Trial Outcomes & Findings for Role of RhuMab-E25 in Reducing Exhaled Nitric Oxide (NO) in Allergic Asthma (NCT NCT00829179)

Results Overview

The primary outcome measure was the change in exhaled nitric oxide levels between baseline and week 12. 12 week value minus baseline value. (Baseline was -1 week, ie 1 week prior to the start of study drug)

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

20 participants

Primary outcome timeframe

13 weeks

Results posted on

2016-02-08

Participant Flow

Subjects were recruited from the Pulmonary clinic and the local community from 10/2002 - 07/2004

The majority of screen failures prior to starting study drug was one of 3 reasons; negative methacholine challenge, IgE, too low, or IgE too high.

Participant milestones

Participant milestones
Measure	RhuMab-E25 Subjects with mild asthma received three doses of study drug subcutaneous injections at one month intervals. Dosing range was 150mg-375mg which was based on baseline IGE and subject body weight. Subjects with a baseline Ige above 30 and up to 100 with a body weight between 30 and 150kg would receive a study drug dose of 150 mg. Subjects with an IGE 100-200 and body weight 30 - 150 kg would receive a dose of 225 mg. And up to subjects with an IGE of 600-700 only body weight of 30 - 60 would be included with a dose of 375 mg.
Overall Study STARTED	20
Overall Study COMPLETED	19
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	RhuMab-E25 Subjects with mild asthma received three doses of study drug subcutaneous injections at one month intervals. Dosing range was 150mg-375mg which was based on baseline IGE and subject body weight. Subjects with a baseline Ige above 30 and up to 100 with a body weight between 30 and 150kg would receive a study drug dose of 150 mg. Subjects with an IGE 100-200 and body weight 30 - 150 kg would receive a dose of 225 mg. And up to subjects with an IGE of 600-700 only body weight of 30 - 60 would be included with a dose of 375 mg.
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Role of RhuMab-E25 in Reducing Exhaled Nitric Oxide (NO) in Allergic Asthma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	RhuMab-E25 n=20 Participants
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	20 Participants n=93 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants
Age, Continuous	31.8 years STANDARD_DEVIATION 9.1 • n=93 Participants
Sex: Female, Male Female	12 Participants n=93 Participants
Sex: Female, Male Male	8 Participants n=93 Participants
Region of Enrollment United States	20 participants n=93 Participants

PRIMARY outcome

Timeframe: 13 weeks

The primary outcome measure was the change in exhaled nitric oxide levels between baseline and week 12. 12 week value minus baseline value. (Baseline was -1 week, ie 1 week prior to the start of study drug)

Outcome measures

Outcome measures
Measure	RhuMab-E25 n=19 Participants
Change in Exhaled Nitric Oxide From Baseline to Week 12	-11.0 parts per billion (ppb) Standard Deviation 13.3

Adverse Events

RhuMab-E25

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	RhuMab-E25 n=20 participants at risk
Nervous system disorders headache	10.0% 2/20 • Number of events 3
Respiratory, thoracic and mediastinal disorders cough	10.0% 2/20 • Number of events 2
Infections and infestations viral syndrome	15.0% 3/20 • Number of events 3

Additional Information

John S. Sundy M.D. PhD

Duke University Medical Center

Phone: (919) 668-2169

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place