Study to Assess the Efficacy and Safety of Orismilast in Psoriasis (IASOS)

UNION Therapeutics

Status and phase: Completed; Phase 2

Conditions: Psoriasis; Skin Diseases

Treatments: Drug: Placebo; Drug: Orismilast modified release tablets

Study type: Interventional

Funder types: Industry

Identifiers

NCT05190419

2021-003209-22 (EudraCT Number)

UNI50001-203

Details and patient eligibility

About

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.

Enrollment: 202 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 Psoriasis Activity and Severity Index (PASI) ≥12, body surface area (BSA) ≥10%, and Investigator Global Assessment (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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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202 participants in 4 patient groups, including a placebo group

Orismilast modified release tablets 20 mg BID

Experimental group

Description:

Oral, twice daily morning and evening for 16 weeks

Treatment:

Drug: Orismilast modified release tablets

Orismilast modified release tablets 30 mg BID

Experimental group

Description:

Oral, twice daily morning and evening for 16 weeks

Treatment:

Drug: Orismilast modified release tablets

Orismilast modified release tablets 40 mg BID

Experimental group

Description:

Oral, twice daily morning and evening for 16 weeks

Treatment:

Drug: Orismilast modified release tablets

Placebo tablets BID

Placebo Comparator group

Description:

Oral, twice daily morning and evening for 16 weeks

Treatment:

Drug: Placebo