Trial Outcomes & Findings for Efficacy of Alicaforsen in Pouchitis Patients Who Have Failed to Respond to at Least One Course of Antibiotics (NCT NCT02525523)

Last Updated: 2020-02-25

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

138 participants

Primary outcome timeframe

Week 10

Results posted on

2020-02-25

Participant Flow

Participant milestones

Participant milestones
Measure	Alicaforsen Alicaforsen enema, 240mg once daily for 6 weeks Alicaforsen	Placebo Placebo enema, once daily for 6 weeks Placebo
Overall Study STARTED	69	69
Overall Study COMPLETED	46	44
Overall Study NOT COMPLETED	23	25

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Alicaforsen n=69 Participants Alicaforsen enema, 240mg once daily for 6 weeks Alicaforsen	Placebo n=69 Participants Placebo enema, once daily for 6 weeks Placebo	Total n=138 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Age, Categorical Between 18 and 65 years	65 Participants n=99 Participants	66 Participants n=107 Participants	131 Participants n=206 Participants
Age, Categorical >=65 years	4 Participants n=99 Participants	3 Participants n=107 Participants	7 Participants n=206 Participants
Sex: Female, Male Female	30 Participants n=99 Participants	28 Participants n=107 Participants	58 Participants n=206 Participants
Sex: Female, Male Male	39 Participants n=99 Participants	41 Participants n=107 Participants	80 Participants n=206 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Asian	1 Participants n=99 Participants	5 Participants n=107 Participants	6 Participants n=206 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Black or African American	1 Participants n=99 Participants	0 Participants n=107 Participants	1 Participants n=206 Participants
Race (NIH/OMB) White	62 Participants n=99 Participants	54 Participants n=107 Participants	116 Participants n=206 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Unknown or Not Reported	5 Participants n=99 Participants	10 Participants n=107 Participants	15 Participants n=206 Participants

PRIMARY outcome

Timeframe: Week 10

Outcome measures

Outcome measures
Measure	Alicaforsen n=65 Participants Alicaforsen enema, 240mg once daily for 6 weeks Alicaforsen	Placebo n=61 Participants Placebo enema, once daily for 6 weeks Placebo
Proportion of Patients With Endoscopic Remission	3 Participants	3 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Alicaforsen n=65 Participants Alicaforsen enema, 240mg once daily for 6 weeks Alicaforsen	Placebo n=61 Participants Placebo enema, once daily for 6 weeks Placebo
Proportion of Patients With a Reduction in Relative Stool Frequency	22 Participants	16 Participants

Adverse Events

Alicaforsen

Serious events: 4 serious events

Other events: 19 other events

Deaths: 0 deaths

Placebo

Serious events: 2 serious events

Other events: 20 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Alicaforsen n=69 participants at risk Alicaforsen enema, 240mg once daily for 6 weeks Alicaforsen	Placebo n=69 participants at risk Placebo enema, once daily for 6 weeks Placebo
Gastrointestinal disorders Diarrhoea	1.4% 1/69 • 10 weeks	0.00% 0/69 • 10 weeks
Gastrointestinal disorders Gastrointestinal obstruction	0.00% 0/69 • 10 weeks	1.4% 1/69 • 10 weeks
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/69 • 10 weeks	1.4% 1/69 • 10 weeks
Infections and infestations Anal Absess	1.4% 1/69 • 10 weeks	0.00% 0/69 • 10 weeks
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lipoma	1.4% 1/69 • 10 weeks	0.00% 0/69 • 10 weeks
Nervous system disorders Facial Paralysis	1.4% 1/69 • 10 weeks	0.00% 0/69 • 10 weeks

Other adverse events

Other adverse events
Measure	Alicaforsen n=69 participants at risk Alicaforsen enema, 240mg once daily for 6 weeks Alicaforsen	Placebo n=69 participants at risk Placebo enema, once daily for 6 weeks Placebo
Gastrointestinal disorders Abdominal pain	2.9% 2/69 • 10 weeks	10.1% 7/69 • 10 weeks
Gastrointestinal disorders Pouchitis	5.8% 4/69 • 10 weeks	7.2% 5/69 • 10 weeks
Gastrointestinal disorders Anorectal discomfort	4.3% 3/69 • 10 weeks	5.8% 4/69 • 10 weeks
Gastrointestinal disorders Diarrhoea	5.8% 4/69 • 10 weeks	1.4% 1/69 • 10 weeks
Infections and infestations Nasopharyngitis	8.7% 6/69 • 10 weeks	4.3% 3/69 • 10 weeks

Additional Information

Dr Chris Dunk, Director of Clinical Development

Atlantic Pharmaceuticals

Phone: +44 1799 513391

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place