2025-521865-29-00招募中2 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 4,999,995
- 试验地点
- 30
- 主要终点
- Proportion of participants achieving IHS4-55 at XXXX.
研究概览
简要总结
- To evaluate the efficacy of LAD328 compared to placebo in patients with moderate-to-severe HS.
- To evaluate the safety and tolerability of LAD328.
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Male or female between 18 and 65 years old inclusive.
- •A body mass index (BMI) of ≤40 kg/m2 and body weight of ≥45 kg at the time of signing the informed consent.
- •Ability to understand and willing to comply with trial requirements as per Investigator’s opinion.
- •Provide written informed consent in accordance with institutional and regulatory guidelines.
- •A diagnosis of moderate-to-severe HS defined as a total of ≥5 inflammatory lesions (ie, 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 (eg, 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, 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 trial participant interview and review of medical history.
- •Agree to use, preferably daily but at least 3 days per week, over-the-counter topical antiseptics on their HS lesions throughout the entirety of the study from at least 2 weeks prior to the Baseline visit.
- •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
排除标准
- •Syndromic HS, ie, HS associated with genetic background, follicular plugging or structural disorders, autoinflammatory pathogenesis, as per Investigator’s judgment.
- •Hypersensitivity or systemic reaction to a prior biologic (antibody-based) therapy (regardless of indication), that was clinically significant, as per judgment of Investigator.
- •Any medical or psychiatric condition that, in the opinion of the Investigator, could jeopardize or would compromise the trial participant’s ability to participate to comply with the trial requirements, as determined by the Investigator based on protocol required assessments.
- •Active chronic or acute infection requiring treatment with systemic antimicrobials, antivirals, antiparasitic, antiprotozoals, or antifungals within 2 weeks before Baseline, or fever > 38°C during within 1 week before Baseline.
- •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).
- •History within 1 year prior to Screening of alcohol or drug abuse, as per Investigator’s judgment.
- •Major surgery (eg, open-heart surgery or organ transplant surgery) within the 3 months prior to the Baseline visit or has major surgery pre-planned for the time of participation in this trial at XXXX.
- •Prior treatment with LAD328
- •Live and attenuated vaccinations 4 weeks prior to XXXX or is planning to receive any such vaccine during the trial.
- •Intention to use any concomitant medication or therapy that is not permitted by this protocol or failure to meet the required wash-out period for a particular prohibited medication prior to XXXX
- •Inadequate response to 2 or more biologics for HS (eg, adalimumab, secukinumab and bimekizumab) having different MoAs (classes), as per the Investigator’s judgment.
- •Active tuberculosis (TB), a positive TB test at Screening, or history of active or latent TB, regardless of prior treatment.
- •Females who are pregnant or breast-feeding or seeking to become pregnant during the trial or for approximately XXXX after the last dose of investigational medicinal product (IMP).
- •Institutionalised because of legal or regulatory order.
- •An employee or relative of the Sponsor, Clinical Research Organization (CRO) or other vendor, clinical trial site, or is an individual or employee otherwise directly involved with the conduct of the trial or is an immediate family member of such an individual.
- •History of malignancy within past 5 years prior to Baseline (other than successfully treated basal cell or squamous cell carcinoma of the skin), regardless of outcome.
- •History of liver disease or clinically significant abnormal (as per judgment of Investigator) liver function test(s) at Screening.
- •HS with >20 draining tunnels either at the Screening or Baseline visits.
- •Presence of skin comorbidities that may interfere with trial assessments, in the opinion of the Investigator (eg, cystic acne, follicular pyodermas, bacterial cellulitis, actinomycosis, candida intertrigo and extensive condyloma).
- •Surgical intervention for the treatment of HS within 3 months prior to Baseline.
- •Ongoing medical conditions (eg, inflammatory bowel disease, rheumatoid arthritis, systemic lupus erythematosus and sarcoidosis) requiring systemic immunosuppressive/immunomodulating treatments (eg, methotrexate, ciclosporin, corticosteroids, XXXX agents and JAK inhibitors) during the trial.
- •Known or suspected hypersensitivity to trial product or any of its excipients.
研究组 & 干预措施
LAD328
Test
干预措施: LAD328 (Drug)
SODIUM CHLORIDE
Placebo
干预措施: SODIUM CHLORIDE (Drug)
结局指标
主要结局
Proportion of participants achieving IHS4-55 at XXXX.
Proportion of participants achieving IHS4-55 at XXXX.
Safety: Frequency and severity of TEAEs, SAEs, AESIs and AEs leading to discontinuation.
Safety: Frequency and severity of TEAEs, SAEs, AESIs and AEs leading to discontinuation.
Safety: Vital signs, ECG and clinical laboratory parameters.
Safety: Vital signs, ECG and clinical laboratory parameters.
次要结局
未报告次要终点
研究者
Estrella Garcia Alvarez
Scientific
Almirall S.A.
研究点 (30)
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