Hidradenitis suppurativa, Hurley stage I-III
Conditions
Interventions
Product Name: LTX-109
Pharmaceutical Form:
Sponsors
None listed
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ? Patients with active hidradenitis in the stage I-III according to Hurley’s classification. (24). ? 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 ? Patients must be at least 18 years of age. 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 12 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: ? Patients in need of emergency medical or surgical treatment of hidradenitis will be excluded until the disease is in a quiet, controlled phase. ? Subjects must not have used the following HS treatments within the specified timeframe prior to Baseline Visit: o Systemic therapy for HS, including but not limited to corticosteroids, antibiotics, dapsone or retinoids within 4 weeks o Targeted biologic treatments (refer to within 5 half-lives [if known]) or within 12 weeks, whichever is longer; o Topical treatments with antibiotics, including but not limited to clindamycin within 4 weeks ? Pregnant or lactating women ? Any reason why, in the opinion of the investigator, the patient should not participate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To document whether LTX-109 is an effective compound on hidradenitis;Secondary Objective: Safety documentation Duration of clinical response (survival of effect);Primary end point(s): Patient reported improvement after invention with LTX-109. Outcome measured by Dermatological Life Quality Index (DLQI)-scores and self-reported disease activity and pain experience. ;Timepoint(s) of evaluation of this end point: [ Time Frame: Interim analysis after 3 weeks. End point analysis 6 weeks]. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Identification of clinical subgroups with best response to intervention as assessed by clinically scored measures . Registration and analysis on investigator scored measures assessed by Hidradenitis suppurativa score (HiSCR) in relation to clinical phenotypes (location, Hurley stage) • Identify if covariates such as age, disease duration, smoking state, BMI and sweating influence patient reported improvement measures Covariate analysis on patient recorded DLQI and self-reported disease activity and pain experience in relation to pre-registered variables Identification of clinical subgroups with best response to intervention as assessed by patient reported improvement Registration and analysis on patient recorded DLQI and self-reported disease activity and pain experience in relation to clinical phenotypes (location specific score (Sartorius), Hurley stage, IHS-4) ;Timepoint(s) of evaluation of this end point: [Time Frame: Interim analysis after 3 weeks. End point analysis 6 weeks and sub group analysis 3 months] | — |
Countries
Norway
Outcome results
None listed