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AsthmaPhase 2NCT01987492

A Study of Lebrikizumab (RO5490255) in Participants With Severe Oral Corticosteroids (OCS) Dependent Asthma

A Phase 2 study testing Lebrikizumab in people with Asthma, run by Hoffmann-La Roche at 71 sites in 16 countries.

Completed

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

Official record
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Trial summary

This randomized, multicenter, double-blind, placebo-controlled, parallel-group study will evaluate the efficacy of lebrikizumab compared with placebo, as measured by the ability of participants to achieve lower daily doses of OCS, among those with severe corticosteroid-dependent asthma. Read more about this study

Who is it for?
Ages 12 to 75 years
Conditions the study is for
Asthma
What is being tested?
Lebrikizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
230 participants
Where
71 sitesin 16 countries
Study dates
28 Feb 2014to 20 Dec 2016
Phase
Phase 2
Are there results?
None posted in the registry

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 to 75 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Severe asthma despite intensive follow-up by an asthma specialist for >/=6 months prior to Visit 1
  • Baseline forced expiratory volume in 1 second (FEV1) >/=40% of predicted prior to randomization
  • Receiving high doses of inhaled glucocorticosteroids at a total daily dose of >/=1500 micrograms (mcg) beclomethasone dipropionate or equivalent and long-acting beta-adrenoceptor agonist (LABA), with or without an additional controller, for at least 3 months prior to Visit 1
  • Chronic treatment with maintenance OCS for >/=6 months prior to Visit 1
  • Assessment to ensure diagnosis of refractory asthma and OCS dependence on minimal effective or maximum tolerated dose prior to Visit 1 with compliance

Who cannot join

  • History of a severe allergic reaction or anaphylactic reaction to a biologic agent or known hypersensitivity to any component of the lebrikizumab injection
  • Asthma exacerbation within 28 days prior to Visit 1 or during screening (prior to Visit 3)
  • For adults: Active tuberculosis requiring treatment within the 12 months prior to Visit 1
  • For adolescents: History of active tuberculosis requiring treatment
  • Evidence of acute or chronic hepatitis or known liver cirrhosis
  • Known current malignancy or current evaluation for a potential malignancy
Show all 14Show fewer
  • History of interstitial lung disease, chronic obstructive pulmonary disease, or other clinically significant lung disease other than asthma
  • Infection requiring hospital admission or requiring treatment with intravenous (IV) or intramuscular (IM) antibiotics within 4 weeks prior to Visit 1 or during screening
  • Upper or lower respiratory tract infection within 4 weeks prior to Visit 1 or during screening
  • Active parasitic infection or Listeria monocytogenes infection within 6 months prior to Visit 1 or during screening
  • Current smoker or former smoker with a smoking history of more than 15 pack-years
  • Current use of an immunomodulatory/ immunosuppressive therapy or past use within 3 months or 5 drug half-lives (whichever is longer) prior to Visit 1
  • Use of a licensed or investigational monoclonal antibody other than anti-interleukin (IL)-13 or anti-IL-4/IL-13, including but not limited to, omalizumab, anti-IL-5, or anti-IL-17, within 6 months or 5 drug half-lives (whichever is longer) prior to Visit 1
  • Receipt of a live attenuated vaccine within the 4 weeks prior to Visit 1 during screening or anticipation of receipt of a live attenuated vaccine throughout the study

Trial locations and contacts

71 sites in 16 countries.

71 sites in 16 countries

United Kingdom14 sites

  • Belfast City Hospital; Respiratory Department

    Belfast, BT9 7AB

  • Heartlands Hospital; Respiratory Department

    Birmingham, B9 5SS

  • Gartnavel General Hospital; Respiratory Department

    Glasgow, G12 0YN

  • New Lister Buliding, Level 1; Clinical Research Facility

    Glasgow, G31 2ER

  • Royal Hospital For Children

    Glasgow, G51 4TF

  • Southampton General Hospital; Respiratory Department

    Hampshire, SO16 6YD

  • Leicester Royal Infirmary NHS Trust

    Leicester, LE1 5WW

  • Glenfield Hospital; Respiratory -Allergy Unit

    Leicester, LE3 9QP

  • St Bartholomew's Hospital (Barts); Respiratory Department

    London, EC1A 7BE

  • Royal Brompton Hospital; Respiratory Department

    London, SW3 6NP

  • Wythenshawe Hospital; North West Lung Research Centre

    Manchester, M23 9LT

  • Freeman Hospital; Respiratory Department

    Newcastle upon Tyne, NE7 7DN

  • Derriford Hospital; The Lind Research Department

    Plymouth, PL6 8DH

  • Sheffield Clinical Research Facility; National Institute for Health Research

    Sheffield, S10 2JF

Other trials in United Kingdom

United States9 sites

  • Georgia Pollens

    Albany, Georgia, 31707

  • Kern Allergy Med Clinic, Inc.

    Bakersfield, California, 93301

  • Pioneer Research Solutions

    Houston, Texas, 77008

  • Allergy & Asthma Care Center of Southern California

    Long Beach, California, 90808

  • Metroplex Pulmonology & Sleep Center

    McKinney, Texas, 75069

  • South Florida Research Center, Inc.

    Miami, Florida, 33135

  • Mount Sinai Medical Center

    New York, New York, 10029

  • Pulmonary Consultants PLLC

    Tacoma, Washington, 98405

  • Allergy & Immunology

    Tulsa, Oklahoma, 74136

Other trials in United States

France9 sites

  • CHU de Grenoble - Hôpital André Michallon

    Grenoble, 38043

  • CH de Bicetre; Pneumologie

    Le Kremlin-Bicêtre, 94275

  • Hôpital de La Croix Rousse

    Lyon, 69004

  • Hôpital Arnaud de Villeneuve

    Montpellier, 34295

  • CHU Nantes - Hôpital Laennec; Service de Pneumologie

    Nantes, 44093

  • CHU de Nice

    Nice, 06001

  • Hopital Bichat Claude Bernard ; Service de Pneumologie

    Paris, 75877

  • CHU de Haut Leveque

    Pessac, 33604

  • Nouvel Hôpital Civil; Pôle de Pathologie Thoracique

    Strabourg, 67091

Other trials in France

Poland7 sites

  • Specjalistyczny Osrodek Alergologiczno-Internistyczny ALL-MED

    Krakow, 31-024

  • Malopolskie Centrum Alergologii

    Krakow, 31-624

  • SPZOZ Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego Uniwersytetu Medycznego w Lodzi

    Lodz, 90-153

  • Specjalistyczna Poradnia Pulmonologiczna

    Ostrów Wielkopolski, 63-400

  • Niepubliczny Zaklad Opieki Zdrowotnej PROFILAKTYKA Wladyslaw Pierzchala

    Ruda Śląska, 41-707

  • Klinika Chorób Wewnetrznych i Alergologii MSW

    Warsaw, 02-507

  • EMC Instytut Medyczny SA; Przychodnia przy ulicy Łowieckiej

    Wroclaw, 50-220

Other trials in Poland

Spain5 sites

  • Hospital de la Santa Creu; i Sant Pau

    Barcelona, 08025

  • Hospital Clinic de Barcelona

    Barcelona, 08036

  • Hospital Clinico Universitario de Salamanca; Servicio de Neumologia

    Salamanca, 37007

  • Complejo Hospitalario Universitario de Santiago; Servicio de Neumología

    Santiago de Compostela, La Coruña, 15706

  • Hospital Universitario Doctor Peset

    Valencia, 46017

Other trials in Spain

Czechia4 sites

  • Hornmed

    Brno, 618 00

  • Nemocnice Liberec; KNL a.s. - TRN

    Liberec, 460 63

  • Nemocnice Nový Jičín

    Nový Jičín, 741-01

  • Rokycanska nemocnice

    Rokycany, 337 22

Other trials in Czechia

New Zealand4 sites

  • NZ Respiratory & Sleep Institute

    Auckland, 1051

  • Dunedin Hospital

    Dunedin

  • Clinical Trials Unit, Bay of Plenty District Health Board

    Tauranga, 3143

  • Medical Research Inst. of New Zealand; Respiratory

    Wellington

Other trials in New Zealand

Australia3 sites

  • Princess Alexandra Hospital, Department of Respiratory and Sleep Medicine

    Brisbane, Queensland, 4102

  • Monash Medical Centre; Respiratory and Sleep Medicine

    Clayton, Victoria, 3168

  • Institute for Respiratory Health Inc

    Nedlands, Western Australia, 6009

Other trials in Australia

Belgium3 sites

  • Clin Univ de Bxl Hôpital Erasme

    Brussels, 1070

  • Longartsenpraktijk

    Genk, 3600

  • UZ Gent

    Ghent, 9000

Other trials in Belgium

Mexico3 sites

  • Instituto Jalisciense de Investigacion Clinica S.A. de C.V.

    Guadalajara, 44100

  • Centro Investigacion Medico Biologica y Terapia Avanzada

    Guadalajara, 44130

  • Centro Integral Médico SJR SC

    Querétaro, 76800

Other trials in Mexico

Netherlands3 sites

  • Academisch Medisch Centrum; Afdeling Longziekten, F5-258

    Amsterdam, 1105 AZ

  • Spaarne Ziekenhuis Hoofddorp; Long Geneeskunde

    Hoofddorp, 2134 TM

  • Antonius Ziekenhuis; Dept of Lung Diseases

    Nieuwegein, 3435 CM

Other trials in Netherlands

Puerto Rico2 sites

  • San Juan Bautista School of Medicine-Clinical Research Unit

    Caguas, 00725

  • Advanced Medical Concepts, PSC

    Cidra, 00739

Other trials in Puerto Rico

Slovakia2 sites

  • ZAPA JJ Sro

    Levice, 934 01

  • Plucna ambulancia

    Spišská Nová Ves, 052 01

Other trials in Slovakia

Canada1 site

  • Inspiration Research Limited

    Toronto, Ontario, M5T 3A9

Other trials in Canada

Denmark1 site

  • Gentofte Hospital, Klinik for Allergi

    Hellerup, 2900

Other trials in Denmark

Slovenia1 site

  • University Clinic of Pulmonary and Allergic Diseases Golnik

    Golnik, 4204

Other trials in Slovenia

About this study

Official title: A Phase II, Randomized, Double-Blind, Placebo Controlled, Multicenter Trial to Assess the Oral Corticosteroid-Sparing Effect of Lebrikizumab in Patients With Severe Corticosteroid Dependent Asthma

This randomized, multicenter, double-blind, placebo-controlled, parallel-group study will evaluate the efficacy of lebrikizumab compared with placebo, as measured by the ability of participants to achieve lower daily doses of OCS, among those with severe corticosteroid-dependent asthma. Prednisone/prednisolone will be the OCS therapy prescribed. Participants will be randomized to receive lebrikizumab or matching placebo for 44 weeks in a double-blind, placebo-controlled (DBPC) period. Those who complete the 44-week period may continue into a 32-week active treatment extension (ATE) period, during which all participants will receive lebrikizumab treatment. Following completion of the ATE period, participants who have both tolerated and derived benefit from treatment with lebrikizumab may continue their lebrikizumab treatment into a long-term extension (LTE) period. Participants will transition to 24 weeks of safety follow-up upon discontinuation of study drug.

Conditions
Asthma
Being tested
Lebrikizumab, Placebo
Medical subject headings
Asthma

What participants receive

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

  • LebrikizumabDrug

    Also called RO5490255

    Lebrikizumab will be administered as SC injections every 4 weeks at dose and schedule described in arm description.

  • PlaceboDrug

    Placebo matching to lebrikizumab will be administered as SC injections every 4 weeks as per schedule described in arm description.

Study groups in NCT01987492
Study groupRoleWhat they receive
Lebrikizumab High DoseExperimentalParticipants will receive lebrikizumab at high dose level as subcutaneous (SC) injection every 4 weeks during the 44-week DBPC period, followed by a 32-week ATE period, and during the LTE period.
Receives: Drug: Lebrikizumab
Lebrikizumab Low DoseExperimentalParticipants will receive lebrikizumab at low dose level as SC injection every 4 weeks during the 44-week DBPC period, followed by a 32-week ATE period, and during the LTE period.
Receives: Drug: Lebrikizumab
PlaceboPlacebo comparatorParticipants will receive placebo matching to lebrikizumab SC injection every 4 weeks during the 44-week DBPC period. Participants will then be randomized to receive either high- or low-dose lebrikizumab every 4 weeks during the 32-week ATE period and will continue same treatment in the LTE period.
Receives: Drug: Lebrikizumab; Drug: Placebo

What is being measured

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

  1. Relative Change From Baseline in Daily OCS Dose at Week 44

    Measured: Baseline, Week 44

Secondary outcomes (8)

  1. Absolute Change From Baseline in Daily OCS Dose at Week 44

    Measured: Baseline, Week 44

  2. Relative Change From Week 12 in Average OCS Dose at Week 44

    Measured: Week 12, Week 44

  3. Percentage of Participants Achieving at Least a 50 percent (%) Reduction in Their Daily OCS Dose at Week 44 Relative to Baseline

    Measured: Baseline, Week 44

  4. Percentage of Participants Discontinuing OCS Therapy or Having Achieved an Adrenal Maintenance Dose at Week 44

    Percentage of participants discontinuing OCS therapy or having achieved adrenal maintenance dose (cortisol level less than or equal to 100 nanomoles per liter) will be reported.

    Measured: Week 44

  5. Percentage of Participants With Asthma Exacerbations

    An asthma exacerbation is defined as new or increased asthma symptoms (including wheeze, cough, dyspnea, chest tightness, or nocturnal awakenings due to these symptoms) that lead to treatment with systemic corticosteroids greater than or equal to (>/=) 30 milligrams (mg) or 0.5 mg per kilogram (kg) for >/=3 consecutive days or to hospitalization.

    Measured: Baseline up to Week 44

  6. Percentage of Participants With Adverse Events

    Measured: Baseline up to 24 weeks after last dose administration (up to a minimum of approximately 2 years)

  7. Percentage of Participants With Anti-therapeutic Antibodies (ATAs) Against Lebrikizumab

    Measured: Predose (0 hours) at Weeks 0, 4, 12, 24, 36, 44, 52, 64, and 76, at early discontinuation (up to a minimum of approximately 2 years), and at 24 weeks after last dose administration (up to a minimum of approximately 2 years)

  8. Minimum Observed Serum Lebrikizumab Concentration (Cmin)

    Measured: Predose (0 hours) at Weeks 4, 12, 24, 36, and 44

Timeline

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

  1. First posted19 Nov 2013 (estimated)
  2. Study start28 Feb 2014
  3. Primary completion20 Dec 2016
  4. Study completion20 Dec 2016

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
230 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01987492
Sponsor's protocol ID
WB28182
Other IDs
2012-000190-24
Status last verified
May 2017
First submitted
12 Nov 2013
Last updated
22 May 2017
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Lebrikizumab in people with Asthma, run by Hoffmann-La Roche at 71 sites in 16 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 14 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 22 May 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 71 sites in United Kingdom, United States, France, Poland, Spain and 11 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Relative Change From Baseline in Daily OCS Dose at Week 44 (time frame: Baseline, Week 44). 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 NCT01987492.

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 22 May 2017; AzTrials last refreshed its copy on 8 Nov 2026.

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