Clinical trial NCT03052725: A Study of Reslizumab in Patients 12 Years of Age and Older With Severe Eosinophilic Asthma
Official title: An Open-Label Extension Study of Reslizumab 110-mg Fixed, Subcutaneous Dosing in Patients 12 Years of Age and Older With Severe Eosinophilic Asthma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Eosinophils, Asthma
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2017-02-14
Enrollment: 391
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a multicenter, open-label (OL) extension study to obtain additional long-term safety data for subcutaneous (sc) administration of reslizumab treatment administered at a fixed dose of 110 mg in patients 12 years of age and older with severe eosinophilic asthma who completed the treatment period of a placebo-controlled Phase 3 trial of sc reslizumab. The study consists of a screening/baseline visit followed by a 36-week OL treatment period and a 15-week follow-up period.


Eligibility criteria: Inclusion Criteria:

• Patient with eosinophilic asthma who completed the treatment period of a double-blind, placebo controlled sc reslizumab study (Study C38072-AS-30025 or C38072-AS-30027)

\~\~ Additional criteria apply, please contact the investigator for more information

Exclusion Criteria:

* Patient has received any reslizumab administration in any previous clinical trial other than Studies C38072-AS-30025 and C38072-AS-30027.
* The patient has any clinically significant, uncontrolled medical condition
* The patient has another confounding underlying lung disorder
* The patient has a known/diagnosed hypereosinophilic syndrome.
* The patient has a diagnosis of malignancy within 5 years of the screening visit, except for treated and cured non-melanoma skin cancers.
* The patient is a pregnant or lactating woman
* The patient is a current smoker (ie, has smoked within the last 6 months before screening) or has a smoking history ≥10 pack-years.
* The patient is currently using any systemic immunosuppressive or immunomodulatory agents other than OCS
* The patient has a history of allergic reaction or hypersensitivity to any component of the study drug.
* The patient has a history of an immunodeficiency disorder including human immunodeficiency virus (HIV).

  * Additional criteria apply, please contact the investigator for more information

Primary outcomes:
measure: Participants With Treatment-Emergent Adverse Events (TEAEs)
timeFrame: Day 1 to up to Day 269; for participants who discontinued early for reasons other than study termination, the timeframe was first dose of study drug to 4 weeks after the last dose of study drug.
Secondary outcomes:
measure: Participants With Potentially Clinically Significant Abnormal Hematology Values
timeFrame: Week 0 (baseline), Weeks 8, 24, 36 plus any unscheduled visits
measure: Participants With Potentially Clinically Significant Abnormal Serum Chemistry Values
timeFrame: Week 0 (baseline), Weeks 4, 8, 24, 36 plus any unscheduled visits
measure: Participants' Tolerability and Injection Site Reactions by Domain and Worst Overall Severity
timeFrame: Weeks 4, 8, 12, 16, 20, 24, 28, and 36
measure: Participants With Potentially Clinically Significant Abnormal Vital Sign Values
timeFrame: Week 0 (baseline), Weeks 4, 8, 12, 16,20, 24, 28, 32, 36 plus any unscheduled visits
measure: Annualized Rate of Clinical Asthma Exacerbations (CAEs)
timeFrame: Day 1 to up to Day 269; for participants who discontinued early for reasons other than study termination, the timeframe was first dose of study drug to 4 weeks after the last dose of study drug.
measure: Annualized Rate of Clinical Asthma Exacerbations (CAEs) Requiring Asthma-Specific Hospital Admissions or Emergency Room Visits
timeFrame: Day 1 to up to Day 269; for participants who discontinued early for reasons other than study termination, the timeframe was first dose of study drug to 4 weeks after the last dose of study drug.
measure: Mean Number of Days of Hospital Stay During the Treatment Period
timeFrame: Day 1 to up to Day 269; for participants who discontinued early for reasons other than study termination, the timeframe was first dose of study drug to 4 weeks after the last dose of study drug
measure: Mean Number of School/Work Days Missed Due to Asthma During the Treatment Period
timeFrame: Day 1 to up to Day 269; for participants who discontinued early for reasons other than study termination, the timeframe was first dose of study drug to 4 weeks after the last dose of study drug
measure: Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1): Baseline Values and Change From Baseline Values at Weeks 8, 24 and 36
timeFrame: Week 0 (baseline), Weeks 8, 24, 36
measure: Morning Ambulatory Forced Expiratory Volume in One Second (FEV1): Baseline Values and Change From Baseline Values at Weeks 1, 4, 8, 24 and 36
timeFrame: Week 0 (baseline), Weeks 1, 4, 8, 24, 36
measure: Percent Change From Baseline in Daily Oral Corticosteroid (OCS) Dose During Weeks 16-20 and Weeks 32-36
timeFrame: Week 0 (baseline), Weeks 16-20, Weeks 32-36
measure: Total Inhalations of Reliever Bronchodilator Medication: Baseline Values and Change From Baseline Values at Weeks 1, 4, 8, 24 and 36
timeFrame: Baseline (Week 0), Weeks 1, 4, 8, 24, 36
measure: Asthma Control Questionnaire-6 (ACQ-6) Total Score: Baseline Values and Change From Baseline Values at Weeks 8, 24 and 36
timeFrame: Baseline (Week 0), Weeks 8, 24, 36
measure: Asthma Quality of Life Questionnaire Administered to Participants Ages 12-70 Years (AQLQ +12) Overall Score: Baseline Values and Change From Baseline Values at Weeks 8, 24 and 36
timeFrame: Baseline (Week 0), Weeks 8, 24, 36
measure: Participants With Treatment-Emergent Anti-Drug Antibody (ADA) Responses
timeFrame: Baseline - date of randomization in the previous study (C38072-AS-30025 or C38072-AS-30027), Weeks 8, 24, 36 or early withdrawal
measure: Participants With Treatment-Emergent Anti-Drug Antibody (ADA) At the End-0f-Study Visit (Week 51)
timeFrame: Week 51
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Teva Investigational Site 14647
state: Alabama
city: Bakersfield
country: United States
facility: Teva Investigational Site 14631
state: California
city: Huntington Beach
country: United States
facility: Teva Investigational Site 14648
state: California
city: Napa
country: United States
facility: Teva Investigational Site 14637
state: California
city: Stockton
country: United States
facility: Teva Investigational Site 14654
state: California
city: Walnut Creek
country: United States
facility: Teva Investigational Site 14636
state: California
city: Aventura
country: United States
facility: Teva Investigational Site 14626
state: Florida
city: Homestead
country: United States
facility: Teva Investigational Site 14634
state: Florida
city: Miami
country: United States
facility: Teva Investigational Site 14650
state: Florida
city: Miami
country: United States
facility: Teva Investigational Site 14629
state: Florida
city: Miami
country: United States
facility: Teva Investigational Site 14619
state: Florida
city: Orlando
country: United States
facility: Teva Investigational Site 14624
state: Florida
city: Tallahassee
country: United States
facility: Teva Investigational Site 14638
state: Florida
city: Buford
country: United States
facility: Teva Investigational Site 14642
state: Georgia
city: Chicago
country: United States
facility: Teva Investigational Site 14651
state: Illinois
city: Michigan City
country: United States
facility: Teva Investigational Site 14645
state: Indiana
city: Owensboro
country: United States
facility: Teva Investigational Site 14620
state: Kentucky
city: Lafayette
country: United States
facility: Teva Investigational Site 14623
state: Louisiana
city: North Dartmouth
country: United States
facility: Teva Investigational Site 14627
state: Massachusetts
city: Boys Town
country: United States
facility: Teva Investigational Site 14644
state: Nebraska
city: Ocean City
country: United States
facility: Teva Investigational Site 14652
state: New Jersey
city: Lake Success
country: United States
facility: Teva Investigational Site 14632
state: New York
city: New York
country: United States
facility: Teva Investigational Site 14646
state: New York
city: Cincinnati
country: United States
facility: Teva Investigational Site 14633
state: Ohio
city: Cleveland
country: United States
facility: Teva Investigational Site 14653
state: Ohio
city: Edmond
country: United States
facility: Teva Investigational Site 14621
state: Oklahoma
city: Edmond
country: United States
facility: Teva Investigational Site 14625
state: Oklahoma
city: Jenkintown
country: United States
facility: Teva Investigational Site 14643
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Teva Investigational Site 14622
state: Pennsylvania
city: East Providence
country: United States
facility: Teva Investigational Site 14630
state: Rhode Island
city: Providence
country: United States
facility: Teva Investigational Site 14649
state: Rhode Island
city: Knoxville
country: United States
facility: Teva Investigational Site 14655
state: Tennessee
city: Corsicana
country: United States
facility: Teva Investigational Site 14639
state: Texas
city: Dallas
country: United States
facility: Teva Investigational Site 14640
state: Texas
city: Provo
country: United States
facility: Teva Investigational Site 14641
state: Utah
city: Abingdon
country: United States
facility: Teva Investigational Site 14628
state: Virginia
city: Falls Church
country: United States
facility: Teva Investigational Site 14635
state: Virginia
city: Bruxelles
country: Belgium
facility: Teva Investigational Site 37082
city: Erpent
country: Belgium
facility: Teva Investigational Site 37081
city: Gent
country: Belgium
facility: Teva Investigational Site 37083
city: Vancouver
country: Canada
facility: Teva Investigational Site 11133
state: British Columbia
city: Etobicoke
country: Canada
facility: Teva Investigational Site 11134
state: Ontario
city: Breclav
country: Czechia
facility: Teva Investigational Site 54151
city: Jablonec nad Nisou
country: Czechia
facility: Teva Investigational Site 54150
city: Jindrichuv Hradec
country: Czechia
facility: Teva Investigational Site 54148
city: Tabor
country: Czechia
facility: Teva Investigational Site 54149
city: Le Kremlin-bicetre
country: France
facility: Teva Investigational Site 35229
city: Strasbourg
country: France
facility: Teva Investigational Site 35227
city: Toulouse
country: France
facility: Teva Investigational Site 35228
city: Berlin-Tempelhof
country: Germany
facility: Teva Investigational Site 32676
city: Berlin
country: Germany
facility: Teva Investigational Site 32670
city: Berlin
country: Germany
facility: Teva Investigational Site 32680
city: Berlin
country: Germany
facility: Teva Investigational Site 32673
city: Frankfurt/Main
country: Germany
facility: Teva Investigational Site 32675
city: Frankfurt
country: Germany
facility: Teva Investigational Site 32679
city: Hamburg
country: Germany
facility: Teva Investigational Site 32678
city: Hannover
country: Germany
facility: Teva Investigational Site 32681
city: Koblenz
country: Germany
facility: Teva Investigational Site 32677
city: Leipzig
country: Germany
facility: Teva Investigational Site 32672
city: Leipzig
country: Germany
facility: Teva Investigational Site 32671
city: Lubeck
country: Germany
facility: Teva Investigational Site 32674
city: Rostock
country: Germany
facility: Teva Investigational Site 32682
city: Balassagyarmat
country: Hungary
facility: Teva Investigational Site 51291
city: Budapest
country: Hungary
facility: Teva Investigational Site 51290
city: Csorna
country: Hungary
facility: Teva Investigational Site 51293
city: Debrecen
country: Hungary
facility: Teva Investigational Site 51292
city: Debrecen
country: Hungary
facility: Teva Investigational Site 51283
city: Godollo
country: Hungary
facility: Teva Investigational Site 51286
city: Gyor
country: Hungary
facility: Teva Investigational Site 51284
city: Hajdunanas
country: Hungary
facility: Teva Investigational Site 51285
city: Kapuvar
country: Hungary
facility: Teva Investigational Site 51282
city: Szeged
country: Hungary
facility: Teva Investigational Site 51288
city: Szigetvar
country: Hungary
facility: Teva Investigational Site 51289
city: Szombathely
country: Hungary
facility: Teva Investigational Site 51280
city: Tatabanya
country: Hungary
facility: Teva Investigational Site 51281
city: Veszprem
country: Hungary
facility: Teva Investigational Site 51287
city: Ashkelon
country: Israel
facility: Teva Investigational Site 80136
city: Haifa
country: Israel
facility: Teva Investigational Site 80129
city: Jerusalem
country: Israel
facility: Teva Investigational Site 80131
city: Jerusalem
country: Israel
facility: Teva Investigational Site 80135
city: Kfar Saba
country: Israel
facility: Teva Investigational Site 80134
city: Petah Tikva
country: Israel
facility: Teva Investigational Site 80132
city: Ramat Gan
country: Israel
facility: Teva Investigational Site 80133
city: Rehovot
country: Israel
facility: Teva Investigational Site 80130
city: Bialystok
country: Poland
facility: Teva Investigational Site 53405
city: Gdansk
country: Poland
facility: Teva Investigational Site 53402
city: Krakow
country: Poland
facility: Teva Investigational Site 53399
city: Lodz
country: Poland
facility: Teva Investigational Site 53408
city: Lodz
country: Poland
facility: Teva Investigational Site 53400
city: Lubin
country: Poland
facility: Teva Investigational Site 53403
city: Ostrow Wielkopolski
country: Poland
facility: Teva Investigational Site 53407
city: Poznan
country: Poland
facility: Teva Investigational Site 53401
city: Tarnow
country: Poland
facility: Teva Investigational Site 53404
city: Wroclaw
country: Poland
facility: Teva Investigational Site 53406
city: Brasov
country: Romania
facility: Teva Investigational Site 52115
city: Brasov
country: Romania
facility: Teva Investigational Site 52116
city: Cluj-Napoca
country: Romania
facility: Teva Investigational Site 52113
city: Targu Mures
country: Romania
facility: Teva Investigational Site 52114
city: Timisoara
country: Romania
facility: Teva Investigational Site 52117
city: Barnaul
country: Russian Federation
facility: Teva Investigational Site 50460
city: Kemerovo
country: Russian Federation
facility: Teva Investigational Site 50453
city: Kemerovo
country: Russian Federation
facility: Teva Investigational Site 50461
city: Moscow
country: Russian Federation
facility: Teva Investigational Site 50456
city: Moscow
country: Russian Federation
facility: Teva Investigational Site 50459
city: Novosibirsk
country: Russian Federation
facility: Teva Investigational Site 50455
city: Saint-Petersburg
country: Russian Federation
facility: Teva Investigational Site 50454
city: St. Petersburg
country: Russian Federation
facility: Teva Investigational Site 50457
city: Tomsk
country: Russian Federation
facility: Teva Investigational Site 50458
city: Barcelona
country: Spain
facility: Teva Investigational Site 31219
city: Valencia
country: Spain
facility: Teva Investigational Site 31218
city: Valencia
country: Spain
facility: Teva Investigational Site 31217
city: Chernivtsi
country: Ukraine
facility: Teva Investigational Site 58283
city: Dnipropetrovsk
country: Ukraine
facility: Teva Investigational Site 58304
city: Dnipropetrovsk
country: Ukraine
facility: Teva Investigational Site 58287
city: Ivano-Frankivsk
country: Ukraine
facility: Teva Investigational Site 58295
city: Kharkiv
country: Ukraine
facility: Teva Investigational Site 58293
city: Kharkiv
country: Ukraine
facility: Teva Investigational Site 58289
city: Kharkiv
country: Ukraine
facility: Teva Investigational Site 58284
city: Kharkiv
country: Ukraine
facility: Teva Investigational Site 58288
city: Kremenchuk
country: Ukraine
facility: Teva Investigational Site 58302
city: Kryvyi Rih
country: Ukraine
facility: Teva Investigational Site 58292
city: Kyiv
country: Ukraine
facility: Teva Investigational Site 58303
city: Kyiv
country: Ukraine
facility: Teva Investigational Site 58282
city: Kyiv
country: Ukraine
facility: Teva Investigational Site 58285
city: Kyiv
country: Ukraine
facility: Teva Investigational Site 58286
city: Kyiv
country: Ukraine
facility: Teva Investigational Site 58290
city: Kyiv
country: Ukraine
facility: Teva Investigational Site 58291
city: Kyiv
country: Ukraine
facility: Teva Investigational Site 58296
city: Kyiv
country: Ukraine
facility: Teva Investigational Site 58299
city: Sumy
country: Ukraine
facility: Teva Investigational Site 58297
city: Vinnytsia
country: Ukraine
facility: Teva Investigational Site 58301
city: Vinnytsya
country: Ukraine
facility: Teva Investigational Site 58294
city: Zaporizhzhya
country: Ukraine
facility: Teva Investigational Site 58298
city: Zaporizhzhya
country: Ukraine
facility: Teva Investigational Site 58300
Study officials:
affiliation: Teva Branded Pharmaceutical Products R&D, Inc.
name: Teva Medical Expert, MD
role: STUDY_DIRECTOR
References: