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AsthmaPhase 3VENTURENCT02528214

Evaluation of Dupilumab in Patients With Severe Steroid Dependent Asthma

A Phase 3 study testing Dupilumab, Oral corticosteroid therapy (prednisone/prednisolone) and Inhaled corticosteroid (ICS) therapy in people with Asthma, run by Sanofi at 80 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

Primary Objective: To evaluate the efficacy of dupilumab, compared with placebo, for reducing the use of maintenance oral corticosteroids (OCS) in participants with severe steroid-dependent asthma. Secondary Objectives: To evaluate the safety and tolerability of dupilumab. Read more about this study

Who is it for?
Ages 12 years and older
Conditions the study is for
Asthma
What is being tested?
Dupilumab, Oral corticosteroid therapy (prednisone/prednisolone) and Inhaled corticosteroid (ICS) therapy
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
210 participants
Where
80 sitesin 17 countries
Study dates
15 Oct 2015to 13 Nov 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

  • Adult and adolescent (12 years of age or older) participants with a physician diagnosis of asthma for >=12 months, based on the Global Initiative for Asthma (GINA) 2014 guidelines and the following criteria:
  • Participants with severe asthma and a well-documented, regular prescribed treatment of maintenance corticosteroids in the 6 months prior to Visit 1 and using a stable OCS dose (ie, no change of OCS dose) for 4 weeks prior to Visit 1. Participants must be taking 5 to 35 mg/day of prednisone/prednisolone, or the equivalent, at Visit 1 and at the randomization visit. In addition, the participants must agree to switch to study-required prednisone/prednisolone as their OCS and use it per protocol for the duration of the study.
  • Existing treatment with high-dose inhaled corticosteroid (ICS; >500 mcg total daily dose of fluticasone propionate or equivalent) in combination with a second controller (ie, long-acting beta agonist [LABA], leukotriene receptor antagonist [LTRA]) for at least 3 months with a stable dose of ICS for >=1 month prior to Visit 1. In addition, participants requiring a third controller for their asthma are considered eligible for this study, and it should also be used for at least 3 months with a stable dose >= 1 month prior to Visit 1.
  • A forced expiratory volume in 1 second (FEV1) <80% of predicted normal for adults and <=90% of predicted normal for adolescents at Visit 1.
  • Evidence of asthma as documented by either: reversibility of at least 12% and 200 mL in FEV1 after the administration of 200 to 400 mcg (2 to 4 inhalations of albuterol/salbutamol or levalbuterol/levosalbutamol, or of a nebulized solution of albuterol/salbutamol or levalbuterol/levosalbutamol, if considered as a standard office practice) before randomization or documented in the 12 months prior to Visit 1 OR airway hyperresponsiveness (methacholine: provocative concentration that causes a positive reaction [PC20] of <8 mg/mL) documented in the 12 months prior to Visit 1.

Who cannot join

  • Participants <12 years of age or the minimum legal age for adolescents in the country of the investigative site, whichever is higher (for those countries where local regulations permit enrollment of adults only, participant recruitment will be restricted to those who were >=18 years of age).
  • Participants who weighed <30.0 kg.
  • Chronic obstructive pulmonary disease (COPD) or other lung diseases (eg, idiopathic pulmonary fibrosis, Churg-Strauss Syndrome, allergic bronchopulmonary aspergillosis, cystic fibrosis) which may impair lung function.
  • Clinical evidence or imaging (eg, chest X-ray, computed tomography, magnetic resonance imaging) within 12 months of Visit 1 with clinically significant findings of lung disease(s) other than asthma, as per local standard of care.
  • A participant who experiences a deterioration of asthma that results in emergency treatment or hospitalization within 4 weeks of Screening Visit 1.
  • A participant who requires 12 puffs or more of rescue medication on any 1 day in the week prior to Visit 1.
Show all 11Show fewer
  • A participant who has experienced an upper or lower respiratory tract infection within the 4 weeks prior to screening.
  • Current smoker or cessation of smoking within 6 months prior to Visit 1.
  • Previous smoker with a smoking history >10 pack-years.
  • Comorbid disease that might interfere with the evaluation of the investigational medicinal product.
  • The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Trial locations and contacts

80 sites in 17 countries.

80 sites in 17 countries

Ukraine9 sites

  • Investigational Site Number 804007

    Chernivtsi, 58001

  • Investigational Site Number 804004

    Ivano-Frankivsk, 76018

  • Investigational Site Number 804009

    Ivano-Frankivsk, 76018

  • Investigational Site Number 804001

    Kharkiv, 61124

  • Investigational Site Number 804003

    Kyiv, 03680

  • Investigational Site Number 804011

    Kyiv, 03680

  • Investigational Site Number 804006

    Odesa, 65025

  • Investigational Site Number 804002

    Poltava, 36038

  • Investigational Site Number 804019

    Vinnytsia, 21001

Other trials in Ukraine

United States8 sites

  • Investigational Site Number 840062

    Amarillo, Texas, 79106

  • Investigational Site Number 840022

    Los Angeles, California, 90048

  • Investigational Site Number 840070

    McKinney, Texas, 75069

  • Investigational Site Number 840128

    McKinney, Texas, 75071

  • Investigational Site Number 840010

    Pittsburgh, Pennsylvania, 15213

  • Investigational Site Number 840118

    Plano, Texas, 75093

  • Investigational Site Number 840014

    Rolling Hills Estates, California, 90274

  • Investigational Site Number 840002

    St Louis, Missouri, 63110

Other trials in United States

Romania7 sites

  • Investigational Site Number 642104

    Bucharest, 011461

  • Investigational Site Number 642103

    Bucharest, 050159

  • Investigational Site Number 642102

    Cluj-Napoca, 400162

  • Investigational Site Number 642107

    Cluj-Napoca, 400371

  • Investigational Site Number 642108

    Cluj-Napoca, 400371

  • Investigational Site Number 642105

    Timișoara, 300310

  • Investigational Site Number 642106

    Timișoara, 300310

Other trials in Romania

Canada6 sites

  • Investigational Site Number 124009

    Calgary, T2N 4Z6

  • Investigational Site Number 124016

    Hamilton, L8N 4A6

  • Investigational Site Number 124003

    Mississauga, L5A 3V4

  • Investigational Site Number 124013

    Ottawa, K1G 6C6

  • Investigational Site Number 124002

    Toronto, M5T 3A9

  • Investigational Site Number 124017

    Vancouver, V6Z 1Y6

Other trials in Canada

Italy6 sites

  • Investigational Site Number 380005

    Catania, 95123

  • Investigational Site Number 380002

    Genova, 16132

  • Investigational Site Number 380008

    Naples, 80131

  • Investigational Site Number 380009

    Palermo, 90146

  • Investigational Site Number 380001

    Pisa, 56124

  • Investigational Site Number 380003

    Reggio Emilia, 42123

Other trials in Italy

Spain6 sites

  • Investigational Site Number 724014

    Barcelona, 08023

  • Investigational Site Number 724002

    Barcelona, 08035

  • Investigational Site Number 724013

    Madrid, 28942

  • Investigational Site Number 724006

    Pozuelo de Alarcón, 28223

  • Investigational Site Number 724007

    Sant Boi de Llobregat, 08830

  • Investigational Site Number 724096

    Santiago de Compostela, 15706

Other trials in Spain

Israel5 sites

  • Investigational Site Number 376003

    Haifa, 34362

  • Investigational Site Number 376001

    Kfar Saba, 44281

  • Investigational Site Number 376005

    Petah Tikva, 49100

  • Investigational Site Number 376002

    Rehovot, 76100

  • Investigational Site Number 376004

    Tel HaShomer, 52621

Other trials in Israel

Mexico5 sites

  • Investigational Site Number 484016

    Acapulco, 39670

  • Investigational Site Number 484013

    Chihuahua City, 31020

  • Investigational Site Number 484001

    Guadalajara, 44100

  • Investigational Site Number 484002

    Mexico City, 06726

  • Investigational Site Number 484003

    Monterrey, 64460

Other trials in Mexico

Poland5 sites

  • Investigational Site Number 616006

    Bialystok, 15-010

  • Investigational Site Number 616097

    Krakow, 31-159

  • Investigational Site Number 616001

    Lodz, 90-141

  • Investigational Site Number 616010

    Warsaw, 04-141

  • Investigational Site Number 616011

    Żnin, 88-400

Other trials in Poland

Russia5 sites

  • Investigational Site Number 643006

    Moscow, 105077

  • Investigational Site Number 643007

    Moscow, 117574

  • Investigational Site Number 643099

    Saint Petersburg, 193231

  • Investigational Site Number 643011

    Saint Petersburg, 194356

  • Investigational Site Number 643009

    Saint Petersburg, 197022

Other trials in Russia

Argentina3 sites

  • Investigational Site Number 032003

    Buenos Aires, C1121ABE

  • Investigational Site Number 032001

    Caba, C1425BEN

  • Investigational Site Number 032091

    Caba, C1426ABP

Other trials in Argentina

Belgium3 sites

  • Investigational Site Number 056002

    Brussels, 1020

  • Investigational Site Number 056003

    Ghent, 9000

  • Investigational Site Number 056001

    Leuven, 3000

Other trials in Belgium

Brazil3 sites

  • Investigational Site Number 076013

    São Bernardo do Campo, 09780-000

  • Investigational Site Number 076011

    São Paulo, 04020-041

  • Investigational Site Number 076002

    Sorocaba, 18040-425

Other trials in Brazil

Chile3 sites

  • Investigational Site Number 152007

    Quillota, 2260877

  • Investigational Site Number 152005

    Santiago, 7500692

  • Investigational Site Number 152008

    Talca, 3460001

Other trials in Chile

Colombia2 sites

  • Investigational Site Number 170001

    Bogotá, 110121

  • Investigational Site Number 170006

    Bogotá

Other trials in Colombia

Hungary2 sites

  • Investigational Site Number 348301

    Balassagyarmat, 2660

  • Investigational Site Number 348303

    Edelény, 3780

Other trials in Hungary

Netherlands2 sites

  • Investigational Site Number 528001

    Arnhem, 6815 AD

  • Investigational Site Number 528002

    Dordrecht, 3318 AT

Other trials in Netherlands

About this study

Official title: A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Dupilumab in Patients With Severe Steroid Dependent Asthma

Primary Objective:

To evaluate the efficacy of dupilumab, compared with placebo, for reducing the use of maintenance oral corticosteroids (OCS) in participants with severe steroid-dependent asthma.

Secondary Objectives:

  • To evaluate the safety and tolerability of dupilumab.
  • To evaluate the effect of dupilumab in improving participants-reported outcomes.
  • To evaluate dupilumab systemic exposure and the incidence of treatment-emergent antidrug antibodies.
Read the detailed description

The total study duration per participant was up to 46 weeks, consisting of a screening period of 3 to up to 8 weeks (up to 10 weeks for participants who experienced a clinically significant asthma exacerbation during the screening period), a randomized treatment period of up to 24 weeks, and a post-treatment period of 12 weeks.

Participants who completed treatment were considered for eligibility into the long term extension study LTS12551 (NCT02134028).

Conditions
Asthma
Being tested
Dupilumab, Placebo, Oral corticosteroid therapy (prednisone/prednisolone), Inhaled corticosteroid (ICS) therapy, Albuterol/Salbutamol
Medical subject headings
Asthma

What participants receive

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

  • DupilumabDrug

    Also called REGN668, SAR231893

    Solution for injection, Subcutaneous injection in the abdomen, upper thigh or upper arm.

  • PlaceboDrug

    Solution for injection, Subcutaneous injection in the abdomen, upper thigh or upper arm.

  • Oral corticosteroid therapy (prednisone/prednisolone)Drug

    Oral administration.

  • Inhaled corticosteroid (ICS) therapyDrug

    Oral inhalation, stable dose (high dose) of ICS in combination with up to 2 other controller medicines (second or third controller therapy).

  • Albuterol/SalbutamolDrug

    Oral inhalation as needed.

  • Levalbuterol/LevosalbutamolDrug

    Oral inhalation as needed.

Study groups in NCT02528214
Study groupRoleWhat they receive
Placebo q2wPlacebo comparator2 subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1, followed by a single injection every 2 weeks (q2w) for 24 weeks in combination with OCS - (prednisone or prednisolone) and stable inhaled corticosteroid (ICS). OCS dose was reduced according to a predetermined titration schedule every 4 weeks until Week 20. Albuterol/salbutamol or levalbuterol/levosalbutamol was given as reliever medication.
Receives: Drug: Placebo; Drug: Oral corticosteroid therapy (prednisone/prednisolone); Drug: Inhaled corticosteroid (ICS) therapy; Drug: Albuterol/Salbutamol; Drug: Levalbuterol/Levosalbutamol
Dupilumab 300 mg q2wExperimental2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection q2w for 24 weeks in combination with OCS - (prednisone or prednisolone) and stable ICS. OCS dose was reduced according to a predetermined titration schedule every 4 weeks until Week 20. Albuterol/salbutamol or levalbuterol/levosalbutamol was given as reliever medication.
Receives: Drug: Dupilumab; Drug: Oral corticosteroid therapy (prednisone/prednisolone); Drug: Inhaled corticosteroid (ICS) therapy; Drug: Albuterol/Salbutamol; Drug: Levalbuterol/Levosalbutamol

What is being measured

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

  1. Percentage Reduction From Baseline in Oral Corticosteroids (OCS) Dose at Week 24 While Maintaining Asthma Control

    Percentage reduction of OCS dose was calculated as (optimized OCS dose [mg/day] at baseline - final OCS dose at Week 24)/optimized OCS dose at baseline x 100. Result is presented as Least Squares Mean (Standard Error) percentage reduction from baseline derived from ANCOVA model with missing data multiply imputed.

    Measured: Baseline, Week 24

  2. Supplementary Presentation of Primary Outcome Measure Data: Median Percentage Reduction From Baseline in Oral Corticosteroids Dose at Week 24 While Maintaining Asthma Control

    The Primary Outcome Measure (Percentage Reduction From Baseline in Oral Corticosteroids Dose at Week 24 While Maintaining Asthma Control) is summarized above, as LS Mean (SE). Table below provides a supplementary presentation of the Primary Outcome Measure data; result is presented as median (inter-quartile range). Percentage reduction of OCS dose was calculated as (optimized OCS dose [mg/day] at baseline - final OCS dose at Week 24)/optimized OCS dose at baseline x 100.

    Measured: Baseline, Week 24

Secondary outcomes (5)

  1. Percentage of Participants Achieving >= 50% Reduction in Oral Corticosteroids Dose at Week 24 While Maintaining Asthma Control

    Participants were classified according to the binary status of whether or not the 50% OCS dose reduction criterion was achieved at week 24.

    Measured: Week 24

  2. Percentage of Participants Achieving a Reduction in Oral Corticosteroids Dose to <5 mg/Day at Week 24 While Maintaining Asthma Control

    Participants were classified according to the binary status of whether or not the reduction of OCS dose to <5 mg/day was achieved at Week 24.

    Measured: Week 24

  3. Percentage of Participants Achieving Maximum Possible Reduction in Oral Corticosteroids Dose Per Protocol at Week 24 While Maintaining Asthma Control

    For all participants except those with baseline OCS dose at 35 mg/day, the maximum possible reduction corresponds to reduction to 0 mg/day (no longer requiring OCS). For participants starting with 35 mg/day at baseline, the maximum possible reduction is 32.5 mg/day (i.e. minimum dose per protocol is 2.5 mg).

    Measured: Week 24

  4. Percentage of Participants Who No Longer Required Oral Corticosteroids Dose at Week 24 While Maintaining Asthma Control

    Participants were classified according to the binary status of whether or not the participant still required OCS at Week 24 while maintaining asthma control.

    Measured: Week 24

  5. Absolute Reduction From Baseline in Oral Corticosteroids Dose at Week 24 While Maintaining Asthma Control

    Absolute reduction was calculated by subtracting Week 24 value from baseline value.

    Measured: Baseline and Week 24

Timeline

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

  1. First posted19 Aug 2015 (estimated)
  2. Study start15 Oct 2015
  3. Primary completion20 Sep 2017
  4. Study completion13 Nov 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
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
210 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02528214
Sponsor's protocol ID
EFC13691
Other IDs
2015-001573-40, U1111-1170-7152, 2015
Acronym
VENTURE
Status last verified
Nov 2017
First submitted
18 Aug 2015
Last updated
1 Oct 2019
Data monitoring committee
Yes

Publications

  • Rabe KF, Nair P, Brusselle G, Maspero JF, Castro M, Sher L, Zhu H, Hamilton JD, Swanson BN, Khan A, Chao J, Staudinger H, Pirozzi G, Antoni C, Amin N, Ruddy M, Akinlade B, Graham NMH, Stahl N, Yancopoulos GD, Teper A. Efficacy and Safety of Dupilumab in Glucocorticoid-Dependent Severe Asthma. N Engl J Med. 2018 Jun 28;378(26):2475-2485. doi: 10.1056/NEJMoa1804093. Epub 2018 May 21.

    PubMed 29782224

  • Sher LD, Passalacqua G, Taille C, Cohn L, Daizadeh N, Pandit-Abid N, Soler X, Khodzhayev A, Jacob-Nara JA, Deniz Y, Rowe PJ, Nag A, Zhang Y. The long-term effect of dupilumab on dyspnea, sleep, and activity in oral corticosteroid-dependent severe asthma. Ann Allergy Asthma Immunol. 2023 Mar;130(3):298-304. doi: 10.1016/j.anai.2022.12.002. Epub 2022 Dec 9.

    PubMed 36509407

  • Berger P, Menzies-Gow A, Peters AT, Kuna P, Rabe KF, Altincatal A, Soler X, Pandit-Abid N, Siddiqui S, Jacob-Nara JA, Deniz Y, Rowe PJ. Long-term efficacy of dupilumab in asthma with or without chronic rhinosinusitis and nasal polyps. Ann Allergy Asthma Immunol. 2023 Feb;130(2):215-224. doi: 10.1016/j.anai.2022.11.006. Epub 2022 Nov 7.

    PubMed 36356712

  • Lugogo N, Mohan A. Are We Poised to Change the Trajectory of Maintenance Oral Corticosteroid Use in Severe Asthma in the Age of Biologics? Chest. 2022 Jul;162(1):4-5. doi: 10.1016/j.chest.2022.04.004. No abstract available.

    PubMed 35809937

  • Wechsler ME, Klion AD, Paggiaro P, Nair P, Staumont-Salle D, Radwan A, Johnson RR, Kapoor U, Khokhar FA, Daizadeh N, Chen Z, Laws E, Ortiz B, Jacob-Nara JA, Mannent LP, Rowe PJ, Deniz Y. Effect of Dupilumab on Blood Eosinophil Counts in Patients With Asthma, Chronic Rhinosinusitis With Nasal Polyps, Atopic Dermatitis, or Eosinophilic Esophagitis. J Allergy Clin Immunol Pract. 2022 Oct;10(10):2695-2709. doi: 10.1016/j.jaip.2022.05.019. Epub 2022 May 28.

    PubMed 35636689

  • Domingo C, Maspero JF, Castro M, Hanania NA, Ford LB, Halpin DMG, Jackson DJ, Daizadeh N, Djandji M, Mitchell CP, Crikelair N, Jacob-Nara JA, Deniz Y, Rowe PJ, Ortiz B. Dupilumab Efficacy in Steroid-Dependent Severe Asthma by Baseline Oral Corticosteroid Dose. J Allergy Clin Immunol Pract. 2022 Jul;10(7):1835-1843. doi: 10.1016/j.jaip.2022.03.020. Epub 2022 Apr 8.

    PubMed 35398549

  • Sher LD, Wechsler ME, Rabe KF, Maspero JF, Daizadeh N, Mao X, Ortiz B, Mannent LP, Laws E, Ruddy M, Pandit-Abid N, Jacob-Nara JA, Gall R, Rowe PJ, Deniz Y, Lederer DJ, Hardin M. Dupilumab Reduces Oral Corticosteroid Use in Patients With Corticosteroid-Dependent Severe Asthma: An Analysis of the Phase 3, Open-Label Extension TRAVERSE Trial. Chest. 2022 Jul;162(1):46-55. doi: 10.1016/j.chest.2022.01.071. Epub 2022 Feb 22.

    PubMed 35217003

  • Tohda Y, Matsumoto H, Miyata M, Taguchi Y, Ueyama M, Joulain F, Arakawa I. Cost-effectiveness analysis of dupilumab among patients with oral corticosteroid-dependent uncontrolled severe asthma in Japan. J Asthma. 2022 Nov;59(11):2162-2173. doi: 10.1080/02770903.2021.1996596. Epub 2021 Dec 8.

    PubMed 34752208

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Dupilumab, Oral corticosteroid therapy (prednisone/prednisolone) and Inhaled corticosteroid (ICS) therapy in people with Asthma, run by Sanofi at 80 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 5 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: finished, as of the sponsor's last update on 1 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 80 sites in Ukraine, United States, Romania, Canada, Italy 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 23 Oct 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?

Percentage Reduction From Baseline in Oral Corticosteroids (OCS) Dose at Week 24 While Maintaining Asthma Control (time frame: Baseline, Week 24). The study lists 2 primary outcomes in all. 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 NCT02528214, which also lists 8 linked publications.

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 1 Oct 2019.

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