Orismilast for the Treatment of Mild to Severe Hidradenitis Suppurativa (OSIRIS)

Orismilast for the Treatment of Mild to Severe Hidradenitis Suppurativa (OSIRIS)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Hidradenitis Suppurativa
• Intervention / Treatment: Drug: Orismilast

• Study Type: Interventional
• Enrollment (Anticipated): 24
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Gregor Jemec, Professor; Phone Number: +4547322601; Email: gbj@regionsjaelland.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Orismilast; Orismilast tablet, oral administration, multiple titrated doses twice daily, 10 mg up to 40 mg, morning and evening, 16 weeks treatment.	Drug: Orismilast; Orismilast is a next generation PD4 inhibitor with demonstrated broad anti inflammatory properties; Other Names: UNI5001

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in abscess, nodule, and draining fistula counts at Week 16	Total count of abscess, inflammatory nodules, and draining fistula	Day 1 to Week 16
Change from Baseline in IHS4 value at Week 16	ISH4 is a validated international clinimetric scale. The score is based on a count of inflamed lesions. The resulting IHS4 score is arrived at by the number of nodules (multiplied by 1) plus the number of abscesses (multiplied by 2) plus the number of draining tunnels (multiplied by 4).	Day 1 to Week 16
Change from Baseline in Patient's Global Assessment of Skin Pain (NRS) at Week 16	Completion of questionnaire covering skin pain Patient's Global Assessment of Skin Pain (0=no pain, 10=worst imaginable pain) 0-10 Numerical Rating Scale (NRS).	Day 1 to Week 16
Change from Baseline in HiSQOL Total Score at Week 16	Patient completion of the Hidradenitis Suppurativa Quality of Life (HiSQOL) questionnaire that contains Hidradenitis Suppurativa specific items such as drainage and odor in addition to more general skin specific items	Change from Baseline in HiSQOL Total Score at Week 16

Collaborators and Investigators

• Sponsor: Gregor Jemec
• Collaborators: UNION therapeutics
• Investigators: Principal Investigator: Gregor Jemec, Professor, Zealand University Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2021
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: July 26, 2021
• First Submitted That Met QC Criteria: July 26, 2021
• First Posted (Actual): July 29, 2021

Study Record Updates

• Last Update Posted (Actual): September 28, 2021
• Last Update Submitted That Met QC Criteria: September 26, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Sweat Gland Diseases; Skin Diseases; Infections; Bacterial Infections; Bacterial Infections and Mycoses; Skin Diseases, Infectious; Suppuration; Skin Diseases, Bacterial; Hidradenitis Suppurativa; Hidradenitis
• Other Study ID Numbers: OSIRIS [UNI50007-201]; 2021-000049-42 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No