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A study to assess the efficacy and safety of OATD-01 for the treatment of active pulmonary sarcoidosis.
EU CTIS ID: 2023-506642-23-00
What this study is testing
To evaluate the response to a 12-week treatment with OATD-01 as a reduction of granulomatous inflammation in pulmonary parenchyma evaluated by [18F]FDG PET/CT imaging in subjects with active pulmonary sarcoidosis
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
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-naive 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:
- 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 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
You likely can't join if
- 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.)
See the full eligibility criteria
Who can join
- Male or female subject aged ≥18 years at Screening
- Diagnosis of active and currently symptomatic pulmonary sarcoidosis, either treatment-naive 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:
- 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 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
- Written informed consent given by the subject before the initiation of any study procedures Note: A witnessed consent is not all
What rules you out
- 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
- Previous potentially effective systemic or inhaled pharmacological (including investigational) therapy for sarcoidosis (whether pulmonary or other disease), with the exception of any of 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 substrates of OCT1, MATE1, MATE2K, OAT3 with a narrow therapeutic index
- Concomitant use or need for treatment with a drug known for QT prolongation effect or a thiazide diuretic
- History or current diagnosis of cardiac arrhythmia (other than non-sustained supraventricular arrhythmia)
- Creatinine clearance (CrCL) <60 mL/min (by CockcroftGault formula
- Heart failure (New York Heart Association class III or IV) and/or known myocardial hypertrophy or Left Ventricle Ejection Fraction <50% in the cardiac MRI
- Subjects currently treated with strong CYP3A4 inhibitors and/or inducers
- PET imaging, or other diagnostic or therapeutic procedure with administration of a radiopharmaceutical, performed within 6 weeks before Screening.*Additionally, with respect to Polish national regulations, subjects included in the study by Polish clinical sites must not have received a total effective dose of radiation of 10 mSv during the 10 years prior to study enrolment due to exposure from participating in biomedical research, clinical trials of medicinal products, clinical investigations of medical devices, clinical performance studies of in vitro diagnostic medical devices, or radiotherapy, if applicable.
- Known neurosarcoidosis or small fiber neuropathy or medical conditions causing primary ataxia
- Subjects currently treated with pirfenidone
- Cardiac sarcoidosis (known or diagnosed at Screening using cardiac Magnetic Resonance Imaging [MRI])
- Hypokalemia (<3.6 mmol/L, mmol/L) or hypocalcemia (<2.1 mmol/L) at Screening
- Marked fasting hyperglycemia or uncontrolled diabetes at Screening with plasma glucose exceeding 8.3 mmol/L, or other contraindication to [18F]FDG administration and/or PET procedure (including body temperature >37°C and any metabolic disease affecting the energy metabolism of muscles) as described in the separately provided PET protocol
- Pregnancy, breastfeeding, or planning to become pregnant or breastfeed, oocyte or sperm donation and cryopreservation during the study and 7 months after EOT. For the purposes of detecting pregnancy occurrence after EOT, the Sponsor will provide urine pregnancy test to subjects to perform at home at monthly intervals after the end of the study last follow-up visit for up until 7 months post last administration of the study drug. The subjects will be advised to report to the sponsor any pregnancies occurring in that time.
- Known positivity for Human Immunodeficiency Virus (HIV 1/2 antibodies), hepatitis B virus (HBV), or hepatitis C virus (HCV), or detected at screening
- Subjects with psychiatric disorder that could affect the conduct of the study and/or compliance with the study treatment
The study team makes the final eligibility decision.
Where it's taking place
- United States
- United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States; United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.