Study to Evaluate Efficacy and Safety of MP1032 in Patients With Chronic Plaque Psoriasis
Summary
The primary objective of this trial is to evaluate the clinical efficacy and safety of two oral doses of MP1032 (150 mg bid and 300 mg bid) when taken for 12 weeks by patients with moderate-to-severe chronic plaque psoriasis.
Timeline
- Start
- 2018-02-27
- Primary completion
- 2019-06-12
- Completion
- 2019-06-12
Outcome
Missed primary endpoint
registry analysis (superiority test); 150 mg MP1032 Bid vs Placebo Bid; p = 0.161; Odds Ratio (OR) 4.12 (95% CI 0.47 to 35.97); Cochran-Mantel-Haenszel NCT03706209 ↗
registry analysis (superiority test); 300 mg MP1032 Bid vs Placebo Bid; p = 0.111; Odds Ratio (OR) 5.52 (95% CI 0.55 to 55.43); Cochran-Mantel-Haenszel NCT03706209 ↗
registry analysis (superiority test); 150 mg MP1032 Bid vs Placebo Bid; p = 0.222; Odds Ratio (OR) 1.73 (95% CI 0.71 to 4.25); Cochran-Mantel-Haenszel NCT03706209 ↗
registry analysis (superiority test); 300 mg MP1032 Bid vs Placebo Bid; p = 0.182; Odds Ratio (OR) 1.91 (95% CI 0.75 to 4.91); Cochran-Mantel-Haenszel NCT03706209 ↗
release “Because of the limited overall number of patients enrolled in the trial a statistical significance improvement in efficacy could not be established.” metriopharm.com ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | MP1032 | Unknown | 150 mg | Oral |
| Subject | MP1032 | Unknown | 300 mg | Oral |