AsthmaPhase 1NCT01152619
A Study of RO4989991 in Patients With Allergic Rhinitis
A Phase 1 study testing RO4989991 in people with Asthma, run by Hoffmann-La Roche at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Asthma
- What is being tested?
- RO4989991
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 4 sitesUnited States
- Study dates
- Jul 2010to Feb 2011
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Study site
Normal, Illinois, 61761
Study site
Raleigh, North Carolina, 27612
Study site
South Miami, Florida, 33143
Study site
Spartanburg, South Carolina, 29303
About this study
Official title: 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
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.
- Conditions
- Asthma
- Being tested
- Placebo, RO4989991
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Subcutaneous repeated dose
RO4989991Drug
Subcutaneous repeated dose
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: RO4989991 |
| 2 | Experimental | Not described Receives: Drug: RO4989991 |
| 3 | Placebo comparator | Not described Receives: Drug: Placebo |
| 4 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the safety and tolerability of RO4989991
Measured: 24 weeks
Secondary outcomes (1)
Assessment of pharmacokinetics
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2010 (estimated)
- Study startJul 2010
- Primary completionFeb 2011
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01152619
- Sponsor's protocol ID
- PP22831
- Status last verified
- Nov 2016
- First submitted
- 28 Jun 2010
- Last updated
- 2 Nov 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01152619
- Acronym / sponsor ID
- PP22831
- Conditions
- Asthma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Jul 2010
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 29 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: RO4989991 |
| 2 | Experimental | Drug: RO4989991 |
| 3 | Placebo comparator | Drug: Placebo |
| 4 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboSubcutaneous repeated dose | Drug | 3, 4 |
| RO4989991Subcutaneous repeated dose | Drug | 1, 2 |
Primary outcome
Assessment of the safety and tolerability of RO4989991
Time frame: 24 weeks
1 secondary outcome
Assessment of pharmacokinetics
Time frame: 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing RO4989991 in people with Asthma, run by Hoffmann-La Roche at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of the safety and tolerability of RO4989991 (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2016.