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CompletedNCT00983658Updated May 28, 2026

A Study of huMAb OX40L in the Prevention of Allergen-Induced Airway Obstruction in Adults With Mild Allergic Asthma

A Phase 2 interventional study of huMAb OX40L and placebo in Asthma, sponsored by Genentech, Inc.. Completed. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-05-28.

Sponsored by Genentech, Inc. · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
29
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Asthma

Keywords

  • Anti-OX40L
  • Mild Allergic Asthma
  • Allergies
  • Allergic Asthma
  • Adult Asthma
03

In context

Asthma

3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.

This study's enrollment of 29 is below the median of 83 across 2,752 interventional studies indexed under Asthma.

Browse Asthma studies →

Lead sponsor

Genentech, Inc. is the lead sponsor of 507 studies on the registry; 23 are open to participants now.

Of its 90 completed or terminated interventional studies of FDA-regulated products, 50 (56%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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
  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
  • 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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
29 participants (actual)

Study arms

  • Experimental
    huMAb OX40L

    Drug: huMAb OX40L

  • Placebo comparator
    Placebo

    Drug: placebo

Interventions

  • DrughuMAb OX40L

    Intravenous repeating dose

  • Drugplacebo

    Intravenous repeating dose

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. LAR after the allergen challenge in patients treated with huMAb OX40L versus placebo

    Time frame: Approximately Day 56 prior to third dose

  2. Change in methacholine challenge response relative to the pre-allergen challenge PC20

    Time frame: 24 hours after each allergen challenge

  3. Early asthmatic response (EAR) in patients treated with huMAb OX40L versus placebo

    Time frame: Between 0 and 2 hours after each allergen challenge

  4. Incidence and nature of treatment-emergent adverse events

    Time frame: Through study completion or early study discontinuation

  5. Incidence and nature of infusion reactions

    Time frame: Through study completion or early study discontinuation

  6. Incidence of infectious complications

    Time frame: Through study completion or early study discontinuation

  7. Incidence, nature, relatedness, and severity of adverse events

    Time frame: Through study completion or early study discontinuation

  8. Clinically significant changes in vital signs, electrocardiograms, FEV1, and safety laboratory measures

    Time frame: Through study completion or early study discontinuation

  9. Incidence of anti-therapeutic antibodies

    Time frame: Through study completion or early study discontinuation

07

Study locations

No study locations are listed for this record.

08

References and documents

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 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 28, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00983658
Lead sponsor
Genentech, Inc.
Responsible party
Sponsor
First posted
Sep 24, 2009
Start date
Sep 2009
Primary completion
Aug 2010
Completion
Jan 5, 2011
Last update
May 28, 2026

Study contacts

Dana McClintock, M.D.
study director · Genentech, Inc.
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2026. You cannot join it, but the record below documents what was studied.

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