Phase 2
Completed N=327
A Study to Evaluate the Effectiveness and Safety of MEDI-528 in Adults
Source: ClinicalTrials.gov NCT00968669 ↗Enrolled (actual)
327
Serious AEs
5.8%
Results posted
Jun 2014
Primary outcomePrimary: Change at Day 92 From Baseline in Mean Asthma Control Questionnaire (ACQ) Scores (Intent-toTreat Analysis) — -1.23; -1.10; -1.26; -1.31 Scores on a scale — p=0.435
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change at Day 92 From Baseline in Mean Asthma Control Questionnaire (ACQ) Scores (Intent-toTreat Analysis) |
-1.23; -1.10; -1.26; -1.31 | 0.435 |
| SECONDARY Weighted Asthma Exacerbation Rate Through Day 92 (Intent-to-Treat Analysis) |
0.53; 0.82; 0.33; 0.39 | 0.271 |
| SECONDARY Weighted Asthma Exacerbation Rate Through Day 176 (Intent-to-Treat Analysis) |
0.58; 0.64; 0.28; 0.58 | 0.756 |
| SECONDARY Proportion of Participants Experiencing at Least One Asthma Exacerbation Through Day 92 (Intent-to-Treat Analysis) |
8; 14; 5; 7 | 0.1764 |
| SECONDARY Proportion of Participants Experiencing at Least One Asthma Exacerbation Through Day 176 (Intent-to-Treat Analysis) |
16; 17; 8; 15 | 0.8475 |
| SECONDARY Time to First Asthma Exacerbation Through Day 92 (Intent-to-Treat Analysis) |
NA; NA; NA; NA | 0.144 |
| SECONDARY Time to First Asthma Exacerbation Through Day 176 (Intent-to-Treat Analysis) |
NA; NA; NA; NA | 0.717 |
| SECONDARY Change at Day 176 From Baseline in Mean Asthma Control Questionnaire Scores (Intent-to-Treat Analysis) |
-1.27; -1.32; -1.46; -1.45 | 0.813 |
| SECONDARY Proportion of Participants Achieving Mean Asthma Control Questionnaire (ACQ) Scores at Day 92 of < or = 0.75, > 0.75 to < 1.5, and > or = 1.5 (Intent-to-Treat Analysis) |
17; 17; 17; 22; 23; 21 | 0.764 |
| SECONDARY Proportion of Participants Achieving Mean Asthma Control Questionnaire (ACQ) Scores at Day 176 of < or = 0.75, > 0.75 to < 1.5, and > or = 1.5 (Intent-to-Treat Analysis) |
25; 29; 24; 25; 19; 18 | 0.986 |
| SECONDARY Time to First Observed Mean Asthma Control Questionnaire (ACQ) Change From Baseline > or = 0.5 Through Day 92 (Intent-to-Treat Analysis) |
15.0; 17.0; 20.0; 20.0 | 0.7171 |
| SECONDARY Time to First Observed Mean Asthma Control Questionnaire (ACQ) Change From Baseline > or = 0.5 Through Day 176 (Intent-to-Treat Analysis) |
15.0; 17.0; 20.0; 20.0 | 0.7120 |
| SECONDARY Change at Day 92 From Baseline in Forced Expiratory Volume in One Second (FEV1) (Intent-to-Treat Analysis) |
0.033; 0.045; 0.048; 0.097 | 0.837 |
| SECONDARY Change at Day 176 From Baseline in Forced Expiratory Volume in One Second (FEV1) (Intent-to-Treat Analysis) |
0.044; -0.005; 0.055; 0.047 | 0.409 |
| SECONDARY Proportion of Participants Who Had a Asthma Quality of Life Questionnaire - Standard (AQLQ[S]) Assessment Response at Day 85 (Intent-to-Treat Analysis) |
53; 43; 52; 49 | 0.208 |
| SECONDARY Proportion of Participants Who Had a Asthma Quality of Life Questionnaire - Standard (AQLQ[S]) Assessment Response at Day 176 (Intent-to-Treat Analysis) |
50; 42; 48; 46 | 0.574 |
| SECONDARY Proportion of Participants With Detectable Anti-drug Antibodies to MEDI-528 |
4; 15; 4; 3 | — |
| SECONDARY First Dose Trough Concentration of MEDI-528 |
2.15; 5.91; 15.80 | — |
| SECONDARY Day 169 Steady State Trough Concentration of MEDI-528 |
5.99; 21.68; 61.57 | — |
| SECONDARY Half Life of MEDI-528 |
39.0; 32.6; 32.2 | — |
| SECONDARY Accumulation Ratio of Trough Concentrations of MEDI-528 |
3.46; 4.18; 4.11 | — |
Eligibility Criteria
Inclusion Criteria
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 15 on the Hospital Anxiety and Depression Scale (HADS) at either Day-28 or Day 1.
- History of suicidal behavior in the previous 3 years as measured by the Columbia Suicide Severity Rating Scale (C-SSRS) at Day -28.
- Acute illness other than asthma at the screening and randomization visits
- History of an active infection within 28 days before and during the screening period, or evidence of clinically significant active infection, including ongoing chronic infection
- History of ingestion of untreated water in a location known to be infected with parasites, resulting in acute or chronic diarrhea; history of recent travel to areas where parasite infestations are endemic within 6 months before screening; or a diagnosis of parasitic infection within 6 months before screening
- Use of immunosuppressive medication (except oral prednisone up to a dose of 20 mg every other day or equivalent [eg, 10 mg a day or 5 mg twice a day] and inhaled and topical corticosteroids) within 28 days before randomization
- Receipt of immunoglobulin or blood products within 28 days before randomization
- Plans to donate blood during the entire study period
- Donated blood or has had a blood transfusion within 28 days before screening
- Receipt of any non-biological study drugs or interventional therapy (including surgical procedures) within 28 days of the first dose of investigational product in this study
- Receipt of any biologicals including MEDI-528 within 5 half-lives before the first dose of investigational product in this study
- History of any known immunodeficiency disorder
- A positive hepatitis B surface antigen, or hepatitis C virus antibody, as determined by medical history and/or subject's verbal report
- A positive human immunodeficiency virus test or is taking antiretroviral medications, as determined by medical history and/or subject's verbal report
- A live attenuated vaccination receiv
Data sourced from ClinicalTrials.gov (NCT00968669). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.