Open-Label Extension Study of Reslizumab in Pediatric Subjects With Eosinophilic Esophagitis

NCT00635089 | Completed Phase 3 Results

• 1 other identifier: Res-5-0004
• Study Type: interventional
• Target: 190
• Locations: 2 countries
• Sites: 36

Brief Summary

This study is an open-label study where all subjects will receive active drug, reslizumab. Subjects are able to enter this trial only through completion of study Res-05-0002 (NCT00538434). The goal of the study is to show longer term safety and efficacy in pediatric subjects who have eosinophilic esophagitis.

Conditions

Eosinophilic Esophagitis

Keywords

Eosinophilic Esophagitis; Cinquil

Outcome Measures

Primary Outcomes (7)

• Number of Participants With Treatment-emergent Adverse Events (AEs), Serious AEs, or Discontinuation Due to AEs

  An AE was defined as any adverse experience, including side effect, injury, toxicity, sensitivity reaction, intercurrent illness, or sudden death, whether or not it was considered related to the use of study drug. Treatment emergent adverse events were those that started any time after the administration of the first dose of study drug (at baseline of this study) and before the cessation of study drug. Serious adverse events that occurred any time after the administration of the first dose of study drug until 30 days after administration of the last dose of study drug were reported as treatment emergent serious adverse events.

  From start of study drug until end of treatment (mean [standard deviation {SD}] duration of treatment was 30.0 [5.89] months)

• Number of Participants With at Least 1 Potentially Clinically Significant Abnormal Hematology Value

  Hematology laboratory tests performed include: hemoglobin, hematocrit, red blood cell count, mean cell volume, mean cell hemoglobin, mean cell hemoglobin concentration, platelet count, white blood cell count, and differential count and percentage (polymorphonuclear leukocytes \[neutrophils\], lymphocytes, eosinophils, monocytes, basophils, platelets).

  From start of study drug until end of treatment (mean [SD] duration of treatment was 30.0 [5.89] months)

• Number of Participants With at Least 1 Potentially Clinically Significant Abnormal Serum Chemistry Laboratory Test Results or Urinalysis Abnormality

  Serum chemistry laboratory tests performed include: calcium, phosphorus, magnesium, sodium, potassium, chloride, creatinine, glucose \[nonfasting\], blood urea nitrogen, total cholesterol, uric acid, alanine aminotransferase, aspartate aminotransferase, lactate dehydrogenase, gamma glutamyl transpeptidase, alkaline phosphatase, bicarbonate, creatine kinase, total protein, albumin, total bilirubin, direct bilirubin, indirect bilirubin. Urinalysis tests performed include: protein, glucose, ketones, bilirubin, urobilinogen, nitrite content, pH, specific gravity, white blood cells, microscopic (red blood cells, white blood cells, casts, crystals).

  From start of study drug until end of treatment (mean [SD] duration of treatment was 30.0 [5.89] months)

• Number of Participants With at Least 1 Potentially Clinically Significant Abnormal Vital Signs Value

  Low systolic blood pressure: \< 90 and decrease (↓) of 30 mm Hg from baseline (BL) (ages 5-18); high systolic blood pressure: \> 160 and increase (↑) of 30 mm Hg from BL (age 5-12), \> 130 and ↑ of 30 mm Hg from BL (age 13-18). Low diastolic blood pressure: \< 45 and ↓ of 12 mm Hg from BL (age 5-12), \< 55 and ↓ of 12 mm Hg from BL (age 13-18), \< 50 and ↓ of 15 mm Hg from BL; high diastolic blood pressure: \> 85 and ↑ of 12 mm Hg from BL (ages 5-18). Low heart rate: \< 80 and and ↓ of 30 beats per minute (bpm) from BL (age 5-12), \< 60 and and ↓ of 30 bpm from BL (age 13-18), \< 50 and and ↓ of 15 bpm from BL (age \> 18); high heart rate: \> 120 and ↑ of 30 bpm from BL (age 5-12), \> 100 and ↑ of 30 bpm from BL (age 13-18), \> 100 and ↑ of 15 bpm from BL (age \> 18). Low oral body temperature: \< 35.8° Celsius (age 5 to \>18); high oral body temperature: \> 38.1° C and ↑ 2° Celsius from BL (age 5-18).

  From start of study drug until end of treatment (mean [SD] duration of treatment was 30.0 [5.89] months)

• Number of Participants With Newly Diagnosed Physical Examination Abnormalities at Endpoint

  HEENT=head, eyes, ears, nose and throat.

  From start of study drug until end of treatment (mean [SD] duration of treatment was 30.0 [5.89] months)

• Infusion Site Evaluations

  The infusion site was assessed before treatment and within 30 minutes after the end of the infusion at each monthly treatment visit (or at early withdrawal if before Week 16). The infusion site was graded according to a 5-point scale as follows: 0=no tenderness at IV site, no erythema, no swelling, no induration, no purulence, no palpable venous cord; 1=tender IV site, no erythema, no swelling, no induration, no purulence, no palpable venous cord; 2=tender IV site with erythema, some degree of swelling, no induration, no purulence, no palpable venous cord; 3=tender IV site with erythema and swelling, with induration or palpable venous cord, no purulence; 4=frank vein thrombosis, along with all signs of grade 3 with purulence; IV may stop running because of thrombosis. After the 16-week visit, formal infusion site evaluations were not continued. However, any infusion site reactions were recorded as adverse events and graded as other adverse events.

  Day 0, Weeks 4, 8, 12, 16, endpoint (last visit), any time during study (mean [SD] duration of treatment was 30.0 [5.89] months)

• Therapeutic Classification of Concomitant Medications in at Least 10% of Participants

  Number of participants receiving therapeutic classes of concomitant medications.

  From start of study drug until end of treatment (mean [SD] duration of treatment was 30.0 [5.89] months)

Secondary Outcomes (7)

• Mean Change From Baseline to Endpoint in Peak Esophageal Eosinophil Counts

  Baseline, Week 16 or early withdrawal (if before Week 16)

• Participant's EoE Predominant Symptoms Over Time

  Every 3 weeks from Day 0 up to Week 42 (mean [SD] duration of treatment was 30.0 [5.89] months)

• Physician's EoE Global Assessment Over Time

  Every 3 weeks from Day 0 up to Week 42 (mean [SD] duration of treatment was 30.0 [5.89] months)

• Mean Change From Baseline to Endpoint in Selected Child Health Questionnaire (CHQ) Scores

  Baseline through Endpoint (last visit; mean [SD] duration of treatment was 30.0 [5.89] months)

• Dietary Question Responses at Endpoint

  Study endpoint (mean [SD] duration of treatment was 30.0 [5.89] months)

Study Arms (1)

Open-Label Reslizumab

OTHER

Open-label reslizumab intravenous (IV) infusion at an initial dose of 1 mg/kg monthly

Drug: reslizumab

Interventions

reslizumab DRUG

Also known as: Cinquil™, CEP-38072, CTx55700

Open-Label Reslizumab

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Informed consent
• Received at least two doses of study drug in Study Res-05-0002 (NCT00538434)
• Did not withdraw from Study Res-05-0002 due to drug related adverse event
• Completed End of Treatment Visit for Study Res-05-0002

You may not qualify if:

• Pregnant or nursing females
• Concurrent Immunodeficiency
• Current use of immunosuppressive drugs
• Did not tolerate study drug in Study Res-05-0002

Sponsors & Collaborators

• Ception Therapeutics: lead
• Cephalon: collaborator

Study Sites (36)

The Children's Hospital of Alabama

Birmingham, Alabama, 35233, United States

Location

University of Arizona Dept. of Pediatrics

Tucson, Arizona, 85724, United States

Location

Arkansas Children's Hospital/University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72202, United States

Location

Kaiser Permanente Hospital- Pediatric Gastroenterology

Hayward, California, 94545, United States

Location

Children'S Hospital of Orange County Pediatric Subspecialty Faculty Division of Allergy and Asthma

Orange, California, 92868, United States

Location

Pediatric Allergy/Immunology

Palo Alto, California, 94305, United States

Location

Children's Hospital of San Diego

San Diego, California, 92123, United States

Location

Denver Childrens At Aurora, Colorado

Aurora, Colorado, 80045, United States

Location

1st Allergy and Clinical Research Center

Centennial, Colorado, 80112, United States

Location

Thomas Jefferson University Medical College

Wilmington, Delaware, 19803, United States

Location

Children's Center for Digestive Health Care

Atlanta, Georgia, 30342, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

Children'S Memorial Hospital Division of Gastroenterology Hepatology & Nutrition

Chicago, Illinois, 66014, United States

Location

Riley Hospital for Children

Indianapolis, Indiana, 46202, United States

Location

Sinai Hospital of Baltimore

Baltimore, Maryland, 21215, United States

Location

Tuft's Floating Hospital

Boston, Massachusetts, 02111, United States

Location

Minnesota Gastroenterology

Plymouth, Minnesota, 55446, United States

Location

Saint Louis University

St Louis, Missouri, 63104, United States

Location

Creighton University Medical Center

Omaha, Nebraska, 68131, United States

Location

Las Vegas Pediatric Gastroenterology Associates

Las Vegas, Nevada, 89109, United States

Location

South Jersey Pediatric Gastroenterology

Mays Landing, New Jersey, 08330, United States

Location

Mount Sinai School of Medicine, Pediatrics

New York, New York, 10029, United States

Location

State University of New York (SUNY)

Syracuse, New York, 13210, United States

Location

Center for Digestive Allergic and Immunologic Diseases

Williamsville, New York, 14221, United States

Location

Pediatric Allergy and Immunology of Duke Medical Center

Durham, North Carolina, 27720, United States

Location

Cincinnati Children's

Cincinnati, Ohio, 45229, United States

Location

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Greenville Health System

Greenville, South Carolina, 29615, United States

Location

University of Texas Southwest Medical Center

Dallas, Texas, 75390, United States

Location

University of Utah School of Medicine

Salt Lake City, Utah, 84113, United States

Location

Children's Pavilion

Richmond, Virginia, 23298-0264, United States

Location

Carilion Medical Center for Children

Roanoke, Virginia, 24013, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Pediatric Allergy and Immunology

Edmonton, Alberta, T6G 2C8, Canada

Location

University of Montreal

Montreal, Quebec, H3T 1C5, Canada

Location

MeSH Terms

Conditions

Eosinophilic Esophagitis

Interventions

reslizumab

Condition Hierarchy (Ancestors)

Esophagitis; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Gastroenteritis; Eosinophilia; Leukocyte Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Director, Clinical Research
• Organization: Teva Branded Pharmaceutical Products, R&D Inc.

ustevatrials@tevapharm.com

215-591-3000

Study Officials

• Sponsor's Medical Expert, MD

  Cephalon

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2008
• First Posted: March 13, 2008
• Study Start: July 1, 2008
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: March 23, 2017
• Results First Posted: March 23, 2017

Record last verified: 2017-02

Locations

US (34); CA (2)