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AzTrials

AsthmaPhase 3NCT02501629

An Efficacy and Safety Study of Reslizumab Subcutaneous in Patients With Oral Corticosteroid Dependent Asthma and Elevated Blood Eosinophils

A Phase 3 study testing Reslizumab, Non-Oral Corticosteroid (non-OCS) Asthma Medication and Oral Corticosteroid (OCS) in people with Asthma and Elevated Blood Eosinophils, run by Teva Branded Pharmaceutical Products R&D, Inc. at 127 sites in 17 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The primary objective of the study is to determine the ability of reslizumab administered by subcutaneous injection to produce a corticosteroid-sparing effect in patients with oral corticosteroid (OCS)-dependent asthma and elevated blood eosinophils, without loss of asthma control. Read more about this study

Who is it for?
Ages 12 years and older
What is being tested?
Reslizumab, Non-Oral Corticosteroid (non-OCS) Asthma Medication and Oral Corticosteroid (OCS)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
177 participants
Where
127 sitesin 17 countries
Study dates
29 Sep 2015to 4 Dec 2017
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

  • The patient is male or female, 12 years of age and older, with a previous diagnosis of asthma.
  • Written informed consent is obtained.
  • The patient requires daily maintenance dose of prednisone or equivalent for asthma of between 5 and 40 mg during the 3 months prior to screening.
  • The patient has a documented elevated blood eosinophils at screening or during the previous 12 months.
  • The patient has required high dose ICS plus another asthma controller for at least 6 months prior to screening.
  • The patient has FEV1 reversibility to inhaled SABA or historical reversibility within the previous 24 months.
  • Other criteria may apply, please contact the investigator for more information.

Who cannot join

  • The patient has any clinically significant, uncontrolled medical condition that would interfere with the study schedule or procedures and interpretation of efficacy results or would compromise the patient's safety.
  • The patient has another confounding underlying lung disorder.
  • The patient has a known hypereosinophilic syndrome.
  • The patient has a history of any malignancy within 5 years of the screening visit, except for treated and cured non-melanoma skin cancers.
  • The patient is pregnant or intends to become pregnant during the study or is lactating.
  • The patient required treatment for an asthma exacerbation within 4 weeks of screening.
Show all 16Show fewer
  • The patient is a current smoker or has a smoking history ≥10 pack-years.
  • The patient is currently using any systemic immunosuppressive or immunomodulatory biologic except maintenance OCS for the treatment of asthma.
  • The patient participated in a clinical study within 30 days or 5 half-lives of the investigational drug before screening, whichever is longer.
  • The patient was previously exposed to benralizumab within 12 months of screening.
  • The patient was previously exposed to reslizumab.
  • The patient has a history of immunodeficiency disorder including human immunodeficiency virus.
  • The patient has current suspected drug and/or alcohol abuse.
  • The patient has had an active helminthic parasitic infection or was treated for one within 6 months of screening.
  • The patient has a history of allergic reactions or hypersensitivity to any component of the study drug.
  • Other criteria may apply, please contact the investigator for more information.

Trial locations and contacts

127 sites in 17 countries.

127 sites in 17 countries

United States26 sites

  • Teva Investigational Site 13357

    Bakersfield, California, 93301

  • Teva Investigational Site 13362

    Biloxi, Mississippi, 39531

  • Teva Investigational Site 13366

    Charleston, South Carolina, 29414

  • Teva Investigational Site 13367

    Chicago, Illinois, 60612

  • Teva Investigational Site 13349

    Cincinnati, Ohio, 45231

  • Teva Investigational Site 13371

    Clermont, Florida, 73034

  • Teva Investigational Site 13377

    Dallas, Texas, 75225

  • Teva Investigational Site 13370

    Edmond, Oklahoma, 73034

  • Teva Investigational Site 13358

    Fairfax, Virginia, 22030

  • Teva Investigational Site 13351

    Homestead, Florida, 33030

  • Teva Investigational Site 13369

    Houston, Texas, 77099

  • Teva Investigational Site 13342

    Kissimmee, Florida, 34741

  • Teva Investigational Site 13348

    Lenexa, Kansas, 66215

  • Teva Investigational Site 13365

    Long Beach, California, 90813

  • Teva Investigational Site 13344

    Miami, Florida, 33015

  • Teva Investigational Site 13372

    Miami, Florida, 33133

  • Teva Investigational Site 13345

    Michigan City, Indiana, 46360

  • Teva Investigational Site 13356

    New York, New York, 10016-9196

  • Teva Investigational Site 13363

    Normal, Illinois, 61761

  • Teva Investigational Site 13347

    Oklahoma City, Oklahoma, 73112

  • Teva Investigational Site 13354

    Pembroke Pines, Florida, 33029

  • Teva Investigational Site 13343

    Saint Cloud, Florida, 34769

  • Teva Investigational Site 13368

    Sebring, Florida, 33870

  • Teva Investigational Site 13350

    St Louis, Missouri, 63106

  • Teva Investigational Site 13352

    St Louis, Missouri, 63143

  • Teva Investigational Site 13346

    Tampa, Florida, 33607

Other trials in United States

Ukraine15 sites

  • Teva Investigational Site 58245

    Dnipro, 49044

  • Teva Investigational Site 58238

    Dnipropetrovsk, 49074

  • Teva Investigational Site 58240

    Ivano-Frankivsk, 76018

  • Teva Investigational Site 58244

    Kharkiv, 61002

  • Teva Investigational Site 58235

    Kharkiv, 61007

  • Teva Investigational Site 58239

    Kharkiv, 61035

  • Teva Investigational Site 58241

    Kharkiv, 61039

  • Teva Investigational Site 58249

    Kremenchuk, 39617

  • Teva Investigational Site 58248

    Kyiv, 03680

  • Teva Investigational Site 58251

    Kyiv, 2091

  • Teva Investigational Site 58237

    Kyiv, 3049

  • Teva Investigational Site 58250

    Kyiv, ?03680

  • Teva Investigational Site 58243

    Sumy, 40022

  • Teva Investigational Site 58246

    Vinnytsia, 21001

  • Teva Investigational Site 58242

    Zhaporizhzhya, 69035

Other trials in Ukraine

Mexico11 sites

  • Teva Investigational Site 21106

    Chihuahua City, 31203

  • Teva Investigational Site 21102

    Distrito Federal, 07020

  • Teva Investigational Site 21104

    Durango, 34080

  • Teva Investigational Site 21094

    Guadalajara, 44100

  • Teva Investigational Site 21091

    Guadalajara, 44130

  • Teva Investigational Site 21100

    Guadalajara, 44160

  • Teva Investigational Site 21093

    Guadalajara, 44220

  • Teva Investigational Site 21090

    Mexico City, 06700

  • Teva Investigational Site 21103

    Monterrey, 64460

  • Teva Investigational Site 21101

    Monterrey, 64718

  • Teva Investigational Site 21105

    Querétaro, 76800

Other trials in Mexico

Russia11 sites

  • Teva Investigational Site 50356

    Barnaul, 656024

  • Teva Investigational Site 50417

    Chelyabinsk, 454021

  • Teva Investigational Site 50385

    Kemerovo, 650002

  • Teva Investigational Site 50382

    Kemerovo, 650099

  • Teva Investigational Site 50384

    Moscow, 129090

  • Teva Investigational Site 50383

    Novosibirsk, 630091

  • Teva Investigational Site 50386

    Novosibirsk, 630099

  • Teva Investigational Site 50357

    Saint Petersburg, 197089

  • Teva Investigational Site 50418

    Tomsk, 634050

  • Teva Investigational Site 50358

    Tomsk, 634063

  • Teva Investigational Site 50419

    Yekaterinburg, 620039

Other trials in Russia

Argentina10 sites

  • Teva Investigational Site 20059

    Buenos Aires, C1028AAP

  • Teva Investigational Site 20058

    Buenos Aires, C1425BEN

  • Teva Investigational Site 20056

    Buenos Aires, C1426ABP

  • Teva Investigational Site 20057

    Buenos Aires

  • Teva Investigational Site 20052

    Córdoba, X5003DCE

  • Teva Investigational Site 20055

    Mendoza, 5500

  • Teva Investigational Site 20050

    Mendoza, M5500CCG

  • Teva Investigational Site 20087

    Rosario, 2000

  • Teva Investigational Site 20051

    San Miguel de Tucumán, T4000CHE

  • Teva Investigational Site 20066

    San Rafael

Other trials in Argentina

Poland9 sites

  • Teva Investigational Site 53316

    Gdansk, 80-952

  • Teva Investigational Site 53318

    Krakow, 31-624

  • Teva Investigational Site 53319

    Lodz, 90-153

  • Teva Investigational Site 53321

    Lodz, 90-153

  • Teva Investigational Site 53322

    Lubin, 59-300

  • Teva Investigational Site 53320

    Ostrów Wielkopolski, 63-400

  • Teva Investigational Site 53358

    Rzeszów, 35-612

  • Teva Investigational Site 53317

    Tarnów, 33-100

  • Teva Investigational Site 53323

    Wroclaw, 54-239

Other trials in Poland

Germany8 sites

  • Teva Investigational Site 32621

    Bad Wörishofen, 86825

  • Teva Investigational Site 32576

    Berlin, 10717

  • Teva Investigational Site 32573

    Berlin, 12159

  • Teva Investigational Site 32578

    Berlin, 13187

  • Teva Investigational Site 32622

    Frankfurt, 60389

  • Teva Investigational Site 32579

    Hanover, 30173

  • Teva Investigational Site 32574

    Leipzig, 4275

  • Teva Investigational Site 32580

    Rostock, 18057

Other trials in Germany

Australia6 sites

  • Teva Investigational Site 78089

    Bedford Park, 5042

  • Teva Investigational Site 78092

    Box Hill, 3128

  • Teva Investigational Site 78097

    Frankston, 3199

  • Teva Investigational Site 78093

    Kent Town, 5067

  • Teva Investigational Site 78090

    Nedlands, 6009

  • Teva Investigational Site 78091

    New Lambton, 2305

Other trials in Australia

South Korea6 sites

  • Teva Investigational Site 87020

    Goyang-si, 411-706

  • Teva Investigational Site 87024

    Jeonju, 561-712

  • Teva Investigational Site 87025

    Seongnam-si, 463-707

  • Teva Investigational Site 87023

    Seoul, 137-701

  • Teva Investigational Site 87022

    Seoul, 138-736

  • Teva Investigational Site 87021

    Seoul, 143-729

Other trials in South Korea

Israel5 sites

  • Teva Investigational Site 80085

    Haifa, 3436212

  • Teva Investigational Site 80083

    Jerusalem, 91120

  • Teva Investigational Site 80091

    Kfar Saba, 44281

  • Teva Investigational Site 80084

    Petah Tikva, 49100

  • Teva Investigational Site 80082

    Rehovot, 76100

Other trials in Israel

France4 sites

  • Teva Investigational Site 35186

    Le Kremlin-Bicêtre, 94275 Cedex

  • Teva Investigational Site 35185

    Lille, 59037

  • Teva Investigational Site 35189

    Lyon, 69317

  • Teva Investigational Site 35187

    Strasbourg, 67091

Other trials in France

Hungary4 sites

  • Teva Investigational Site 51254

    Csorna, 9300

  • Teva Investigational Site 51232

    Dombóvár, 7200

  • Teva Investigational Site 51233

    Hatvan, 3000

  • Teva Investigational Site 51253

    Szombathely, 9700

Other trials in Hungary

Spain4 sites

  • Teva Investigational Site 31159

    Barcelona, ?08025

  • Teva Investigational Site 31161

    Girona, 17004

  • Teva Investigational Site 31160

    Valencia, 46017

  • Teva Investigational Site 31158

    Valencia, 46026

Other trials in Spain

Belgium2 sites

  • Teva Investigational Site 37059

    Brussels, 1200

  • Teva Investigational Site 37058

    Gembloux, 5030

Other trials in Belgium

Czechia2 sites

  • Teva Investigational Site 54133

    Břeclav, 690 74

  • Teva Investigational Site 54132

    Jindřichův Hradec, 377 38

Other trials in Czechia

Italy2 sites

  • Teva Investigational Site 30152

    Catanzaro, 88100

  • Teva Investigational Site 30154

    Genova, 16132

Other trials in Italy

Netherlands2 sites

  • Teva Investigational Site 38084

    Leeuwarden, 8901 BR

  • Teva Investigational Site 38085

    Zwolle, 8025-AB

Other trials in Netherlands

About this study

Official title: A Phase 3, 24-Week Double-Blind, Placebo-Controlled, Parallel-Group, Efficacy and Safety Study of Reslizumab Subcutaneous Dosing (110 mg Every 4 Weeks) in Patients With Oral Corticosteroid Dependent Asthma and Elevated Blood Eosinophils

The primary objective of the study is to determine the ability of reslizumab administered by subcutaneous injection to produce a corticosteroid-sparing effect in patients with oral corticosteroid (OCS)-dependent asthma and elevated blood eosinophils, without loss of asthma control.

Being tested
Reslizumab, Placebo, Non-Oral Corticosteroid (non-OCS) Asthma Medication, Oral Corticosteroid (OCS)
Keywords
Asthma, Elevated Blood Eosinophils, Oral corticosteroid dependence, 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 110 mg was administered by qualified study personnel as subcutaneous injections in the upper arm(s) once every 4 weeks for a total of 6 doses. Drug was supplied in pre-filled syringes.

  • PlaceboDrug

    Placebo was administered by qualified study personnel as subcutaneous injections in the upper arm(s) once every 4 weeks for a total of 6 doses. Drug was supplied in pre-filled syringes.

  • Non-Oral Corticosteroid (non-OCS) Asthma MedicationDrug

    Participants continue using their non-OCS background asthma medications without change during the study's treatment period.

  • Oral Corticosteroid (OCS)Drug

    After screening and prior to study start, the participant's OCS dose was adjusted to determine the minimal effective OCS requirement.

Study groups in NCT02501629
Study groupRoleWhat they receive
Reslizumab 110 mgExperimentalReslizumab was administered by subcutaneous injection (sc) in a dosage of 110 mg (1.0 mL) every 4 weeks for a total of six doses.
Receives: Drug: Reslizumab; Drug: Non-Oral Corticosteroid (non-OCS) Asthma Medication; Drug: Oral Corticosteroid (OCS)
PlaceboPlacebo comparatorMatching placebo was administered by subcutaneous injection (sc) 1.0 mL every 4 weeks for a total of six doses.
Receives: Drug: Placebo; Drug: Non-Oral Corticosteroid (non-OCS) Asthma Medication; Drug: Oral Corticosteroid (OCS)

What is being measured

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

  1. Number of Participants With Reduction In Daily Oral Corticosteroid (OCS) Dose During Weeks 20-24 As Compared to the Optimized Dose At Baseline

    The primary endpoint was the 5-level categorized percent reduction in OCS dose during weeks 20 to 24 compared with the optimized dose at baseline. The primary analysis incorporated data from all randomized patients. Analysis of the primary and secondary variables related to categorical OCS dose reduction incorporated missing data as non-responders.

    No decrease indicates there was no decrease in OCS, loss of baseline asthma control during weeks 20 to 24, or discontinuation from study drug.

    Measured: Baseline (Day 1), Weeks 20-24

Secondary outcomes (8)

  1. Percentage of Participants Achieving a >=50% Reduction in OCS Dose at Weeks 20-24 Compared to Baseline While Maintaining Asthma Control

    Percentage of patients whose OCS dose at weeks 20-24 was reduced >=50% compared to baseline while maintaining asthma control.

    Patients listed as "no" did not achieve the 50% reduction in baseline OCS dose goal, or did achieve that goal but lost asthma control during weeks 20 to 24, or discontinued from study drug.

    Measured: Baseline (Day 1), Weeks 20-24

  2. Percentage of Participants Achieving an OCS Dose of <=5 mg at Weeks 20-24 While Maintaining Asthma Control

    Percentage of participants whose OCS dose at weeks 20-24 was <=5 mg and they maintained asthma control.

    Patients listed as "no" had a week 20-24 OCS dose > 5 mg, or whose OCS dose was <=5 mg at weeks 20-24 but did not maintain asthma control, or they discontinued from study drug.

    Measured: Weeks 20-24

  3. Percent Change From Baseline in Daily Oral Corticosteroid (OCS) Dose During Weeks 20-24 Using a Mixed Model for Repeated Measures

    The baseline OCS dose is the prescribed optimized OCS dose following the OCS optimization period. Endpoint data are presented using an on-treatment approach. In this context, 'endpoint' was defined as the last observation obtained at a scheduled or qualified early termination visit during the treatment period. Weeks 20-24 data is included between the Week 20 dose and Week 24 for completed patients; last dose of study drug to 4 weeks after the last dose of study drug for patients who discontinued treatment early. Measurements collected outside of these defined timeframes are excluded from the analyses.

    The mixed model repeated measures (MMRM) included fixed effects for treatment, visit, treatment by visit interaction, age group, and OCS dose group, duration of OCS use and baseline value as covariates, and patient as a random effect. Unstructured covariance was assumed for the repeated measures.

    Measured: Baseline (Day 1), Weeks 20-24

  4. Percentage of Participants Achieving a >=5 mg Reduction in OCS Dose at Weeks 20-24 Compared to Baseline While Maintaining Asthma Control

    Percentage of participants whose OCS dose at weeks 20-24 was reduced by at least 5mg from baseline and maintained asthma control. Patients listed as "no" had a week 20-24 OCS dose that did not meet the threshold of a 5mg reduction, or whose OCS dose met the threshold but did not maintain asthma control, or discontinued from study drug.

    Measured: Baseline (Day 1), Weeks 20-24

  5. Annualized Rate of Clinical Asthma Exacerbations (CAEs)

    The annual exacerbation rate is based on clinical asthma exacerbations reported by the investigator in the eCRF.

    Measured: Day 1 through Week 24

  6. Percentage of Participants Achieving an OCS Dose of 0 mg at Weeks 20-24 While Maintaining Asthma Control

    Percentage of participants who discontinue use of OCS during weeks 20-24 while maintaining asthma control.

    Patients listed as "no" continued to use OCS during weeks 20-24, or who discontinued use of OCS during weeks 20-24 but lost control of their asthma, or discontinued from study drug.

    Measured: Weeks 20-24

  7. 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: Weeks 4, 8, 12, 24 or early withdrawal.

  8. Participants With Adverse Events

    An adverse event is any untoward medical occurrence in a patient administered a pharmaceutical product, regardless of whether it has a causal relationship with this treatment. In this study, asthma exacerbations (which are efficacy parameters) should not be recorded as adverse events unless assessed by the investigator as more severe than the patient's usual disease course. 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.

    Treatment-related adverse events or adverse events related to OCS use included events with missing relationship to study drug or OCS use, respectively.

    Measured: Day 1 up to Week 24 (end of treatment visit); Data were included between Day 1 and Week 24 for completed patients, and Day 1 and 4 weeks after the last dose of study drug for patients who discontinued treatment early.

Timeline

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

  1. First posted17 Jul 2015 (estimated)
  2. Study start29 Sep 2015
  3. Primary completion19 Jun 2017
  4. Study completion4 Dec 2017

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
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
177 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02501629
Sponsor's protocol ID
C38072-AS-30027
Other IDs
2015-001580-39, 2015
Status last verified
Nov 2021
First submitted
14 Jul 2015
Last updated
9 Nov 2021
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Bernstein JA, Virchow JC, Murphy K, Maspero JF, Jacobs J, Adir Y, Humbert M, Castro M, Marsteller DA, McElhattan J, Hickey L, Garin M, Vanlandingham R, Brusselle G. Effect of fixed-dose subcutaneous reslizumab on asthma exacerbations in patients with severe uncontrolled asthma and corticosteroid sparing in patients with oral corticosteroid-dependent asthma: results from two phase 3, randomised, double-blind, placebo-controlled trials. Lancet Respir Med. 2020 May;8(5):461-474. doi: 10.1016/S2213-2600(19)30372-8. Epub 2020 Feb 14.

    PubMed 32066536

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Reslizumab, Non-Oral Corticosteroid (non-OCS) Asthma Medication and Oral Corticosteroid (OCS) in people with Asthma and Elevated Blood Eosinophils, run by Teva Branded Pharmaceutical Products R&D, Inc. at 127 sites in 17 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 7 inclusion and 16 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: finished, as of the sponsor's last update on 9 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 127 sites in United States, Ukraine, Mexico, Russia, Argentina and 12 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. Some participants in this study may receive a placebo. 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 13 Sep 2018). 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?

Number of Participants With Reduction In Daily Oral Corticosteroid (OCS) Dose During Weeks 20-24 As Compared to the Optimized Dose At Baseline (time frame: Baseline (Day 1), Weeks 20-24). 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 NCT02501629, which also lists 1 linked publication.

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 9 Nov 2021.

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