Hidradenitis Suppurativa
Conditions
Keywords
Hidradenitis, Skin Diseases, Infections
Brief summary
The main purpose of this study is to evaluate the effect of LAD328 compared to placebo in participants with moderate-to-severe Hidradenitis Suppurativa (HS), and to access the safety, tolerability, pharmacokinetic and immunogenicity in participants with moderate-to-severe HS.
Detailed description
Hidradenitis suppurativa (HS) is a chronic skin disease of unclear etiology that affects approximately 1% of the general population. The purpose of this study is to assess the efficacy of LAD328 compared to placebo in participants with moderate-to-severe HS. The study participants will be randomized to one of the following treatment arms: LAD328 or Placebo. The study includes up to 4 weeks screening period 12-week double-blind, placebo-controlled period and 8-week safety follow-up. The total duration of study participation will be up to 20 weeks
Interventions
DRUGLAD328
LAD328 administered intravenously.
OTHERPlacebo
Placebo administered intravenously.
Sponsors
Almirall, S.A.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Male or female between 18 and 65 years old inclusive. * A diagnosis of moderate-to-severe HS defined as a total of \>=5 inflammatory lesions (i.e., number of abscesses plus number of inflammatory nodules) at both the Screening and Baseline visits, with a clinical history of HS for at least 6 months. * HS lesions present in at least 2 distinct anatomic areas (e.g., left and right axilla), one of which must be at least Hurley Stage II or Hurley Stage III at both the Screening and Baseline visits. * History of inadequate response, or intolerance or contraindication, to a course of a systemic antibiotics for treatment of HS at the Screening visit. * Agree to regularly use, over-the-counter topical antiseptics on their HS lesions throughout the entirety of the study. * Participants who are woman of child-bearing potential (WOCBP) and male participants must agree to the requirements for the avoidance of pregnancy and exposure of the participant's partner to LAD328 during the trial.
Exclusion criteria
* HS with \>20 draining tunnels either at the Screening or Baseline visits. * Ongoing medical conditions (e.g., inflammatory bowel disease, rheumatoid arthritis, systemic lupus erythematosus and sarcoidosis) requiring systemic immunosuppressive/immunomodulating treatments (e.g., methotrexate, ciclosporin, corticosteroids, cytokine-targeted therapy and JAK inhibitors) during the trial. * Known or suspected hypersensitivity to trial product or any of its excipients. * Hypersensitivity or systemic reaction to a prior biologic (antibody-based) therapy (regardless of indication), that was clinically significant, as per judgment of Investigator. * Prior treatment with LAD328. * Live and attenuated vaccinations 4 weeks prior Pre-treatment or is planning to receive any such vaccine during the trial. * Females who are pregnant or breast-feeding or seeking to become pregnant during the trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Participants Achieving 55 Percent (%) Reduction from Baseline in International Hidradenitis Suppurativa Severity Score System (IHS4-55) | At Week 12 | IHS4 assigns different weights to different lesion types: inflammatory nodules (1 point), abscesses (2 points), and draining tunnels (4 points). The number of each lesion type is multiplied by its respective weight and the three obtained values are then summed to obtain the IHS4 total score. IHS4-55 is a dichotomous IHS4 variable based on a \>=55% reduction of the total score. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Participants Achieving 50% Reduction from Baseline in Hidradenitis Suppurativa Clinical Response (HiSCR50) | At Week 12 | The HiSCR is defined as \>=50% reduction in the abscess and inflammatory nodule count (AN count) with no increase in abscess count and no increase in draining fistula count relative to baseline. |
| Proportion of Participants Achieving 75% Reduction from Baseline in HiSCR-75 | At Week 12 | The HiSCR is defined as \>=75% reduction in the abscess and inflammatory nodule count (AN count) with no increase in abscess count and no increase in draining fistula count relative to baseline. |
| Proportion of Participants Achieving 90% Reduction from Baseline in HiSCR-90 | At Week 12 | The HiSCR is defined as \>=90% reduction in the abscess and inflammatory nodule count (AN count) with no increase in abscess count and no increase in draining fistula count relative to baseline. |
| Change from Baseline in Skin Pain Numerical Rating Scale (NRS) | At Week 12 | Skin Pain NRS is an 11-point scale in which participants are asked to rate their skin pain over the prior 24 hours, where 0 is no skin pain and 10 is pain as bad as you can imagine. |
| Change from Baseline in Hidradenitis Suppurativa Quality of Life (HiSQOL) | At Week 12 | HiSQOL was specifically developed for use in clinical trials and comprises a 17-item questionnaire grouped into 3 sub-scales covering symptoms, psychosocial, and activity-adaptation aspects, with a recall period of 7 days. Individual item scores are summed and a total score ranging from 0 to 68 is calculated, where the higher the score the more impact HS has on QoL. |
Countries
Poland
Contacts
CONTACTEstrella Garcia
CONTACTAndrea Pejenaute
STUDY_DIRECTORStudy Director
Almirall, S.A.
Outcome results
None listed