LTX-109 as Treatment for Hidradenitis Suppurativa

• Status: Completed
• Trial end date: 2021-07-01
• Target enrollment: 0
• Participant gender: All

Summary

An Open label Phase II//proof of concept-study to demonstrate if percutaneous application of LTX-109 in a gel vehicle is a safe treatment of Hidradenitis suppurativa and to identify clinical response to intervention, as well to identify if covariates such as age, disease duration, smoking state and BMI influence patient reported measures.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pharma Holdings AS
• Collaborator: University Hospital of North Norway

Criteria

Inclusion Criteria:

1. Patients with active hidradenitis in the stage I-II according to Hurley's classification.

2. Patients are referred to a dermatology out-patient clinic or patients already in an established treatment program, where there is indication for new or different treatment, or surgical intervention.

3. Patients must have typical affection of the disease of either axillae, groins, and/or perigenital/perianal area

4. Signed informed consent and expected cooperation of the patients for the treatment and follow up must be obtained and documented according to international guidelines, and national/local regulations.

5. For women in fertile age: Concents to use highly effective contraception until the end of the study

Exclusion Criteria:

1. Patients in need of emergency medical or surgical treatment of hidradenitis

2. Subjects must not have used the following HS treatments within the specified timeframe prior to Baseline Visit:

1. Systemic therapy for HS, including but not limited to corticosteroids, antibiotics, dapsone or retinoids within 4 weeks

2. Targeted biologic treatments (refer to within 5 half-lives [if known]) or within 12 weeks, whichever is longer.

3. Topical treatments with antibiotics, including but not limited to clindamycin within 4 weeks

3. Patients with hidradenitis affecting larger areas (>5 palm units)

4. Patient does not agree to be registered in the national quality register for HS

5. Pregnant or lactating women

6. Any reason why, in the opinion of the investigator, the patient should not participate