Orismilast for the Treatment of Mild to Severe Hidradenitis Suppurativa

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-01

Study Completion Date

2022-12-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to assess the efficacy and safety of oral administration of orismilast for treatment of mild, moderate, or severe hidradenitis suppurativa (HS) in adults.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Study to Evaluate Tulisokibart for Hidradenitis Suppurativa (MK-7240-012)

NCT06956235

Hidradenitis Suppurativa

ACTIVE_NOT_RECRUITING PHASE2

Study of Efficacy and Safety of Investigational Treatment in Patients With Hidradenitis Suppurativa

NCT04989517

Hidradenitis Suppurativa

COMPLETED PHASE1

A Study Investigating Long-term Treatment With Spesolimab in People With a Skin Disease Called Hidradenitis Suppurativa Who Completed a Previous Clinical Trial

NCT04876391

Hidradenitis Suppurativa

COMPLETED PHASE2

The Safety and Efficacy of Roflumilast Foam in HS

NCT07263230

Hidradenitis Suppurativa (HS)

NOT_YET_RECRUITING PHASE2

Study of Single Doses of SBT777101 in Subjects With Hidradenitis Suppurativa

NCT06361836

Hidradenitis Suppurativa

RECRUITING PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hidradenitis Suppurativa

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Patients will be graded and assigned to a severity group (mild, moderate, or severe). All groups will receive the same intervention

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Orismilast

Orismilast tablet, oral administration, multiple titrated doses twice daily, 10 mg up to 40 mg, morning and evening, 16 weeks treatment.

Group Type EXPERIMENTAL

Orismilast

Intervention Type DRUG

Orismilast is a next generation PD4 inhibitor with demonstrated broad anti inflammatory properties

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Orismilast

Orismilast is a next generation PD4 inhibitor with demonstrated broad anti inflammatory properties

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

UNI5001

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Male or female adult patients, 18 years of age or older.
2. Have mild to severe HS for at least 1 year prior to the baseline visit, as determined by the investigator through participant interview and/or review of the medical history.
3. Have HS lesions in at least 2 distinct anatomic area (right/left axillary, inguinal, inframammary, abdominal, perineal).
4. Has a total inflammatory lesions (AN) count of greater than or equal to 2.
5. Total draining fistula count of less than or equal to 30.
6. A stable analgesic dose for 2 weeks prior to baseline.

Exclusion Criteria

1. Presence of active skin lesions other than HS that could interfere with the assessment of HS.
2. Receipt of prescription topical therapies for HS within 7 days prior to the baseline visit (Visit 2).
3. Receipt of systemic therapies for HS, within 28 days prior to the baseline visit.
4. Any oral antibiotic within 28 days prior to baseline visit.
5. Receipt of a live vaccine within 14 days prior to screening.
6. Biologic use for indications other than HS within a minimum of 30 days or 5 half-lives of the drug, whichever is longer, prior to baseline.
7. Treatment with any investigational drug of chemical or biologic nature within a minimum of 30 days or 5 half-lives of the drug, whichever is longer, prior to baseline.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No