BVCT ex-ante prediction vs. reported outcome

On 24 Feb 2025, BioinvestGPT's BVCT predicted technical failure and commercial failure for this trial. The 2 Jul 2025 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically insignificant and commercially insufficient.

Clinical Trial

Drug Name
ABBV-113 (NX-13)
Drug MoA
oral NLRX1 agonist
Drug Modality
small molecule
Drug Class
First-In-Class
Therapeutic Area
Immune System Diseases
Indication
Moderate to Severe Ulcerative Colitis (UC)
Human Patients
81
Sponsor
AbbVie
Phase
Phase 2

Prediction of , index 1735

Prospective Prediction
Prediction Index
1735
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient clinical benefit in modified Mayo score inferior to PRA023)
Technical Prediction
FAILURE (statistically insignificant clinical benefit in modified Mayo score compared with placebo)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
128 days in advance
Readout Data Interpretation
NX-13’s further development has been discontinued due to an inadequately differentiated benefit-risk assessment.
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 Randomized, Double-Blind, Placebo-Controlled, Multiple Dose, Multicenter Phase 2 Induction Study With Long-Term Extension to Evaluate the Clinical Activity and Safety of Oral NX-13 in Participants w/ Moderate to Severe Ulcerative Colitis
Phase
Phase 2
Status
Terminated
Enrollment
81
Lead sponsor
AbbVie
Conditions
Ulcerative Colitis
Interventions
DRUG: NX-13 250mg; DRUG: NX-13 750mg; DRUG: NX-13 Placebo
Design
Randomized · Parallel · Quadruple
Primary purpose
Treatment
Start
2023-04-24
Primary completion
2025-05-30
Completion
2025-05-30
Results first posted
2026-06-15
Primary outcomes
  • Change From Baseline in Modified Mayo Score (MMS) at Week 12 (Baseline, Week 12)

NCT05785715 on ClinicalTrials.gov

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