A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Nemolizumab (CD14152) in Subjects With Prurigo Nodularis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Galderma R&D
- 入组人数
- 286
- 试验地点
- 1
- 主要终点
- Number of Participants With an Improvement of Greater Than or Equal to (>=) 4 From Baseline in Weekly Average Peak Pruritus Numeric Rating Scale (PP NRS) at Week 16
研究概览
简要总结
The primary objective was to assess the efficacy of nemolizumab (CD14152) compared to placebo in participants greater than or equal to (>=) 18 years of age with prurigo nodularis (PN) after a 16 week treatment period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of PN for at least 6 months with: Pruriginous nodular lesions on upper limbs, trunk, and/or lower limbs, at least 20 nodules on the entire body with a bilateral distribution and Investigator Global Assessment (IGA) score more than equal to (>=) 3 (based on the IGA scale ranging from 0 to 4, in which 3 was moderate and 4 is severe) at both the screening and baseline visits.
- •Severe pruritus was defined as follows on the PP NRS:
- •At the screening visit (Visit 1): PP NRS score was >= 7.0 for the 24-hour period immediately preceding the screening visit.
- •At the baseline visit (Visit 2): Mean of the daily intensity of the PP NRS score was >= 7.0 over the previous week.
- •Female participants of childbearing potential (that is [i.e,], fertile, following menarche and until becoming post-menopausal unless permanently sterile) must agree to use at least 1 adequate and approved method of contraception throughout the study and for 12 weeks after the last study drug injection.
- •Participant was willing and able to comply with all of the time commitments and procedural requirements of the clinical study protocol, including daily diary recordings by the participant using an electronic handheld device provided for this study.
排除标准
- •Body weight less than < 30 kg.
- •Chronic pruritus resulting from another active condition other than PN, such as but not limited to scabies, lichen simplex chronicus, psoriasis, atopic dermatitis, contact dermatitis, acne, folliculitis, lichen planus, habitual picking/excoriation disorder, sporotrichosis, bullous autoimmune disease, end-stage renal disease, or cholestatic liver disease (example [e.g.] primary biliary cirrhosis) or diabetes mellitus or thyroid disease that is not adequately treated, as per standard of care.
- •Unilateral lesions of prurigo (e.g., only one arm affected).
- •History of or current confounding skin condition (e.g., Netherton syndrome, cutaneous T-cell lymphoma [mycosis fungoides or Sezary syndrome], chronic actinic dermatitis, dermatitis herpetiformis).
- •Participants with a current medical history of chronic obstructive pulmonary disease and/or chronic bronchitis.
- •Neuropathic and psychogenic pruritus such as but not limited to notalgia paresthetica, brachioradial pruritus, small fiber neuropathy, skin picking syndrome, or delusional parasitosis.
- •Requiring rescue therapy for PN during the screening period or expected to require rescue therapy within 4 weeks following the baseline visit.
- •Positive serology results (hepatitis B surface antigen [HBsAg] or hepatitis B core antibody [HBcAb], hepatitis C (HCV) antibody with positive confirmatory test for HCV (e.g., polymerase chain reaction [PCR]), or human immunodeficiency virus antibody) at the screening visit.
研究组 & 干预措施
Nemolizumab
Participants weighing less than (<) 90 kilogram (kg) received two subcutaneous (SC) injections of 30 milligrams (mg) nemolizumab (60 mg loading dose) at baseline then one SC injection once every 4 weeks (Q4W). Participants weighing greater than or equal to (>=) 90 kg received two SC injections of 30 mg nemolizumab (60 mg total) at baseline (no loading dose) and two SC injections Q4W throughout the treatment period of 16 weeks.
干预措施: Nemolizumab 30 mg (Drug)
Placebo
Participants weighing < 90 kg received two SC injections of matching placebo at baseline, then one SC injection Q4W. Participants weighing >= 90 kg received two SC injections of matching placebo at baseline, then two SC injections Q4W throughout the treatment period of 16 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants With an Improvement of Greater Than or Equal to (>=) 4 From Baseline in Weekly Average Peak Pruritus Numeric Rating Scale (PP NRS) at Week 16
时间窗: Baseline, Week 16
The Peak Pruritus NRS is a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours. For maximum itch intensity: the scores were provided on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable'. Higher scores indicate worse outcome. Weekly values are calculated as the average of 7 consecutive days of data up to the target study day (excluding) and set to missing if less than 4 days of data are available. Analysis window extension was applied to both timepoints, as described in the SAP. If a participant received any rescue therapy, composite variable strategy is applied, the underlying data at/after receipt of rescue therapy is set as worst possible value, and the response is derived from underlying data value. Participants with missing results are considered as non-responders.
Number of Participants With an Investigator Global Assessment (IGA) Success at Week 16
时间窗: Baseline, Week 16
IGA success is defined as clear (0) or almost clear (1), and a reduction from baseline of greater than or equal to 2 points at week 16. Full scale is scored from 0-4, higher score indicates more severe symptoms. If a participant received any rescue therapy, composite variable strategy is applied, the underlying data at/after receipt of rescue therapy is set as worst possible value, and the response is derived from underlying data value. Participants with missing results are considered as non-responders.
次要结局
- Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Adverse Events of Special Interest (AESIs), and Serious Adverse Events (SAEs)(From Baseline up to end of treatment period (24 weeks))
- Number of Participants With an Improvement of >= 4 From Baseline in Weekly Average PP NRS at Week 4(Baseline, Week 4)
- Number of Participants With PP NRS < 2 at Week 16(Week 16)
- Number of Participants With an Improvement of >=4 From Baseline in Sleep Disturbance Numeric Rating Scale (SD NRS) at Week 16(Baseline, Week 16)
- Number of Participants With an Improvement of >=4 From Baseline in SD NRS at Week 4(Baseline, Week 4)
- Number of Participants With PP NRS < 2 at Week 4(Week 4)