A Study to Evaluate the Safety and Tolerability of the Administration of MEDI-528 When Administered in Multiple Doses to Adults With Mild Persistent Asthma

NCT00507130 | Completed Phase 2 Results

• 2 other identifiers: MI-CP131NCT00507130
• Study Type: interventional
• Target: 36
• Locations: 2 countries
• Sites: 9

Brief Summary

The primary objective of this study is to evaluate the safety and tolerability of escalating multiple SC doses of MEDI-528 in adult patients with mild persistent asthma.

Conditions

Asthma

Outcome Measures

Primary Outcomes (5)

• Incidence of Adverse Events

  Number of participants experiencing adverse events (includes both adverse events and serious adverse events)

  Days 0 - 150

• Incidence of Abnormal Troponin Levels

  Number of participants with troponin levels greater than upper limit of normal

  Days 0, 14, 28, 56, 84, and 150

• Incidence of Abnormal Clinically Significant Electrocardiogram (ECG) Results

  Number of participants with abnormal clinically significant ECG results

  Days -14 to -1, 14, 28, 56, 84, and 150

• Incidence of Abnormal Clinically Significant Magnetic Resonance Imaging (MRI) Results

  Number of participants experiencing abnormal clinically significant MRI results

  Days -14 to -1 and 28

• Incidence of Serious Adverse Events

  Number of participants experiencing serious adverse events

  Days 0 - 150

Secondary Outcomes (4)

• Incidence of Anti-drug Antibodies (ADA) to MEDI-528

  Days 0, 28, 56, 84, 119, and 150

• Time to Observed Maximum Serum Concentration (Tmax)

  Days 0, 3, 7, 10, 14, 17, 21, 24, 26, 28, 31, 35, 42, 49, 56, 70, 84, 119, and 150

• Observed Maximum Serum Concentration (Cmax)

  Days 0, 3, 7, 10, 14, 17, 21, 24, 26, 28, 31, 35, 42, 49, 56, 70, 84, 119, and 150

• Terminal Phase Half-life (T1/2)

  Days 0, 3, 7, 10, 14, 17, 21, 24, 26, 28, 31, 35, 42, 49, 56, 70, 84, 119, and 150

Study Arms (4)

MEDI528 0.3 mg/kg

EXPERIMENTAL

MEDI-528 at a dose of 0.3 mg/kg administered twice weekly as a subcutaneous (SC) dose for 4 weeks

Biological: MEDI528 0.3 mg/kg

MEDI528 1 mg/kg

EXPERIMENTAL

MEDI-528 at a dose of 1 mg/kg administered twice weekly as a subcutaneous (SC) dose for 4 weeks

Biological: MEDI528 1 mg/kg

MEDI528 3 mg/kg

EXPERIMENTAL

MEDI-528 at a dose of 3 mg/kg administered twice weekly as a subcutaneous (SC) dose for 4 weeks

Biological: MEDI528 3 mg/kg

PLACEBO

PLACEBO COMPARATOR

Placebo administered twice weekly as a subcutaneous (SC) dose for 4 weeks

Other: PLACEBO

Interventions

MEDI528 0.3 mg/kg BIOLOGICAL

MEDI-528 at a dose of 0.3 mg/kg administered twice weekly as a subcutaneous (SC) dose for 4 weeks

MEDI528 0.3 mg/kg

MEDI528 1 mg/kg BIOLOGICAL

MEDI-528 at a dose of 1 mg/kg administered twice weekly as a subcutaneous (SC) dose for 4 weeks

MEDI528 1 mg/kg

MEDI528 3 mg/kg BIOLOGICAL

MEDI-528 at a dose of 3 mg/kg administered twice weekly as a subcutaneous (SC) dose for 4 weeks

MEDI528 3 mg/kg

PLACEBO OTHER

Placebo administered twice weekly as a subcutaneous (SC) dose for 4 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:

• Male or female adults, age 18 through 65 years of age at time of screening;
• Weight ≤ 100 kg and body mass index ≤ 35;
• Written informed consent obtained from the patient prior to receipt of any study medication or beginning study procedures;
• Previously documented diagnosis of asthma based on episodic symptoms of airflow obstruction such as wheezing or chest tightness, with alternative diagnoses (e.g., chronic obstructive pulmonary disease) ruled out;
• Currently receiving treatment with short-acting β2 agonists, ICS at doses ≤ 264 μg/day fluticasone or equivalent, or both (National Heart, Lung, and Blood Institute \[NHLBI\], 2002);
• FEV1 or peak expiratory flow (PEF) ≥ 80% of predictable value;
• Have had a diagnosis of mild persistent asthma, defined as having asthma symptoms with a frequency of more than twice a week but less than once daily, or nighttime symptoms with a frequency of more than twice a month but less than once a week (NHLBI, 2002);
• Have AHR based on documented clinical history of either methacholine inhalation challenge with PC20 ≤ 16 mg/mL or partial reversibility of ≤ 12% in FEV1 within the past 18 months (including screening);
• Able to provide spirometry readings that meet American Thoracic Society/European Respiratory Society standards (Miller, 2005);
• Sexually active females, unless surgically sterile or at least 1 year post-menopausal, must use an effective method of avoiding pregnancy (including oral, implanted, or transdermal contraceptives, intrauterine device, female condom, diaphragm with spermicide, cervical cap, abstinence, use of a condom by the sexual partner or sterile sexual partner) for 21 days prior to the first dose of study drug, and must agree to continue using such precautions through Study Day 150. Cessation of birth control after this point should be discussed with a responsible physician. Sexually active males, unless surgically sterile, must likewise use an effective method of birth control (condom) and must agree to continue using such precautions through Study Day 150;
• Ability to complete the study period, including follow-up period, of up to 150 days; and
• Willing to forego other forms of experimental treatment and study procedures during the study.

You may not qualify if:

• Receipt of MEDI-528 in any previous clinical study or prior randomization into the trial;
• History of allergy or reaction to any component of the MEDI-528 formulation;
• Lung disease other than persistent asthma (e.g. chronic bronchitis);
• FEV1 \< 80% of predicted values;
• History of severe asthma or asthma exacerbation requiring intubation;
• Use of systemic immunosuppressive drugs including systemic corticosteroids or ICS with doses \> 264 μg/day fluticasone or equivalent within 4 weeks prior to Study Day 0;
• Use of long-acting β2 agonists, theophylline, cromolyn sodium, nedocromil sodium, leukotriene receptor antagonists, or any other inhaled or systemic medication for asthma (except short-acting β2 agonists or ICS at doses ≤ 264 μg/day fluticasone or equivalent) within the 2 weeks prior to Study Day 0;
• Current use of any β-adrenergic antagonist (e.g., propranolol);
• Any disease or illness, other than asthma, that may require the use of systemic corticosteroids during the study period;
• Acute illnesses or evidence of significant active infection, such as fever ≥ 38.0°C (100.5°F) at screening and up through time of the first dose of study drug;
• Current allergy vaccination therapy (desensitization immunotherapy), with less than 3 months of stable maintenance doses prior to screening;
• Receipt of any investigational drug therapy within 30 days or any biologic(s) within 5 half-lives of the agent prior to the first dose of study drug through Study Day 150;
• Receipt of any therapy with a leukocyte-depleting agent unless recovery in white cell count has been documented before screening;
• Pregnancy (sexually active females must have a negative serum pregnancy test at screening and a negative urine pregnancy test prior to study drug administration on Study Day 0);
• Lactating or breastfeeding woman;

Sponsors & Collaborators

• MedImmune LLC: lead

Study Sites (9)

Colorado Allergy & Asthma Centers, PC

Denver, Colorado, 80230, United States

Location

Northeast Medical Research Associates, Inc.

North Dartmouth, Massachusetts, 02747, United States

Location

Clinical Research Institute, Inc.

Minneapolis, Minnesota, 55402, United States

Location

North Carolina Clinical Research

Raleigh, North Carolina, 27607, United States

Location

Toledo Center for Clinical Research

Sylvania, Ohio, 43560, United States

Location

Spartanburg Medical Research

Spartanburg, South Carolina, 29303, United States

Location

McMaster University

Hamilton, Ontario, L8N 3Z5, Canada

Location

Hôpital du Sacré-Coeur de Montréal

Montreal, Quebec, H4J 1C5, Canada

Location

Hopital Laval

Québec, Quebec, G1V 4G5, Canada

Location

Related Publications (1)

• Parker JM, Oh CK, LaForce C, Miller SD, Pearlman DS, Le C, Robbie GJ, White WI, White B, Molfino NA; MEDI-528 Clinical Trials Group. Safety profile and clinical activity of multiple subcutaneous doses of MEDI-528, a humanized anti-interleukin-9 monoclonal antibody, in two randomized phase 2a studies in subjects with asthma. BMC Pulm Med. 2011 Feb 28;11:14. doi: 10.1186/1471-2466-11-14.

  PMID: 21356110 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: Don Raible, MD
• Organization: MedImmune

raibleD@medimmune.com

301-398-0000

Study Officials

• Joe Parker, 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: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2007
• First Posted: July 25, 2007
• Study Start: July 1, 2007
• Primary Completion: July 1, 2008
• Study Completion: September 1, 2008
• Last Updated: December 11, 2013
• Results First Posted: December 11, 2013

Record last verified: 2013-10

Locations

US (6); CA (3)