Study to Assess the Efficacy and Safety of Orismilast in Psoriasis

NCT05190419 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: UNI50001-2032021-003209-22
• Study Type: interventional
• Target: 202
• Locations: 4 countries
• Sites: 34

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.

Conditions

Psoriasis; Skin Diseases

Keywords

Psoriasis; Orismilast

Outcome Measures

Primary Outcomes (1)

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

  The Psoriasis Activity and Severity Index (PASI) is a measure of psoriatic disease severity, taking into account qualitative lesion characteristics (erythema, induration, and desquamation) and percentage of affected skin surface area on defined anatomical regions. PASI score ranges from 0 to 72, with higher scores reflecting greater disease severity. Erythema, induration/thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The total qualitative score (sum of erythema, thickness, and scaling scores) is multiplied by the degree of involvement for each anatomic region and then multiplied by a constant. The scores for each anatomic region are combined to yield the final PASI.

  Baseline and Week 16

Secondary Outcomes (11)

• Percentage of Participants Who Achieved 75% Reduction in PASI (PASI75) Response at Week 16

  At Week 16

• 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

  At Week 16

• 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

  At Weeks 4, 8, 12, and 20

• Percentage of Participants Who Achieved 75% Reduction in PASI (PASI75) Response at Weeks 4, 8, 12, and 20

  At Weeks 4, 8, 12, and 20

• Percentage of Participants Who Achieved 50%, 90%, and 100% Reduction in PASI Response at Weeks 4, 8, 12, 16, and 20

  At Weeks 4, 8, 12, 16, and 20

Study Arms (4)

Orismilast modified release tablets 20 mg BID

EXPERIMENTAL

Oral, twice daily morning and evening for 16 weeks

Drug: Orismilast modified release tablets

Orismilast modified release tablets 30 mg BID

EXPERIMENTAL

Oral, twice daily morning and evening for 16 weeks

Drug: Orismilast modified release tablets

Orismilast modified release tablets 40 mg BID

EXPERIMENTAL

Oral, twice daily morning and evening for 16 weeks

Drug: Orismilast modified release tablets

Placebo tablets BID

PLACEBO COMPARATOR

Oral, twice daily morning and evening for 16 weeks

Drug: Placebo

Interventions

Orismilast modified release tablets DRUG

Orismilast modified release is a next generation phosphodiesterase-4 (PDE4) inhibitor with high selectivity for the PDE4 subtypes linked to inflammation.

Also known as: UNI50001, LEO32731

Orismilast modified release tablets 20 mg BID; Orismilast modified release tablets 30 mg BID; Orismilast modified release tablets 40 mg BID

Placebo DRUG

Matching placebo tablets

Placebo tablets BID

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• UNION therapeutics: lead

Study Sites (34)

Central Connecticut Dermatology

Cromwell, Connecticut, 06416, United States

Location

GWU MFA

Washington D.C., District of Columbia, 20037, United States

Location

ALLCUTIS Research, LLC

Beverly, Massachusetts, 01915, United States

Location

ALLCUTIS Research, LLC

Portsmouth, New Hampshire, 03801, United States

Location

Bruce E. Katz, MD

New York, New York, 10022, United States

Location

Sadick Research Group LLC

New York, New York, 10075, United States

Location

Apex Clinical Research Center

Mayfield Heights, Ohio, 44124, United States

Location

Fachklinik Bad Bentheim

Bad Bentheim, Germany

Location

ISA - Interdisciplinary Study Association GmbH

Berlin, Germany

Location

Rosenpark Research GmbH

Darmstadt, Germany

Location

Hautarztpraxis Dr.Gerlach

Dresden, Germany

Location

Derma-Study-Center-Friedrichshafen

Friedrichshafen, Germany

Location

Klinische Forschung Hamburg GmbH

Hamburg, Germany

Location

TFS Trial From Support GmbH

Hamburg, Germany

Location

MVZ DermaKiel GmbH

Kiel, Germany

Location

Studienzentrum Dr.Beate Schwarz

Langenau, Germany

Location

Hautarztpraxis Mahlow

Mahlow, Germany

Location

LMU Muenchen, Klinik und Poliklinik fur Dermatologie und Allergologie

München, Germany

Location

KliFOs - Klinische Forschung Osnabrueck

Osnabrück, Germany

Location

NZOZ Specjalistyczny Orodek Dermatologiczny DERMAL

Bialystok, Poland

Location

Specjalistyczna Praktyka Lekarska Gabinet Dermatologiczny dr n.med. Edyta Gebska

Chorzów, Poland

Location

Zespol Naukowo - Leczniczy Dermatologiczne Centrum Uzdrowiskowe Iwolang Sp. z o.o.

Iwonicz-Zdrój, Poland

Location

Provita Sp. z o.o.

Katowice, Poland

Location

Centrum Medyczne All-Med

Krakow, Poland

Location

Klinika Badawcza

Malbork, Poland

Location

Laser Clinic

Szczecin, Poland

Location

Twoja Przychodnia - Szczecinskie Centrum Medyczne

Szczecin, Poland

Location

ALERGO-MED Specjalistyczna Przychodnia Lekarska Sp. z o. o.

Tarnów, Poland

Location

High-Med.Przychodnia Specjalistyczna

Warsaw, Poland

Location

Klinika Ambroziak

Warsaw, Poland

Location

CityClinic Przychodnia Lekarsko-Psychologiczna

Wroclaw, Poland

Location

dermMedica Sp z.o.o

Wroclaw, Poland

Location

Wromedica

Wroclaw, Poland

Location

Medicines Evaluation Unit

Manchester, United Kingdom

Location

Related Publications (1)

• Warren RB, Weiss A, Felding J, Sommer MOA, Garcet S, Krueger JG. Orismilast, a Potent and Selective PDE4B/D Inhibitor, Reduces Protein Levels of Key Disease Driving Cytokines in the Skin of Patients With Plaque Psoriasis. Exp Dermatol. 2025 Sep;34(9):e70153. doi: 10.1111/exd.70153.

  PMID: 40970551 DERIVED

MeSH Terms

Conditions

Psoriasis; Skin Diseases

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: UNION therapeutics A/S
• Organization: UNION therapeutics A/S

clinicaltrials@uniontherapeutics.com

+4561777435

Study Officials

• P. A., MD

  UNION therapeutics A/S

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Tablets will be packaged in the same type of blister and the active and placebo tablets will have the same appearance (in terms of size, form, weight, and color).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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)

Study Record Dates

• First Submitted: December 30, 2021
• First Posted: January 13, 2022
• Study Start: December 30, 2021
• Primary Completion: November 24, 2022
• Study Completion: December 20, 2022
• Last Updated: April 16, 2024
• Results First Posted: April 16, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (7); PL (14); DE (12); GB (1)