A Study to Evaluate the Effectiveness and Safety of MEDI-528 in Adults

NCT00968669 | Completed Phase 2 Results DMC

• 1 other identifier: MI-CP198
• Study Type: interventional
• Target: 329
• Locations: 9 countries
• Sites: 56

Brief Summary

To study the effectiveness and safety of multiple-doses of MEDI-528 on asthma control in adult participants with uncontrolled, moderate-to-severe, persistent asthma.

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

• Change at Day 92 From Baseline in Mean Asthma Control Questionnaire (ACQ) Scores (Intent-toTreat Analysis)

  Change at Day 92 from baseline (Day 1, prior to dosing) in mean ACQ scores in pariticpants receiving 30, 100, or 300 mg MEDI-528 versus placebo (Intent-to-Treat Analysis). The 6-item ACQ is a participant-reported questionnaire assessing asthma symptoms (night-time waking, symptoms on waking, activity limitation, shortness of breath, wheezing) and daily rescue bronchodilator use. Participants were asked to recall how their asthma had been during the previous week. Questions were weighted equally and scored from 0 (totally controlled) to 6 (severely uncontrolled). The mean ACQ score is the mean of the responses. Mean scores of ≤ 0.75 indicate well-controlled asthma, scores between 0.76 and \< 1.5 indicate partly controlled asthma, and a score ≥ 1.5 indicates uncontrolled asthma. Individual changes of at least 0.5 are considered to be clinically meaningful.

  Day 92

Secondary Outcomes (20)

• Weighted Asthma Exacerbation Rate Through Day 92 (Intent-to-Treat Analysis)

  Days 1 - 92

• Weighted Asthma Exacerbation Rate Through Day 176 (Intent-to-Treat Analysis)

  Days 1 - 176

• Proportion of Participants Experiencing at Least One Asthma Exacerbation Through Day 92 (Intent-to-Treat Analysis)

  Days 1 - 92

• Proportion of Participants Experiencing at Least One Asthma Exacerbation Through Day 176 (Intent-to-Treat Analysis)

  Days 1 - 176

• Time to First Asthma Exacerbation Through Day 92 (Intent-to-Treat Analysis)

  Days 1 - 92

Study Arms (4)

MEDI528 30 mg

EXPERIMENTAL

MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks

Biological: MEDI528 30 mg

MEDI528 100 mg

EXPERIMENTAL

MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks

Biological: MEDI528 100 mg

MEDI528 300 mg

EXPERIMENTAL

MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks

Biological: MEDI528 300 mg

Placebo

EXPERIMENTAL

Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks

Other: Placebo

Interventions

MEDI528 30 mg BIOLOGICAL

MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks

MEDI528 30 mg

MEDI528 100 mg BIOLOGICAL

MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks

MEDI528 100 mg

MEDI528 300 mg BIOLOGICAL

MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks

MEDI528 300 mg

Placebo OTHER

Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must meet all of the following criteria:
• Male or female
• Age 18 through 65 years at the time of screening
• Written informed consent and any locally required authorization obtained from the subject prior to performing any protocol-related procedures, including screening evaluations
• Female subjects of childbearing potential who are sexually active with non-sterilized male partner must use adequate contraception from screening through the end of the study. An acceptable method of contraception is defined as one that has no higher than a 1% failure rate. Sustained abstinence is an acceptable practice; however, periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of contraception
• Non-sterilized males who are sexually active with a female of child-bearing potential must use adequate contraception from screening through the end of the study
• Females or female partners not of childbearing potential must have been surgically sterilized (eg, hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or postmenopausal (defined as at least 1 year since last regular menses)
• Sterilized males must be at least 1-year post vasectomy and have obtained documentation of the absence of sperm in the ejaculate
• Weight ≥ 45 kg but ≤ 120 kg and body mass index (BMI) between 18 and 35 kg/m2
• Physician-diagnosed asthma by medical chart
• Currently taking inhaled corticosteroids (ICS) or is a candidate to receive ICS per Expert Panel Report (EPR)-3
• Pre-bronchodilator forced expiratory volume in 1 second (FEV1) value ≥ 40% at Day -28 and Day 1
• A post-bronchodilator increase in FEV1 and/or FVC ≥ 12% and ≥ 200 mL at Day -28 OR meeting any one of the following criteria:
• Proof of post-bronchodilator reversibility of airflow obstruction ≥ 12% documented within 36 months prior to randomization or proof of a positive response to a methacholine challenge documented within 36 months prior to randomization; OR
• Proof of partial reversibility of ≥ 8% to \< 12% improvement in post-bronchodilator FEV1 on Day -28 and achievement of ≥ 12% reversibility at a second time between Day -27 and Day -15; OR

You may not qualify if:

• Uncontrolled asthma consistent with EPR-3. In the 28 days before screening, subjects should have a history of one or more of the following:
• Daytime asthma symptoms ≥ 2 days/week
• Nighttime awakening ≥ 1 night/week
• Albuterol/salbutamol use ≥ 2 days/week
• An Asthma Control Questionnaire (ACQ) score ≥ 1.5 at Day -28 and at Day 1.
• At least one asthma exacerbation in the 12 months before screening that required intake of systemic corticosteroids after an unscheduled medical encounter or as agreed with a physician based on an asthma action plan that defines when oral steroids can be taken by the subject
• Ability and willingness to complete the follow-up period through Day 323 as required by the protocol.
• Any of the following would exclude the subject from participation in the study:
• Any condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of subject safety or study results
• Concurrent enrollment in another clinical study
• Employees of the clinical study site or any other individuals involved with the conduct of the study, or immediate family members of such individuals
• Known history of allergy or reaction to any component of the investigational product formulation
• History of anaphylaxis to other biologic therapy
• Lung disease other than asthma (eg, chronic obstructive pulmonary disease \[COPD\], cystic fibrosis)
• Severe depression as measured by a depression score \> 15 on the Hospital Anxiety and Depression Scale (HADS) at either Day-28 or Day 1.

Sponsors & Collaborators

• MedImmune LLC: lead

Study Sites (57)

Research Site

Pell City, Alabama, 35128, United States

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Los Angeles, California, 90025, United States

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Sacramento, California, 95819, United States

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San Diego, California, 92123, United States

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Centennial, Colorado, 80112, United States

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Colarado Springs, Colorado, 80907, United States

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Thornton, Colorado, 80233, United States

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Waterbury, Connecticut, 06708, United States

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Kissimmee, Florida, 34741, United States

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Normal, Illinois, 61761, United States

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Overland Park, Kansas, 66210, United States

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Louisville, Kentucky, 40215, United States

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Baltimore, Maryland, 21236, United States

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Silver Spring, Maryland, 20902, United States

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North Dartmouth, Massachusetts, 02747, United States

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Minneapolis, Minnesota, 55402, United States

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Omaha, Nebraska, 68131, United States

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Mount Laurel, New Jersey, 08054, United States

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Sylvania, Ohio, 43560, United States

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Medford, Oregon, 97504, United States

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Lincoln, Rhode Island, 02865, United States

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Greenville, South Carolina, 29607, United States

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El Paso, Texas, 79903, United States

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San Antonio, Texas, 78229, United States

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Buenos Aire, Buenos Aires F.D., 1425, Argentina

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Ciudad Autonoma Bs As, Buenos Aires F.D., 1405, Argentina

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Rosario, Santa Fe Province, 2000, Argentina

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San Miguel de Tucumán, Tucumán Province, T4000IAR, Argentina

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Buenos Aires, C1424BSF, Argentina

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Ciudad de Buenos Aire, 1425, Argentina

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Porto Alegre, Rio Grande do Sul, 90020-090, Brazil

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Porto Alegre, Rio Grande do Sul, 90610-000, Brazil

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Florianópolis, Santa Catarina, 88040-970, Brazil

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Santo André, 09060-870, Brazil

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São Paulo, 05403-000, Brazil

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Calgary, Alberta, T2N 4Z6, Canada

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Edmonton, Alberta, T6G 2B7, Canada

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Vancouver, British Columbia, V5Z 1M9, Canada

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Mississauga, Ontario, L5A 3V4, Canada

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Ottawa, Ontario, K1Y 4G2, Canada

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Montreal, Quebec, H2X 2P4, Canada

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Québec, Quebec, G1V 4M6, Canada

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Québec, Quebec, Canada

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Bogota DC, Cundinamarca, Colombia

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Bogota, Cundinamarca, Colombia

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Bogotá D.C., Cundinamarca, Colombia

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San Francisco de Dos Ríos, Provincia de San José, Costa Rica

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Panama City, Panama

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Lima, Lima Province, Lima 27, Peru

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Lima, Lima Province, LIMA 33, Peru

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Lima, Lima Province, Peru

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Jesus Maria, Lima region, Lima 11, Peru

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Lipa City, Batangas, Philippines

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Iloilo City, Iloilo, 5000, Philippines

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Quezon City, National Capital Region, 870, Philippines

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Kaohsiung City, Taiwan

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Taoyuan District, Taiwan

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Related Publications (2)

• Oh CK, Leigh R, McLaurin KK, Kim K, Hultquist M, Molfino NA. A randomized, controlled trial to evaluate the effect of an anti-interleukin-9 monoclonal antibody in adults with uncontrolled asthma. Respir Res. 2013 Sep 19;14(1):93. doi: 10.1186/1465-9921-14-93.

  PMID: 24050312 DERIVED

• Lloyd CM, Hessel EM. Functions of T cells in asthma: more than just T(H)2 cells. Nat Rev Immunol. 2010 Dec;10(12):838-48. doi: 10.1038/nri2870. Epub 2010 Nov 9.

  PMID: 21060320 DERIVED

MeSH Terms

Conditions

Asthma

Interventions

enokizumab

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Joe Parker, MD
• Organization: MedImmune

parkerJ@medimmune.com

301-398-0000

Study Officials

• Chad Oh, M.D.

  MedImmune LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2009
• First Posted: August 31, 2009
• Study Start: December 1, 2009
• Primary Completion: November 1, 2011
• Study Completion: January 1, 2012
• Last Updated: June 4, 2014
• Results First Posted: June 4, 2014

Record last verified: 2014-05

Locations

PH (3); CO (3); AR (6); US (24); PA (1); CA (8); PE (4); TW (2); BR (5)