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NCT01951326 · ClinicalTrials.gov registry record · Phase 3

Efficacy and Safety of Anti-MAP Therapy in Adult Crohn's Disease

A Phase 3 study, sponsored by RedHill Biopharma Limited.

Completed
Registry status
Phase 3
Development phase
331
Enrollment target

NCT01951326: Completed Phase 3 study, sponsored by RedHill Biopharma Limited.

NCT01951326 is a Phase 3 study that has completed, run by RedHill Biopharma Limited. The registered enrollment target is 331 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (57% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01951326, a Phase 3 study, has completed, sponsored by RedHill Biopharma Limited.

COMPLETED
Registry status
Phase 3
Development phase
331 participants
Enrollment target

Study Summary

The investigators hypothesize that RHB-104 will have greater efficacy than placebo in Crohn's disease.

Primary Outcome

Reduction of the total Crohn's Disease Activity Index (CDAI) score to less than 150. Lower CDAI scores indicate a better outcome.

Interventions

  • DRUG Placebo
  • DRUG RHB-104

Trial Details

FieldValue
Enrollment Target 331 participants
Start Date 2013-09
Est. Completion 2019-08
Phase Phase 3
RedHill Biopharma Limited

13 total trials

What the finished NCT01951326 record still lists

NCT01951326 is an interventional study that assigns participants to a tested intervention. The registered 331 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (57% lower).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT01951326 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01951326 about?

NCT01951326 is a clinical study titled "Efficacy and Safety of Anti-MAP Therapy in Adult Crohn's Disease". The investigators hypothesize that RHB-104 will have greater efficacy than placebo in Crohn's disease.

What is the current status of trial NCT01951326?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 331 participants. The study started on 2013-09. Estimated completion is 2019-08.

What interventions are being tested in trial NCT01951326?

The interventions under investigation include: Placebo (DRUG), RHB-104 (DRUG).

Who is sponsoring clinical trial NCT01951326?

This trial is sponsored by RedHill Biopharma Limited, which has 13 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01951326's enrollment target sits among peer trials

331 1066th of 2000 higher than 935 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01951326, the US trial registry maintained by the National Library of Medicine. NCT01951326 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.