PsoriasisPhase 2IASOSNCT05190419
Study to Assess the Efficacy and Safety of Orismilast in Psoriasis
A Phase 2 study testing Orismilast modified release tablets in people with Psoriasis and Skin Diseases, run by UNION therapeutics at 34 sites in 4 countries.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis, Skin Diseases
- What is being tested?
- Orismilast modified release tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 202 participants
- Where
- 34 sitesin 4 countries
- Study dates
- 30 Dec 2021to 20 Dec 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
34 sites in 4 countries.
34 sites in 4 countries
Poland14 sites
NZOZ Specjalistyczny Orodek Dermatologiczny DERMAL
Bialystok
Specjalistyczna Praktyka Lekarska Gabinet Dermatologiczny dr n.med. Edyta Gebska
Chorzów
Zespol Naukowo - Leczniczy Dermatologiczne Centrum Uzdrowiskowe Iwolang Sp. z o.o.
Iwonicz-Zdrój
Provita Sp. z o.o.
Katowice
Centrum Medyczne All-Med
Krakow
Klinika Badawcza
Malbork
Laser Clinic
Szczecin
Twoja Przychodnia - Szczecinskie Centrum Medyczne
Szczecin
ALERGO-MED Specjalistyczna Przychodnia Lekarska Sp. z o. o.
Tarnów
High-Med.Przychodnia Specjalistyczna
Warsaw
Klinika Ambroziak
Warsaw
CityClinic Przychodnia Lekarsko-Psychologiczna
Wroclaw
dermMedica Sp z.o.o
Wroclaw
Wromedica
Wroclaw
Germany12 sites
Fachklinik Bad Bentheim
Bad Bentheim
ISA - Interdisciplinary Study Association GmbH
Berlin
Rosenpark Research GmbH
Darmstadt
Hautarztpraxis Dr.Gerlach
Dresden
Derma-Study-Center-Friedrichshafen
Friedrichshafen
Klinische Forschung Hamburg GmbH
Hamburg
TFS Trial From Support GmbH
Hamburg
MVZ DermaKiel GmbH
Kiel
Studienzentrum Dr.Beate Schwarz
Langenau
Hautarztpraxis Mahlow
Mahlow
LMU Muenchen, Klinik und Poliklinik fur Dermatologie und Allergologie
München
KliFOs - Klinische Forschung Osnabrueck
Osnabrück
United States7 sites
ALLCUTIS Research, LLC
Beverly, Massachusetts, 01915
Central Connecticut Dermatology
Cromwell, Connecticut, 06416
Apex Clinical Research Center
Mayfield Heights, Ohio, 44124
Bruce E. Katz, MD
New York, New York, 10022
Sadick Research Group LLC
New York, New York, 10075
ALLCUTIS Research, LLC
Portsmouth, New Hampshire, 03801
GWU MFA
Washington D.C., District of Columbia, 20037
About this study
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
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
- Being tested
- Orismilast modified release tablets, Placebo
- Keywords
- Psoriasis, Orismilast
- Medical subject headings
- Psoriasis, Skin Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orismilast modified release tabletsDrug
Also called UNI50001, LEO32731
Orismilast modified release is a next generation phosphodiesterase-4 (PDE4) inhibitor with high selectivity for the PDE4 subtypes linked to inflammation.
PlaceboDrug
Matching placebo tablets
| Study group | Role | What they receive |
|---|---|---|
| Orismilast modified release tablets 20 mg BID | Experimental | Oral, twice daily morning and evening for 16 weeks Receives: Drug: Orismilast modified release tablets |
| Orismilast modified release tablets 30 mg BID | Experimental | Oral, twice daily morning and evening for 16 weeks Receives: Drug: Orismilast modified release tablets |
| Orismilast modified release tablets 40 mg BID | Experimental | Oral, twice daily morning and evening for 16 weeks Receives: Drug: Orismilast modified release tablets |
| Placebo tablets BID | Placebo comparator | Oral, twice daily morning and evening for 16 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and Week 16
Secondary outcomes (11)
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.
Measured: 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
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).
Measured: 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
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).
Measured: 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
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.
Measured: 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
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.
Measured: At Weeks 4, 8, 12, 16, and 20
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.
Measured: Baseline and Weeks 4, 8, 12, and 20
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.
Measured: Baseline and Weeks 16 and 20
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.
Measured: Baseline and Weeks 4, 8, 12, 16, and 20
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.
Measured: Baseline and Weeks 4, 8, 12, 16, and 20
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.
Measured: Baseline and Weeks 4, 8, 12, 16, and 20
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.
Measured: At Week 20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2022
- Study start30 Dec 2021
- Primary completion24 Nov 2022
- Study completion20 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 202 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNION therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- P. A., MD, Study director, UNION therapeutics A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05190419
- Sponsor's protocol ID
- UNI50001-203
- Other IDs
- 2021-003209-22
- Acronym
- IASOS
- Status last verified
- Mar 2024
- First submitted
- 30 Dec 2021
- Last updated
- 16 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40970551
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05190419
- Acronym / sponsor ID
- IASOS / UNI50001-203
- Conditions
- Psoriasis, Skin Diseases
- Keywords
- Psoriasis, Orismilast
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 202 participants (actual)
- Lead sponsor
- UNION therapeuticsIndustry (pharma, biotech, devices)
- Study start
- 30 Dec 2021 (actual)
- Primary completion
- 24 Nov 2022 (actual)
- Study completion
- 20 Dec 2022 (actual)
- First posted
- 13 Jan 2022 (actual)
- Results
- Posted 16 Apr 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- 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)
| Arm | Type | Receives |
|---|---|---|
| Orismilast modified release tablets 20 mg BID | Experimental | Drug: Orismilast modified release tabletsOral, twice daily morning and evening for 16 weeks |
| Orismilast modified release tablets 30 mg BID | Experimental | Drug: Orismilast modified release tabletsOral, twice daily morning and evening for 16 weeks |
| Orismilast modified release tablets 40 mg BID | Experimental | Drug: Orismilast modified release tabletsOral, twice daily morning and evening for 16 weeks |
| Placebo tablets BID | Placebo comparator | Drug: PlaceboOral, twice daily morning and evening for 16 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Orismilast modified release tabletsAlso: UNI50001, LEO32731Orismilast modified release is a next generation phosphodiesterase-4 (PDE4) inhibitor with high selectivity for the PDE4 subtypes linked to inflammation. | Drug | Orismilast modified release tablets 20 mg BID, Orismilast modified release tablets 30 mg BID, Orismilast modified release tablets 40 mg BID |
| PlaceboMatching placebo tablets | Drug | Placebo tablets BID |
Primary outcome
Percent Change From Baseline in Psoriasis Activity and Severity Index (PASI) Score at Week 16
Time frame: 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.
11 secondary outcomes
Percentage of Participants Who Achieved 75% Reduction in PASI (PASI75) Response at Week 16
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: At Weeks 4, 8, 12, 16, and 20
Percent Change From Baseline in Psoriasis Activity and Severity Index (PASI) Score at Weeks 4, 8, 12, and 20
Time frame: Baseline and Weeks 4, 8, 12, and 20
Percent Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Weeks 16 and 20
Time frame: Baseline and Weeks 16 and 20
Percent Change From Baseline in Affected Body Surface Area (BSA) at Weeks 4, 8, 12, 16, and 20
Time frame: Baseline and Weeks 4, 8, 12, 16, and 20
Percent Change From Baseline in Total Score of Psoriasis Symptom Scale (PSS) at Weeks 4, 8, 12, 16, and 20
Time frame: Baseline and Weeks 4, 8, 12, 16, and 20
Percent Change From Baseline in Each Individual Item of Psoriasis Symptom Scale (PSS) at Weeks 4, 8, 12, 16, and 20
Time frame: Baseline and Weeks 4, 8, 12, 16, and 20
Percentage of Participants Who Experienced Psoriasis Rebound by Week 20
Time frame: At Week 20
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40970551Warren 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
P. A., MD study director
UNION therapeutics A/S
34 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Orismilast modified release tablets in people with Psoriasis and Skin Diseases, run by UNION therapeutics at 34 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 sites in Poland, Germany, United States, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Change From Baseline in Psoriasis Activity and Severity Index (PASI) Score at Week 16 (time frame: Baseline and Week 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05190419, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2024.