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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| huMAb OX40L | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| huMAb OX40L | Drug | Intravenous repeating dose |
| |
| placebo |
| Measure | Description | Time Frame |
|---|---|---|
| The primary outcome measure is the late asthmatic response (LAR) in patients treated with huMAb OX40L versus placebo | 16 weeks after the first dose |
| Measure | Description | Time Frame |
|---|---|---|
| LAR after the allergen challenge in patients treated with huMAb OX40L versus placebo | Approximately Day 56 prior to third dose | |
| Change in methacholine challenge response relative to the pre-allergen challenge PC20 | 24 hours after each allergen challenge |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dana McClintock, M.D. | Genentech, Inc. | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24224471 | Derived | 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. |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| D006967 | Hypersensitivity |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| Drug |
Intravenous repeating dose |
|
| Early asthmatic response (EAR) in patients treated with huMAb OX40L versus placebo | Between 0 and 2 hours after each allergen challenge |
| Incidence and nature of treatment-emergent adverse events | Through study completion or early study discontinuation |
| Incidence and nature of infusion reactions | Through study completion or early study discontinuation |
| Incidence of infectious complications | Through study completion or early study discontinuation |
| Incidence, nature, relatedness, and severity of adverse events | Through study completion or early study discontinuation |
| Clinically significant changes in vital signs, electrocardiograms, FEV1, and safety laboratory measures | Through study completion or early study discontinuation |
| Incidence of anti-therapeutic antibodies | Through study completion or early study discontinuation |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D007154 | Immune System Diseases |