Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:23 PM
Ignite Modification Date:
2025-12-24 @ 10:23 PM
NCT ID:
NCT07191535
Eligibility Criteria:
Inclusion Criteria:
* Patients aged 18 - 85 years at the time of signing informed consent
* Patient is able to provide written informed consent.
* Documented physician´s diagnosis of Type 2 high asthma, as per the Global Initiative for Asthma (GINA) 2023 guideline 2023 at Screening.
* Patients with existing treatment with at least low to medium doses of ICS therapy in combination with LABA as a second controller for at least 90 days and a stable/optimized dose ≥30 days prior to Day 1. Patients on triple therapy with a long-acting muscarinic antagonist (LAMA) will be excluded.
* An ACQ score ≥ 1.5 at Screening.
* Patients with a pre-bronchodilator FEV1 value of 40% to 80% of the patient's predicted value at Screening.
* Patients must have experienced at least once, within 2 years prior to Screening, one of the following asthma exacerbation events: Treatment with a systemic steroid (oral or parenteral) for worsening asthma. Hospitalization or emergency medical care visit for worsening asthma.
* Males with a partner of childbearing potential must use a condom for the duration of study treatment and at least 96 hours after discontinuing the study drug.
* Female patients of childbearing potential (including those \< 1 year post-menopausal) must use a highly effective method of contraception per Clinical Trial Facilitation Group (CTFG) recommendation during the conduct of the study and for 30 days after the last dose of study drug. Highly effective contraceptive measures for female patients of childbearing potential include: combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: oral, intravaginal, transdermal. Progestogen-only hormonal contraception associated with inhibition of ovulation: oral, injectable, implantable. intrauterine device (IUD), intrauterine hormone-releasing system (IUS), bilateral tubal occlusion, vasectomized partner (when partner is the sole sexual partner of the female patient and when the partner has received medical assessment of the surgical success), sexual abstinence.
* Women not of childbearing potential are defined as: Post-menopausal women (defined as at least 12 months with no menses without an alternative medical cause); in women \<45 years of age, a high follicle-stimulating hormone (FSH) level in the post-menopausal range may be used to confirm a post-menopausal state in women not using hormonal contraception or hormonal replacement therapy; OR Have had a hysterectomy and/or bilateral oophorectomy, bilateral salpingectomy, or bilateral tubal ligation/occlusion at least 6 weeks prior to Screening OR Have a congenital or acquired condition that prevents childbearing.
Exclusion Criteria:
* Pregnant or breastfeeding.
* Current smoker (including vaping) or cessation of smoking within the 6 months prior to Day 1, or \> 10 pack-year history of smoking.
* Participation in another clinical trial of an investigational agent within 3 months (small molecule) / 6 months (biologics) or 5 half-lives (if known) of the agent, whichever is longer, prior to randomization.
* Evidence of COVID-19 infection at Screening, as judged by the Investigator.
* Advanced congestive heart failure \[New York Heart Association (NYHA) class 3 or 4\].
* Known hypersensitivity to any component of the formulation of linvemastat or any component of the excipient.
* Live or messenger ribonucleic acid (mRNA) vaccination within 2 weeks before Day 1 or inoculation with a live or mRNA vaccine is planned during study participation.
* History of solid organ transplant.
* Anti-immunoglobulin E (IgE) therapy \[e.g., omalizumab (Xolair®)\] within 130 days prior to Screening or any other biologic therapy \[including anti-TSLP, anti-IL-4/4R or IL-5/5R monoclonal antibodies (mAb)\] 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 Screening, whichever is longer.
* Evidence of active tuberculosis (TB) infection at Screening, as judged by the Investigator.
* Active acute or chronic psychiatric illness that, in the opinion of the Investigator, may prevent from complying with study instructions.
* Known positive history of malignancy within 5 years of Screening (with the exception of basal cell skin cancer, carcinoma in-situ of the cervix, or low-risk prostate cancer after curative therapy).
* Positive test result for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, or human immunodeficiency virus (HIV) infection at Screening.
* Concurrent emphysema.
* Use of any therapeutics that are strong inhibitors and inducers of CYP3A4 or CYP2C8 \[e.g., rifampicin, ketoconazole, phenytoin, ritonavir, macrolide antibiotics (e.g., telithromycin), and carbamazepine\].
* History of liver dysfunction, including patients with moderate (Child-Pugh B) or severe (Child-Pugh C) impairment or disordered coagulation.
* Abnormal ECG: ventricular arrhythmias (non-sustained ventricular tachycardia \[VT\], multifocal or frequent premature ventricular contractions, clinically significant bundle branch block or axis deviation \[as assessed by PI\], or abnormal Q waves). In the case of a corrected QT interval using Fridericia's formula (QTcF) interval \>450 ms (men) or \>480 ms (women; patients with bundle branch block) or PR (P to QRS) interval outside the range of 120 to 220 ms, the assessment may be repeated once for eligibility determination at Screening or Baseline.
* Known uncontrolled hypertension or diabetes at the discretion of the Investigator.
* Any condition that required hospitalization (except for asthma exacerbation) within the 3 months prior to Day 1 or is likely to require so during the study.
* Clinically significant abnormalities in the Screening physical examination, medical history, vital signs, ECG, or clinical laboratory tests that are not known to be due to concurrent asthma in the opinion of the Investigator and Medical Monitor should preclude the patient's participation in the clinical study.
* The following laboratory parameters are excluded:
1. Hemoglobin (Hg) \<10 g/dL (100 g/L)
2. White blood cells (WBC) \< 3000/μL (\< 3000/mm3). African American patients who are known to have low WBC of \< 3000/μL but ≥ 1500/μL will be eligible.
3. Platelet count \< 70,000/μL (70,000/mm3)
4. Serum creatinine \> 1.5 x upper limit of normal (ULN)
5. Glomerular filtration rate ≤ 60 mL/min/1.73 m2 or evidence of acute kidney injury or history of severe hypersensitivity reactions to gadolinium-based contrast agents
6. Serum total bilirubin \> 1.5 ULN
7. Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 2 x ULN or serum alkaline phosphatase \> 2 x ULN
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT07191535
Study Brief:
Protocol Section:
NCT07191535