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

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ClinicalTrials.gov Identifier: NCT05190419
Recruitment Status : Recruiting
First Posted : January 13, 2022
Last Update Posted : June 24, 2022
Sponsor:
Information provided by (Responsible Party):
UNION therapeutics

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.

Condition or disease Intervention/treatment Phase
Psoriasis Skin Diseases Drug: Orismilast modified release tablets Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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)
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes 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).
Primary Purpose: Treatment
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
Actual Study Start Date : December 30, 2021
Estimated Primary Completion Date : December 19, 2022
Estimated Study Completion Date : January 17, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
Experimental: Orismilast modified release tablets 20 mg BID
Oral, twice daily morning and evening
Drug: Orismilast modified release tablets
Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PD4 subtypes linked to inflammation.
Other Names:
  • UNI50001
  • LEO32731

Experimental: Orismilast modified release tablets 30 mg BID
Oral, twice daily morning and evening
Drug: Orismilast modified release tablets
Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PD4 subtypes linked to inflammation.
Other Names:
  • UNI50001
  • LEO32731

Experimental: Orismilast modified release tablets 40 mg BID
Oral, twice daily morning and evening
Drug: Orismilast modified release tablets
Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PD4 subtypes linked to inflammation.
Other Names:
  • UNI50001
  • LEO32731

Placebo Comparator: Placebo tablets BID
Oral, twice daily morning and evening
Drug: Placebo
Matching placebo tablets




Primary Outcome Measures :
  1. Percent change from Baseline in Psoriasis Activity and Severity Index (PASI) score at Week 16 [ Time Frame: Day 1 to 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 :
  1. Patients achieving 75% reduction in PASI (PASI75) response at Week 16. [ Time Frame: Day 1 to 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.

  2. 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. [ Time Frame: Day 1 to 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).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05190419


Contacts
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Contact: UNION therapeutics A/S +4561777435 clinicaltrials@uniontherapeutics.com
Contact: UNION therapeutics A/S Study Director +4561777435 clinicaltrials@uniontherapeutics.com

Locations
Show Show 34 study locations
Sponsors and Collaborators
UNION therapeutics
Investigators
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Study Director: P. A., MD UNION therapeutics A/S
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Responsible Party: UNION therapeutics
ClinicalTrials.gov Identifier: NCT05190419    
Other Study ID Numbers: UNI50001-203
2021-003209-22 ( EudraCT Number )
First Posted: January 13, 2022    Key Record Dates
Last Update Posted: June 24, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by UNION therapeutics:
Psoriasis
Orismilast
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases
Skin Diseases, Papulosquamous