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NCT06886360
An Open-label Study of Patients with Primary Sclerosing Cholangitis (PSC) Treated with Norucholic Acid Tablets
Phase 3 trial testing norucholic acid in Primary Sclerosing Cholangitis in 120 participants. Not yet recruiting.
1 September 2027
Quick facts
| Lead sponsor | Dr. Falk Pharma GmbH |
|---|---|
| Phase | Phase 3 |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 120 |
| Start date | 1 March 2025 |
| Primary completion | 1 September 2027 |
| Estimated completion | 1 September 2027 |
Drugs / interventions tested
- norucholic acid — full drug profile →
Conditions studied
- Primary Sclerosing Cholangitis — all drugs for Primary Sclerosing Cholangitis →
Sponsor
Dr. Falk Pharma GmbH — full company profile →
Who can join
18 and older, any sex, with Primary Sclerosing Cholangitis. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Occurrence of treatment emergent adverse events
Time frame: 72 weeks from enrollment to end of treatment -
Occurrence of serious treatment emergent adverse events
Time frame: 72 weeks from enrollment to end of treatment -
Occurrence of severe treatment emergent adverse events
Time frame: 72 weeks from enrollment to end of treatment -
Occurrence of adverse drug reactions
Time frame: 72 weeks from enrollment to end of treatment -
Occurrence of unexpected treatment emergent adverse events
Time frame: 72 weeks from enrollment to end of treatment -
Occurrence of treatment emergent adverse events leading to study withdrawal
Time frame: 72 weeks from enrollment to end of treatment
Sponsor's own description
Open-label, multi-center, phase III trial. Oral treatment with 1500 mg norucholic acid in Primary Sclerosing cholangitis
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06886360
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Primary Sclerosing Cholangitis
Currently open trials in the same condition.
- NCT07229911 — A Study of TAK-781 in Healthy Volunteers and in Participants With Non-Cirrhotic Primary Sclerosing Cholangitis (PSC) · Phase 1 · recruiting
- NCT06905054 — Pharmacologic Approaches to Preventing Primary Sclerosing Cholangitis Recurrence After Liver Transplantation · Phase 2 · recruiting
- NCT06455280 — A Study of SIPLIZUMAB in AILD and LT Patients · Phase 1 · recruiting
- NCT06519162 — Liver-gut Axis Study Through Identification of Liver Disease-specific Microbiome · recruiting
- NCT06351696 — The Effects of Bromelain Supplement in Patients With Ulcerative Colitis · NA · recruiting
Other Dr. Falk Pharma GmbH trials
Trials by the same sponsor.
- NCT05488405 — Mesalazine Oral Suspension in Active Eosinophilic Esophagitis · Phase 2 · completed
- NCT05621811 — Different Doses of Naronapride vs. Placebo in Gastroparesis · Phase 2 · completed
- NCT05305599 — Different Doses of ZED1227 vs. Placebo in NAFLD · Phase 2 · completed
- NCT02493335 — Maintenance of Remission With Budesonide Orodispersible Tablets vs. Placebo in Eosinophilic Esophagitis · Phase 3 · completed
- NCT02434029 — Budesonide Orodispersible Tablet vs. Placebo in Active Eosinophilic Esophagitis · Phase 3 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06886360 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Dr. Falk Pharma GmbH
- Last refreshed: 19 March 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06886360.