Study to Assess the Efficacy and Safety of Orismilast in Psoriasis

Psoriasis Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05190419
• Other study ID #: UNI50001-203
• Secondary ID: 2021-003209-22
• Status: Completed
• Phase: Phase 2
• Start date: December 30, 2021
• Est. completion date: December 20, 2022

Study information

• Verified date: March 2024
• Source: UNION therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 202
• Est. completion date: December 20, 2022
• Est. primary completion date: November 24, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Psoriasis
• Skin Diseases

Intervention

Drug:
• Orismilast modified release tablets
Orismilast modified release is a next generation phosphodiesterase-4 (PDE4) inhibitor with high selectivity for the PDE4 subtypes linked to inflammation.
• Placebo
Matching placebo tablets

Locations

Country	Name	City	State
Germany	Fachklinik Bad Bentheim	Bad Bentheim
Germany	ISA - Interdisciplinary Study Association GmbH	Berlin
Germany	Rosenpark Research GmbH	Darmstadt
Germany	Hautarztpraxis Dr.Gerlach	Dresden
Germany	Derma-Study-Center-Friedrichshafen	Friedrichshafen
Germany	Klinische Forschung Hamburg GmbH	Hamburg
Germany	TFS Trial From Support GmbH	Hamburg
Germany	MVZ DermaKiel GmbH	Kiel
Germany	Studienzentrum Dr.Beate Schwarz	Langenau
Germany	Hautarztpraxis Mahlow	Mahlow
Germany	LMU Muenchen, Klinik und Poliklinik fur Dermatologie und Allergologie	Muenchen
Germany	KliFOs - Klinische Forschung Osnabrueck	Osnabrück
Poland	NZOZ Specjalistyczny Orodek Dermatologiczny DERMAL	Bialystok
Poland	Specjalistyczna Praktyka Lekarska Gabinet Dermatologiczny dr n.med. Edyta Gebska	Chorzów
Poland	Zespol Naukowo - Leczniczy Dermatologiczne Centrum Uzdrowiskowe Iwolang Sp. z o.o.	Iwonicz-Zdrój
Poland	Provita Sp. z o.o.	Katowice
Poland	Centrum Medyczne All-Med	Kraków
Poland	Klinika Badawcza	Malbork
Poland	Laser Clinic	Szczecin
Poland	Twoja Przychodnia - Szczecinskie Centrum Medyczne	Szczecin
Poland	ALERGO-MED Specjalistyczna Przychodnia Lekarska Sp. z o. o.	Tarnów
Poland	High-Med.Przychodnia Specjalistyczna	Warsaw
Poland	Klinika Ambroziak	Warsaw
Poland	CityClinic Przychodnia Lekarsko-Psychologiczna	Wroclaw
Poland	dermMedica Sp z.o.o	Wroclaw
Poland	Wromedica	Wroclaw
United Kingdom	Medicines Evaluation Unit	Manchester
United States	ALLCUTIS Research, LLC	Beverly	Massachusetts
United States	Central Connecticut Dermatology	Cromwell	Connecticut
United States	Apex Clinical Research Center	Mayfield Heights	Ohio
United States	Bruce E. Katz, MD	New York	New York
United States	Sadick Research Group LLC	New York	New York
United States	ALLCUTIS Research, LLC	Portsmouth	New Hampshire
United States	GWU MFA	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
UNION therapeutics

Countries where clinical trial is conducted

United States,  Germany,  Poland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Percentage of Participants Who Achieved 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. 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. PASI75 is 75% reduction from Baseline in PASI score.	At Week 16
Secondary	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	The IGA is a measure used by physicians to determine the patient's overall severity of disease. The static version 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).	At Week 16
Secondary	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	The IGA is a measure used by physicians to determine the patient's overall severity of disease. The static version 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).	At Weeks 4, 8, 12, and 20
Secondary	Percentage of Participants Who Achieved 75% Reduction in PASI (PASI75) Response at Weeks 4, 8, 12, and 20	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. 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. PASI75 is 75% reduction from Baseline in PASI score.	At Weeks 4, 8, 12, and 20
Secondary	Percentage of Participants Who Achieved 50%, 90%, and 100% Reduction in PASI Response at Weeks 4, 8, 12, 16, and 20	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. 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. PASI 50, 90, and 100 is 50%, 90%, and 100% reduction from Baseline in PASI score, respectively.	At Weeks 4, 8, 12, 16, and 20
Secondary	Percent Change From Baseline in Psoriasis Activity and Severity Index (PASI) Score at Weeks 4, 8, 12, and 20	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 Weeks 4, 8, 12, and 20
Secondary	Percent Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Weeks 16 and 20	The DLQI is a 10-item validated questionnaire completed by the patient used to assess the impact of skin disease on the patient's quality of life (QoL) during the previous week. The 10 questions cover the following topics: symptoms, embarrassment, shopping and home care, clothes, social and leisure, sport, work or study, close relationships, sex, and treatment. Each question is scored from 0 to 3 ("not at all," "a little," "a lot," and "very much," respectively), giving a total score ranging from 0 to 30. A high score is indicative of a poor QoL.	Baseline and Weeks 16 and 20
Secondary	Percent Change From Baseline in Affected Body Surface Area (BSA) at Weeks 4, 8, 12, 16, and 20	The BSA assessment estimates the extent of disease or skin affected by psoriasis and is expressed as a percentage of total body surface. BSA was determined by the Investigator or designee using the patient palm = 1% BSA rule. The patient's palm is measured from the wrist to the proximal interphalangeal and thumb.	Baseline and Weeks 4, 8, 12, 16, and 20
Secondary	Percent Change From Baseline in Total Score of Psoriasis Symptom Scale (PSS) at Weeks 4, 8, 12, 16, and 20	The PSS is a 4-item patient-completed questionnaire (Rentz 2017). It is patient relevant, its domains are reliable and valid, and it takes few minutes to complete. The PSS assesses severity of pain, itching, redness, and burning during the past 24 hours using a 5-point severity scale from 0 = none to 4 = very severe.	Baseline and Weeks 4, 8, 12, 16, and 20
Secondary	Percent Change From Baseline in Each Individual Item of Psoriasis Symptom Scale (PSS) at Weeks 4, 8, 12, 16, and 20	The PSS is a 4-item patient-completed questionnaire (Rentz 2017). It is patient relevant, its domains are reliable and valid, and it takes few minutes to complete. The PSS assesses severity of pain, itching, redness, and burning during the past 24 hours using a 5-point severity scale from 0 = none to 4 = very severe.	Baseline and Weeks 4, 8, 12, 16, and 20
Secondary	Percentage of Participants Who Experienced Psoriasis Rebound by Week 20	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.	At Week 20