Pulmonary SarcoidosisPhase 2NCT06205121
Efficacy and Safety Study of OATD-01 in Patients With Active Pulmonary Sarcoidosis
A Phase 2 study testing OATD-01 in people with Pulmonary Sarcoidosis, run by Molecure S.A. at 28 sites in 8 countries.
Trial summary
This is a Phase 2, randomized, double-blind, placebo-controlled, adaptive, multicenter study to evaluate the efficacy, safety, tolerability, Pharmacodynamics (PD), and Pharmacokinetics (PK) of OATD-01 in the treatment of subjects with active pulmonary sarcoidosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Sarcoidosis
- What is being tested?
- OATD-01
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 28 sitesin 8 countries
- Study dates
- 21 Mar 2024to Sep 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female subjects with active symptomatic pulmonary sarcoidosis, (definite diagnosis of active pulmonary sarcoidosis per ATS guidelines)
- Treatment-naïve or previously treated (no recruitment cap)
- Parenchymal pulmonary involvement on [18F]FDG PET/CT
Who cannot join
- Requirement for immediate start of standard of care therapy for pulmonary sarcoidosis
- Active cardiac or neuro- sarcoidosis
- History of/active Löfgren syndrome
- Clinically significant lung disease other than sarcoidosis (e.g. tuberculosis, asthma, Chronic Obstructive Pulmonary Disease, interstitial lung disease, lung cancer) or any current inflammatory or immunological systemic disease other than sarcoidosis
- Potentially effective systemic or inhaled pharmacological (including investigational) therapy for sarcoidosis (whether pulmonary or other disease), with the exception of any of the following:
- corticosteroids received not later than 3 months prior to enrolment
Show all 16Show fewer
- immunosuppressants or anti-Tumor Necrosis Factor (TNF) agents (or other anti-inflammatory/anti-fibrotic treatment) received not later than 4 months prior to enrolment
- Systemic treatment indication being an extrapulmonary location of sarcoidosis (e.g., neurological)
- Heart conditions: QTcF interval prolongation, cardiac arrhythmia (other than non-sustained supraventricular arrhythmia), 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
- Known neurosarcoidosis or small fiber neuropathy or medical conditions causing primary ataxia
- Lab abnormalities: Abnormal bilirubin, transaminases, alkaline phosphatase (ALP), Creatinine clearance (CrCL) Hypokalemia hypocalcemia (\<2.1 mmol/L), marked fasting hyperglycemia at screening
- 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 PET protocol
- Known positivity for Human Immunodeficiency Virus (HIV 1/2 antibodies), hepatitis B virus (HBV), or hepatitis C virus (HCV), or detected at screening
- Severe, uncontrolled systemic disease (e.g., 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)
- Prohibited medications: Current treatment with drug with QT prolongation effect, thiazide diuretics, strong CYP3A4 inhibitors and/or inducers, P-glycoprotein and/or BCRP strong inhibitors, drugs that are sensitive substrates of OCT1, MATE1, MATE2K, OAT3 with a narrow therapeutic index, pirfenidone and nintedanib.
Trial locations and contacts
28 sites in 8 countries. Contact the study team or a site near you to ask about taking part.
28 sites in 8 countries
United States7 sites, 4 recruiting
- Recruiting
Molecure Investigative Site
Baltimore, Maryland, 21224
- Withdrawn
Molecure Investigative Site
Birmingham, Alabama, 35209
- Recruiting
Molecure Investigative Site
Charleston, South Carolina, 29425
- Recruiting
Molecure Investigative Site
Cleveland, Ohio, 44195
- Withdrawn
Molecure Investigative Site
Kansas City, Kansas, 66062
- Recruiting
Molecure Investigative Site
Philadelphia, Pennsylvania, 19140
- Withdrawn
Molecure Investigative Site
Rochester, Minnesota, 55905
United Kingdom5 sites, 4 recruiting
- Recruiting
Molecure Investigative Site
Birmingham, B15 2GW
- Withdrawn
Molecure Investigative Site
Cambridge, CB2 0AY
- Recruiting
Molecure Investigative Site
Edinburgh, EH16 4SA
- Recruiting
Molecure Investigative Site
London, SE5 9RS
- Recruiting
Molecure Investigative Site
London, SW3 6JY
France4 sites, 3 recruiting
- Withdrawn
Molecure Investigative Site
Bobigny, 93000
- Recruiting
Molecure Investigative Site
Montpellier, 34295
- Recruiting
Molecure Investigative Site
Paris, 75013
- Recruiting
Molecure Investigative Site
Paris, 75015
Greece4 sites, 3 recruiting
- Withdrawn
Molecure Investigative Site
Corfu, 49100
- Recruiting
Molecure Investigative Site
Heraklion, 71500
- Recruiting
Molecure Investigative Site
Pátrai, 26500
- Recruiting
Molecure Investigative Site
Thessaloniki, 57010
Germany3 sites, 3 recruiting
- Recruiting
Molecure Investigative Site
Essen, 45239
- Recruiting
Molecure Investigative Site
Freiburg im Breisgau, 79106
- Recruiting
Molecure Investigative Site
Mainz-GE, 55131
Netherlands2 sites, 2 recruiting
- Recruiting
Molecure Investigative Site
Nieuwegein, 3435 CM
- Recruiting
Molecure Investigative Site
Rotterdam, 3015 GD
Norway2 sites, 2 recruiting
- Recruiting
Molecure Investigative Site
Bergen, 5009
- Recruiting
Molecure Investigative Site
Oslo, 1478
About this study
Official title: 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)
This is a Phase 2, randomized, double-blind, placebo-controlled, adaptive, multicenter study to evaluate the efficacy, safety, tolerability, Pharmacodynamics (PD), and Pharmacokinetics (PK) of OATD-01 in the treatment of subjects with active pulmonary sarcoidosis.
Read the detailed description
Adult subjects (≥ 18 years of age) diagnosed with symptomatic pulmonary sarcoidosis and active granulomatous process captured by [18F]Fluorodeoxyglucose Positron emission tomography/computed tomography ([18F]FDG PET/CT) imaging, treatment-naïve or previously treated but currently untreated, will be enrolled in the study. The diagnosis of pulmonary sarcoidosis will be based on the diagnostic criteria for pulmonary sarcoidosis recommended by the American Thoracic Society (ATS, 2020).
Subjects will be randomized in a 1:1 ratio to receive either OATD-01 or placebo for 12 weeks. A stratification of the study population based on previous treatment status for sarcoidosis (previously treated/treatment-naïve) will be applied for statistical analysis without limitation for the ratio between the subject groups. Double-blind conditions will be kept for the whole treatment duration.
- Conditions
- Pulmonary Sarcoidosis
- Being tested
- OATD-01, Placebo
- Keywords
- Pulmonary Sarcoidosis, Sarcoidosis, Chitinase
- Medical subject headings
- Sarcoidosis, Pulmonary, Sarcoidosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OATD-01Drug
OATD-01 is an oral inhibitor of chitinase-1 (CHIT1)
PlaceboDrug
Matching placebo tablets
| Study group | Role | What they receive |
|---|---|---|
| Active Arm | Experimental | Subjects will receive OATD-01 as 25mg film-coated tablets for oral administration once daily for 12 weeks Receives: Drug: OATD-01 |
| Placebo Arm | Placebo comparator | Subjects will receive placebo as film-coated tablets for oral administration once daily for 12 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response to treatment
Response classed as Complete response, Partial response, Stable disease and Progressive disease based on Standard Uptake Volume (SUV) changes in the uptake for {18F]FDG-PET/CT above the background (pulmonary parenchyma /ascending aorta) in pulmonary target lesions and any new lesions.
Measured: After 12 weeks of treatment, i.e. from baseline (randomization) visit to End-of-Treatment (EOT) visit.
Secondary outcomes (17)
Total granulomatous inflammation evaluation
Evaluation by [18F]FDG PET/CT imaging, quantified as the percent change of maximum, mean, peak SUV (SUVmax, SUVmean, SUVpeak), and volume of the lesions in pulmonary parenchyma, mediastinal/hilar nodes, and extrathoracic locations.
Measured: After 12 weeks of treatment, i.e. from baseline (randomization) visit to EOT visit.
Pulmonary function Forced Vital Capacity (FVC)
Absolute change in FVC (% predicted).
Measured: At Screening visit and over 12 weeks of treatment - at baseline (randomization) visit, at week 4 of treatment, week 8 and week 12 (EOT).
Pulmonary function Forced Expiratory Volume in the first second (FEV1)
Absolute change in FEV1 (% predicted).
Measured: At Screening visit and over 12 weeks of treatment - at baseline (randomization) visit, at week 4 of treatment, week 8 and week 12 (EOT).
Quality of life assessment
Change in the quality of life measured by the Kings Sarcoidosis Questionnaire General and Lung (KSQ GENERAL and LUNG) scores. Range of each module 0-100, 100= best health status.
Measured: Assessed at baseline (randomization) visit and after 12 weeks of treatment (EOT visit) or study participation (week 12 visit).
Fatigue Assessment Scale (FAS)
Change in FAS total score. Range: 10 (no fatigue) - 50 (extreme fatigue).
Measured: Assessed at baseline (randomization) visit and after 12 weeks of treatment (EOT visit) or study participation (week 12 visit).
Adverse events
Occurrence of Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events, Adverse Events of Special Interest (AESIs), TEAEs leading to discontinuation and TEAEs leading to death.
Measured: Recorded from the time of signature of informed consent and until 30 days after the last dose of OATD-01/Placebo.
Laboratory tests
Occurrence of clinically significant laboratory (hematology and biochemistry) parameter abnormalities (number of subjects with clinically significant abnormal laboratory values).
Measured: Measured at screening and over 12 weeks of treatment or study participation - at baseline (randomization) visit, at week 2 of treatment, week 4, week 8 and week 12 (EOT).
Vital signs - Systolic Blood Pressure
Mean change in Systolic Blood Pressure.
Measured: Measured at screening and over 12 weeks of treatment or study participation - at baseline (randomization) visit, at week 2 of treatment, week 4, week 8, week 12 (EOT) and any Follow-up (UP) visits
Vital signs - Diastolic Blood Pressure
Mean change in Diastolic Blood Pressure.
Measured: Measured at screening and over 12 weeks of treatment or study participation - at baseline (randomization) visit, at week 2 of treatment, week 4, week 8, week 12 (EOT) and any FUP visits.
Vital signs
Mean change in Heart Rate.
Measured: Measured at screening and over 12 weeks of treatment or study participation - at baseline (randomization) visit, at week 2 of treatment, week 4, week 8, week 12 (EOT) and any FUP visits.
Vital signs - Respiratory Rate
Mean change in Respiratory Rate
Measured: Measured at screening and over 12 weeks of treatment or study participation - at baseline (randomization) visit, at week 2 of treatment, week 4, week 8, week 12 (EOT) and any FUP visits
Electrocardiography
Occurrence of any clinically significant abnormalities (number of patients with any clinically significant Heart rhythm, PR Interval, QTcF interval or QRS width interval abnormalities) in 12-lead electrocardiography (ECG) or 24-h ECG.
Measured: 12-lead-ECG measured at screening and over 12 weeks of treatment or study participation - at randomization visit, at week 2 of treatment, week 4, week 8, week 12 (EOT) and any FUP visits. 2-week 24-h-ECG recordings at weeks 0, 4 and 8 post randomization.
Electrocardiography - specific parameters
Occurrence of: a) QTcF >450 ms (male), >470 ms (female) and >500 ms (any sex) b) Change from baseline in QTcF >30 ms and >60 ms c) Heart rhythm abnormalities including supraventricular arrhythmias, ventricular arrhythmias, and non-sustained ventricular tachycardias.
Measured: Measured at screening and over 12 weeks of treatment or study participation - at baseline (randomization) visit, at week 2 of treatment, week 4, week 8, week 12 (EOT) and any FUP visits.
Male fertility
Occurrence of a clinically significant abnormality of sperm parameters and/ or free testosterone concentration in males (optional testing)
Measured: Measured at baseline (randomization) visit and at week 8 or week 12 (EOT) of treatment.
Neurological status
Occurrence of TEAEs of sensation abnormalities or ataxia.
Measured: TEAEs detected during 12 weeks of treatment or study participation - from baseline (randomization) visit and up to FUP visit 7-10 days after last dose
Thyroid and renal function
Proportion of subjects with clinically significant thyroid parameters (Thyroid Stimulating Hormone [TSH], Free Triiodothyronine [FT3], and Free Thyroxine [FT4] and renal function parameters [blood urea nitrogen (BUN)/total urea, creatinine, creatinine clearance (CrCL)].
Measured: Clinically significant abnormalities detected during 12 weeks of treatment - at baseline (randomization) visit, at week 4 of treatment, week 8 and week 12 (EOT).
Pharmacokinetics assessment
Mean plasma OATD-01 concentrations.
Measured: Measured during 2 weeks of treatment - at baseline (randomization) visit, at week 4 of treatment, week 8 and week 12 (EOT).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2024
- Study start21 Mar 2024
- Primary completionAug 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary SarcoidosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Molecure S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dariusz Stencel, MD, Study chair, CMO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06205121
- Sponsor's protocol ID
- OATD-01-C-03
- Other IDs
- 2023-506642-23, 2023
- Status last verified
- Oct 2026
- First submitted
- 13 Dec 2023
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT06205121
- Acronym / sponsor ID
- OATD-01-C-03
- Conditions
- Pulmonary Sarcoidosis
- Keywords
- Pulmonary Sarcoidosis, Sarcoidosis, Chitinase
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Molecure S.A.Industry (pharma, biotech, devices)
- Study start
- 21 Mar 2024 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 12 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase 2, randomized, double-blind, placebo-controlled, adaptive, multicenter study to evaluate the efficacy, safety, tolerability, Pharmacodynamics (PD), and Pharmacokinetics (PK) of OATD-01 in the treatment of subjects with active pulmonary sarcoidosis.
Detailed description
Adult subjects (≥ 18 years of age) diagnosed with symptomatic pulmonary sarcoidosis and active granulomatous process captured by [18F]Fluorodeoxyglucose Positron emission tomography/computed tomography ([18F]FDG PET/CT) imaging, treatment-naïve or previously treated but currently untreated, will be enrolled in the study. The diagnosis of pulmonary sarcoidosis will be based on the diagnostic criteria for pulmonary sarcoidosis recommended by the American Thoracic Society (ATS, 2020).
Subjects will be randomized in a 1:1 ratio to receive either OATD-01 or placebo for 12 weeks. A stratification of the study population based on previous treatment status for sarcoidosis (previously treated/treatment-naïve) will be applied for statistical analysis without limitation for the ratio between the subject groups. Double-blind conditions will be kept for the whole treatment duration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Arm | Experimental | Drug: OATD-01Subjects will receive OATD-01 as 25mg film-coated tablets for oral administration once daily for 12 weeks |
| Placebo Arm | Placebo comparator | Drug: PlaceboSubjects will receive placebo as film-coated tablets for oral administration once daily for 12 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male and female subjects with active symptomatic pulmonary sarcoidosis, (definite diagnosis of active pulmonary sarcoidosis per ATS guidelines)
- Treatment-naïve or previously treated (no recruitment cap)
- Parenchymal pulmonary involvement on [18F]FDG PET/CT
Key exclusion criteria (16 listed)
- Requirement for immediate start of standard of care therapy for pulmonary sarcoidosis
- Active cardiac or neuro- sarcoidosis
- History of/active Löfgren syndrome
- Clinically significant lung disease other than sarcoidosis (e.g. tuberculosis, asthma, Chronic Obstructive Pulmonary Disease, interstitial lung disease, lung cancer) or any current inflammatory or immunological systemic disease other than sarcoidosis
- Potentially effective systemic or inhaled pharmacological (including investigational) therapy for sarcoidosis (whether pulmonary or other disease), with the exception of any of the following:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OATD-01OATD-01 is an oral inhibitor of chitinase-1 (CHIT1) | Drug | Active Arm |
| PlaceboMatching placebo tablets | Drug | Placebo Arm |
Primary outcome
Response to treatment
Time frame: After 12 weeks of treatment, i.e. from baseline (randomization) visit to End-of-Treatment (EOT) visit.
Response classed as Complete response, Partial response, Stable disease and Progressive disease based on Standard Uptake Volume (SUV) changes in the uptake for {18F]FDG-PET/CT above the background (pulmonary parenchyma /ascending aorta) in pulmonary target lesions and any new lesions.
17 secondary outcomes
Total granulomatous inflammation evaluation
Time frame: After 12 weeks of treatment, i.e. from baseline (randomization) visit to EOT visit.
Pulmonary function Forced Vital Capacity (FVC)
Time frame: At Screening visit and over 12 weeks of treatment - at baseline (randomization) visit, at week 4 of treatment, week 8 and week 12 (EOT).
Pulmonary function Forced Expiratory Volume in the first second (FEV1)
Time frame: At Screening visit and over 12 weeks of treatment - at baseline (randomization) visit, at week 4 of treatment, week 8 and week 12 (EOT).
Quality of life assessment
Time frame: Assessed at baseline (randomization) visit and after 12 weeks of treatment (EOT visit) or study participation (week 12 visit).
Fatigue Assessment Scale (FAS)
Time frame: Assessed at baseline (randomization) visit and after 12 weeks of treatment (EOT visit) or study participation (week 12 visit).
Adverse events
Time frame: Recorded from the time of signature of informed consent and until 30 days after the last dose of OATD-01/Placebo.
Laboratory tests
Time frame: Measured at screening and over 12 weeks of treatment or study participation - at baseline (randomization) visit, at week 2 of treatment, week 4, week 8 and week 12 (EOT).
Vital signs - Systolic Blood Pressure
Time frame: Measured at screening and over 12 weeks of treatment or study participation - at baseline (randomization) visit, at week 2 of treatment, week 4, week 8, week 12 (EOT) and any Follow-up (UP) visits
Vital signs - Diastolic Blood Pressure
Time frame: Measured at screening and over 12 weeks of treatment or study participation - at baseline (randomization) visit, at week 2 of treatment, week 4, week 8, week 12 (EOT) and any FUP visits.
Vital signs
Time frame: Measured at screening and over 12 weeks of treatment or study participation - at baseline (randomization) visit, at week 2 of treatment, week 4, week 8, week 12 (EOT) and any FUP visits.
Vital signs - Respiratory Rate
Time frame: Measured at screening and over 12 weeks of treatment or study participation - at baseline (randomization) visit, at week 2 of treatment, week 4, week 8, week 12 (EOT) and any FUP visits
Electrocardiography
Time frame: 12-lead-ECG measured at screening and over 12 weeks of treatment or study participation - at randomization visit, at week 2 of treatment, week 4, week 8, week 12 (EOT) and any FUP visits. 2-week 24-h-ECG recordings at weeks 0, 4 and 8 post randomization.
Electrocardiography - specific parameters
Time frame: Measured at screening and over 12 weeks of treatment or study participation - at baseline (randomization) visit, at week 2 of treatment, week 4, week 8, week 12 (EOT) and any FUP visits.
Male fertility
Time frame: Measured at baseline (randomization) visit and at week 8 or week 12 (EOT) of treatment.
Neurological status
Time frame: TEAEs detected during 12 weeks of treatment or study participation - from baseline (randomization) visit and up to FUP visit 7-10 days after last dose
Thyroid and renal function
Time frame: Clinically significant abnormalities detected during 12 weeks of treatment - at baseline (randomization) visit, at week 4 of treatment, week 8 and week 12 (EOT).
Pharmacokinetics assessment
Time frame: Measured during 2 weeks of treatment - at baseline (randomization) visit, at week 4 of treatment, week 8 and week 12 (EOT).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dariusz Stencel, MD study chair
CMO
28 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing OATD-01 in people with Pulmonary Sarcoidosis, run by Molecure S.A. at 28 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in United States, United Kingdom, France, Greece, Germany and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Molecure SA (+48 22 552 67 24, contact@molecure.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response to treatment (time frame: After 12 weeks of treatment, i.e. from baseline (randomization) visit to End-of-Treatment (EOT) visit.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.