KPL-716-C201: A Phase 2a/b, Randomized, Double-Blind, Placebo Controlled Study to Investigate the Efficacy, Safety, Tolerability and Pharmacokinetics of KPL-716 in Reducing Pruritus in Subjects with Prurigo Nodularis - KPL-716-C201

Kiniksa Pharmaceuticals, Ltd0 个研究点目标入组 180 人开始时间: 2021年6月7日最近更新: 2022年4月4日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方: Kiniksa Pharmaceuticals, Ltd
入组人数: 180

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional clinical trial of medicinal product

入排标准

性别: All

入选标准

•1. Male or female aged 18 to 80 years, inclusive, at the time of consent.
•2. Have a physician-documented diagnosis of PN that is confirmed by review of medical photography (as outlined in the Study Manual) during the Screening Period. Duration of PN (since the time of first PN nodule) must be at least 6 months from the time of first PN nodule to Day 1, as affirmed by the subject.
•3. Have at least 20 nodules of approximately 0.5 to 2 cm at the Screening Visit and Day 1. The nodules must be pruritic and present on at least 2 different anatomical locations (not be localized), involve the extremities, with extensor extremity involvement greater than the flexor extremity involvement. Nodules on the head (face and scalp) are not counted as an anatomical location for eligibility criteria. Each arm, each leg, and trunk are considered different anatomical locations.
•4. Subject has severe pruritus, defined as WI-NRS =7 at the Screening Visit and a mean weekly WI-NRS =7 for the week (7 consecutive days) immediately prior to randomization (at least 5 days of recordings) on eDiary.
•5. PN-IGA score of =3 (on a scale of 0-4, in which 3 is moderate and 4 is severe) at Screening and Baseline Visits
•6. Sexually active female subjects must be:
•postmenopausal, defined as at least 12 consecutive months post cessation of menses (without an alternative medical cause) and confirmed by a follicular stimulating hormone (FSH) test, or
•surgically sterile following documented hysterectomy, bilateral salpingectomy, bilateral oophorectomy or
•nonpregnant, nonlactating, and having agreed to use a highly effective method of contraception from the Screening Visit until 16 weeks after final study drug administration.
•7. Sexually active male subjects must have documented vasectomy or must agree to use a highly effective method of contraception as defined above with their partners of childbearing potential from first dose until 16 weeks after final study drug administration.
•8. Male subjects must agree to refrain from donating sperm from first dose until 16 weeks after the last study drug administration. Female subjects must agree to refrain from donating eggs from first dose until 16 weeks after the last study drug administration.
•9. Female of childbearing potential must have a negative serum ß-hCG test at the Screening Visit and negative urine pregnancy test on Day 1.
•10. Able to comprehend and willing to sign an Informed Consent Form and able to abide by the study restrictions and comply with all study procedures for the duration of the study.
•11. Subjects must be on optimized and stable treatment for co-morbidities for at least 28 days prior to Day 1.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 120
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 60

排除标准

•1. Use of the following medications within the indicated timeframe prior to Day 1 and does not agree to refrain from the use of the medications throughout the study (except those specified in the Pharmacy Manual):
•a. Systemic corticosteroids (IV/IM/oral): 4 weeks; Note: Intranasal corticosteroids, eye drops containing corticosteroids, and inhaled corticosteroids for stable medical conditions are allowed.
•b. Intralesional corticosteroids and intra-articular corticosteroids: 6 weeks
•c. Topical treatments for PN including but not limited to corticosteroids, calcineurin inhibitors, phosphodiesterase inhibitors, retinoids, calcipotriol, capsaicin, camphor, polidocanol, cannabinoids, gabapentin, or tars: 2 weeks
•d. Antihistamines: 2 weeks
•e. Immunomodulators (for example, cyclosporin, methotrexate, retinoids, azathioprine, mycophenolate, and thalidomide): 4 weeks
•f. Neuroactive drugs such as gabapentin and pregabalin: 4 weeks
•g. Cannabinoids: 2 weeks
•h. Opioid antagonists or agonists: 5 half-lives if known or 4 weeks
•i. Janus kinase inhibitors: 5 half-lives if known or 4 weeks
•j. Dupilumab: 8 weeks
•k. Any other marketed biologic: 5 half-lives or within 4 months of using rituximab
•l. Any investigational drug: 5 half-lives
•m. Phototherapy involving UVA, UVB, or excimer: 4 weeks
•n. Tanning salon use: 4 weeks
•o. Live attenuated vaccine: 12 weeks
•2. Has received any investigational biologic or non-biologic drug that targets Oncostatin M, IL-31, IL-31 receptor a, or Oncostatin M receptor ß in the past 3 months.
•3. Required rescue therapy for PN during the Screening Period or expected to require rescue therapy within 4 weeks following the Baseline Visit.
•4. Has a significant exacerbation and/or skin eruption during the Screening Period (prior to the study drug administration) that requires medical intervention.
•5. Presence of scabies, insect bite, lichen simplex chronicus, psoriasis, acne, folliculitis, habitual picking, lymphomatoid papulosis, chronic actinic dermatitis, dermatitis herpetiformis, sporotrichosis, bullous disease, and/or skin condition other than PN or atopic dermatitis unless approved by the Sponsor.
•6. Plan to change emollients or moisturizers, or to have bath oil treatment for relief of pruritus during the course of the trial.
•7. Presence of psychogenic pruritus or neuropathic pruritus at the Screening Visit.
•8. Presence of moderately severe depression as indicated by PHQ-9 total score of =15 or item 9 score >0 at the Screening Visit or Day 1.
•9. Presence of severe anxiety as indicated by GAD-7 score of =15 at the Screening Visit or Day 1.
•10. Presence of severe chronic pain (e.g., back pain, migraine, osteoarthritis, etc., defined as =7.0 on 0 to 10 NRS scale with 0 being no pain and 10 being the worst pain possible) at the Screening Visit.
•11. Presence of uncontrolled hyperthyroidism or hypothyroidism or uncontrolled diabetes defined as hemoglobin A1c >7.5%.
•12. Presence or history of cancer or lymphoproliferative disease within 5 years prior to the Screening Visit, with the exception of basal and squamous cell carcinoma of the skin or in situ carcinoma of the cervix successfully treated and considered controlled.
•13. Presence or history of immune deficiency, or opportunistic infections.
•14. Positive results for hepatitis B surface antigen (HbsAg) and/or hepatitis B anti-core antibody (anti-HBc) but negative results for anti-surface antibody (anti-HBs) at the Screening Visit.

研究者

发起方

Kiniksa Pharmaceuticals, Ltd

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