Orismilast for the Treatment of Mild to Severe Hidradenitis Suppurativa

NCT04982432 | Unknown Phase 2

• 2 other identifiers: OSIRIS [UNI50007-201]2021-000049-42
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Hidradenitis Suppurativa

Outcome Measures

Primary Outcomes (1)

• Percent change from Baseline in AN (abscesses and nodules) count at Week 16

  Total count of abscess and inflammatory nodules

  Day 1 to Week 16

Secondary Outcomes (4)

• Change from Baseline in abscess, nodule, and draining fistula counts at Week 16

  Day 1 to Week 16

• Change from Baseline in IHS4 value at Week 16

  Day 1 to Week 16

• Change from Baseline in Patient's Global Assessment of Skin Pain (NRS) at Week 16

  Day 1 to Week 16

• Change from Baseline in HiSQOL Total Score at Week 16

  Change from Baseline in HiSQOL Total Score at Week 16

Study Arms (1)

Orismilast

EXPERIMENTAL

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

Drug: Orismilast

Interventions

Orismilast DRUG

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

Also known as: UNI5001

Orismilast

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female adult patients, 18 years of age or older.
• 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.
• Have HS lesions in at least 2 distinct anatomic area (right/left axillary, inguinal, inframammary, abdominal, perineal).
• Has a total inflammatory lesions (AN) count of greater than or equal to 2.
• Total draining fistula count of less than or equal to 30.
• A stable analgesic dose for 2 weeks prior to baseline.

You may not qualify if:

• Presence of active skin lesions other than HS that could interfere with the assessment of HS.
• Receipt of prescription topical therapies for HS within 7 days prior to the baseline visit (Visit 2).
• Receipt of systemic therapies for HS, within 28 days prior to the baseline visit.
• Any oral antibiotic within 28 days prior to baseline visit.
• Receipt of a live vaccine within 14 days prior to screening.
• 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.
• 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.

Sponsors & Collaborators

• Gregor Jemec: lead
• UNION therapeutics: collaborator

MeSH Terms

Conditions

Hidradenitis Suppurativa

Condition Hierarchy (Ancestors)

Skin Diseases, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Suppuration; Skin Diseases; Skin and Connective Tissue Diseases; Hidradenitis; Sweat Gland Diseases

Study Officials

• Gregor Jemec, Professor

  Zealand University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gregor Jemec, Professor

CONTACT

+4547322601; gbj@regionsjaelland.dk

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

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

Study Record Dates

• First Submitted: July 26, 2021
• First Posted: July 29, 2021
• Study Start: October 1, 2021
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: September 28, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share