Study to Assess the Efficacy and Safety of Orismilast in Psoriasis

• Status: Recruiting
• Trial end date: 2022-10-26
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: UNION therapeutics

Criteria

Inclusion Criteria:

1. Capable of giving signed informed consent.

2. Male and female patients ≥18 years of age

3. Body weight of >40 kg

4. Diagnosis of chronic, stable plaque-type psoriasis. If the patient is diagnosed with psoriasis arthritis, the arthritis should be stable.

5. Moderate-to-severe plaque-type psoriasis as defined by PASI ≥12, BSA ≥10%, and IGA ≥3.

6. Candidate for systemic antipsoriatic treatment or phototherapy.

Exclusion Criteria:

1. Therapy-resistant psoriasis

2. Unstable psoriasis or psoriatic arthritis with acute deterioration within 4 weeks of the Screening visit.

3. History of allergy or hypersensitivity to any component of the study treatment.

4. Active infection (eg, bacteria, viral, fungal) requiring treatment with systemic antibiotics within 4 weeks of the Screening visit.

5. Malignancy or history of malignancy except for treated (ie, cured) basal cell skin carcinomas.