Clinical trial NCT05190419: Study to Assess the Efficacy and Safety of Orismilast in Psoriasis
Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2b Dose-Ranging Study to Evaluate the Efficacy and Safety of Orismilast in Adults With Moderate-to-Severe Plaque-Type Psoriasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Psoriasis
Skin Diseases
Keywords: Psoriasis
Orismilast
Lead sponsor: UNION therapeutics
Sponsor class: INDUSTRY
First posted: 2022-01-13
Enrollment: 202
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be assigned randomly in a 1:1:1:1 ratio to receive 1 of the 3 orismilast modified release doses (20 mg, 30 mg, or 40 mg) or placebo twice daily (BID)
Primary purpose: TREATMENT

Brief 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.


Eligibility 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 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.

Primary outcomes:
measure: Percent Change From Baseline in Psoriasis Activity and Severity Index (PASI) Score at Week 16
timeFrame: Baseline and Week 16
Secondary outcomes:
measure: Percentage of Participants Who Achieved 75% Reduction in PASI (PASI75) Response at Week 16
timeFrame: At Week 16
measure: 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
timeFrame: At Week 16
measure: 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
timeFrame: At Weeks 4, 8, 12, and 20
measure: Percentage of Participants Who Achieved 75% Reduction in PASI (PASI75) Response at Weeks 4, 8, 12, and 20
timeFrame: At Weeks 4, 8, 12, and 20
measure: Percentage of Participants Who Achieved 50%, 90%, and 100% Reduction in PASI Response at Weeks 4, 8, 12, 16, and 20
timeFrame: At Weeks 4, 8, 12, 16, and 20
measure: Percent Change From Baseline in Psoriasis Activity and Severity Index (PASI) Score at Weeks 4, 8, 12, and 20
timeFrame: Baseline and Weeks 4, 8, 12, and 20
measure: Percent Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Weeks 16 and 20
timeFrame: Baseline and Weeks 16 and 20
measure: Percent Change From Baseline in Affected Body Surface Area (BSA) at Weeks 4, 8, 12, 16, and 20
timeFrame: Baseline and Weeks 4, 8, 12, 16, and 20
measure: Percent Change From Baseline in Total Score of Psoriasis Symptom Scale (PSS) at Weeks 4, 8, 12, 16, and 20
timeFrame: Baseline and Weeks 4, 8, 12, 16, and 20
measure: Percent Change From Baseline in Each Individual Item of Psoriasis Symptom Scale (PSS) at Weeks 4, 8, 12, 16, and 20
timeFrame: Baseline and Weeks 4, 8, 12, 16, and 20
measure: Percentage of Participants Who Experienced Psoriasis Rebound by Week 20
timeFrame: At Week 20
Other outcomes:
Locations:
city: Cromwell
country: United States
facility: Central Connecticut Dermatology
state: Connecticut
city: Washington
country: United States
facility: GWU MFA
state: District of Columbia
city: Beverly
country: United States
facility: ALLCUTIS Research, LLC
state: Massachusetts
city: Portsmouth
country: United States
facility: ALLCUTIS Research, LLC
state: New Hampshire
city: New York
country: United States
facility: Bruce E. Katz, MD
state: New York
city: New York
country: United States
facility: Sadick Research Group LLC
state: New York
city: Mayfield Heights
country: United States
facility: Apex Clinical Research Center
state: Ohio
city: Bad Bentheim
country: Germany
facility: Fachklinik Bad Bentheim
city: Berlin
country: Germany
facility: ISA - Interdisciplinary Study Association GmbH
city: Darmstadt
country: Germany
facility: Rosenpark Research GmbH
city: Dresden
country: Germany
facility: Hautarztpraxis Dr.Gerlach
city: Friedrichshafen
country: Germany
facility: Derma-Study-Center-Friedrichshafen
city: Hamburg
country: Germany
facility: Klinische Forschung Hamburg GmbH
city: Hamburg
country: Germany
facility: TFS Trial From Support GmbH
city: Kiel
country: Germany
facility: MVZ DermaKiel GmbH
city: Langenau
country: Germany
facility: Studienzentrum Dr.Beate Schwarz
city: Mahlow
country: Germany
facility: Hautarztpraxis Mahlow
city: Muenchen
country: Germany
facility: LMU Muenchen, Klinik und Poliklinik fur Dermatologie und Allergologie
city: Osnabrück
country: Germany
facility: KliFOs - Klinische Forschung Osnabrueck
city: Białystok
country: Poland
facility: NZOZ Specjalistyczny Orodek Dermatologiczny DERMAL
city: Chorzów
country: Poland
facility: Specjalistyczna Praktyka Lekarska Gabinet Dermatologiczny dr n.med. Edyta Gebska
city: Iwonicz-Zdrój
country: Poland
facility: Zespol Naukowo - Leczniczy Dermatologiczne Centrum Uzdrowiskowe Iwolang Sp. z o.o.
city: Katowice
country: Poland
facility: Provita Sp. z o.o.
city: Kraków
country: Poland
facility: Centrum Medyczne All-Med
city: Malbork
country: Poland
facility: Klinika Badawcza
city: Szczecin
country: Poland
facility: Laser Clinic
city: Szczecin
country: Poland
facility: Twoja Przychodnia - Szczecinskie Centrum Medyczne
city: Tarnów
country: Poland
facility: ALERGO-MED Specjalistyczna Przychodnia Lekarska Sp. z o. o.
city: Warsaw
country: Poland
facility: High-Med.Przychodnia Specjalistyczna
city: Warsaw
country: Poland
facility: Klinika Ambroziak
city: Wrocław
country: Poland
facility: CityClinic Przychodnia Lekarsko-Psychologiczna
city: Wrocław
country: Poland
facility: dermMedica Sp z.o.o
city: Wrocław
country: Poland
facility: Wromedica
city: Manchester
country: United Kingdom
facility: Medicines Evaluation Unit
Study officials:
affiliation: UNION therapeutics A/S
name: P. A., MD
role: STUDY_DIRECTOR
References: