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HAE1

Phase 2

Allergic Asthma | Small molecule | Respiratory |Roche Holding AG|Trials Updated: Jan 2, 2008

HAE1 target and mechanism

ModalitySmall molecule

Also known as HAE1 (PRO98498)

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment50

FDA Designations

No designations recorded

HAE1 clinical trials

HAE1 · 1 trial · 1 indication

Phase 2 1
NCT00406965A Study to Evaluate the Safety and Efficacy of HAE1 in Subjects With Moderate to Severe Allergic AsthmaAllergic Asthma
COMPLETED50 Analytics
PHASE2COMPLETED
A Study to Evaluate the Safety and Efficacy of HAE1 in Subjects With Moderate to Severe Allergic Asthma
Allergic AsthmaUnlock trial analytics

Study Endpoints

Primary Endpoints

The primary outcome measure is the change from baseline (Visit 1) in total asthma symptom score to Visit 10 (Day 140).

Secondary Endpoints

Incidence and severity of treatment-emergent adverse events and targeted adverse events and incidence of HAE-1 specific antibodies from Visit 1 to the end of the study
Change from baseline (Visit 1) in asthma symptom scores (nocturnal, morning, daytime, and total) at Visits 5, 6, 7, 8, and 10 (Days 28, 56, 84, 112, and 140)
Change from baseline (Visit 1) in the number of puffs per day of beta2-agonist rescue medication at Visits 5, 6, 7, 8, and 10 (Days 28, 56, 84, 112, and 140)
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Study Design & Arms

PurposeTREATMENT

Interventions

NameTypeDescription
HAE1 (PRO98498)DRUG -
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Eligibility Criteria

Age Range12 Years to 75 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Signed Informed Consent Form(s) * Male and females 12-75 years of age with the diagnosis of allergic asthma for 12 months according to the standards of the American Thoracic Society * Baseline FEV1 values ≥ 40% to ≤ 80% of the predicted normal value for the subject * Demonstra...

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Frequently asked questions about HAE1

What is HAE1 used for?

HAE1 is an investigational small molecule being studied for the treatment of allergic asthma. It was evaluated in patients with moderate to severe allergic asthma, including adolescents aged 12 years and older. HAE1 has not been approved for any indication and remains in clinical development.

Who is developing HAE1?

HAE1 is being developed by Roche Holding AG, which trades on the OTC market under the ticker RHHBY. Roche is the sponsor of the clinical program evaluating HAE1 in respiratory disease.

What phase is HAE1 in?

HAE1 is in Phase 2 development. One Phase 2 trial has been completed, and no trials are currently active. The program has enrolled 50 participants in total. HAE1 is investigational and has not received FDA approval for any indication.

What clinical trials is HAE1 in?

HAE1 has been studied in one Phase 2 trial, NCT00406965, titled A Study to Evaluate the Safety and Efficacy of HAE1 in Subjects With Moderate to Severe Allergic Asthma. That trial is completed and enrolled 50 participants. It was an uncontrolled study without randomization or double blinding.

Is HAE1 the same as PRO98498?

Yes, HAE1 is also known as PRO98498. Both names refer to the same investigational small molecule developed by Roche Holding AG for allergic asthma. Readers searching for PRO98498 will find the same Phase 2 program and the same completed trial, NCT00406965.