Trial · NCT02525523

Efficacy of Alicaforsen in Pouchitis Patients Who Have Failed to Respond to at Least One Course of Antibiotics

NCT02525523, Phase 3, Completed, Atlantic Pharmaceuticals Ltd; results first posted 2020-02-25

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Efficacy of Alicaforsen in Pouchitis Patients Who Have Failed to Respond to at Least One Course of Antibiotics. Trials, record NCT02525523. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02525523

On this page

Trial

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

Title: Efficacy of Alicaforsen in Pouchitis Patients Who Have Failed to Respond to at Least One Course of Antibiotics
NCT number: NCT02525523
Status: Completed
Phases: Phase 3
Enrollment: 138 participants, actual
Lead sponsor: Atlantic Pharmaceuticals Ltd
Conditions: Pouchitis
Interventions: Alicaforsen, Placebo
First posted: 2015-08-17
Last updated: 2020-02-25
Results first posted: 2020-02-25

Source ClinicalTrials.gov

Registered outcomes2

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

List	Outcome	Time frame	Description
Primary	Proportion of Patients With Endoscopic Remission	Week 10	The group of patients with an improvement in their endoscopic score between screening and week 10 as shown by an reduced modified MAYO score. Remission is defined as absence of friability and ulceration, represented by a score of ≤1.
Primary	Proportion of Patients With a Reduction in Relative Stool Frequency	Week 10	Group of patients with a lowering of stool frequency from baseline to week 10, where the subject's stool frequency is represented by a MAYO subscore of ≤1 at week 10.

Source ClinicalTrials.gov

Outcomes2

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Proportion of Patients With Endoscopic Remission	Week 10		Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Proportion of Patients With a Reduction in Relative Stool Frequency	Week 10		Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group4

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

Outcome	Group	Value	Units
Proportion of Patients With Endoscopic Remission	Alicaforsen	3	Participants
Proportion of Patients With Endoscopic Remission	Placebo	3	Participants
Proportion of Patients With a Reduction in Relative Stool Frequency	Alicaforsen	22	Participants
Proportion of Patients With a Reduction in Relative Stool Frequency	Placebo	16	Participants

Source ClinicalTrials.gov

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Alicaforsen	69
Overall Study	STARTED	Placebo	69
Overall Study	COMPLETED	Alicaforsen	46
Overall Study	COMPLETED	Placebo	44
Overall Study	NOT COMPLETED	Alicaforsen	23
Overall Study	NOT COMPLETED	Placebo	25

Source ClinicalTrials.gov

Adverse events22

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	Abdominal pain	Gastrointestinal disorders	Alicaforsen	2	69
other	Abdominal pain	Gastrointestinal disorders	Placebo	7	69
other	Pouchitis	Gastrointestinal disorders	Alicaforsen	4	69
other	Pouchitis	Gastrointestinal disorders	Placebo	5	69
other	Anorectal discomfort	Gastrointestinal disorders	Alicaforsen	3	69
other	Anorectal discomfort	Gastrointestinal disorders	Placebo	4	69
other	Diarrhoea	Gastrointestinal disorders	Alicaforsen	4	69
other	Diarrhoea	Gastrointestinal disorders	Placebo	1	69
other	Nasopharyngitis	Infections and infestations	Alicaforsen	6	69
other	Nasopharyngitis	Infections and infestations	Placebo	3	69

1 to 10 of 22Source ClinicalTrials.gov

See all 22 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Alicaforsen	0	69
Total, all-cause mortality	Placebo	0	69
Total, other adverse events	Alicaforsen	19	69
Total, other adverse events	Placebo	20	69
Total, serious adverse events	Alicaforsen	4	69
Total, serious adverse events	Placebo	2	69

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

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 comparisons4

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

Comparison	Source
Alicaforsen vs Placebo: Proportion of Patients With Endoscopic Remission	Trial comparisons
Alicaforsen vs Placebo: deaths from any cause	Trial comparisons
Alicaforsen vs Placebo: Proportion of Patients With a Reduction in Relative Stool Frequency	Trial comparisons
Alicaforsen 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.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT02525523

GET https://conductscience.org/api/trials/v1/NCT02525523/events?page=2

API reference For AI assistants