Phase 2 Interstitial Lung Disease Trial, Recruiting NCT06205121 Sponsor: Molecure S.A. Condition: Interstitial Lung Disease
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Phase 2 Interstitial Lung Disease Trial, Recruiting

NCT06205121
Recruiting Phase 2

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People who have been diagnosed with active pulmonary sarcoidosis (sarcoidosis affecting the lungs) that is causing symptoms, confirmed according to established medical guidelines.
  • People who are either new to treatment for sarcoidosis or have been treated for it before.
  • People whose lung tissue shows signs of active disease on a special type of body scan called an [18F]FDG PET/CT scan.

Who may not be able to join:

  • People who need to start standard sarcoidosis treatment immediately.
  • People who have sarcoidosis that is currently affecting the heart or nervous system.
  • People who have a history of, or currently have, a condition called Löfgren syndrome (a specific form of sarcoidosis).
  • People who have a significant lung disease other than sarcoidosis — such as tuberculosis, asthma, chronic obstructive pulmonary disease (COPD), another type of scarring lung disease, or lung cancer — or who have any other ongoing inflammatory or immune system disease besides sarcoidosis.
  • People who are currently taking, or have recently taken, certain medications for sarcoidosis: specifically, corticosteroids taken within the last 3 months, or immunosuppressants or anti-inflammatory/anti-fibrotic drugs taken within the last 4 months.
  • People whose main reason for needing systemic treatment is sarcoidosis in a part of the body other than the lungs (for example, in the nervous system).
  • People with certain heart conditions, including a specific abnormality on a heart tracing (prolonged QTcF interval), certain heart rhythm problems, moderate-to-severe heart failure, known thickening of the heart muscle, or reduced heart pumping function seen on a cardiac MRI.
  • People with a known diagnosis of neurosarcoidosis (sarcoidosis affecting the nerves), a nerve condition called small fiber neuropathy, or any medical condition that causes problems with balance and coordination (primary ataxia).
  • People with certain abnormal blood test results at the time of screening, including abnormal liver markers, abnormal kidney function, low potassium, low calcium, or significantly elevated fasting blood sugar levels.
  • People with poorly controlled diabetes at the time of screening, a body temperature above 37°C, or any other condition that would make the PET/CT scan unsuitable or unsafe (confirm with trial site).
  • People who test positive for HIV, hepatitis B, or hepatitis C, either previously known or detected at screening.
  • People with a severe or poorly controlled serious illness — such as a heart, lung, thyroid, kidney, or metabolic condition — that the trial doctor believes could affect safety or the ability to participate.
  • People who currently smoke more than 5 cigarettes or e-cigarettes per day, or regularly use other nicotine products such as patches or chewing gum.
  • People currently taking certain medications, including drugs known to affect heart rhythm (QT-prolonging drugs), thiazide diuretics (a type of fluid tablet), certain drugs that affect how the body processes other medications (strong CYP3A4 inhibitors or inducers, P-glycoprotein or BCRP inhibitors, or specific drug transporters with a narrow margin of safety), or the lung-scarring medications pirfenidone or nintedanib.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 21 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Piotr Iwanowski, MD, CMO

Phone: +48789125928

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Sponsor
Molecure S.A.
Registry
ClinicalTrials.gov
Start date
21 March 2024
Est. completion
1 August 2027

Where this trial is recruiting

🇩🇰 Denmark 🇫🇷 France 🇩🇪 Germany 🇬🇷 Greece 🇳🇱 Netherlands 🇳🇴 Norway 🇬🇧 United Kingdom 🇺🇸 United States

Primary endpoints

Response to treatment

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 21 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov