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NCT Number: NCT01582503

A Study of MEMP1972A in Patients With Allergic Asthma Inadequately Controlled on Inhaled Steroids And A Second Controller (COSTA)

This randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of 3 dosing regimens of MEMP1972A in patients with allergic asthma who remain inadequately controlled on chronic therapy with high dose inhaled corticosteroids and a second controller medication.Patients will be randomized to 4 Arms to receive subcutaneous repeating dose of either MEMP1972A 150 mg, 300 mg, or 450 mg, or placebo. Patients will continue their usual asthma medication throughout the study. Anticipated time on study treatment is 36 weeks, with a 48-week follow-up.

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult patients, 18 to 75 years of age inclusive
  • Body weight >/= 40 kg
  • Physician's diagnosis of asthma for at least 12 months
  • Evidence of documented bronchodilator reversibility as defined by protocol
  • Prebronchodilator FEV1 >/= 40% and </= 80% predicted at Visit 1
  • Required daily use of ICS and a second controller for a minimum of 3 consecutive months prior to Visit 1
  • History of at least one protocol-defined asthma exacerbation in the 18 months prior to Visit 1
  • Inadequately controlled asthma despite compliance with asthma controller therapy

Exclusion criteria

  • Asthma exacerbation requiring systemic steroids in the 30 days prior to Visit 1
  • Pre-existing active lung disease other than asthma
  • Any infection
  • Clinically significant medical disease that is uncontrolled despite treatment or is likely to require a change in therapy during study or is of unknown etiology
  • Known immunodeficiency, including but not limited to HIV infection, regardless of treatment status
  • Current substance abuse
  • Former smoker with >10 pack-year history or current smoker; former smokers must have stopped smoking more than 12 months prior to Visit 1
  • History of anaphylaxis
  • Pregnant and lactating women

Treatment and study plan

MEMP1972A

Drug

Subcutaneous repeating dose

Placebo

Drug

Subcutaneous repeating dose

Primary outcomes

  1. Rate of protocol-defined asthma exacerbations (new or increased asthma symptoms that lead to treatment with systemic corticosteroids or to hospitalization) from baseline to Week 36

    Time frame: 36 weeks

Secondary outcomes

  1. Relative change in pre-bronchodilator FEV1 (volume)

    Time frame: from baseline to Week 12

  2. Relative change in FEV1 (volume)

    Time frame: from baseline to Week 36

  3. Change in asthma symptoms

    Time frame: from baseline to Week 12

  4. Change in asthma symptoms

    Time frame: from baseline to Week 36

  5. Proportion of "well-controlled" weeks (no nighttime awakenings due to asthma symptoms and </= 2 days of SABA use per weeks, as documented by patient diary) from Week 24 to Week 36

    Time frame: 12 weeks

  6. Safety: Incidence of adverse events

    Time frame: 48 weeks

  7. Incidence of anti-therapeutic antibodies (ATAs)

    Time frame: 84 weeks

  8. Pharmacokinetics: Area under the concentration-time curve (AUC)

    Time frame: Pre- and post-dose Weeks 0, 4, 12, 24 and 36

Sponsors and collaborators

Lead sponsor

Genentech, Inc.

Industry

Registry information

Official study title

A Phase IIb, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Dosing Regimens of MEMP1972A in Adults With Allergic Asthma Who Are Inadequately Controlled on Inhaled Corticosteroids and a Second Controller (COSTA)

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Apr 20, 2012
Registry last updated
Nov 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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