LTX-109 as Treatment for Hidradenitis Suppurativa

NCT04756336 | Completed Phase 1

• 1 other identifier: C20-109-07
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hidradenitis Suppurativa

Outcome Measures

Primary Outcomes (2)

• Investigator assessed signs for local reactions to the Investigational Medicinal Product

  Investigator assessment of signs of local reactions

  End point analysis at 6 weeks

• Patient reported symptoms for local reactions to the Investigational Medicinal Product

  Patient reported symptoms for local reactions

  End point analysis at 6 weeks

Secondary Outcomes (5)

• Change in Investigator assessment of condition from Baseline

  End point analysis after 6 weeks

• Change in Investigator assessment disease activity from Baseline

  End point analysis after 6 weeks

• Change in Investigator assessed number of lesions from Baseline

  End point analysis after 6 weeks

• Change in Patient recorded Dermatology Life Quality Index (DLQI) from Baseline

  Endpoint analysis at week 6

• Change in Patient recorded Visual Analog Score for pain (VAS) from Baseline

  Endpoint analysis at week 6

Study Arms (1)

LTX-109 treatment

EXPERIMENTAL

Patients are treated with LTX-109 gel, 3% w/w twice daily (morning- evening) by application on active hidradenitis lesions during the intervention period of 6 weeks

Drug: LTX-109 gel, 3% w/w

Interventions

LTX-109 gel, 3% w/w DRUG

The drug is applied to affected lesions according to treatment regimen

LTX-109 treatment

Eligibility Criteria

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

You may qualify if:

• Patients with active hidradenitis in the stage I-II according to Hurley's classification.
• 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.
• Patients must have typical affection of the disease of either axillae, groins, and/or perigenital/perianal area
• 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.
• For women in fertile age: Concents to use highly effective contraception until the end of the study

You may not qualify if:

• Patients in need of emergency medical or surgical treatment of hidradenitis
• Subjects must not have used the following HS treatments within the specified timeframe prior to Baseline Visit:
• Systemic therapy for HS, including but not limited to corticosteroids, antibiotics, dapsone or retinoids within 4 weeks
• Targeted biologic treatments (refer to within 5 half-lives \[if known\]) or within 12 weeks, whichever is longer.
• Topical treatments with antibiotics, including but not limited to clindamycin within 4 weeks
• Patients with hidradenitis affecting larger areas (\>5 palm units)
• Patient does not agree to be registered in the national quality register for HS
• Pregnant or lactating women
• Any reason why, in the opinion of the investigator, the patient should not participate

Sponsors & Collaborators

• Pharma Holdings AS: lead
• University Hospital of North Norway: collaborator

Study Sites (1)

University Hospital of North Norway

Tromsø, 9038, Norway

Location

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

• Øystein Grimstad, Phd., MD

  University Hospital of North Norway

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Consecutive case series

Study Record Dates

• First Submitted: January 21, 2021
• First Posted: February 16, 2021
• Study Start: March 5, 2021
• Primary Completion: July 1, 2021
• Study Completion: July 1, 2021
• Last Updated: August 30, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)