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Eosinophils, AsthmaPhase 3NCT03052725

A Study of Reslizumab in Patients 12 Years of Age and Older With Severe Eosinophilic Asthma

A Phase 3 study testing reslizumab in people with Eosinophils, Asthma, run by Teva Branded Pharmaceutical Products R&D, Inc. at 134 sites in 13 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 12 years and older
Conditions the study is for
Eosinophils, Asthma
What is being tested?
reslizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
391 participants
Where
134 sitesin 13 countries
Study dates
10 Mar 2017to 22 Feb 2018
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 11Show fewer
  • 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

Trial locations and contacts

134 sites in 13 countries.

134 sites in 13 countries

United States37 sites

  • Teva Investigational Site 14628

    Abingdon, Virginia, 24210

  • Teva Investigational Site 14626

    Aventura, Florida, 33180

  • Teva Investigational Site 14631

    Bakersfield, California, 93301

  • Teva Investigational Site 14647

    Birmingham, Alabama, 35209

  • Teva Investigational Site 14644

    Boys Town, Nebraska, 68010

  • Teva Investigational Site 14642

    Buford, Georgia, 30518

  • Teva Investigational Site 14651

    Chicago, Illinois, 60612

  • Teva Investigational Site 14633

    Cincinnati, Ohio, 45221

  • Teva Investigational Site 14653

    Cleveland, Ohio, 44106

  • Teva Investigational Site 14639

    Corsicana, Texas, 75110

  • Teva Investigational Site 14640

    Dallas, Texas, 75225

  • Teva Investigational Site 14630

    East Providence, Rhode Island, 02914

  • Teva Investigational Site 14621

    Edmond, Oklahoma, 73034

  • Teva Investigational Site 14625

    Edmond, Oklahoma, 73034

  • Teva Investigational Site 14635

    Falls Church, Virginia, 22044

  • Teva Investigational Site 14634

    Homestead, Florida, 33030

  • Teva Investigational Site 14648

    Huntington Beach, California, 92647

  • Teva Investigational Site 14643

    Jenkintown, Pennsylvania, 19046

  • Teva Investigational Site 14655

    Knoxville, Tennessee, 37919

  • Teva Investigational Site 14623

    Lafayette, Louisiana, 70508

  • Teva Investigational Site 14632

    Lake Success, New York, 11042

  • Teva Investigational Site 14650

    Miami, Florida, 33015

  • Teva Investigational Site 14629

    Miami, Florida, 33173

  • Teva Investigational Site 14619

    Miami, Florida, 33186

  • Teva Investigational Site 14645

    Michigan City, Indiana, 46360

  • Teva Investigational Site 14637

    Napa, California, 94558

  • Teva Investigational Site 14646

    New York, New York, 10016-9196

  • Teva Investigational Site 14627

    North Dartmouth, Massachusetts, 02747

  • Teva Investigational Site 14652

    Ocean City, New Jersey, 07712

  • Teva Investigational Site 14624

    Orlando, Florida, 32819

  • Teva Investigational Site 14620

    Owensboro, Kentucky, 42301

  • Teva Investigational Site 14622

    Pittsburgh, Pennsylvania, 15241

  • Teva Investigational Site 14649

    Providence, Rhode Island, 02909

  • Teva Investigational Site 14641

    Provo, Utah, 84604

  • Teva Investigational Site 14654

    Stockton, California, 95207

  • Teva Investigational Site 14638

    Tallahassee, Florida, 32308

  • Teva Investigational Site 14636

    Walnut Creek, California, 94598

Other trials in United States

Ukraine23 sites

  • Teva Investigational Site 58283

    Chernivtsi, 58023

  • Teva Investigational Site 58304

    Dnipropetrovsk, 49074

  • Teva Investigational Site 58287

    Dnipropetrovsk, 49101

  • Teva Investigational Site 58295

    Ivano-Frankivsk, 76018

  • Teva Investigational Site 58293

    Kharkiv, 61002

  • Teva Investigational Site 58289

    Kharkiv, 61007

  • Teva Investigational Site 58284

    Kharkiv, 61035

  • Teva Investigational Site 58288

    Kharkiv, 61039

  • Teva Investigational Site 58302

    Kremenchuk, 39617

  • Teva Investigational Site 58292

    Kryvyi Rih, 50082

  • Teva Investigational Site 58303

    Kyiv, 2091

  • Teva Investigational Site 58282

    Kyiv, 3049

  • Teva Investigational Site 58285

    Kyiv, 3680

  • Teva Investigational Site 58286

    Kyiv, 3680

  • Teva Investigational Site 58290

    Kyiv, 3680

  • Teva Investigational Site 58291

    Kyiv, 4050

  • Teva Investigational Site 58296

    Kyiv, 4107

  • Teva Investigational Site 58299

    Kyiv, 4201

  • Teva Investigational Site 58297

    Sumy, 40022

  • Teva Investigational Site 58294

    Vinnytsia, 21001

  • Teva Investigational Site 58301

    Vinnytsia, 21001

  • Teva Investigational Site 58298

    Zaporizhzhya, 69063

  • Teva Investigational Site 58300

    Zaporizhzhya, 69118

Other trials in Ukraine

Hungary14 sites

  • Teva Investigational Site 51291

    Balassagyarmat, 2660

  • Teva Investigational Site 51290

    Budapest, H-1036

  • Teva Investigational Site 51293

    Csorna, 9300

  • Teva Investigational Site 51292

    Debrecen, 4032

  • Teva Investigational Site 51283

    Debrecen, 4043

  • Teva Investigational Site 51286

    Gödöllő, 2100

  • Teva Investigational Site 51284

    Győr, 9023

  • Teva Investigational Site 51285

    Hajdúnánás, 4080

  • Teva Investigational Site 51282

    Kapuvár, 9330

  • Teva Investigational Site 51288

    Szeged, 6720

  • Teva Investigational Site 51289

    Szigetvár, 7900

  • Teva Investigational Site 51280

    Szombathely, 9700

  • Teva Investigational Site 51281

    Tatabánya, 2800

  • Teva Investigational Site 51287

    Veszprém, 8200

Other trials in Hungary

Germany13 sites

  • Teva Investigational Site 32670

    Berlin, 10717

  • Teva Investigational Site 32680

    Berlin, 10969

  • Teva Investigational Site 32673

    Berlin, 14059

  • Teva Investigational Site 32679

    Frankfurt, 60596

  • Teva Investigational Site 32675

    Frankfurt am Main, 60389

  • Teva Investigational Site 32678

    Hamburg, 22299

  • Teva Investigational Site 32681

    Hanover, 30173

  • Teva Investigational Site 32677

    Koblenz, 56068

  • Teva Investigational Site 32672

    Leipzig, 4357

  • Teva Investigational Site 32671

    Leipzig, ?04275

  • Teva Investigational Site 32674

    Lübeck, 23552

  • Teva Investigational Site 32682

    Rostock, 18057

  • Teva Investigational Site 32676

    Tempelhof, 12099

Other trials in Germany

Poland10 sites

  • Teva Investigational Site 53405

    Bialystok, 15-044

  • Teva Investigational Site 53402

    Gdansk, 80-952

  • Teva Investigational Site 53399

    Krakow, 31-624

  • Teva Investigational Site 53408

    Lodz, 90-153

  • Teva Investigational Site 53400

    Lodz, 90-329

  • Teva Investigational Site 53403

    Lubin, 59-300

  • Teva Investigational Site 53407

    Ostrów Wielkopolski, 63-400

  • Teva Investigational Site 53401

    Poznan, 60-214

  • Teva Investigational Site 53404

    Tarnów, 33-100

  • Teva Investigational Site 53406

    Wroclaw, 54-239

Other trials in Poland

Russia9 sites

  • Teva Investigational Site 50460

    Barnaul, 656024

  • Teva Investigational Site 50453

    Kemerovo, 650002

  • Teva Investigational Site 50461

    Kemerovo, 650099

  • Teva Investigational Site 50456

    Moscow, 115478

  • Teva Investigational Site 50459

    Moscow, 119991

  • Teva Investigational Site 50455

    Novosibirsk, 630091

  • Teva Investigational Site 50454

    Saint Petersburg, 194223

  • Teva Investigational Site 50457

    Saint Petersburg, 197022

  • Teva Investigational Site 50458

    Tomsk, 634063

Other trials in Russia

Israel8 sites

  • Teva Investigational Site 80136

    Ashkelon, 7830604

  • Teva Investigational Site 80129

    Haifa, 3436212

  • Teva Investigational Site 80131

    Jerusalem, 91031

  • Teva Investigational Site 80135

    Jerusalem, 9112001

  • Teva Investigational Site 80134

    Kfar Saba, 4428164

  • Teva Investigational Site 80132

    Petah Tikva, 49100

  • Teva Investigational Site 80133

    Ramat Gan, 5262100

  • Teva Investigational Site 80130

    Rehovot, 76100

Other trials in Israel

Romania5 sites

  • Teva Investigational Site 52115

    Brasov, 500051

  • Teva Investigational Site 52116

    Brasov, 500086

  • Teva Investigational Site 52113

    Cluj-Napoca, 400371

  • Teva Investigational Site 52114

    Târgu Mureş, 540136

  • Teva Investigational Site 52117

    Timișoara, 300310

Other trials in Romania

Czechia4 sites

  • Teva Investigational Site 54151

    Břeclav, 690 74

  • Teva Investigational Site 54150

    Jablonec nad Nisou, 46601

  • Teva Investigational Site 54148

    Jindřichův Hradec, 377 38

  • Teva Investigational Site 54149

    Tábor, 39001

Other trials in Czechia

Belgium3 sites

  • Teva Investigational Site 37082

    Brussels, 1200

  • Teva Investigational Site 37081

    Erpent, 5101

  • Teva Investigational Site 37083

    Ghent, 9000

Other trials in Belgium

France3 sites

  • Teva Investigational Site 35229

    Le Kremlin-Bicêtre, 94275 Cedex

  • Teva Investigational Site 35227

    Strasbourg, 67091

  • Teva Investigational Site 35228

    Toulouse, 31059

Other trials in France

Spain3 sites

  • Teva Investigational Site 31219

    Barcelona, 8041

  • Teva Investigational Site 31218

    Valencia, 46017

  • Teva Investigational Site 31217

    Valencia, 46026

Other trials in Spain

Canada2 sites

  • Teva Investigational Site 11134

    Etobicoke, Ontario, M9V 4B4

  • Teva Investigational Site 11133

    Vancouver, British Columbia, V5Z 4E1

Other trials in Canada

About this study

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

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.

Being tested
reslizumab
Medical subject headings
Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • reslizumabDrug

    Also called CEP38072

    Reslizumab was provided in a pre-filled syringe.

Study groups in NCT03052725
Study groupRoleWhat they receive
reslizumab 110 mgExperimentalReslizumab was administered as 110 mg subcutaneous (sc) injection in the thigh, abdomen, or upper arm(s) once every 4 weeks for a total of 9 doses.
Receives: Drug: reslizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Participants With Treatment-Emergent Adverse Events (TEAEs)

    An adverse event is any untoward medical occurrence, regardless of whether it has a causal relationship with study treatment. In this study, asthma exacerbations should not be recorded as adverse events unless assessed by the investigator as more severe than the patient's usual disease course. The period for reporting treatment-emergent adverse events was defined as the period after the first dose of study drug was administered until the end of treatment visit. Relation of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes.

    Measured: 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 (16)

  1. Participants With Potentially Clinically Significant Abnormal Hematology Values

    Participants are included in the counts if the worst study value reaches the following clinically significant levels:

    Eosinophils (high): >=1.5*10^9/L and increase >0 Hematocrit (low): >=18 years old: <0.32 L/L for females; <0.37 L/L for males plus a decrease >0 for both or 12 to <18 years old: <0.30 L/L and a decrease >0 for both females and males Hemoglobin (low): >=18 years old: <=95 g/L and decrease >0; 12 to <18 years old: <=100 g/L and decrease >0 Leukocytes (high): >=20*10^9/L and increase >0 Leukocytes (low): <=3*10^9/L and decrease >0 Neutrophils (low): <=1*10^9/L and decrease >0 Platelets (low): <=75*10^9/L and decrease >0

    Measured: Week 0 (baseline), Weeks 8, 24, 36 plus any unscheduled visits

  2. Participants With Potentially Clinically Significant Abnormal Serum Chemistry Values

    Participants are included in the counts if the worst study value reaches the following clinically significant levels:

    Alanine Aminotransferase (high): >=3* upper limit of normal (ULN) and increase >0 Aspartate Aminotransferase (high): >=3* upper limit of normal (ULN) and increase >0 Bilirubin (high): >=34.2 micromol/L and increase >0 Blood Urea Nitrogen (high): >=10.71 mmol/L and increase >0 Creatine Phosphokinase (high): >10* ULN and increase >0 Creatine Phosphokinase (medium high): >=3.1*ULN and <=10*ULN and increase >0 Creatinine (high): >=177 micromol/L and increase >0

    Measured: Week 0 (baseline), Weeks 4, 8, 24, 36 plus any unscheduled visits

  3. Participants' Tolerability and Injection Site Reactions by Domain and Worst Overall Severity

    The worst finding for participants in each tolerability and injection site domain from all treatment weeks is summarized. Local tolerability at the injection site was assessed approximately 1 hour after study drug administration.

    Severity was rated on a 4-level scale of none, mild, moderate and severe.

    Measured: Weeks 4, 8, 12, 16, 20, 24, 28, and 36

  4. Participants With Potentially Clinically Significant Abnormal Vital Sign Values

    Participants are included in the counts if the worst study value reaches the following clinically significant levels:

    Diastolic blood pressure (high): >100 mmHg and increase >=12 for participants >=18 years; >85 mmHg and increase >=12 for participants 12 - < 18 years Pulse rate (high): >100 beats/minute and increase >=12 Respiratory rate (high): >24 breaths/minute and increase >=10 for participants >=18 years >20 breaths/minute and increase >=10 for participants 12 - < 18 years Systolic blood pressure (high): >160 mmHg and increase >=30 for participants >=18 years; >130 mmHg and increase >=30 for participants 12 - < 18 years Temperature (high): >38.1 celsius and increase >=1.1 Temperature (low): <35.8 celsius

    Measured: Week 0 (baseline), Weeks 4, 8, 12, 16,20, 24, 28, 32, 36 plus any unscheduled visits

  5. Annualized Rate of Clinical Asthma Exacerbations (CAEs)

    Data is included between the first dose of study drug to the end of treatment visit for completed participants, and the first dose of study drug to 4 weeks after the last dose of study drug for patients who discontinued treatment early.

    Annual rate is defined as the number of events/(duration of treatment [days]/365.25).

    Participants with zero events are included.

    Measured: 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.

  6. Annualized Rate of Clinical Asthma Exacerbations (CAEs) Requiring Asthma-Specific Hospital Admissions or Emergency Room Visits

    Data is included between the first dose of study drug to the end of treatment visit for completed participants, and the first dose of study drug to 4 weeks after the last dose of study drug for patients who discontinued treatment early.

    Annual rate is defined as the number of events/(duration of treatment [days]/365.25).

    Participants with zero events are included.

    Measured: 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.

  7. Mean Number of Days of Hospital Stay During the Treatment Period

    Participants with no hospitalizations are included.

    Measured: 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

  8. Mean Number of School/Work Days Missed Due to Asthma During the Treatment Period

    Participants with no school or work days missed due to asthma are included in the counts.

    Measured: 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

  9. Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1): Baseline Values and Change From Baseline Values at Weeks 8, 24 and 36

    The FEV1 is the volume of air that can be forcibly exhaled from the lungs in the first second, measured in liters.

    Pre-bronchodilator spirometry assessments at designated clinic visits (weeks 0, 8, and 24, and 36) should only be performed after withholding short-acting bronchodilators (ie, inhaled short-acting beta-adrenergic agonists and/or short-acting anticholinergics) for at least 6 hours and long-acting bronchodilators ie, inhaled long-acting beta-adrenergic agonists and long acting anticholinergic agents) for at least 12 or 24 hours, according to their labeled dose schedule.

    Measured: Week 0 (baseline), Weeks 8, 24, 36

  10. Morning Ambulatory Forced Expiratory Volume in One Second (FEV1): Baseline Values and Change From Baseline Values at Weeks 1, 4, 8, 24 and 36

    A weekly average of daily morning ambulatory FEV1 (measured by the handheld spirometry device) was derived using 7-day window intervals. The average was calculated as the sum of all values divided by the number of non-missing assessments. There will be no imputation of missing data. At least 4 of the 7 measurements need to be recorded for a week to be included in the analysis; otherwise the week was treated as missing.

    Measured: Week 0 (baseline), Weeks 1, 4, 8, 24, 36

  11. Percent Change From Baseline in Daily Oral Corticosteroid (OCS) Dose During Weeks 16-20 and Weeks 32-36

    Daily OCS dose is defined as total OCS dose in a day (accounting for reported dose and dose frequency) and converting the total daily dose to a prednisone-equivalent dose.

    Baseline dose is the prescribed OCS dose on the day of first dose of study drug in this study. Dose at Weeks 16-20 and 32-36 is the mean of all daily OCS doses during the week range.

    Percent change = 100 * (absolute change / baseline dose)

    Measured: Week 0 (baseline), Weeks 16-20, Weeks 32-36

  12. Total Inhalations of Reliever Bronchodilator Medication: Baseline Values and Change From Baseline Values at Weeks 1, 4, 8, 24 and 36

    Total inhalations of reliever bronchodilator medication (eg, short-acting beta-agonist [SABA]) measured using weekly averages.

    The average was calculated as the sum of all values divided by the number of non-missing assessments. There was no imputation of missing data. At least 4 of the 7 measurements need to be recorded for a week to be included in the analysis; otherwise the week was treated as missing.

    Measured: Baseline (Week 0), Weeks 1, 4, 8, 24, 36

  13. Asthma Control Questionnaire-6 (ACQ-6) Total Score: Baseline Values and Change From Baseline Values at Weeks 8, 24 and 36

    The ACQ-6 is a validated asthma assessment tool that has been widely used. There are 6 self-assessment questions. Each item on the ACQ-6 has a possible score ranging from 0 to 6 and the total score is the mean of all responses. The seven-point response scale: 0 = 'totally controlled' and 6 = 'severely uncontrolled.' Negative change from baseline values indicate improved asthma control.

    Measured: Baseline (Week 0), Weeks 8, 24, 36

  14. 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

    The AQLQ +12 is a modified version of the standardized AQLQ, which was developed to measure functional impairments experienced by adults ≥17 years of age. The AQLQ +12 is valid for patients 12 to 70 years of age and includes 32 questions in 4 domains (symptoms, activity limitation, emotional function, and environmental stimuli). Participants were asked to recall their experiences during the previous 2 weeks and score each of the questions on a 7-point scale, where 7=not at all limited and 1=totally limited. The overall score of the AQLQ +12 was derived as the average of the 32 questions, thus, the total score ranges from 1 (indicates "total impairment") to 7 (indicates "no impairment").

    Positive change from baseline values indicate improved quality of life.

    Measured: Baseline (Week 0), Weeks 8, 24, 36

  15. Participants With Treatment-Emergent Anti-Drug Antibody (ADA) Responses

    Treatment-emergent responses were defined as a positive sample post-baseline (negative baseline) OR a titer increase of >=4-fold relative to a positive baseline sample.

    Two types of antibody assay were performed, an immunogenicity status assay (ADA) and neutralizing assay (NAb).

    The ADA assay produces a positive or negative result. For samples with a positive result, a neutralizing assay was performed, which also produces a positive or negative result.

    Measured: Baseline - date of randomization in the previous study (C38072-AS-30025 or C38072-AS-30027), Weeks 8, 24, 36 or early withdrawal

  16. Participants With Treatment-Emergent Anti-Drug Antibody (ADA) At the End-0f-Study Visit (Week 51)

    The endpoint was defined to evaluate immunogenicity after study drug washout since the end of study visit on Week 51 was to be 19 weeks after the final dose of study drug. Due to the early termination of the study no participants had an end of study visit.

    Measured: Week 51

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Feb 2017
  2. Study start10 Mar 2017
  3. Primary completion22 Feb 2018
  4. Study completion22 Feb 2018

Why it stopped: Parent Studies didn't meet their primary endpoint so study was terminated.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
391 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03052725
Sponsor's protocol ID
C38072-AS-30066
Other IDs
2016-004661-23, 2016
Status last verified
Dec 2022
First submitted
7 Feb 2017
Last updated
14 Dec 2022
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing reslizumab in people with Eosinophils, Asthma, run by Teva Branded Pharmaceutical Products R&D, Inc. at 134 sites in 13 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 14 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 134 sites in United States, Ukraine, Hungary, Germany, Poland and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Mar 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Participants With Treatment-Emergent Adverse Events (TEAEs) (time frame: 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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03052725.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2022.

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