A prospective, randomised, double-blind, placebo-controlled, parallel group dose ranging study in asthma patients in Iceland to assess the safety, tolerability and efficacy of the MLK inhibitor, CEP-1347

Phase 1

• Conditions: Asthma

• Registration Number: EUCTR2004-002812-27-IS
• Lead Sponsor: deCODE genetics ehf.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-04-18
• Last Update Posted: 17 October 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

The criteria listed below will be assessed at Visit 1 unless stated otherwise. Laboratory measurements to be performed require an overnight fasting =8 hours in duration.

1.Age =18 years and =75 years.
2.Carrier of MAP3K9 haplotype (based on results of previous deCODE genetics’ studies, to be confirmed by analysis of a blood sample collected at Visit 2).
3.Physician diagnosis of persistent mild, moderate or severe asthma as defined by the NIH 1997 guidelines.
4.Lung function measurements (spirometry, airway challenge test or peak expiratory flow (PEF) reading) consistent with the diagnosis of mild persistent, moderate or severe asthma.
5.Confirmed airway reversibility of ?12% FEV1 using a ß-adrenergic agonist and/or positive metacholine airway challenge test (=8 µg/ml). In selective cases, the screening physician can omit this requirement if prior medical history indicates significant reactive airway disease.
6.FEV1 values =45% of predicted value at baseline.
7.Regular use of inhaled glucocorticoid drugs (such as budesonide, fluticasone, mometasone, beclomethasone) with or without long-term beta-agonist drugs (such as salmeterol or formoterol) in accordance with standard practice of care.
8. Males and post-menopausal women are not required to use contraception. Only those women of childbearing potential willing to use two adequate methods of contraception or willing to abstain from heterosexual activity throughout the study, starting with Visit 1 and for 14 days after the last dose of study medication are eligible for the study. Refer to section 13.6.2 for information on adequate contraceptive methods.
Note: Women of childbearing potential are defined as premenopausal, not having had surgical sterilisation (hysterectomy or bilateral tubal ligation or bilateral oophorectomy). Postmenopausal status is defined as =45 years of age with >2 years since last menses.
9.Signed and dated informed consent form prior to any protocol specific procedures.
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Individuals are excluded from participation in the study if they meet any of the following criteria at Visit 1:

1.Confirmed diagnosis of chronic obstructive pulmonary disease (COPD).
2.Subject unable to perform acceptable spirometry and peak flow measurements.
3.Any experimental treatment within 2 months of screening or planned for the following 3 months.
4.Smoking history =15 pack-years and any smoker who has smoked within the previous 6 months.
5.Recent severe exacerbation of asthma (4 weeks).
6.Abnormal liver function tests (LFTs), including ALT >3×ULN; AST >3×ULN; bilirubin >2×ULN.
7.Serum creatinine >1.8×ULN.
8.Oral corticosteroids within the previous 4 weeks.
9.Active infection requiring antibiotic therapy within the past 2 weeks.
10.Subjects receiving desensitisation immunotherapy.
11.Immunocompromised subjects, including subjects known to be HIV positive.
12.Subjects known to have positive serology results for HBsAg, HCV Ab.
13.Major surgery within 6 weeks of study entry.
14. Patients with any history of seizure disorders or posttraumatic epilepsy.
15.Subjects not willing to adhere to restrictions of alcohol use for the duration of the study (=3 units of alcohol/day or =15 units of alcohol/week and no alcohol for 24 hours prior to clinic visits).
Note: A unit of alcohol is defined as a single measure of spirit (25 ml), one small glass of sherry or fortified spirit (50 ml), one small glass of wine (125 ml) or one small regular strength beer (330 ml, 4-5%).
16.Known or suspected hypersensitivity to any component of the study medication, including placebo.
17.Any other major intercurrent illness and other condition which, in the investigator’s judgement, will interfere with the subject’s participation in this study.
18.Pregnant or lactating women.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified