Phase 2
Completed N=202
Study to Assess the Efficacy and Safety of Orismilast in Psoriasis
Psoriasis · Skin Diseases
Source: ClinicalTrials.gov NCT05190419 ↗
Enrolled (actual)
202
Serious AEs
1.0%
Results posted
Apr 2024
Primary outcomePrimary: Percent Change From Baseline in Psoriasis Activity and Severity Index (PASI) Score at Week 16 — -17.30; -52.60; -61.20; -63.70 percent change — p=<0.001
Summary
This study investigates 3 different doses of orismilast modified release compared to placebo in adult patients with moderate-to-severe plaque-type psoriasis. The purpose of the study is to assess the effect of orismilast modified release in moderate-to-severe plaque-type psoriasis and assess the safety aspects of these 3 different doses.The patients will receive an oral treatment of either orismilast modified release tablets or placebo tablets 2 times a day for 16 weeks.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline in Psoriasis Activity and Severity Index (PASI) Score at Week 16 |
-17.30; -52.60; -61.20; -63.70 | <0.001 sig |
| SECONDARY Percentage of Participants Who Achieved 75% Reduction in PASI (PASI75) Response at Week 16 |
16.5; 39.5; 49.0; 46.4; 83.5; 60.5 | — |
| SECONDARY Percentage of Participants Who Achieved a Score of Clear (0) or Almost Clear (1) and an at Least 2-point Improvement in Investigator Global Assessment (IGA) at Week 16 |
6.9; 26.2; 24.5; 20.6; 93.1; 73.8 | — |
| SECONDARY Percentage of Participants Who Achieved a Score of Clear (0) or Almost Clear (1) and an at Least 2-point Improvement in Investigator Global Assessment (IGA) at Weeks 4, 8, 12, and 20 |
2.1; 4.2; 4.3; 4.1; 97.9; 95.8 | — |
| SECONDARY Percentage of Participants Who Achieved 75% Reduction in PASI (PASI75) Response at Weeks 4, 8, 12, and 20 |
6.0; 8.4; 10.8; 9.6; 94.0; 91.6 | — |
| SECONDARY Percentage of Participants Who Achieved 50%, 90%, and 100% Reduction in PASI Response at Weeks 4, 8, 12, 16, and 20 |
8; 16; 18; 21; 0; 1 | — |
| SECONDARY Percent Change From Baseline in Psoriasis Activity and Severity Index (PASI) Score at Weeks 4, 8, 12, and 20 |
-14.40; -35.40; -38.40; -38.70; -16.10; -48.30 | — |
| SECONDARY Percent Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Weeks 16 and 20 |
-4.9; -8.8; -7.7; -7.3; -5.1; -5.0 | — |
| SECONDARY Percent Change From Baseline in Affected Body Surface Area (BSA) at Weeks 4, 8, 12, 16, and 20 |
-2.30; -5.60; -7.20; -6.50; -3.80; -9.20 | — |
| SECONDARY Percent Change From Baseline in Total Score of Psoriasis Symptom Scale (PSS) at Weeks 4, 8, 12, 16, and 20 |
-1.1; -4.6; -3.2; -3.8; -1.8; -4.9 | — |
| SECONDARY Percent Change From Baseline in Each Individual Item of Psoriasis Symptom Scale (PSS) at Weeks 4, 8, 12, 16, and 20 |
-0.6; -1.0; -0.5; -0.8; -0.6; -0.9 | — |
| SECONDARY Percentage of Participants Who Experienced Psoriasis Rebound by Week 20 |
6; 2; 5; 2 | — |
Eligibility Criteria
Inclusion Criteria
- Capable of giving signed informed consent.
- Male and female patients ≥18 years of age
- Body weight of >40 kg
- Diagnosis of chronic, stable plaque-type psoriasis. If the patient is diagnosed with psoriasis arthritis, the arthritis should be stable.
- Moderate-to-severe plaque-type psoriasis as defined by Psoriasis Activity and Severity Index (PASI) ≥12, body surface area (BSA) ≥10%, and Investigator Global Assessment (IGA) ≥3.
- Candidate for systemic antipsoriatic treatment or phototherapy.
Exclusion Criteria
- Therapy-resistant psoriasis
- Unstable psoriasis or psoriatic arthritis with acute deterioration within 4 weeks of the Screening visit.
- History of allergy or hypersensitivity to any component of the study treatment.
- Active infection (eg, bacteria, viral, fungal) requiring treatment with systemic antibiotics within 4 weeks of the Screening visit.
- Malignancy or history of malignancy except for treated (ie, cured) basal cell skin carcinomas.
Data sourced from ClinicalTrials.gov (NCT05190419). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.