AsthmaPhase 2NCT01196039
A Study of MEMP1972A in the Prevention of Allergen-Induced Airway Obstruction in Patients With Mild Asthma (SOLARIO)
A Phase 2 study testing MEMP1972A in people with Asthma, run by Genentech, Inc. at 7 sites in 2 countries.
Trial summary
This Phase II, double-blind, placebo-controlled, randomized, parallel-group study is designed to evaluate the efficacy, safety and tolerability of MEMP1972A when administered to patients by intravenous (IV) infusion for the treatment of allergen-induced asthma. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Asthma
- What is being tested?
- MEMP1972A
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 29 participants
- Where
- 7 sitesin 2 countries
- Study dates
- Dec 2010to Jan 2012
- Phase
- Phase 2
- 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
- Mild, stable allergic asthma
- History of episodic wheeze and shortness of breath
- FEV1 at baseline >= 70% of the predicted value
- Males or females who are surgically sterilized, post menopausal for the past year, or are using two acceptable methods of contraception against pregnancy through at least 5 months following the last administration of study drug
- Documented PC20 value for prediction of the starting allergen concentration at screening
- Positive skin prick test to common standard aeroallergens extracts
- Positive allergen-induced early and late airway response
Who cannot join
- A worsening of asthma within 6 weeks preceding Visit 1
- Acute respiratory infection within 6 weeks preceding Visit 2 or any ongoing chronic infection
- History of recurrent bacterial infection as an adult or history or presence of any chronic infectious condition
- Risk of exposure, as determined by the investigator, to water-borne parasites or clinical diagnosis of parasitic infection that is untreated within 3 months prior to Visit 5
- Lung disease other than mild allergic asthma
- History of clinically significant hypotensive episodes or symptoms of fainting, dizziness, or lightheadedness
Show all 29Show fewer
- History or symptoms of cardiovascular disease
- History or symptoms of significant neurologic disease
- History of significant hepatic or renal impairment
- Evidence of an active or suspected cancer or history of treatment for cancer
- History or symptoms of clinically significant autoimmune disease
- Any acquired or congenital immune deficiency
- Confirmed positive test for HIV or hepatitis B or C
- Concomitant disease or condition, which could interfere with the conduct of the study, or for which the treatment might interfere with the conduct of the study, or which would, in the opinion of the investigator, poses an unacceptable risk to the patients in this study
- History of serious adverse reaction or hypersensitivity to any drug
- Clinically significant abnormal chest radiograph within the last 12 months
- Pregnancy or lactation or positive serum pregnancy test at screening
- Use of corticosteroids, immunosuppressives, anticoagulants, or any medications that may interact with study drug within 4 weeks prior to Visit 2
- Chronic use of any other medication for treatment of allergic lung disease other than short-acting β2-agonists or ipratropium bromide
- Use of cromoglycate, nedocromil, leukotriene receptor antagonists, and inhibitors of 5-lipoxygenase are not permitted within 4 weeks prior to Visit 2
- Allergen or peptide immunotherapy within 6 months prior to study treatment
- Participation in any other investigational drug study within the preceding 30 days or 5 half-lives of that drug, whichever is longer at the time of Visit 2
- Current (or history of) treatment with a monoclonal antibody or chimeric biomolecule within the past 5 months, including omalizumab, at the time of Visit 2
- Use of statins are not permitted within 4 weeks prior to Visit 2
- Received live or attenuated vaccine within 30 days prior to Visit 5
- Regular use of tobacco products of any kind or within the previous 6 months, or smoking history > 10 pack-years
- History of drug or alcohol abuse
- Donation of blood over 500 mL within 3 months prior to Visit 5
- Unwillingness or inability to comply with the study protocol for any other reason
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
Canada6 sites
Study site
Calgary, Alberta, T2N 4Z6
Study site
Edmonton, Alberta, T6G1Z1
Study site
Hamilton, Ontario, L8N 3Z5
Study site
Saskatoon, Saskatchewan, S7N 0W8
Study site
Ste. Foy, Quebec, G1V 4G5
Study site
Vancouver, British Columbia, V5Z 1M9
About this study
Official title: A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy, Safety, and Tolerability of Intravenous MEMP1972A in the Prevention of Allergen-Induced Airway Obstruction in Patients With Mild Asthma
This Phase II, double-blind, placebo-controlled, randomized, parallel-group study is designed to evaluate the efficacy, safety and tolerability of MEMP1972A when administered to patients by intravenous (IV) infusion for the treatment of allergen-induced asthma.
- Conditions
- Asthma
- Being tested
- MEMP1972A, placebo
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MEMP1972ADrug
Intravenous repeating dose
placeboDrug
Intravenous repeating dose
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Drug: MEMP1972A |
| B | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Late airway response (LAR) area under the concentration-time curve (AUC) (percent decline in forced expiratory volume in 1 second [FEV1] over time)
Measured: Between 3 and 7 hours after allergen challenge at Day 86 after the first dose
Secondary outcomes (3)
Maximum percent decline in FEV1
Measured: Immediately prior to the allergen challenge to between 3 and 7 hours after allergen challenge on Day 86 after the first dose
Change in methacholine challenge PC20 relative to the pre-allergen challenge PC20
Measured: Day 87
Maximum percent decline in FEV1 and early airway response (EAR) AUC (percent decline in FEV1 over time)
Measured: Between 0 and 3 hours after post-treatment allergen challenge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2010 (estimated)
- Study startDec 2010
- Primary completionAug 2011
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Genentech, Inc.The 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genentech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jeffrey Harris, MD, Ph.D, Study director, Genentech, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01196039
- Sponsor's protocol ID
- MOP4843g
- Other IDs
- GA01332
- Status last verified
- Nov 2016
- First submitted
- 3 Sep 2010
- Last updated
- 2 Nov 2016
- Results posted
- No
Publications
Gauvreau GM, Harris JM, Boulet LP, Scheerens H, Fitzgerald JM, Putnam WS, Cockcroft DW, Davis BE, Leigh R, Zheng Y, Dahlen B, Wang Y, Maciuca R, Mayers I, Liao XC, Wu LC, Matthews JG, O'Byrne PM. Targeting membrane-expressed IgE B cell receptor with an antibody to the M1 prime epitope reduces IgE production. Sci Transl Med. 2014 Jul 2;6(243):243ra85. doi: 10.1126/scitranslmed.3008961.
PubMed 24990880
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 Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy, Safety, and Tolerability of Intravenous MEMP1972A in the Prevention of Allergen-Induced Airway Obstruction in Patients With Mild Asthma
- ClinicalTrials.gov ID
- NCT01196039
- Acronym / sponsor ID
- MOP4843g
- Conditions
- Asthma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Genentech, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2010
- Primary completion
- Aug 2011 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 8 Sep 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 Phase II, double-blind, placebo-controlled, randomized, parallel-group study is designed to evaluate the efficacy, safety and tolerability of MEMP1972A when administered to patients by intravenous (IV) infusion for the treatment of allergen-induced asthma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: MEMP1972A |
| B | 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 (7 listed)
- Mild, stable allergic asthma
- History of episodic wheeze and shortness of breath
- FEV1 at baseline >= 70% of the predicted value
- Males or females who are surgically sterilized, post menopausal for the past year, or are using two acceptable methods of contraception against pregnancy through at least 5 months following the last administration of study drug
- Documented PC20 value for prediction of the starting allergen concentration at screening
Key exclusion criteria (29 listed)
- A worsening of asthma within 6 weeks preceding Visit 1
- Acute respiratory infection within 6 weeks preceding Visit 2 or any ongoing chronic infection
- History of recurrent bacterial infection as an adult or history or presence of any chronic infectious condition
- Risk of exposure, as determined by the investigator, to water-borne parasites or clinical diagnosis of parasitic infection that is untreated within 3 months prior to Visit 5
- Lung disease other than mild allergic asthma
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 |
|---|---|---|
| MEMP1972AIntravenous repeating dose | Drug | A |
| placeboIntravenous repeating dose | Drug | B |
Primary outcome
Late airway response (LAR) area under the concentration-time curve (AUC) (percent decline in forced expiratory volume in 1 second [FEV1] over time)
Time frame: Between 3 and 7 hours after allergen challenge at Day 86 after the first dose
3 secondary outcomes
Maximum percent decline in FEV1
Time frame: Immediately prior to the allergen challenge to between 3 and 7 hours after allergen challenge on Day 86 after the first dose
Change in methacholine challenge PC20 relative to the pre-allergen challenge PC20
Time frame: Day 87
Maximum percent decline in FEV1 and early airway response (EAR) AUC (percent decline in FEV1 over time)
Time frame: Between 0 and 3 hours after post-treatment allergen challenge
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.
- Derived from this study: PubMed 24990880Gauvreau GM, Harris JM, Boulet LP, Scheerens H, Fitzgerald JM, Putnam WS, Cockcroft DW, Davis BE, Leigh R, Zheng Y, Dahlen B, Wang Y, Maciuca R, Mayers I, Liao XC, Wu LC, Matthews JG, O'Byrne PM. Targeting membrane-expressed IgE B cell receptor with an antibody to the M1 prime epitope reduces IgE production. Sci Transl Med. 2014 Jul 2;6(243):243ra85. doi: 10.1126/scitranslmed.3008961.
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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.
Jeffrey Harris, MD, Ph.D study director
Genentech, Inc.
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MEMP1972A in people with Asthma, run by Genentech, Inc. at 7 sites in 2 countries.
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 7 inclusion and 29 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 7 sites in Canada, Sweden. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Late airway response (LAR) area under the concentration-time curve (AUC) (percent decline in forced expiratory volume in 1 second [FEV1] over time) (time frame: Between 3 and 7 hours after allergen challenge at Day 86 after the first dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01196039, which also lists 1 linked publication.
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.