CompletedPhase 2

Study to Assess the Efficacy and Safety of Orismilast in Psoriasis

United States202 participantsStarted 2021-12-30

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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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.

What they're measuring

Percent Change From Baseline in Psoriasis Activity and Severity Index (PASI) Score at Week 16

Timeframe: Baseline and Week 16

Trial details

NCT IDNCT05190419

SponsorUNION therapeutics

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-11-24

Results submitted2023-11-22

View on ClinicalTrials.gov More Psoriasis trials