EUCTR2021-003029-31-DE进行中（未招募）1 期
A Randomized, Double-blind, Placebo-controlled, Dose Ranging Phase 2 Study to Evaluate the Efficacy and Safety of RIST4721 in Subjects with Palmoplantar Pustulosis - RIST4721 in Subjects with Palmoplantar Pustulosis
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 156
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
- •Age and Sex
- •1. Male or female subject aged =18 years and < 75 years of age at the time of consent.
- •Type of Subject and Disease Characteristics
- •2. A physician-confirmed diagnosis of PPP (sterile, macroscopically visible pustules on the palms and/or soles) for at least 6 months prior to screening without evidence of infection on palms and soles.
- •3. Moderate or severe PPP, as defined by PPPASI =12 and PPPGA =3 at screening and confirmed by central photographic assessment at screening. Subjects must have an area involvement of at least 30% on 2 palmoplantar surfaces or at least 60% on one palmoplantar surface.
- •4. At randomization visit, all of the following must be met:
- •PPPASI score must be = 90% of the score at screening and PPPASI score of =12;
- •PPPGA score must be =3 and = the score at screening;
- •PPPASI subscore of pustules/vesicles on at least one palm or sole =2.
- •5. Candidate for systemic therapy, defined as having PPP inadequately controlled by topical treatment, phototherapy, and/or previous systemic therapy. Eligible subjects shall demonstrate a lack of response or tolerability to local standard of care therapy for PPP or be contraindicated to such therapies.
- •6. Subject who wants to use an emollient should agree to use the same emollient, at the same frequency of application, for 7 days before Day 1/baseline and throughout the study.
- •Note: On the day of scheduled visits, subjects cannot apply emollient before their scheduled visit time. For more information on concomitant therapies, please refer to Section 6.7 of the Study Protocol.
- •7. At screening, the results of the ANC performed at the central laboratory must be =3.0 x 109 cells/L.
- •8. Subject has been previously vaccinated for SARS-CoV-2 or has chosen not to be vaccinated at the start of participation (screening) in the clinical study.
- •Contraception
- •Contraception use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Refer to Section 10.4 of the Study Protocol for more details.
- •9. Women of childbearing potential (WOCBP) must have a negative serum pregnancy test at screening and negative urine pregnancy test at baseline, prior to randomization.
- •10. Female subject agrees to use a contraceptive method that is highly effective from consent until at least 5 days after the last study treatment administration
- •11. Male subject agrees to use condom and spermicide from consent until at least 5 days after the last study treatment administration.
- •Informed Consent
- •12. Evidence of a personally signed and dated ICF indicating that the subject has been informed of all pertinent aspects of the study prior to initiation of any subject-mandated procedures.
- •13. Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
- •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 130
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 26
排除标准
- •Medical Conditions and Diagnostic Assessments
- •1. Current diagnosis of superinfected hand dermatitis as a variant of contact or atopic hand dermatitis.
- •2. Any condition that, in the opinion of the investigator, would make participation not be in the best interest (e.g., compromise the well being) of the subject or that could prevent, limit, or confound the protocol-specified assessments (Refer section 5.2. of the Study Protocol for more details)
- •3. Evidence of latent tuberculosis (TB) infection (either purified protein derivative [PPD] =5 mm of induration or positive QuantiFERON-TB Gold test, irrespective of bacille Calmette-Guérin vaccination status).
- •Note: Subject will be evaluated for latent TB infection with a PPD test or a QuantiFERON-TB Gold test if one has not been performed in the last 6 months. Subjects with documented completed treatment for latent TB will be allowed to participate in the study without retesting.
- •4. Breastfeeding, pregnant, or planning to become pregnant during the study.
- •Prior Therapy and Prior/Concurrent Clinical Study Experience
- •5. Any topical medication (exception of emollients [see Section 6.7 of the Study Protocol]) to treat PPP, including corticosteroids, dapsone, retinoids, vitamin D analogs (such as calcipotriol), or tar withing 2 weeks prior to Day 1.
- •6. Any systemic treatment that affects PPP, including, but not limited to, corticosteroids, oral retinoids, immunosuppressive medication, methotrexate, cyclosporine, dapsone, colchicine, or apremilast within 4 weeks prior to Day 1. Note: Intranasal corticosteroids and inhaled corticosteroids for stable medical conditions are allowed if subject has been on a stable dose for at least 4 weeks prior to Day 1 and agrees to maintain the same dose for the duration of the study. Eye drops containing corticosteroids are allowed.
- •7. Any ultraviolet (UV)-B phototherapy (including tanning beds) or excimer laser within 4 weeks prior to Day 1.
- •8. PUVA treatment within 4 weeks prior to Day 1.
- •9. Use of any marketed or investigational biological agent within 12 weeks or 5 half-lives (whichever is longer) prior to screening.
- •10. Currently receiving a nonbiological investigational product or investigational device or has received one within 4 weeks prior to Day 1.
- •11. Strong cytochrome P450 (CYP)3A inhibitors and/or CYP3A inducers within 4 weeks prior to Day 1 (e.g., cobicistat, boceprevir, ritonavir, indinavir, telaprevir, nelfinavir, itraconazole, ketoconazole, posaconazole, voriconazole, troleandomycin, clarithromycin, idelalisib, conivaptan, nefazodone, (carbamazepine, enzalutamide, mitotane, phenytoin, rifampin, St. John’s wort).
- •12. Received RIST4721 in prior study.
- •Other Exclusion Criteria
- •13. Excessive sun exposure or has used tanning booths within 4 weeks prior to Day 1, or subject is planning a trip where excessive sun exposure is expected or is not willing to minimize natural and artificial sunlight exposure during the study. Use of sunscreen products and protective apparel are permitted when exposure cannot be avoided.
- •14. Consumption of any food or beverages containing cranberry, pomegranate, starfruit, grapefruit, pomelos, exotic citrus fruits, or Seville oranges (including marmalade and juices made from these fruits) within 7 days before baseline and unwillingness to avoid these during the study.
- •15. Known or suspected allergy to RIST4721 or any component of the study treatment.
- •16. Close affiliation with the investigator (e.g., a close relative), incl
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