A Study of LAD191 in Adults With Hidradenitis Suppurativa
Not Applicable
Not yet recruiting
- Conditions
- Hidradenitis Suppurativa
- Interventions
- Registration Number
- NCT07151937
- Lead Sponsor
- Almirall, S.A.
- Brief Summary
The main purpose of this study is to assess the efficacy of multiple dosing regimens of LAD191 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
This is a adaptive treatment-selection study design and, initially, participants will be randomized in a 1:1:1:1 ratio to one of the following cohorts: LAD191 dose A, LAD191 dose B; LAD191 dose C or Placebo.
The randomization will be stratified for Hurley Stage (II vs III) and prior use of biologics for HS.
Following an interim analysis, at least 1 dose of LAD191 will be dropped from the randomization and an active control arm, adalimumab arm will be added.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 200
Inclusion Criteria
- Ability to understand the purpose and risks of the trial, willingness and ability to comply with the protocol, provide written informed consent in accordance with institutional and regulatory guidelines, and, for participants at US sites, authorization to use protected health information (Health Insurance Portability and Accountability Act [HIPAA]).
- Aged greater than or equal to (>=) 18 to less than or equal to (<=) 65 years.
- A Body mass index (BMI) less than or equal to (<=) 40 kilogram per square meter (kg/m^2).
- 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/Day 1 visits, with signs and symptoms 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/Day 1 visits.
- History of inadequate response, intolerance, or contraindication to a course of a systemic antibiotics for treatment of HS at the Screening visit, including participants who responded to course(s) of systemic antibiotic(s) and subsequently exhibited recurrence after discontinuation of the antibiotic, as assessed by the Investigator through study participant interview and review of medical history.
- Regular use of over-the-counter topical antiseptics on HS lesions for at least 2 weeks prior to Baseline/Day 1 visit and agrees to regular use, preferably daily but at least 3 days per week, throughout the entirety of the study.
- Participants who are women of child-bearing potential (WOBCP) and male participants must agree to the requirements for the avoidance of pregnancy and exposure of the participant's partner to LAD191 during the study,
Exclusion Criteria
HS, Skin-Specific, and Other Inflammatory Diseases
- Presence of skin comorbidities that may interfere with study assessments, in the opinion of the Investigator (e.g., cystic acne, follicular pyodermas, bacterial cellulitis, actinomycosis, candida intertrigo, extensive condyloma).
- HS with >20 draining tunnels at the Screening or Baseline/Day 1 visit.
- Syndromic HS, i.e., HS associated with genetic background, follicular plugging or structural disorders, autoinflammatory pathogenesis, as per Investigator's judgment.
- Surgical intervention for the treatment of HS within 3 months prior to Baseline/Day 1.
- Ongoing medical conditions (e.g., inflammatory bowel disease, rheumatoid arthritis, systemic lupus erythematosus, sarcoidosis) requiring systemic immunosuppressive/immunomodulating treatments during the study (e.g., methotrexate, ciclosporin, corticosteroids, or Janus kinase [JAK]-inhibitors).
Other Medical Conditions:
- Known hypersensitivity to LAD191 or any of its excipients.
- Known hypersensitivity to adalimumab or biosimilar or any of its excipients or meeting any warning or contraindication to adalimumab treatment as per the approved product information, and as per the Investigator's judgment.
- Hypersensitivity or systemic reaction to a prior biologic (antibody-based) therapy, regardless of indication, that was clinically significant, as per the Investigator's judgment.
- Medical or psychiatric condition that, in the opinion of the Investigator, could jeopardize or would compromise the study participant's ability to comply with the study requirements, as determined by the Investigator based on protocol-specified assessments.
- Active chronic or acute infection requiring systemic antimicrobial, antiviral, antiparasitic, antiprotozoal, or antifungal treatment within 2 weeks before Baseline/Day 1, or fever ≥38°C within 1 week before Baseline/Day 1.
- Active tuberculosis (TB), a positive TB test at Screening, or history of active or latent TB, regardless of prior treatment.
- Malignancy within past 5 years prior to Screening regardless of outcome, with the exception of successfully treated basal or squamous cell carcinoma of the skin.
- History of liver disease or clinically significant abnormal (as per the Investigator's judgment) liver function test(s) at Screening.
- Positive test result at Screening for hepatitis B surface antigen (HBsAg), or antibody to hepatitis B core antigen (anti-HBc antibody), or antibody to the hepatitis C virus (anti-HCV), or antibody to the human immunodeficiency virus (anti-HIV-1/2 antibody).
- Neutrophil count <2.0×10^9/L at Screening.
- History within 1 year prior to Screening of alcohol or drug abuse, as per the Investigator's judgment.
- History of major surgery (e.g., open-heart surgery or organ transplant surgery) within the 3 months prior to the Baseline/Day 1 visit or has major surgery pre-planned for the time of participation in this study.
Prior/Concomitant Therapy:
- Prior treatment with LAD191.
- Live or attenuated vaccinations 4 weeks prior to Baseline/Day 1 or is planning to receive any such vaccine during the study.
- Prior treatment with any inflammation drug, whether investigational or any commercially available (e.g., anakinra, canakinumab, or rilonacept), for any indication and did not respond adequately, as per the Investigator's judgment.
- Inadequate response to two or more biologics for HS (e.g., adalimumab, secukinumab, bimekizumab) having different MoAs (classes), as per the Investigator's judgment.
- Intention to use any concomitant medication or therapy that is not permitted by this protocol or failure to meet the required washout period for a particular prohibited medication prior to Baseline/Day 1.
Other Exclusions:
- Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study.
- Institutionalized because of legal or regulatory order.
- An employee or relative of the Sponsor, CRO, or other vendor, clinical trial site, or is an individual or employee otherwise directly involved with the conduct of the study or is an immediate family member of such an individual.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Treatment Period 1: LAD191 (Cohort 1) LAD191 Participants will receive dose A LAD191 subcutaneous (SC) injection during Treatment Period 1. Treatment Period 1: LAD191 (Cohort 2) LAD191 Participants will receive dose B LAD191 SC injection starting with a loading dose of LAD191 during Treatment Period 1. Treatment Period 1: LAD191 (Cohort 3) LAD191 Participants will receive dose C LAD191 SC injection starting with a loading dose of LAD191 during Treatment Period 1. Treatment Period 1: Placebo Placebo Participants will receive matching LAD191 placebo SC injection during Treatment Period 1. Treatment Period 1: Adalimumab Adalimumab Participants will receive adalimumab SC injection during Treatment Period 1. Treatment Period 2: LAD191 LAD191 Participants from the above LAD191 treatment arms who completed the Treatment Period 1 assessments will receive the highest available dose of LAD191 during Treatment Period 2. Treatment Period 2: Placebo to LAD191 LAD191 Participants randomized to placebo will begin treatment with the highest dose of LAD191 under study at the time the participant completes the Treatment Period 1 assessments during Treatment Period 2. Treatment Period 2: Adalimumab to LAD191 LAD191 Participants randomized to adalimumab will begin treatment with the highest dose of LAD191 under study starting during Treatment Period 2, following completion of the Treatment Period 1.
- Primary Outcome Measures
Name Time Method Proportion of Participants Achieving 50 Percent (%) Reduction from Baseline in Hidradenitis Suppurativa Clinical Response (HiSCR-50) At Week 16 HiSCR was developed as a tool that is responsive to improvement in disease activity, simplifies the scoring process, and increases the sensitivity to detect HS-specific lesions during clinical evaluation. HiSCR evaluation is based on a count of HS lesions, including abscesses, inflammatory nodules, and draining fistulas. The HiSCR is derived through statistical programming based on investigator documentation of lesion counts.
- Secondary Outcome Measures
Name Time Method