Trial Outcomes & Findings for The Safety and Efficacy of a Peanut Immunotherapy Dissolving Film for Peanut Allergy (NCT NCT01897077)

NCT ID: NCT01897077

Last Updated: 2018-07-03

Results Overview

No healthy volunteers discontinued the study for treatment related reasons. No active participants enrolled.

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

5 participants

Primary outcome timeframe

18 months

Results posted on

2018-07-03

Participant Flow

Participant milestones

Participant milestones
Measure	Peanut Allergic Only one intervention will be given. Peanut allergic study subjects, will receive gradually increasing doses of the dissolving peanut film. Peanut Dissolving Film. No subjects were enrolled before termination.	Healthy Volunteers Healthy volunteers will receive active peanut dissolving films in an expedited manner in order to determine safety dissolving films. Peanut Dissolving Film 5 subjects received the active film.
Overall Study STARTED	0	5
Overall Study COMPLETED	0	5
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Safety and Efficacy of a Peanut Immunotherapy Dissolving Film for Peanut Allergy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Peanut Allergic Only one intervention will be given. Peanut allergic study subjects, will receive gradually increasing doses of the dissolving peanut film. Peanut Dissolving Film	Healthy Volunteers n=5 Participants Healthy volunteers will receive active peanut dissolving films in an expedited manner in order to determine safety dissolving films. Peanut Dissolving Film	Total n=5 Participants Total of all reporting groups
Age, Categorical <=18 years	—	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	—	5 Participants n=7 Participants	5 Participants n=5 Participants
Age, Categorical >=65 years	—	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	—	3 Participants n=7 Participants	3 Participants n=5 Participants
Sex: Female, Male Male	—	2 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	—	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	—	2 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	—	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	—	2 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) White	—	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) More than one race	—	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	—	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	—	5 participants n=7 Participants	5 participants n=5 Participants

PRIMARY outcome

Timeframe: 18 months

Population: There were no peanut allergic subjects enrolled because the study ended prematurely due to manufacturing issues with the study product.

No healthy volunteers discontinued the study for treatment related reasons. No active participants enrolled.

Outcome measures

Outcome measures
Measure	Peanut Allergic Only one intervention will be given. Peanut allergic study subjects, will receive gradually increasing doses of the dissolving peanut film. Peanut Dissolving Film. No subjects were enrolled before termination.	Healthy Volunteers n=5 Participants Healthy volunteers will receive active peanut dissolving films in an expedited manner in order to determine safety dissolving films. Peanut Dissolving Film 5 subjects received the active film.
The Proportion of Subjects That Discontinue the Study for Treatment Related Reasons	—	0 Participants

SECONDARY outcome

Timeframe: 18 months

Population: No participants were analyzed for this secondary outcome because data was not collected due to early termination of the study

For peanut allergic subjects only

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 18 months

Population: No participants were analyzed for this secondary outcome in the peanut allergic group because data was not collected due to early termination of the study

Outcome measures

Outcome measures
Measure	Peanut Allergic Only one intervention will be given. Peanut allergic study subjects, will receive gradually increasing doses of the dissolving peanut film. Peanut Dissolving Film. No subjects were enrolled before termination.	Healthy Volunteers n=5 Participants Healthy volunteers will receive active peanut dissolving films in an expedited manner in order to determine safety dissolving films. Peanut Dissolving Film 5 subjects received the active film.
Number of Participants With Serious and Non-serious Adverse Effects With Therapy	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 18 months

Population: No participants were analyzed for this secondary outcome because no data for the outcome was collected due to early termination of the study

For peanut allergic subjects only.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 18 months

Population: No participants were analyzed for this secondary outcome because data was not collected due to early termination of the study

Only in peanut allergic subjects

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 18 months

Population: No participants were analyzed for this secondary outcome in the peanut allergic group because no data was collected due to early termination of the study

Outcome measures

Outcome measures
Measure	Peanut Allergic Only one intervention will be given. Peanut allergic study subjects, will receive gradually increasing doses of the dissolving peanut film. Peanut Dissolving Film. No subjects were enrolled before termination.	Healthy Volunteers n=5 Participants Healthy volunteers will receive active peanut dissolving films in an expedited manner in order to determine safety dissolving films. Peanut Dissolving Film 5 subjects received the active film.
Number of Participants With Serious Adverse Events With Dosing	—	0 participants

Adverse Events

Peanut Allergic

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Healthy Volunteers

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Corinne Keet

Johns Hopkins School of Medicine

Phone: 410-955-5883

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place