A Proof-of-Concept Study of LAD328 in Adults With Hidradenitis Suppurativa
A legfontosabb adatok
- Fázis
- 2. fázis
Ennek a vizsgálatnak nincs helyszíne itt: Egyesült Államok.
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Magadról válaszolj. Ez nem döntés: hogy részt vehetsz-e, azt csak a vizsgálat csapata mondhatja meg.
- 18 és 65 év között vagy?
Forrás: NCT07547813: ki vehet részt
Kérdések a vizsgálat csapatának
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- Mi történik, ha ki akarok lépni?
Contact the study team: see the registry record → Contacts and Locations
Oldal nyomtatása az orvosomnakA vizsgálat adatai
- Ki végzi
- Almirall, S.A.
- Azonosító
- NCT07547813EU 2025-521865-29-00
- A regiszteradat frissítve
- 2026. augusztus 17.
- Eredeti leírás
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.A teljes eredeti leírásKevesebb
A Phase 2, Randomized, Placebo-controlled, Double-blind Clinical Study to Evaluate Efficacy and Safety of LAD328 in Adult Subjects With Moderate-to-Severe Hidradenitis Suppurativa
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.
Bevonási feltételek: 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.
Kizáró feltételek: 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; 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; HS with >20 draining tunnels either at the Screening or Baseline visits; Females who are pregnant or breast-feeding or seeking to become pregnant during the trial.