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

Primary Purpose

Psoriasis, Skin Diseases

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Orismilast modified release tablets
Placebo
Sponsored by
UNION therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psoriasis focused on measuring Psoriasis, Orismilast

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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 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.

Sites / Locations

  • Central Connecticut Dermatology
  • GWU MFA
  • ALLCUTIS Research, LLC
  • ALLCUTIS Research, LLC
  • Bruce E. Katz, MD
  • Sadick Research Group LLC
  • Apex Clinical Research Center
  • Fachklinik Bad Bentheim
  • ISA - Interdisciplinary Study Association GmbH
  • Rosenpark Research GmbH
  • Hautarztpraxis Dr.Gerlach
  • Derma-Study-Center-Friedrichshafen
  • Klinische Forschung Hamburg GmbH
  • TFS Trial From Support GmbH
  • MVZ DermaKiel GmbH
  • Studienzentrum Dr.Beate Schwarz
  • Hautarztpraxis Mahlow
  • LMU Muenchen, Klinik und Poliklinik fur Dermatologie und Allergologie
  • KliFOs - Klinische Forschung Osnabrueck
  • NZOZ Specjalistyczny Orodek Dermatologiczny DERMAL
  • Specjalistyczna Praktyka Lekarska Gabinet Dermatologiczny dr n.med. Edyta Gebska
  • Zespol Naukowo - Leczniczy Dermatologiczne Centrum Uzdrowiskowe Iwolang Sp. z o.o.
  • Provita Sp. z o.o.
  • Centrum Medyczne All-Med
  • Klinika Badawcza
  • Laser Clinic
  • Twoja Przychodnia - Szczecinskie Centrum Medyczne
  • ALERGO-MED Specjalistyczna Przychodnia Lekarska Sp. z o. o.
  • High-Med.Przychodnia Specjalistyczna
  • Klinika Ambroziak
  • CityClinic Przychodnia Lekarsko-Psychologiczna
  • dermMedica Sp z.o.o
  • Wromedica
  • Medicines Evaluation Unit

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Orismilast modified release tablets 20 mg BID

Orismilast modified release tablets 30 mg BID

Orismilast modified release tablets 40 mg BID

Placebo tablets BID

Arm Description

Oral, twice daily morning and evening

Oral, twice daily morning and evening

Oral, twice daily morning and evening

Oral, twice daily morning and evening

Outcomes

Primary Outcome Measures

Percent change from Baseline in Psoriasis Activity and Severity Index (PASI) score at Week 16
The 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.

Secondary Outcome Measures

Patients achieving 75% reduction in PASI (PASI75) response at Week 16.
The 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.
Patients achieving a score of Clear (0) or Almost Clear (1) and an at least 2-point improvement in Investigator Global Assessment (IGA) at Week 16.
The IGA is a measure used by physicians to determine the patient's overall severity of disease. The static version (Langley 2015) is used in this trial for measurement at a single point in time as indicated in the schedule of assessments. The investigator will rate the severity of patient's psoriasis on a 5-point scale ranging from 0 (clear) to 4 (severe).

Full Information

First Posted
December 30, 2021
Last Updated
January 10, 2023
Sponsor
UNION therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT05190419
Brief Title
Study to Assess the Efficacy and Safety of Orismilast in Psoriasis
Acronym
IASOS
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

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
December 30, 2021 (Actual)
Primary Completion Date
November 24, 2022 (Actual)
Study Completion Date
December 20, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UNION therapeutics

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis, Skin Diseases
Keywords
Psoriasis, Orismilast

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
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)
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
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).
Allocation
Randomized
Enrollment
202 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Orismilast modified release tablets 20 mg BID
Arm Type
Experimental
Arm Description
Oral, twice daily morning and evening
Arm Title
Orismilast modified release tablets 30 mg BID
Arm Type
Experimental
Arm Description
Oral, twice daily morning and evening
Arm Title
Orismilast modified release tablets 40 mg BID
Arm Type
Experimental
Arm Description
Oral, twice daily morning and evening
Arm Title
Placebo tablets BID
Arm Type
Placebo Comparator
Arm Description
Oral, twice daily morning and evening
Intervention Type
Drug
Intervention Name(s)
Orismilast modified release tablets
Other Intervention Name(s)
UNI50001, LEO32731
Intervention Description
Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PD4 subtypes linked to inflammation.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching placebo tablets
Primary Outcome Measure Information:
Title
Percent change from Baseline in Psoriasis Activity and Severity Index (PASI) score at Week 16
Description
The 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.
Time Frame
Day 1 to Week 16.
Secondary Outcome Measure Information:
Title
Patients achieving 75% reduction in PASI (PASI75) response at Week 16.
Description
The 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.
Time Frame
Day 1 to Week 16
Title
Patients achieving a score of Clear (0) or Almost Clear (1) and an at least 2-point improvement in Investigator Global Assessment (IGA) at Week 16.
Description
The IGA is a measure used by physicians to determine the patient's overall severity of disease. The static version (Langley 2015) is used in this trial for measurement at a single point in time as indicated in the schedule of assessments. The investigator will rate the severity of patient's psoriasis on a 5-point scale ranging from 0 (clear) to 4 (severe).
Time Frame
Day 1 to Week 16

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 PASI ≥12, BSA ≥10%, and 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
P. A., MD
Organizational Affiliation
UNION therapeutics A/S
Official's Role
Study Director
Facility Information:
Facility Name
Central Connecticut Dermatology
City
Cromwell
State/Province
Connecticut
ZIP/Postal Code
06416
Country
United States
Facility Name
GWU MFA
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Facility Name
ALLCUTIS Research, LLC
City
Beverly
State/Province
Massachusetts
ZIP/Postal Code
01915
Country
United States
Facility Name
ALLCUTIS Research, LLC
City
Portsmouth
State/Province
New Hampshire
ZIP/Postal Code
03801
Country
United States
Facility Name
Bruce E. Katz, MD
City
New York
State/Province
New York
ZIP/Postal Code
10022
Country
United States
Facility Name
Sadick Research Group LLC
City
New York
State/Province
New York
ZIP/Postal Code
10075
Country
United States
Facility Name
Apex Clinical Research Center
City
Mayfield Heights
State/Province
Ohio
ZIP/Postal Code
44124
Country
United States
Facility Name
Fachklinik Bad Bentheim
City
Bad Bentheim
Country
Germany
Facility Name
ISA - Interdisciplinary Study Association GmbH
City
Berlin
Country
Germany
Facility Name
Rosenpark Research GmbH
City
Darmstadt
Country
Germany
Facility Name
Hautarztpraxis Dr.Gerlach
City
Dresden
Country
Germany
Facility Name
Derma-Study-Center-Friedrichshafen
City
Friedrichshafen
Country
Germany
Facility Name
Klinische Forschung Hamburg GmbH
City
Hamburg
Country
Germany
Facility Name
TFS Trial From Support GmbH
City
Hamburg
Country
Germany
Facility Name
MVZ DermaKiel GmbH
City
Kiel
Country
Germany
Facility Name
Studienzentrum Dr.Beate Schwarz
City
Langenau
Country
Germany
Facility Name
Hautarztpraxis Mahlow
City
Mahlow
Country
Germany
Facility Name
LMU Muenchen, Klinik und Poliklinik fur Dermatologie und Allergologie
City
Muenchen
Country
Germany
Facility Name
KliFOs - Klinische Forschung Osnabrueck
City
Osnabrück
Country
Germany
Facility Name
NZOZ Specjalistyczny Orodek Dermatologiczny DERMAL
City
Białystok
Country
Poland
Facility Name
Specjalistyczna Praktyka Lekarska Gabinet Dermatologiczny dr n.med. Edyta Gebska
City
Chorzów
Country
Poland
Facility Name
Zespol Naukowo - Leczniczy Dermatologiczne Centrum Uzdrowiskowe Iwolang Sp. z o.o.
City
Iwonicz-Zdrój
Country
Poland
Facility Name
Provita Sp. z o.o.
City
Katowice
Country
Poland
Facility Name
Centrum Medyczne All-Med
City
Kraków
Country
Poland
Facility Name
Klinika Badawcza
City
Malbork
Country
Poland
Facility Name
Laser Clinic
City
Szczecin
Country
Poland
Facility Name
Twoja Przychodnia - Szczecinskie Centrum Medyczne
City
Szczecin
Country
Poland
Facility Name
ALERGO-MED Specjalistyczna Przychodnia Lekarska Sp. z o. o.
City
Tarnów
Country
Poland
Facility Name
High-Med.Przychodnia Specjalistyczna
City
Warsaw
Country
Poland
Facility Name
Klinika Ambroziak
City
Warsaw
Country
Poland
Facility Name
CityClinic Przychodnia Lekarsko-Psychologiczna
City
Wrocław
Country
Poland
Facility Name
dermMedica Sp z.o.o
City
Wrocław
Country
Poland
Facility Name
Wromedica
City
Wrocław
Country
Poland
Facility Name
Medicines Evaluation Unit
City
Manchester
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

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Study to Assess the Efficacy and Safety of Orismilast in Psoriasis

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