A Study of RO4989991 in Patients With Allergic Rhinitis
A Multi-center, Randomized, Observer-blind, Placebo-controlled Safety and Tolerability Study of Repeated Administration of Two Dose Levels of RO4989991 Administered Subcutaneously to Patients With Allergic Rhinitis
1 other identifier
interventional
24
1 country
4
Brief Summary
This multi-center, randomized, observer-blinded, placebo-controlled study will evaluate the safety and tolerability of subcutaneous doses of RO4989991 in patients with allergic rhinitis who are otherwise healthy. The anticipated time on study treatment is 2 weeks.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 asthma
Started Jul 2010
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 28, 2010
CompletedFirst Posted
Study publicly available on registry
June 29, 2010
CompletedStudy Start
First participant enrolled
July 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2011
CompletedNovember 2, 2016
November 1, 2016
7 months
June 28, 2010
November 1, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Assessment of the safety and tolerability of RO4989991
24 weeks
Secondary Outcomes (1)
Assessment of pharmacokinetics
24 weeks
Study Arms (4)
1
EXPERIMENTAL2
EXPERIMENTAL3
PLACEBO COMPARATOR4
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Adult patients, 18-65 years of age, inclusively
- A history of allergic rhinitis diagnosed by a physician, but otherwise healthy
- A positive skin prick test to at least one standardized allergen at screening
- A body mass index (BMI) between 18 and 32 kg/m2, inclusively
You may not qualify if:
- History or presence of any respiratory disease or condition other than allergic rhinitis
- Use of prescription medication or herbal remedies within 14 days of dosing the study drug
- Use of over-the-counter (OTC) medications within 7 days of dosing the study drug
- Acute infection (including viral infections) 6 weeks (8 weeks for respiratory infections) preceding dosing or any ongoing chronic infection
- Positive test for human immunodeficiency virus (HIV) or hepatitis B or C
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Unknown Facility
South Miami, Florida, 33143, United States
Unknown Facility
Normal, Illinois, 61761, United States
Unknown Facility
Raleigh, North Carolina, 27612, United States
Unknown Facility
Spartanburg, South Carolina, 29303, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 28, 2010
First Posted
June 29, 2010
Study Start
July 1, 2010
Primary Completion
February 1, 2011
Study Completion
February 1, 2011
Last Updated
November 2, 2016
Record last verified: 2016-11