EUCTR2021-002490-26-ESActive, not recruitingPhase 1
A randomized, double-blind, placebo-controlled, parallel-group, 12 week Proof-of-Concept (PoC) study to assess the efficacy, safety, and tolerability of rilzabrutinib in participants with moderate-to-severe asthma who are not well controlled on inhaled corticosteroid (ICS) plus long-acting ß2 adrenergic agonist (LABA) therapy
Sanofi aventis recherche et developpement0 sites213 target enrollmentStarted: August 5, 2021Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Enrollment
- 213
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •- A physician diagnosis of asthma for at least 12 months based on the Global Initiative for Asthma (GINA) 2018,2019, 2020 Guidelines.
- •- Participants with existing treatment with at least moderate to high doses of ICS therapy in combination with a LABA as second controller for at least 3 months with a stable dose =1 month prior to Visit 1.
- •- Participants with prebronchodilator FEV1 >40% of predicted normal at Visit 1/Screening. Prebronchodilator FEV1 =50% but =85% of predicted normal at Visit 2/Baseline.
- •- Participants with reversibility of at least 12% and 200 mL in FEV1 15 to 30 minutes after administration of 2 to 4 puffs (200-400 mcg) of albuterol/salbutamol or levalbuterol/levosalbutamol during screening or documented history of a reversibility test that meets this criteria within 12 months prior to Visit 1 or documented positive response to methacholine challenge (a decrease in FEV by 20% [PC20] of <8mg/mL) within 12 months prior to Visit 1/Screening is considered acceptable to meet this inclusion criterion.
- •- Participants must have experienced, within 2 years prior to Visit 1, any of the following asthma exacerbation events at least once: Treatment with a systemic steroid (oral or parenteral) for worsening asthma OR Hospitalization or emergency medical care visit for worsening asthma.
- •- Body mass index (BMI) =17.5 and =40 kg/m2
- •- All Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 200
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 13
Exclusion Criteria
- •- History of serious infections requiring intravenous therapy with the potential for recurrence or currently active moderate to severe infection at Screening (Grade 2 or higher) including active coronavirus disease 2019 (COVID-19).
- •- Chronic lung disease (for example, chronic obstructive pulmonary disease [COPD], or idiopathic pulmonary fibrosis [IPF]) which may impair lung function, or another diagnosed pulmonary or systemic disease associated with elevated peripheral eosinophil counts, for e.g. eosinophilic granulomatosis with polyangiitis.
- •- History of life-threatening asthma (i.e., severe exacerbation that requires intubation).
- •- Participants with any of the following events within the 4 weeks prior to their Screening Visit 1 or during the screening period: Treatment with 1 or more systemic (oral and/or parenteral) steroid bursts for worsening asthma OR Hospitalization or emergency medical care visit for worsening asthma
- •- Asthma Control Questionnaire 5-question version (ACQ-5) score <1.25 or >3.0 at V2/randomization. During the screening period an ACQ-5 of up to =4 is acceptable.
- •- Current smoker or cessation of smoking within the 6 months prior to Visit 1.
- •- Previous smoker with a smoking history >10 pack-years.
- •- Current or chronic history of liver disease.
- •- Known hepatic or biliary abnormalities.
- •- Symptomatic herpes zoster within 3 months prior to screening.
- •- Refractory nausea and vomiting, malabsorption, external biliary shunt, or significant bowel resection that would preclude adequate rilzabrutinib/placebo absorption.
- •- Conditions that may predispose the participant to excessive bleeding
- •- History of solid organ transplant.
- •- A history of malignancy of any type within 5 years before Day 1, other than surgically excised non-melanoma skin cancers or in situ cervical cancer.
- •- Is not up-to-date with recommended vaccinations per local guidelines.
- •- Anti-immunoglobulin E (IgE) therapy (e.g., omalizumab [Xolair®]) within 130 days prior to Visit 1 or any other biologic therapy (including anti-IL4/4R or IL-5/5R monoclonal antibodies [mAb]) or systemic immunosuppressant (e.g., methotrexate) to treat inflammatory disease or autoimmune disease (e.g., rheumatoid arthritis, inflammatory bowel disease, primary biliary cirrhosis, systemic lupus erythematosus, multiple sclerosis) and other diseases, within 2 months or 5 half-lives prior to Visit 1, whichever is longer.
- •- Use of inhalers other than ICSs, LABAs, and short-acting beta agonists (no LAMAs or mucolytics) and leukotriene receptor antagonists (montelukast, zafirkulast) during the study period.
- •- Participants who have received bronchial thermoplasty within 2 years prior to Visit 1 or plan to begin therapy during the screening period or the randomized treatment period.
- •- Use of proton pump inhibitor drugs such as omeprazole and esomeprazole within 3 days of Day 1.
- •- Use of known strong-to-moderate inducers or inhibitors of CYP3A within 14 days or 5 half-lives (whichever is longer) of Study Day 1 and until the end of the active treatment period.
- •- Live vaccine except Bacille Calmette Guerinn-vaccination within 28 days prior to Day 1 or plans to receive one during the trial; Calmette Guerin-vaccination within 12 months prior to Screening.
- •- COVID-19 vaccine within 14 days prior to Study Day 1.
- •- Previous use of a Bruton tyrosine kinase (BTK) inhibitor.
- •- Has received any investigational drug (or is currently using an investigational device) within the 30 days before Day 1, or at
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