A STUDY OF LEBRIKIZUMAB IN PATIENTS WITH SEVERE ASTHMA WHO DEPEND ON ORAL CORTICOSTEROIDS.

• Register: EUCTR
• Last refreshed on: 8 May 2017
• Main ID: EUCTR2012-000190-24-PL
• Date of registration: 18/02/2015
• Prospective Registration: Yes
• Primary sponsor: F. Hoffmann-La Roche Ltd
• Public title: A STUDY OF LEBRIKIZUMAB IN PATIENTS WITH SEVERE ASTHMA WHO DEPEND ON ORAL CORTICOSTEROIDS.
• Scientific 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. -
• Date of first enrolment: 12/04/2015
• Target sample size: 225
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2012-000190-24
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: yes Other trial design description: Active treatment extension (ATE) and Long term active treatment extension (LTE) If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 3
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Australia, Belgium, Bulgaria, Canada, Chile, Czech Republic, Denmark, France, Mexico, Netherlands, New Zealand, Poland, Puerto Rico, Slovakia, Slovenia, Spain, United Kingdom, United States

Contacts

• Name: Trial Information Support Line-TISL
• Affiliation: F. Hoffmann-La Roche Ltd

• Name: Trial Information Support Line-TISL
• Affiliation: F. Hoffmann-La Roche Ltd

Key inclusion & exclusion criteria

Inclusion criteria:
- Patients, age 12-75 years at the time of informed consent

- Severe asthma despite intensive follow-up by an asthma specialist for at least 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 mcg beclomethasone dipropionate daily 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 oral corticosteroids (prednisone/prednisolone) for at least 6 months prior to Visit 1

- Assessment to ensure diagnosis of refractory asthma and oral corticosteroid (prednisone/prednisolone) dependence on minimal effective or maximum tolerated dose prior to Visit 1 with compliance
Are the trial subjects under 18? yes
Number of subjects for this age range: 15
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 190
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion criteria:
- 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

- 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 IV or 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 >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 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 alive, attenuated vaccine throughout the study


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Asthma
MedDRA version: 18.1 Level: PT Classification code 10003553 Term: Asthma System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders

Intervention(s)

Product Name: lebrikizumab
Product Code: RO5490255/F01-02
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: LEBRIKIZUMAB
Current Sponsor code: RO5490255
Other descriptive name: TNX-650, rhuMAb anti-IL13, aIL-13, MILR1444A
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 125-
Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe
Route of administration of the placebo: Subcutaneous use

Primary Outcome(s)

Secondary Objective: • To assess the efficacy of lebrikizumab compared with placebo as measured by asthma exacerbation rate, lung function, fraction of exhaled nitric oxide (FeNO).

Main Objective: • To evaluate the efficacy of lebrikizumab compared with placebo as measured by the ability of patients to achieve lower daily doses of oral corticosteroids (OCS; prednisone/prednisolone) while maintaining control of their asthma
• To evaluate periostin as a predictive biomarker to select patients most likely to receive benefit from lebrikizumab therapy
• To evaluate the safety and tolerability of lebrikizumab compared with placebo.

Timepoint(s) of evaluation of this end point: from baseline to week 44

Primary end point(s): Relative change in daily oral corticosteroids dose

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: 1. week 44
2. from baseline to Week 44
3. from week 12 to week 44
4. from baseline to week 44
5-7. 44 weeks

Secondary end point(s): 1. Percentage of patients achieving at least a 50% reduction in their daily oral corticosteroid dose relative to baseline

2. Percentage of patients discontinuing oral corticosteroid therapy or having achieved an adrenal maintenance dose


3.Relative change in average oral corticosteroids dose during the oral corticosteroids reduction phase

4. Absolute change in daily oral corticosteriods dose

5. Rate of asthma exacerbations during the stable treatment phase and
oral corticosteroids reduction phase (DBPC period)

6. Incidence and frequency of treatment-emergent adverse events
during the stable treatment phase and oral corticosteroids reduction
phase

7. Severity of treatment-emergent adverse events during the stable treatment phase and oral corticosteroids reduction phase

Secondary ID(s)

2012-000190-24-GB

NCT01987492

WB28182

Source(s) of Monetary Support

F. Hoffmann-La Roche Ltd