AsthmaPhase 2NCT00983658
A Study of huMAb OX40L in the Prevention of Allergen-Induced Airway Obstruction in Adults With Mild Allergic Asthma
A Phase 2 study testing huMAb OX40L in people with Asthma, run by Genentech, Inc..
Trial summary
This Phase II, double-blind, placebo-controlled, randomized, parallel-group study is designed to evaluate the efficacy, safety, and tolerability of huMAb OX40L administered to patients by 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?
- huMAb OX40L
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 29 participants
- Where
- No sites listed yet
- Study dates
- Sep 2009to 5 Jan 2011
- 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
- Weight between 50 and 125 kg
- Mild, stable allergic asthma
- History of episodic wheeze and shortness of breath
- FEV1 at baseline ≥ 70% of the predicted value
- For women of childbearing potential, agreement to use an effective means of contraception while enrolled in the study
- For men with partners of childbearing potential, willingness to use condoms with spermicide during treatment
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- Ability to comprehend and follow all required study procedures
- Positive skin prick test to common aeroallergens (e.g., cat, dust, mite, grass, and pollen)
- Positive allergen-induced early and late airway bronchoconstriction
Who cannot join
- A worsening of asthma or a respiratory tract infection within 6 weeks preceding study entry
- Acute infection (including viral infection) within the 6 weeks preceding dosing (8 weeks for respiratory infections) or any ongoing chronic infection
- History of recurrent bacterial infection as an adult or history or presence of any chronic infectious condition, including (but not limited to), tuberculosis, parasitic infection, etc.
- Lung disease other than mild allergic asthma
- History of heart, lung, kidney, liver, neurologic or chronic infectious disease
- Concomitant disease or condition, which could interfere with the conduct of the study, including, but not limited to, cancer, alcoholism, drug dependency or abuse, or psychiatric disease
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- History of serious adverse reaction or hypersensitivity to any drug
- Pregnancy or lactation or positive serum pregnancy test at screening
- Chronic use of any other medication for treatment of allergic lung disease other than short-acting β2-agonists or ipratropium bromide
- Current (or history of) treatment with a monoclonal antibody or chimeric biomolecule within the past 5 months (5 half-lives of the drug), including omalizumab
- Regular use of tobacco products of any kind or within the previous 6 months, or smoking history > 10 pack-years
About this study
Official title: A Phase II, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy, Safety, and Tolerability of Intravenous huMAb OX40L (RO4989991) in the Prevention of Allergen-Induced Airway Obstruction in Adults With Mild Allergic Asthma
This Phase II, double-blind, placebo-controlled, randomized, parallel-group study is designed to evaluate the efficacy, safety, and tolerability of huMAb OX40L administered to patients by IV infusion for the treatment of allergen-induced asthma.
- Conditions
- Asthma
- Being tested
- huMAb OX40L, placebo
- Keywords
- Anti-OX40L, Mild Allergic Asthma, Allergies, Allergic Asthma, Adult Asthma
- Medical subject headings
- Asthma, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
huMAb OX40LDrug
Intravenous repeating dose
placeboDrug
Intravenous repeating dose
| Study group | Role | What they receive |
|---|---|---|
| huMAb OX40L | Experimental | Not described Receives: Drug: huMAb OX40L |
| Placebo | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome measure is the late asthmatic response (LAR) in patients treated with huMAb OX40L versus placebo
Measured: 16 weeks after the first dose
Secondary outcomes (9)
LAR after the allergen challenge in patients treated with huMAb OX40L versus placebo
Measured: Approximately Day 56 prior to third dose
Change in methacholine challenge response relative to the pre-allergen challenge PC20
Measured: 24 hours after each allergen challenge
Early asthmatic response (EAR) in patients treated with huMAb OX40L versus placebo
Measured: Between 0 and 2 hours after each allergen challenge
Incidence and nature of treatment-emergent adverse events
Measured: Through study completion or early study discontinuation
Incidence and nature of infusion reactions
Measured: Through study completion or early study discontinuation
Incidence of infectious complications
Measured: Through study completion or early study discontinuation
Incidence, nature, relatedness, and severity of adverse events
Measured: Through study completion or early study discontinuation
Clinically significant changes in vital signs, electrocardiograms, FEV1, and safety laboratory measures
Measured: Through study completion or early study discontinuation
Incidence of anti-therapeutic antibodies
Measured: Through study completion or early study discontinuation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2009 (estimated)
- Study startSep 2009
- Primary completionAug 2010
- Study completion5 Jan 2011
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
- Dana McClintock, M.D., Study director, Genentech, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00983658
- Sponsor's protocol ID
- OXF4696g
- Status last verified
- May 2026
- First submitted
- 21 Sep 2009
- Last updated
- 28 May 2026
- Results posted
- No
Publications
Gauvreau GM, Boulet LP, Cockcroft DW, FitzGerald JM, Mayers I, Carlsten C, Laviolette M, Killian KJ, Davis BE, Larche M, Kipling C, Dua B, Mosesova S, Putnam W, Zheng Y, Scheerens H, McClintock D, Matthews JG, O'Byrne PM. OX40L blockade and allergen-induced airway responses in subjects with mild asthma. Clin Exp Allergy. 2014 Jan;44(1):29-37. doi: 10.1111/cea.12235.
PubMed 24224471
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy, Safety, and Tolerability of Intravenous huMAb OX40L (RO4989991) in the Prevention of Allergen-Induced Airway Obstruction in Adults With Mild Allergic Asthma
- ClinicalTrials.gov ID
- NCT00983658
- Acronym / sponsor ID
- OXF4696g
- Conditions
- Asthma
- Keywords
- Anti-OX40L, Mild Allergic Asthma, Allergies, Allergic Asthma, Adult Asthma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Genentech, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2009 (actual)
- Primary completion
- Aug 2010 (actual)
- Study completion
- 5 Jan 2011 (actual)
- First posted
- 24 Sep 2009 (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 huMAb OX40L administered to patients by 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 |
|---|---|---|
| huMAb OX40L | Experimental | Drug: huMAb OX40L |
| Placebo | 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 (9 listed)
- Weight between 50 and 125 kg
- Mild, stable allergic asthma
- History of episodic wheeze and shortness of breath
- FEV1 at baseline ≥ 70% of the predicted value
- For women of childbearing potential, agreement to use an effective means of contraception while enrolled in the study
Key exclusion criteria (11 listed)
- A worsening of asthma or a respiratory tract infection within 6 weeks preceding study entry
- Acute infection (including viral infection) within the 6 weeks preceding dosing (8 weeks for respiratory infections) or any ongoing chronic infection
- History of recurrent bacterial infection as an adult or history or presence of any chronic infectious condition, including (but not limited to), tuberculosis, parasitic infection, etc.
- Lung disease other than mild allergic asthma
- History of heart, lung, kidney, liver, neurologic or chronic infectious disease
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 |
|---|---|---|
| huMAb OX40LIntravenous repeating dose | Drug | huMAb OX40L |
| placeboIntravenous repeating dose | Drug | Placebo |
Primary outcome
The primary outcome measure is the late asthmatic response (LAR) in patients treated with huMAb OX40L versus placebo
Time frame: 16 weeks after the first dose
9 secondary outcomes
LAR after the allergen challenge in patients treated with huMAb OX40L versus placebo
Time frame: Approximately Day 56 prior to third dose
Change in methacholine challenge response relative to the pre-allergen challenge PC20
Time frame: 24 hours after each allergen challenge
Early asthmatic response (EAR) in patients treated with huMAb OX40L versus placebo
Time frame: Between 0 and 2 hours after each allergen challenge
Incidence and nature of treatment-emergent adverse events
Time frame: Through study completion or early study discontinuation
Incidence and nature of infusion reactions
Time frame: Through study completion or early study discontinuation
Incidence of infectious complications
Time frame: Through study completion or early study discontinuation
Incidence, nature, relatedness, and severity of adverse events
Time frame: Through study completion or early study discontinuation
Clinically significant changes in vital signs, electrocardiograms, FEV1, and safety laboratory measures
Time frame: Through study completion or early study discontinuation
Incidence of anti-therapeutic antibodies
Time frame: Through study completion or early study discontinuation
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 28 May 2026.
- Derived from this study: PubMed 24224471Gauvreau GM, Boulet LP, Cockcroft DW, FitzGerald JM, Mayers I, Carlsten C, Laviolette M, Killian KJ, Davis BE, Larche M, Kipling C, Dua B, Mosesova S, Putnam W, Zheng Y, Scheerens H, McClintock D, Matthews JG, O'Byrne PM. OX40L blockade and allergen-induced airway responses in subjects with mild asthma. Clin Exp Allergy. 2014 Jan;44(1):29-37. doi: 10.1111/cea.12235.
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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.
Dana McClintock, M.D. study director
Genentech, Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing huMAb OX40L in people with Asthma, run by Genentech, Inc..
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 9 inclusion and 11 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 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
The primary outcome measure is the late asthmatic response (LAR) in patients treated with huMAb OX40L versus placebo (time frame: 16 weeks 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 NCT00983658, 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 28 May 2026; AzTrials last refreshed its copy on 8 Nov 2026.