Trial Outcomes & Findings for Safety and Tolerability of Single Doses Oral CNDO 201 Trichuris Suis Ova in Patients With Crohn's Disease (NCT NCT01434693)

Last Updated: 2013-05-20

Results Overview

Comparison of safety and tolerability was performed across the dose levels by evaluating the post-dose tolerability of TSO in patients with Crohn's Disease via incidence of adverse events (i.e. # events) with a specific focus on reported gastrointestinal signs and symptoms

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

36 participants

Primary outcome timeframe

6 mo

Results posted on

2013-05-20

Participant Flow

A total of 8 clinical sites were initiated, all in the United States, with 6 of these sites enrolling at least one patient. Patients were enrolled from Nov, 2011 to Jan 30, 2012.

All patients were immediately assigned to a treatment group upon enrollment.

Participant milestones

Participant milestones
Measure	Placebo Placebo: single dose	TSO 500 Trichuris suis ova : single dose	TSO 2500 Trichuris suis ova : single dose	TSO 7500 Trichuris suis ova : single dose
Overall Study STARTED	9	9	9	9
Overall Study COMPLETED	6	9	8	8
Overall Study NOT COMPLETED	3	0	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Placebo: single dose	TSO 2500 Trichuris suis ova : single dose	TSO 7500 Trichuris suis ova : single dose
Overall Study Adverse Event	1	0	0
Overall Study Withdrawal by Subject	1	1	1
Overall Study Lost to Follow-up	1	0	0

Baseline Characteristics

Safety and Tolerability of Single Doses Oral CNDO 201 Trichuris Suis Ova in Patients With Crohn's Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	TSO 500 n=9 Participants Trichuris suis ova : single dose	TSO 2500 n=9 Participants Trichuris suis ova : single dose	TSO 7500 n=9 Participants Trichuris suis ova : single dose	Total n=36 Participants Total of all reporting groups	Placebo n=9 Participants Placebo: single dose
Age, Categorical <=18 years	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=157 Participants	0 Participants n=390 Participants	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=107 Participants	9 Participants n=206 Participants	9 Participants n=157 Participants	36 Participants n=390 Participants	9 Participants n=99 Participants
Age, Categorical >=65 years	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=157 Participants	0 Participants n=390 Participants	0 Participants n=99 Participants
Age Continuous	30.8 years STANDARD_DEVIATION 3.19 • n=107 Participants	31.1 years STANDARD_DEVIATION 3.36 • n=206 Participants	36.9 years STANDARD_DEVIATION 3.27 • n=157 Participants	32.9 years STANDARD_DEVIATION 1.90 • n=390 Participants	43.0 years STANDARD_DEVIATION 3.11 • n=99 Participants
Sex: Female, Male Female	6 Participants n=107 Participants	3 Participants n=206 Participants	5 Participants n=157 Participants	18 Participants n=390 Participants	4 Participants n=99 Participants
Sex: Female, Male Male	3 Participants n=107 Participants	6 Participants n=206 Participants	4 Participants n=157 Participants	18 Participants n=390 Participants	5 Participants n=99 Participants
Region of Enrollment United States	9 participants n=107 Participants	9 participants n=206 Participants	9 participants n=157 Participants	36 participants n=390 Participants	9 participants n=99 Participants

PRIMARY outcome

Timeframe: 6 mo

Population: All patients who were randomized were treated according to the protocol and therefore were all included in the Safety Population.

Outcome measures

Outcome measures
Measure	Placebo n=9 Participants Placebo: single dose	TSO 500 n=9 Participants Trichuris suis ova : single dose	TSO 2500 n=9 Participants Trichuris suis ova : single dose	TSO 7500 n=9 Participants Trichuris suis ova : single dose
Incidence of Adverse Events	7 events	4 events	1 events	7 events

Adverse Events

Placebo

Serious events: 2 serious events

Other events: 5 other events

Deaths: 0 deaths

TSO 500

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

TSO 2500

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

TSO 7500

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo n=9 participants at risk Placebo: single dose	TSO 500 n=9 participants at risk Trichuris suis ova : single dose	TSO 2500 n=9 participants at risk Trichuris suis ova : single dose	TSO 7500 n=9 participants at risk Trichuris suis ova : single dose
Surgical and medical procedures small intestinal resection	11.1% 1/9	0.00% 0/9	0.00% 0/9	0.00% 0/9
Gastrointestinal disorders ABDOMINAL PAIN	11.1% 1/9	0.00% 0/9	0.00% 0/9	0.00% 0/9
Gastrointestinal disorders Crohn's disease flare	0.00% 0/9	0.00% 0/9	0.00% 0/9	11.1% 1/9
Gastrointestinal disorders ANOVULVAR FISTULA	0.00% 0/9	0.00% 0/9	0.00% 0/9	11.1% 1/9
Infections and infestations CLOSTRIDIAL INFECTION	0.00% 0/9	0.00% 0/9	0.00% 0/9	11.1% 1/9

Other adverse events

Other adverse events
Measure	Placebo n=9 participants at risk Placebo: single dose	TSO 500 n=9 participants at risk Trichuris suis ova : single dose	TSO 2500 n=9 participants at risk Trichuris suis ova : single dose	TSO 7500 n=9 participants at risk Trichuris suis ova : single dose
Gastrointestinal disorders Diarrhea	0.00% 0/9	33.3% 3/9	0.00% 0/9	0.00% 0/9
Gastrointestinal disorders Vomitting	0.00% 0/9	11.1% 1/9	0.00% 0/9	11.1% 1/9
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/9	11.1% 1/9	0.00% 0/9	11.1% 1/9
Gastrointestinal disorders Nausea	11.1% 1/9	11.1% 1/9	0.00% 0/9	11.1% 1/9
Gastrointestinal disorders Abdominal pain	0.00% 0/9	22.2% 2/9	0.00% 0/9	0.00% 0/9
Nervous system disorders Syncope	0.00% 0/9	0.00% 0/9	0.00% 0/9	11.1% 1/9
Infections and infestations Sinusitis	0.00% 0/9	11.1% 1/9	0.00% 0/9	0.00% 0/9
Respiratory, thoracic and mediastinal disorders Sinus congestion	0.00% 0/9	0.00% 0/9	0.00% 0/9	11.1% 1/9
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/9	0.00% 0/9	0.00% 0/9	11.1% 1/9
Gastrointestinal disorders Mucous stools	0.00% 0/9	11.1% 1/9	0.00% 0/9	0.00% 0/9
Respiratory, thoracic and mediastinal disorders Laryngeal oedema	0.00% 0/9	0.00% 0/9	11.1% 1/9	0.00% 0/9
Musculoskeletal and connective tissue disorders Joint swelling	0.00% 0/9	0.00% 0/9	0.00% 0/9	11.1% 1/9
Gastrointestinal disorders Flatulence	0.00% 0/9	11.1% 1/9	0.00% 0/9	0.00% 0/9
Skin and subcutaneous tissue disorders Erythema nodosum	0.00% 0/9	0.00% 0/9	0.00% 0/9	11.1% 1/9
Nervous system disorders Dysgeusia	11.1% 1/9	0.00% 0/9	0.00% 0/9	11.1% 1/9
Metabolism and nutrition disorders Decreased appetite	0.00% 0/9	0.00% 0/9	0.00% 0/9	11.1% 1/9
Gastrointestinal disorders Crohn's disease	11.1% 1/9	0.00% 0/9	0.00% 0/9	0.00% 0/9
Gastrointestinal disorders Aphthous stomatitis	0.00% 0/9	0.00% 0/9	0.00% 0/9	11.1% 1/9
Injury, poisoning and procedural complications Road traffic accident	11.1% 1/9	0.00% 0/9	0.00% 0/9	0.00% 0/9
Reproductive system and breast disorders Ovarian cyst	11.1% 1/9	0.00% 0/9	0.00% 0/9	0.00% 0/9
Infections and infestations Nasopharyngitis	11.1% 1/9	0.00% 0/9	0.00% 0/9	11.1% 1/9
Psychiatric disorders Insomnia	11.1% 1/9	0.00% 0/9	0.00% 0/9	0.00% 0/9
Nervous system disorders Headache	11.1% 1/9	0.00% 0/9	0.00% 0/9	0.00% 0/9
Gastrointestinal disorders Gastrointestinal reflux disease	11.1% 1/9	0.00% 0/9	0.00% 0/9	0.00% 0/9

Additional Information

Vice President Clinical Operations

Coronado Biosciences

Phone: 781.652.4516

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60