Study to Assess the Efficacy and Safety of Orismilast in Psoriasis

Phase 2

Completed

Conditions: Psoriasis
Skin Diseases

Interventions: Drug: Orismilast modified release tablets
Drug: Placebo

Registration Number: NCT05190419

Lead Sponsor: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 202

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 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.

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Orismilast modified release tablets 20 mg BID	Orismilast modified release tablets	Oral, twice daily morning and evening for 16 weeks
Orismilast modified release tablets 30 mg BID	Orismilast modified release tablets	Oral, twice daily morning and evening for 16 weeks
Orismilast modified release tablets 40 mg BID	Orismilast modified release tablets	Oral, twice daily morning and evening for 16 weeks
Placebo tablets BID	Placebo	Oral, twice daily morning and evening for 16 weeks

Primary Outcome Measures

Name	Time	Method
Percent Change From Baseline in Psoriasis Activity and Severity Index (PASI) Score at Week 16	Baseline and 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.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants Who Achieved 75% Reduction in PASI (PASI75) Response at Week 16	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.
Percent Change From Baseline in Affected Body Surface Area (BSA) at Weeks 4, 8, 12, 16, and 20	Baseline and 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.
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	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).
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	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).
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	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.
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	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.
Percent Change From Baseline in Psoriasis Activity and Severity Index (PASI) Score at Weeks 4, 8, 12, and 20	Baseline and 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.
Percent Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Weeks 16 and 20	Baseline and 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.
Percent Change From Baseline in Total Score of Psoriasis Symptom Scale (PSS) at Weeks 4, 8, 12, 16, and 20	Baseline and 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.
Percent Change From Baseline in Each Individual Item of Psoriasis Symptom Scale (PSS) at Weeks 4, 8, 12, 16, and 20	Baseline and 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.
Percentage of Participants Who Experienced Psoriasis Rebound by Week 20	At 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.

Trial Locations

Locations (33): ISA - Interdisciplinary Study Association GmbH
🇩🇪
Berlin, Germany
MVZ DermaKiel GmbH
🇩🇪
Kiel, Germany
Central Connecticut Dermatology
🇺🇸
Cromwell, Connecticut, United States
Fachklinik Bad Bentheim
🇩🇪
Bad Bentheim, Germany
GWU MFA
🇺🇸
Washington, District of Columbia, United States
ALLCUTIS Research, LLC
🇺🇸
Portsmouth, New Hampshire, United States
Bruce E. Katz, MD
🇺🇸
New York, New York, United States
Rosenpark Research GmbH
🇩🇪
Darmstadt, Germany
Sadick Research Group LLC
🇺🇸
New York, New York, United States
Hautarztpraxis Dr.Gerlach
🇩🇪
Dresden, Germany
Derma-Study-Center-Friedrichshafen
🇩🇪
Friedrichshafen, Germany
TFS Trial From Support GmbH
🇩🇪
Hamburg, Germany
Studienzentrum Dr.Beate Schwarz
🇩🇪
Langenau, Germany
Klinische Forschung Hamburg GmbH
🇩🇪
Hamburg, Germany
Hautarztpraxis Mahlow
🇩🇪
Mahlow, Germany
KliFOs - Klinische Forschung Osnabrueck
🇩🇪
Osnabrück, Germany
LMU Muenchen, Klinik und Poliklinik fur Dermatologie und Allergologie
🇩🇪
Muenchen, Germany
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
NZOZ Specjalistyczny Orodek Dermatologiczny DERMAL
🇵🇱
Białystok, Poland
Centrum Medyczne All-Med
🇵🇱
Kraków, Poland
Provita Sp. z o.o.
🇵🇱
Katowice, Poland
Klinika Badawcza
🇵🇱
Malbork, Poland
High-Med.Przychodnia Specjalistyczna
🇵🇱
Warsaw, Poland
Klinika Ambroziak
🇵🇱
Warsaw, Poland
ALERGO-MED Specjalistyczna Przychodnia Lekarska Sp. z o. o.
🇵🇱
Tarnów, Poland
Medicines Evaluation Unit
🇬🇧
Manchester, United Kingdom
CityClinic Przychodnia Lekarsko-Psychologiczna
🇵🇱
Wrocław, Poland
dermMedica Sp z.o.o
🇵🇱
Wrocław, Poland
Wromedica
🇵🇱
Wrocław, Poland
Apex Clinical Research Center
🇺🇸
Mayfield Heights, Ohio, United States
Laser Clinic
🇵🇱
Szczecin, Poland
Twoja Przychodnia - Szczecinskie Centrum Medyczne
🇵🇱
Szczecin, Poland