A study to assess the efficacy and safety of OATD-01 for the treatment of active pulmonary sarcoidosis.

You may be able to join if

• 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 three: - known previous positive biopsy from any body site showing pathologic features consistent with sarcoidosis, obtained at any point in the past - history of or active Lupus pernio or Heerfordt’s syndrome positive BAL result with the ratio of CD4+ to CD8+ T-lymphocytes higher than 3.5 supported by a documented positive opinion on diagnosis of sarcoidosis by an independent expert, assigned by sponsor, based on a highly suggestive clinical and radiological picture * 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 (or performed at the study site within 3 months prior to enrolment under certain conditions detailed in section 7.2.2.8)
• 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 sexual partner of the WOCBP trial participant and that the vasectomised partner has received medical assessment of the surgical success. ***Sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the subject.
• Capable of understanding and complying with protocol requirements