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A Phase 2a Study to Evaluate the Effects of Sirukumab in Subjects With Severe Poorly Controlled Asthma | Clinical Trials | Clareo Health

WITHDRAWNPHASE2

A Phase 2a Study to Evaluate the Effects of Sirukumab in Subjects With Severe Poorly Controlled Asthma

205076: A Phase II, Multicenter, Randomized, Double-blind (Sponsor-unblind), Placebo- Controlled, Parallel Group Trial to Evaluate the Efficacy and Safety of Sirukumab in Subjects With Severe, Poorly Controlled Asthma

NCT02794519•GlaxoSmithKline

View on ClinicalTrials.gov

Summary

Sirukumab is a fully human anti interleukin (IL)-6 immunoglobulin G1-kappa monoclonal antibody (MAb) which is in development for the treatment of rheumatoid arthritis (RA). The continuing unmet need in subjects with asthma refractory to corticosteroid therapy and increased understanding of asthma pathogenesis have stimulated the development of targeted biologics based on predictive biomarkers. The majority of approaches to date have targeted T Helper 2 (Th2) cytokines or their downstream effects. Targeting IL-6 in severe asthma represents an unprecedented approach that has potential to address non-Th2 drivers of severe asthma. This multicenter, randomized, double-blind (sponsor-unblind), placebo-controlled, parallel group study will investigate the efficacy of sirukumab compared to placebo in subjects having uncontrolled severe asthma despite use of high dose inhaled corticosteroid (ICS) in combination with long-acting Beta-agonist (LABA). The study will employ a variable treatment period for individual subjects. Dosing will continue every 4 weeks until week 44 (inclusive), or until 24 weeks after the final subject has been randomized, whichever the sooner. Upon receiving the final dose of study medicine or placebo, subjects will enter a 16 week Follow Up period. Overall, the duration of participation for subjects who complete the full 44-week treatment period and Follow Up period may be up to 64 weeks. Approximately 175 subjects will be randomized such that 140 evaluable subjects complete the study.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Subjects aged 18 - 75 years, inclusive.
•Severe, uncontrolled asthma according to the following criteria: Physician-diagnosed asthma for \>=12 months, and; treatment for at least 3 months with \>=880 microgram per day of fluticasone propionate (FP) dry powder for inhalation (DPI) or its equivalent, plus a long acting beta agonist (LABA), and' ACQ-7 score \>=1.5, and; a documented history (e.g., medical record verification) in the 12 months prior to Visit 2 of \>=1 exacerbation resulting in prescription for systemic oral corticosteroids or hospitalisation or extended observation in a hospital emergency room or outpatient centre. \[For subjects on maintenance systemic corticosteroids, at least double the existing maintenance dose for at least 3 days is required\] and; pre-bronchodilator FEV1 35-80% inclusive, with evidence of \>=12% (and 200 milliliter \[mL\]) reversibility in FEV1 measured 15-30 minutes following 4 actuations of salbutamol (100 microgram per actuation) or albuterol (90 microgram per actuation) via pre-metered dose inhaler (pMDI). This reversibility criterion should have been documented in the 12-months prior to Screening. If no prior data are available this should be demonstrated either at Screening (Visit 2) or at the Randomization visit (Visit 3); blood eosinophil count \<300 cells per microliter at screening.
•Body mass index 18-45 kilogram per meter square.
•Male or Females and Male subjects with female partners of child bearing potential must comply with the following contraception requirements from the time of first dose of study medication until a cycle of spermatogenesis following five terminal half- lives after the last dose of study medication: Vasectomy with documentation of azoospermia; Male condom plus partner use of one of the following contraceptive options: Contraceptive subdermal implant; Intrauterine device or intrauterine system; Combined estrogen and progestogen oral contraceptive; Injectable progesterone; Contraceptive vaginal ring; Percutaneous contraceptive patches.
•This is an all-inclusive list of those methods that meet the following GlaxoSmithKline (GSK) definition of highly effective: having a failure rate of less than 1% per year when used consistently and correctly and, when applicable, in accordance with the product label. For non-product methods (e.g., male sterility), the investigator determines what is consistent and correct use. The GSK definition is based on the definition provided by The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH).
•The investigator is responsible for ensuring that subjects understand how to properly use these methods of contraception.
•A female subject is eligible to participate if she is of non-child bearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as age greater than 60 or 12 months of spontaneous amenorrhea with an appropriate clinical profile \[in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) \>40 milliinternational units per milliliter (MlU/mL) and estradiol \<40 picogram per milliliter (pg/mL) (\<140 picomole per liter \[pmol/L\] is confirmatory) or if of child-bearing potential is using a highly effective method for avoidance of pregnancy for the duration of dosing and until 4 months post last-dose.
•Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.

Exclusion Criteria

•Presence of a known pre-existing, clinically important lung condition other than asthma. This includes chronic obstructive pulmonary disease (COPD), bronchiectasis, pulmonary fibrosis, bronchopulmonary aspergillosis, or a history of lung cancer.
•Lower respiratory tract infection (LRTI) or asthma exacerbation requiring antibiotics or systemic corticosteroids within 6 weeks of screening.
•Evidence of respiratory infection at screening.
•Has a history of chronic or recurrent infectious disease or ongoing infection including, but not limited to, chronic renal infection, chronic chest infection, recurrent urinary tract infection (example, recurrent pyelonephritis, chronic non-remitting cystitis), or open, draining skin wound or an ulcer.
•Serious infection within 8 weeks of enrolment, including, but not limited to hepatitis, pneumonia, sepsis, or pyelonephritis; or has been hospitalized for an infection; or has been treated with intravenous (IV) antibiotics for an infection, within 8 weeks prior to the first administration of study drug.
•Opportunistic infection, example, a nontuberculous mycobacterial infection or cytomegalovirus, pneumocystosis, aspergillosis within 6 months prior to screening.
•Evidence of poorly controlled chronic medical conditions other than asthma, example, subjects with known, pre-existing, clinically significant endocrine, autoimmune, metabolic, neurological, renal, gastrointestinal, hepatic, and haematological or any other system abnormalities that are uncontrolled with standard treatment.
•Current history of suicidal ideation or a past history of suicide attempt.
•Lactating, pregnant, or planning to become pregnant during the study.
•Malignancy within 5 years (except local basal cell carcinoma, or fully excised local dermal, squamous cell carcinoma).
+20 more criteria

Locations (8)

GSK Investigational Site

Long Beach, California, United States

GSK Investigational Site

Aventura, Florida, United States

GSK Investigational Site

Cincinnati, Ohio, United States

GSK Investigational Site

Richmond, Virginia, United States

GSK Investigational Site

Richmond, Virginia, United States

GSK Investigational Site

Alcorcón (Madrid), Spain

GSK Investigational Site

Girona, Spain

GSK Investigational Site

Santiago de Compostela. La Coruña., Spain

Key Dates

Start Date

September 23, 2016

Primary Completion Date

October 4, 2016

Completion Date

October 4, 2016

Last Updated

August 31, 2018

Conditions

Asthma

Interventions

Sirukumab

DRUG

Placebo

DRUG

Rescue medication

DRUG

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Asthma

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 31, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

A Phase 2a Study to Evaluate the Effects of Sirukumab in Subjects With Severe Poorly Controlled Asthma

Inclusion Criteria

Exclusion Criteria

NHALES (Natural History of Asthma With Longitudinal Environmental Sampling)

A Study to Evaluate Brenipatide Compared With Placebo in Adult Participants With Uncontrolled Moderate to Severe Asthma

Blood Eosinophil Guided Versus Usual Care In The Management Of Mild To Moderate Asthma at Primary Care (BEAM)

Relationship of Airway Microbiota, Endotype and Phenotype in Adult Asthma

To Assess the Management of Patients on Global Initiative of Asthma (GINA) Step 4 and 5 Treatment in Hong Kong

A Study to Investigate Efficacy and Safety of PT027 Compared With PT007 in Symptomatic Chinese Adults With Asthma