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

Primary Purpose

Hidradenitis Suppurativa

Status

Unknown status

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

Orismilast

About this trial

This is an interventional treatment trial for Hidradenitis Suppurativa

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Orismilast

Arm Description

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

Outcomes

Primary Outcome Measures

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

Total count of abscess and inflammatory nodules

Secondary Outcome Measures

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

Total count of abscess, inflammatory nodules, and draining fistula

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).

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).

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

Full Information

NCT ID

NCT04982432

First Posted

July 26, 2021

Last Updated

September 26, 2021

Sponsor

Gregor Jemec

Collaborators

UNION therapeutics

1. Study Identification

Unique Protocol Identification Number

NCT04982432

Brief Title

Orismilast for the Treatment of Mild to Severe Hidradenitis Suppurativa

Acronym

OSIRIS

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2021

Overall Recruitment Status

Unknown status

Study Start Date

October 1, 2021 (Anticipated)

Primary Completion Date

December 1, 2022 (Anticipated)

Study Completion Date

December 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Gregor Jemec

Collaborators

UNION therapeutics

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hidradenitis Suppurativa

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Model Description

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

Masking

None (Open Label)

Allocation

N/A

Enrollment

24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Orismilast

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Orismilast

Other Intervention Name(s)

UNI5001

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

Total count of abscess and inflammatory nodules

Time Frame

Day 1 to Week 16

Secondary Outcome Measure Information:

Title

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

Description

Total count of abscess, inflammatory nodules, and draining fistula

Time Frame

Day 1 to Week 16

Title

Change from Baseline in IHS4 value at Week 16

Description

Time Frame

Day 1 to Week 16

Title

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

Description

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).

Time Frame

Day 1 to Week 16

Title

Change from Baseline in HiSQOL Total Score at Week 16

Description

Time Frame

Change from Baseline in HiSQOL Total Score at Week 16

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Gregor Jemec, Professor

Phone

+4547322601

gbj@regionsjaelland.dk

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gregor Jemec, Professor

Organizational Affiliation

Zealand University Hospital

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Orismilast for the Treatment of Mild to Severe Hidradenitis Suppurativa

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