CTIS2023-506642-23-01进行中（未招募）1 期
A randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy and safety of a 12-week administration of OATD-01, an oral inhibitor of chitinase-1 (CHIT1), for the treatment of active pulmonary sarcoidosis (the KITE study) - OATD-01-C-03
Molecure S.A.0 个研究点目标入组 112 人开始时间: 2024年2月9日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 112
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
- 性别
- All
入选标准
- •Male or female subject aged =18 years at Screening, Diagnosis of active and currently symptomatic pulmonary sarcoidosis, either treatment-naïve or previously treated but currently untreated, with diagnostic criteria adapted from Official American Thoracic Society Clinical Practice Guideline 2020 and with limitations described in the exclusion criteria section: •Bilateral hilar adenopathy (BHA) on any chest X-ray within 3 months or chest CT* within 12 months prior to enrolment OR •Perilymphatic nodules, peribronchial thickening (on chest CT*), or upper lobe or diffuse infiltrates (on any chest imaging) within 3 months prior to enrolment and at least one of the two: - known previous positive biopsy of a mediastinal and/or hilar or lymph node biopsy, consistent with sarcoidosis - history of or active Lupus pernio or Heerfordt’s syndrome * to avoid CT-derived excessive cumulative radiation, a minimum interval of 12 weeks (or longer as defined by local standards) is to be respected between any chest (High Resolution-)CT performed pre-study before the informed consent and the planned baseline [18F]FDG PET/CT at screening., Parenchymal pulmonary involvement evidenced by [ 18F]FDG PET/CT imaging at Screening, Body Mass Index within the range of 18 - 46 kg/m2, Subjects willing to avoid pregnancy or fathering a child and agree to use acceptable effective methods of birth control (per recommendations from Heads of Medicines Agencies - Clinical Trials Facilitation and Coordination Group) defined as those, alone or in combination, that result in a low failure rate for the entire duration of the study including: •Woman of nonchildbearing potential* •Woman of childbearing potential* who has a negative serum pregnancy test at Screening and at any timepoint before the first study drug dose on Day 1 and who agrees to take highly effective contraceptive measure to avoid pregnancy (with a failure rate of less than 1% per year when used consistently and correctly) from Screening until 7 months after EOT. As highly effective contraceptive measures are considered: -combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation : ?oral ?intravaginal ?transdermal -progestogen-only hormonal contraception associated with inhibition of ovulation: ?oral ?injectable ?implantable -intrauterine device -intrauterine hormone-releasing system -bilateral tubal occlusion -vasectomised partner** -sexual abstinence*** •Man who agrees to use double barrier contraception (condoms - or diaphragm/ cervical cap used by their female partner- plus spermicidal agent: foam, gel, film etc.) to avoid fathering a child from Screening until 100 days after EOT, or is surgically sterilized. *A woman is considered of childbearing potential i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a post-menopausal state in women not using hormonal contraception or hormonal replacement therapy. However in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient. **Vasectomised partner is a highly effective birth control method provided that partner is the sole sexua
排除标准
- •Evidence of pulmonary sarcoidosis that requires immediate start of treatment (or start within the next 3 months) with corticosteroids, immunosuppressants, or anti-TNF agents (or other anti-inflammatory/anti-fibrotic treatment),according to the treating physician following the evaluation of risk for: future mortality from sarcoidosis, permanent disability from sarcoidosis, and deterioration of quality of life due to sarcoidosis, Alcohol consumption above 20 units/week for men and 10 units/week for women, Known allergy to excipients of the study drug, Any contraindication to cardiac MRI and PET CT procedure, including severe claustrophobia and known hypersensitivity to the contrast medium, Severe, uncontrolled systemic disease (e.g., clinically significant cardiovascular, pulmonary, thyroid, renal or metabolic disease) at Screening, or other condition, which in the opinion of the investigator, would compromise the safety of the subject or the subject’s ability to participate in the study, Current smoker of >5 cigarettes or e-cigarettes per day or user of nicotine releasing alternatives (patches, chewing gums etc.), Unable to take oral medications, History of or active Löfgren’s syndrome, Participation in another clinical study within 1 month prior to enrolment, Subject deprived of liberty by a judicial or administrative decision, subject admitted to a social institution or who is under a measure of legal protection, subject hospitalized without consent or who is in an emergency situation, Established alternative diagnosis of a non-infectious or infectious systemic disease, or suspicion thereof, undermining the suspicion/diagnosis of sarcoidosis, Total serum bilirubin >1.5 x upper limit of normal (ULN) or alanine aminotransferase (ALT) or asparagine aminotransferase (AST) > 2.5 x ULN, or alkaline phosphatase (ALP) >1.5 x ULN, or liver failure and/or cirrhosis or subjects with moderate to severe hepatic impairment (i.e., Child-Pugh score =7), If performed pre-study, mediastinal and/or hilar lymph node biopsy result not consistent with sarcoidosis (as per Key Pathological Features of Sarcoidosis by the Official American Thoracic Society Clinical Practice Guideline, Crouser et al. 2020), Clinically significant lung disease other than sarcoidosis (including but not limited to tuberculosis, asthma, Chronic Obstructive Pulmonary Disease, interstitial lung disease, lung cancer) or any current inflammatory or immunological systemic disease other than sarcoidosis, Subjects that have previously received potentially effective systemic or inhaled pharmacological (including investigational) therapy for pulmonary or other organ sarcoidosis in the past (if any received) other than the following: a.corticosteroids, received not later than 3 months prior to enrolment b.immunosuppressants or anti-TNF agents (or other anti-inflammatory/anti-fibrotic treatment), received not later than 4 months prior to enrolment, Known repeated demonstration of QTcF interval prolongation (>450 ms in a male and QTc >470 ms in a female) at Screening, Current systemic pharmacological treatment for sarcoidosis or any inflammatory or immunological systemic disease, including any investigational drugs, Primary systemic treatment indication being an extrapulmonary location of sarcoidosis (e.g., neurological), Subjects currently treated with P-glycoprotein and/or BCRP strong inhibitors, Subjects currently treated with drugs that are sensitive
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