A Pilot Study of Rimegepant in Moderate Plaque-type Psoriasis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 2
- 主要终点
- Change in Severity of Psoriasis as Measured by Percentage Change in the Psoriasis Area and Severity Index (PASI) Instrument
研究概览
简要总结
The purpose of this study is to examine the use of a new investigational medication for the treatment of moderate plaque-type psoriasis. The study medication is rimegepant, an orally administered small molecule competitive inhibitor of the calcitonin gene-related peptide (CGRP) receptor. This medication, rimegepant, has been approved by the FDA under the trade name Nurtec for the treatment of acute migraine. However, rimegepant has not been studied in the treatment of moderate plaque-type psoriasis and is investigational for this indication.
详细描述
This is a randomized, double-blind, placebo-controlled study of rimegepant 75 mg dosed every other day for the treatment of mild to moderate psoriasis. Subjects must have at 3% body surface area involvement before entry into the study. Psoriasis Area and Severity Index (PASI) and Investigator's Global Assessment (IGA) scores will be calculated and subjects will each complete the Dermatology Life Quality Index (DLQI) instrument as well an itch assessments. These assessments will be performed at baseline and every 2 weeks in follow-up. Areas of psoriasis in each subject will be photographed at baseline and two very similar appearing lesions identified for biopsy of one on day 1 and the other at the end of week 16. Patients will also repeat the DLQI at each visit. Subjects will also be photographed at each visit. Subjects will discontinue medications after the end of week 16. Subjects who complete the 20-week protocol will have the option of entering a 3-month, open-label extension of the study in which they will take 75 mg of rimegepant every other day for an additional 12 weeks. Eligible subjects have 2 weeks past visit 11 to enroll in the extension. For those rolling over before visit 11, visits 11 and 12 can be combined. They will have the same 7 assessments as in the previous portion of the study every 4 Protocol #20-07022368 Version Date 5/10/24 weeks including an EKG. The inclusion and exclusion criteria remain the same.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients with at least 3% body surface are involved with psoriasis and a PASI score >
- •Between 18 and 75 years of age.
- •Documentation of a definite diagnosis of psoriasis by a dermatologist or biopsy.
- •For women of childbearing potential, a negative urine pregnancy test within 48 hours of randomization. Female subjects should not have attempted to become pregnant in the month prior to exposure to rimegepant and agree not to attempt to become pregnant for 8 weeks after exposure to rimegepant.
- •A valid form of contraception must be documented for men and women of child-bearing potential.
- •The two methods for women of childbearing potential should include:
- •One barrier method (for example, Diaphragm with spermicidal gel, condom with spermicidal gel, cervical caps or intrauterine devices placed for at least four weeks before sexual intercourse); AND
- •One additional method. The other method could include hormonal contraceptives, or second barrier method as listed above.
- •The two options for men of childbearing potential should include:
- •Simultaneous use of male condom, and for the female partner, hormonal contraceptives (for example, birth control pills, implants, patch, depot injection, used since at least 4 weeks) or intra-uterine contraceptive device (placed since at least 4 weeks) before sexual intercourse; OR simultaneous use of male condom, and for the female partner, diaphragm with intravaginally applied spermicide.
排除标准
- •Any ongoing medical illness or condition that places the participant at higher risk for adverse outcomes or inability to complete study procedures in the opinion of the study investigator.
- •Pregnancy or breastfeeding.
- •Known autoimmune disorders other than psoriasis.
- •Current use of corticosteroids or immunosuppressive medications (for any reason).
- •Immunodeficiency diseases.
- •Use of any biologic agent/monoclonal antibody within 5 half-lifes prior to baseline.
- •Ultraviolet light treatment, cyclosporine, oral corticosteroids, methotrexate, oral retinoids, mycophenolate mofetil, thioguanine, hydroxyurea, sirolimus or azathioprine within the 4 weeks prior to baseline or had topical psoriasis treatment within the previous 2 weeks prior to baseline.
- •Participation in another clinical trial involving an investigational drug within the last 30 days prior to baseline.
- •Inability for woman of child-bearing potential to use an effective form of contraception if sexually active.
- •Use of any medication that is a strong or moderate inhibitor of CYP3A, a strong or moderate inducer of CYP3A, or an inhibitor of glycoprotein (P-gp) or Breast Cancer Resistance Protein (BCRP). Please see Section 7.8 for more information.
- •Subject history with current evidence of uncontrolled, unstable or recently diagnosed cardiovascular disease, such as ischemic heart disease, coronary artery vasospasm, and cerebral ischemia. Subjects with myocardial infarction (MI), acute coronary syndrome (ACS), percutaneous coronary intervention (PCI), cardiac surgery, stroke or transient ischemic attack (TIA) during 6 months (24 weeks) prior to screening.
- •Uncontrolled hypertension or uncontrolled diabetes (however, subjects can be included who have stable hypertension and/or diabetes for 3 months (12 weeks) prior to screening). Blood pressure greater than 150 mm Hg systolic or 100 mm Hg diastolic after 10 minutes of rest is exclusionary
- •Subjects with an active episode of major depressive episode within the last 6 months are ineligible. Subjects with major depressive disorder or any anxiety disorder are eligible only if they are on stable medication for each disorder for at least 3 months prior to the Screening visit.
- •Subject has a history or diagnosis of Gilbert's Syndrome or any other active hepatic or biliary disorder
- •Hematologic or solid malignancy diagnosis within 5 years prior to screening. Subjects with a history of localized basal cell or squamous cell skin cancer are eligible for the study if they are cancer-free prior to the screening visit in this study.
- •Subject has current diagnosis of major depressive disorder requiring treatment with atypical antipsychotics, schizophrenia, bipolar disorder, or borderline personality disorder.
- •History of gallstones.
- •Subject has current diagnosis of major depressive disorder requiring treatment with atypical antipsychotics, schizophrenia, bipolar disorder, or borderline personality disorder.
- •The use of CGRP antagonists (biologic [e.g. Aimovig™, Emgality® and Ajovy™, VyeptiTM] or small molecule [ e.g. Ubrelvy™ {ubrogepant]]) other than rimegepant is prohibited during the study.
- •Concomitant use of atypical antipsychotics such as Abilify (aripiprazole), Zyprexa (olanzapine), Seroquel (quetiapine), Geodon (ziprasidone), or Risperdal (risperidone).
- •Depakote/Depakene (divalproex/valproic acid/valproate) is prohibited during the study.
- •Concomitant use of LAMICTAL (lamotrigine) is prohibited during the study.
- •Concomitant use of Modafinil (PROVIGIL®) is prohibited during the study.
- •Exclusionary screening lab test findings:
- •Serum bilirubin (Total, Direct or Indirect) > 1 x ULN (Only abnormal values of between 1-1.5x ULN may be repeated once for assessment of eligibility prior to randomization)
- •AST or ALT > 1 x ULN (Only abnormal values of between 1-1.5x ULN may be repeated once for assessment of eligibility prior to randomization)
- •Neutrophil count ≤ 1000/μL (or equivalent)
- •HbA1c > 6.5%
研究组 & 干预措施
Rimegepant
Participants receive a rimegepant 75 mg tablet orally every other day for 16 weeks.
干预措施: Rimegepant (Drug)
Rimegepant Extension-Previously Received Rimegepant-Open Label
Participants who previously received rimegepant receive a rimegepant 75 mg tablet orally every other day for an additional 12 weeks.
Rimegepant: Active Agent
干预措施: Rimegepant (Drug)
Rimegepant Extension-Previously Received Placebo-Open Label
Participants who previously received placebo receive a rimegepant 75 mg tablet orally every other day for an additional 12 weeks.
Rimegepant: Active Agent
干预措施: Rimegepant (Drug)
Placebo
Participants receive a placebo tablet matching rimegepant orally every other day for 16 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Severity of Psoriasis as Measured by Percentage Change in the Psoriasis Area and Severity Index (PASI) Instrument
时间窗: Baseline and Week 16 for placebo controlled trial. For Extension Phase, Visit 11/12 (Day 1) to Visit 15 (Week 12).
Total score of Psoriasis Area and Severity Index ranges from 0 to 72. Change = (Week 16 score - Baseline score) for the placebo-controlled phase and (Week 15 score-Visit 12 score) for the extension phase. A low score means less severe disease while a high score reflects more severe disease. A score of 0 means no psoriasis. A PASI score of 5 to 10 is considered moderate disease and a score over 10 is considered severe. A score over 40 is rare. The primary outcome measure is the mean percent change in PASI score from baseline to week 16 in the placebo-controlled phase. For the extension phase, it is particularly interesting if a change is noted in the group that received placebo prior to the extension phase.
次要结局
- Number of Subjects Who Had a 50% or Greater Reduction in Psoriasis Area and Severity Index Instrument Score(Baseline and Week 16 for placebo controlled trial. For Extension Phase, Visit 11/12 (Day 1) to Visit 15 (Week 12).)
- Change in Severity of Psoriasis as Assessed by the Investigator's Global Assessment Instrument(Baseline and Week 16 for placebo controlled trial. For Extension Phase, Visit 11/12 (Day 1) to Week 12.)
- Change in Dermatology Quality of Life Index(Baseline and Week 16 for placebo controlled trial. For Extension Phase, Visit 11/12 (Day 1) to Visit 15 (Week 12).)
- Change in Degree of Itching Assessed by the Visual Analogue Scale(Baseline and Week 16 for placebo controlled trial. For Extension Phase, Visit 11/12 (Day 1) to Week 12.)