A Proof-of-Concept Study of LAD328 in Adults With Hidradenitis Suppurativa
Фаза 2 – изследване на ефективността и дозировката
Заболявания:
Hidradenitis Suppurativa
Спонсор: Almirall, S.A.
Налично на:
БГ
Обобщение
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.
Описание
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
Кой може да участва
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.