A proof of concept trial to assess the efficacy and safety of orismilast in adult patients with mild, moderate, and severe hidradenitis suppurativa;

Phase 1

• Conditions: Hidradenitis suppurativa; MedDRA version: 20.0Level: LLTClassification code 10020041Term: Hidradenitis suppurativaSystem Organ Class: 100000004858; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2021-000049-42-DK
• Lead Sponsor: Zealand University Hospital (Universitetshospital Sjælland)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-02-03
• Last Update Posted: 27 November 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 24

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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 24
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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.
8.Women who are pregnant, nursing, or who plan to become pregnant while in the trial. Women who stop nursing before the study drug administration do not need to be excluded from participating.

9.Active systemic infection and/or fever – or clinical signs of local infection (stinging, increased soreness, burning sensation, erythematous perilesional halo or other signs of infection) - during the last 2 weeks prior to first drug administration.
10.History of allergy/hypersensitivity to the systemically administered trial medication agent or its excipients.
11.Patient with a transplanted organ (with exception of a corneal transplant > 12 weeks prior to screening) or who have ever received stem cell therapy (e.g., Remestemcel-L).
12.Any documented active or suspected malignancy or history of malignancy within 5 years prior to the screening visit, except appropriately treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin or in situ carcinoma of uterine cervix.
13.Relevant chronic or acute infections (exception: common cold), as determined by the investigator, including human immunodeficiency virus (HIV) or viral hepatitis. A patient can be re-screened if the patient was treated and is cured from the acute infection.
a. In case of a positive hepatitis C antibody test, a positive reflex testing for Hepatitis C RNA PCR is considered positive.
14.Major surgery (major according to the investigator) performed within 12 weeks prior to first study drug administration or planned during the study (e.g. hip replacement, aneurysm removal, stomach ligation).
15.Severe, progressive, or uncontrolled hepatic disease, defined as >3-fold Upper Limit of Normal (ULN) elevation in AST or ALT or alkaline phosphatase, and >2-fold ULN elevation in alkaline phosphatase.
16.Evidence of a current or previous disease, medical condition (including chronic alcohol or drug abuse or any condition) other than HS, surgical procedure, psychiatric or social problems, medical examination finding (including vital signs and ECG), or laboratory value at the screening outside the reference range that in the opinion of the investigator is clinically significant and would compromise the safety of the patient or compromise the quality of the data, make the study participant unreliable to adhere to the protocol, comply with all study visits/procedures or to complete the trial.
17.Planned use of laser or other hair removal procedures over HS-affected areas during the trial period.
18.Planned HS surgery during the trial period.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Secondary Objective: The secondary objective is to add depth and detail to the primary endpoint through the use of validated scores and patient reported out-come measures<br><br>An exploratory objective is to assess the long-term efficacy, safety and tolerability of orismilast in the oral treatment of patients who responded after the initial 16 week of treatment ;Primary end point(s): Percent change from Baseline in AN (abscesses and nodules) count at Week 16.;Timepoint(s) of evaluation of this end point: week 2, 4, 12, 16;Main Objective: Explore evidence of efficacy of orismilast in the oral treatment of patients with HS when applied twice daily for up to 16 weeks

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Change from Baseline in abscess, nodule, and draining fistula counts at Week 16.<br>• Change from Baseline in IHS4 value at Week 16.<br>• Change from Baseline in Patient’s Global Assessment of Skin Pain (NRS) at Week 16.<br>• Change from Baseline in HiSQOL Total Score at Week 16.<br><br>• Occurrence of treatment emergent adverse events (AEs).<br>• Change in clinical laboratory parameters (haematology and biochemistry).<br>• Change in vital signs.<br>• Change in weight<br><br>Efficacy, safety and tolerability assessed every 3 months during the extension period <br>;Timepoint(s) of evaluation of this end point: weekly<br><br>every 3 month during extension period