Phase 2 Coeliac Disease Trial, Recruiting NCT07298343 Sponsor: Dr. Falk Pharma GmbH Condition: Coeliac Disease
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Phase 2 Coeliac Disease Trial, Recruiting

NCT07298343
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:

  • You are willing and able to sign a consent form agreeing to take part in the trial
  • You are a man or woman aged between 18 and 80 years old (inclusive)
  • You were diagnosed with celiac disease confirmed by a biopsy, or — if biopsy records are unavailable — you had a specific blood test result (TG2-IgA) that was more than 10 times the normal limit at the time of diagnosis, and this diagnosis was made at least 12 months before joining the trial
  • You have been following a strict gluten-free diet for at least 12 months before joining the trial
  • A genetic test (HLA-DQ typing) shows a result that is consistent with celiac disease

Who may not be able to join:

  • You have an underactive or overactive thyroid — however, if your thyroid condition has been well-controlled for the past 3 months, you may still be eligible (confirm with trial site)
  • You have been diagnosed with a severe form of celiac disease that does not respond to a gluten-free diet (called refractory celiac disease type I or II), although some people with the type I form may still qualify under specific conditions (confirm with trial site)
  • You have serious complications resulting from your celiac disease
  • You have another condition affecting your gut or digestive system, such as Crohn's disease, ulcerative colitis, severe irritable bowel syndrome, or certain other digestive conditions that could affect how your symptoms are measured in the trial
  • You have, or have previously had, a skin condition linked to celiac disease called dermatitis herpetiformis

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 28 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.

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Trial details

Status
Recruiting
Phase
Phase 2
Sponsor
Dr. Falk Pharma GmbH
Registry
ClinicalTrials.gov
Start date
10 June 2024
Est. completion
1 August 2027

Where this trial is recruiting

🇩🇪 Germany

Primary endpoints

Change in CDSD GI Specific Symptom Score

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: 28 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