EUCTR2013-002351-15-BGActive, not recruitingNot Applicable
A Phase III, Randomized, Double-Blind, Double Dummy, Multicenter Trial Comparing the Efficacy and Safety of 2 Doses of Daily Oral ONO 4641 (0.05 mg and 0.1 mg) versus Interferon-ß-1a 30 µg IM Weekly in Subjects with Relapsing-Remitting Multiple Sclerosis - Efficacy and safety of ONO-4641 versus Interferon-ß-1a in patients with multiple sclerosis
Conditions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Merck KGaA
- Enrollment
- 1,176
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •For inclusion in the trial, all of the following inclusion criteria must be fulfilled:
- •A. Signed Informed Consent
- •1. Written informed consent obtained prior to the initiation of any protocol-required procedures.
- •B. Target Population
- •2. Diagnosis of MS as defined by McDonald criteria of 2010
- •3. Onset of MS symptoms within 12 years
- •4. At least 1 documented relapse during the previous year OR at least 2 documented relapses during the previous 2 years prior to Randomization 5. EDSS (Expanded Disability Status Score) of 0 to 5.5, inclusive
- •6. Clinically stable, with no relapse within 30 days prior to Randomization
- •C. Age and Reproductive Status
- •7. Male or female subjects 18 to 55 years of age
- •8. Women of childbearing potential (WOCBP) must use 2 adequate forms of contraception to avoid pregnancy throughout the trial (such as a double barrier method) and for up to 8 weeks after the last dose of IMP in such a manner that the risk of pregnancy is minimized
- •NOTE: WOCBP includes any female who has experienced menarche and who has not undergone successful sterilization (such as hysterectomy, bilateral tubal ligation, bilateral oophorectomy) or is not postmenopausal (defined as amenorrhea > 12 consecutive months, or women on hormone replacement therapy with documented serum follicle stimulating hormone [FSH] level > 35 mIU/mL). Women using oral, implanted, or injectable contraceptive hormones or using mechanical products (such as an intrauterine device, diaphragm, condoms, etc) to prevent pregnancy; or practicing abstinence; or where the partner is sterile (such as with a vasectomy), must be considered to be of childbearing potential.
- •9. WOCBP must have a negative serum pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [hCG]) at the time of Screening AND a negative urine (dipstick) pregnancy test at the time of Randomization
- •10. Women must not be breastfeeding
- •11. Males must be surgically sterilized or agree to the use of a double-barrier method for the duration of the trial and must agree to refrain from sperm donation for the duration of the trial
- •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 1176
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- •A. Medical History and Concurrent Diseases
- •1. Neuromyelitis optica, clinically isolated syndrome, primary or secondary progressive multiple sclerosis
- •2. Chronic disease of the immune system other than MS or a known immunodeficiency syndrome
- •3. Malignancy
- •4. Macular edema or uveitis
- •5. Corneal herpes
- •6. Inability to undergo slit lamp and OCT assessments
- •7. Inability to complete an MRI or contraindications for MRI
- •8. History of sudden cardiac arrest
- •9. Ischemic cardiac disease including myocardial infarction, stable angina pectoris, unstable angina pectoris
- •10. Congestive heart failure New York Heart Association Class III or Class IV
- •11. Uncontrolled hypertension
- •12. Severe untreated sleep apnea
- •13. Cerebrovascular disease in the 6 months prior to Randomization
- •14. Symptomatic bradycardia or recurrent syncope
- •15. Mobitz Type II second degree or high-grade AV block
- •16. Sinoatrial heart block or sick sinus syndrome
- •17. Resting HR of < 50 bpm on Screening ECG
- •18. Higher risk of symptomatic bradycardia or heart block due to coexisting medical condition or certain concomitant medications
- •19. Concurrent therapy with drugs that slow the HR or AV conduction
- •20. Family history of long QT syndrome or sudden death
- •21. Subjects receiving Class Ia or Class III anti-arrhythmic drugs
- •22. Other arrhythmias such as ventricular tachycardia or atrial fibrillation requiring treatment
- •23. Uncontrolled diabetes mellitus (Type I or Type II)
- •24. Active or latent viral, fungal or other infections, including hepatitis B virus, hepatitis C virus, or known history of human immunodeficiency virus (HIV)-1 or HIV-2
- •25. Active or chronic bacterial infection, including untreated tuberculosis, or history of untreated borreliosis (Lyme disease)
- •26. Alcohol or drug abuse in the 12 months prior to Randomization
- •27. Subject has been vaccinated with live, attenuated vaccines within 2 months prior to Randomization
- •28. Renal condition that would preclude the administration of Gd
- •29. Respiratory disease, such as pulmonary fibrosis, or asthma requiring chronic daily therapy (exception: resolved childhood asthma)
- •30. Abnormal chest X-ray suggestive of active pulmonary disease
- •31. Abnormal Pulmonary Function Tests: forced expiratory volume in 1 second (FEV1) or forced vital capacity (FVC) < 75% or DLCO < 60%
- •32. Any other unstable medical conditions (such as congenital heart disease, acute or chronic liver diseases, etc.)
- •33. Current uncontrolled or untreated major depressive disorder, and/or at imminent risk of self harm or harm to others
- •34. Known hypersensitivity to the trial treatment(s)
- •B. Physical and Laboratory Test Findings
- •35. Any other abnormal ECG finding, laboratory test result, or vital sign result
- •36. Resting HR < 50 bpm based on ECG at Screening, or history of any cardiac conditions that might increase the risk of a significant reduction in HR
- •37. Fridericia-corrected QT interval > 450 msec for male subjects and > 470 msec for female subjects on 12-lead ECG
- •38. Left bundle branch block
- •39. Right bundle branch block with fascicular block (left or right) or any ECG with RBBB and first degree AV block (PR interval > 240 msec) or RBBB with a QRS duration > 140 msec
- •40. Intraventricular conduction defect with a QRS duration > 140 msec
- •Laboratory exclusions:
- •41. ALT or AST > 2 x ULN at Screening
- •42. Serum creatinine > 1.5 mg/dL at Screening
- •43. Total bilirubin > 1.5 x ULN (except for Gilbert’s disease) at S
Investigators
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