Trial · NCT01951326

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

NCT01951326, Phase 3, Completed, RedHill Biopharma Limited; results first posted 2020-05-01

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Efficacy and Safety of Anti-MAP Therapy in Adult Crohn's Disease. Trials, record NCT01951326. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01951326

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Efficacy and Safety of Anti-MAP Therapy in Adult Crohn's Disease
NCT number: NCT01951326
Status: Completed
Phases: Phase 3
Enrollment: 331 participants, actual
Lead sponsor: RedHill Biopharma Limited
Conditions: Crohn's Disease
Interventions: RHB-104, Placebo
First posted: 2013-09-26
Last updated: 2020-12-08
Results first posted: 2020-05-01

Source ClinicalTrials.gov

Registered outcomes14

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Remission at Week 26	Week 26	Reduction of the total Crohn's Disease Activity Index (CDAI) score to less than 150. Lower CDAI scores indicate a better outcome.
Secondary	Response at Week 26	Week 26	Reduction of Crohn's Disease Activity Index (CDAI) score by a minimum of 100 points. Lower CDAI scores indicate a better outcome.
Secondary	Remission at Week 52	Week 52	Reduction of the total Crohn's Disease Activity Index (CDAI) score to less than 150. Lower CDAI scores indicate a better outcome.
Secondary	Durable Remission Week 26 Through Week 52	Week 26 through week 52	When a subject is in remission with a maximum CDAI score of 149 at every visit from Week 26 through and including Week 52
Secondary	Remission at Week 16	Week 16	Reduction of the total Crohn's Disease Activity Index (CDAI) score to less than 150. Lower CDAI scores indicate a better outcome.
Secondary	Steroid Free Remission at Week 52	Week 52	Subjects who are maintained off steroids for a minimum of 3 weeks
Other	Duration of Remission	Baseline through week 52	Number of weeks that a subject is in a state of remission. Subjects who experienced remission and continued to be in remission at the time of their last CDAI assessment are censored at the date of their last CDAI assessment.
Other	Duration of Response	Baseline through week 52	Number of weeks a subject is in a state of response. Subjects who experienced response and continued to be in response at the time of their last CDAI assessment are censored at the date of their last CDAI assessment.
Other	Time to Remission	Baseline through week 52	\[Date of first observed remission (CDAI score \< 150) - Date of first dose or date of randomization if not dosed + 1\] / 7 Days. Subjects who never experienced remission during the study are censored at the date of their last CDAI assessment.
Other	Time to Response	Baseline through week 52	\[Date of first observed response (a reduction from baseline of ≥ 100 in CDAI score) - Date of first dose or date of randomization if not dosed + 1\] / 7 Days. Subjects who never experienced response during the study are censored at the date of their last CDAI assessment.

1 to 10 of 14Source ClinicalTrials.gov

See all 14 registered outcomes

Outcomes14

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Remission at Week 26	Week 26		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Response at Week 26	Week 26		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Remission at Week 52	Week 52		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Durable Remission Week 26 Through Week 52	Week 26 through week 52		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Remission at Week 16	Week 16		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Steroid Free Remission at Week 52	Week 52		Participants	COUNT_OF_PARTICIPANTS
OTHER_PRE_SPECIFIED	Duration of Remission	Baseline through week 52	Reached duration of remission (dropped out of remission during the study), n (%): RHB-104 54 (53.5); Placebo: 49 (62.8). Censored (remain in remission during the study), n (%): RHB-104: 47 (46.5); Placebo 29 (37.2)	weeks	MEDIAN
OTHER_PRE_SPECIFIED	Duration of Response	Baseline through week 52	Reached duration of response (dropped out of response during the study), n (%) RHB-104: 52 (45.2); Placebo: 55 (59.8). Censored (remain in response during the study), n (%): RHB-104: 63 (54.8); Placebo: 37 (40.2)	weeks	MEDIAN
OTHER_PRE_SPECIFIED	Time to Remission	Baseline through week 52	Number of subjects achieved remission, n (%) RHB-104: 101 (60.8); Placebo 78 (47.3). Censored, n (%): RHB-104: 65 (39.2); Placebo 87 (52.7)	weeks	MEDIAN
OTHER_PRE_SPECIFIED	Time to Response	Baseline through week 52	Number of subjects achieved response, n (%): RHB-104: 115 (69.3); Placebo: 92 (55.8); Censored, n (%): RHB-104: 51 (30.7); Placebo: 73 (44.2)	weeks	MEDIAN

1 to 10 of 14Source ClinicalTrials.gov

See all 14 outcomes

Results by group28

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Units
Remission at Week 26	RHB-104	61	Participants
Remission at Week 26	Placebo	37	Participants
Response at Week 26	RHB-104	73	Participants
Response at Week 26	Placebo	50	Participants
Remission at Week 52	RHB-104	47	Participants
Remission at Week 52	Placebo	32	Participants
Durable Remission Week 26 Through Week 52	RHB-104	33	Participants
Durable Remission Week 26 Through Week 52	Placebo	21	Participants
Remission at Week 16	RHB-104	70	Participants
Remission at Week 16	Placebo	48	Participants

1 to 10 of 28Source ClinicalTrials.gov

See all 28 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	RHB-104	166
Overall Study	STARTED	Placebo	165
Overall Study	COMPLETED	RHB-104	87
Overall Study	COMPLETED	Placebo	87
Overall Study	NOT COMPLETED	RHB-104	79
Overall Study	NOT COMPLETED	Placebo	78

Source ClinicalTrials.gov

Adverse events54

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Crohn's Disease	Gastrointestinal disorders	RHB-104	21	166
other	Crohn's Disease	Gastrointestinal disorders	Placebo	25	165
other	Abdominal Pain	Gastrointestinal disorders	RHB-104	24	166
other	Abdominal Pain	Gastrointestinal disorders	Placebo	19	165
other	Nausea	Gastrointestinal disorders	RHB-104	22	166
other	Nausea	Gastrointestinal disorders	Placebo	12	165
other	Diarrheoa	Gastrointestinal disorders	RHB-104	11	166
other	Diarrheoa	Gastrointestinal disorders	Placebo	8	165
other	Vomiting	Gastrointestinal disorders	RHB-104	12	166
other	Vomiting	Gastrointestinal disorders	Placebo	7	165

1 to 10 of 54Source ClinicalTrials.gov

See all 54 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	RHB-104	0	166
Total, all-cause mortality	Placebo	0	165
Total, other adverse events	RHB-104	115	166
Total, other adverse events	Placebo	90	165
Total, serious adverse events	RHB-104	31	166
Total, serious adverse events	Placebo	31	165

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
39199994	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons10

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
RHB-104 vs Placebo: Durable Remission Week 26 Through Week 52	Trial comparisons
RHB-104 vs Placebo: Remission at Week 26	Trial comparisons
RHB-104 vs Placebo: Steroid Free Remission at Week 52	Trial comparisons
RHB-104 vs Placebo: Response at Week 16	Trial comparisons
RHB-104 vs Placebo: Durable Remission Week 16 Through Week 52	Trial comparisons
RHB-104 vs Placebo: Remission at Week 52	Trial comparisons
RHB-104 vs Placebo: Remission at Week 16	Trial comparisons
RHB-104 vs Placebo: Response at Week 26	Trial comparisons
RHB-104 vs Placebo: deaths from any cause	Trial comparisons
RHB-104 vs Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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