EUCTR2021-000028-36-LTActive, not recruitingPhase 1
A Multi-Center, Randomized, Double-Blinded Phase 3 Study to Evaluate theEfficacy, Safety, and Tolerability of IMU-838 versus Placebo in Adults withRelapsing Multiple Sclerosis (ENSURE-1) - ENSURE-1
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Immunic AG
- Enrollment
- 1,050
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •Inclusion criteria for the Main period of the Trial:
- •1. Male or female patient (age =18 to =55 years)
- •2. Patients with an established diagnosis of MS according to 2017
- •McDonald Criteria
- •3. Patients with RMS comprising of relapsing remitting MS (RRMS) and active secondary progressive MS, both defined according to Lublin criteria 1996 and 2014. Patients are eligible for this trial if their disease modifying treatment has failed due to
- •efficacy, safety, or tolerability issues, if they have contraindications or no access to treatment, or if they refuse the offered MS treatment.
- •4. Active disease as defined by Lublin 2014 evidenced prior to Screening
- •a.At least 2 relapses(a) in the last 24 months before randomization, or
- •b.At least 1 relapse(a) in the last 12 months before randomization, or
- •c.A positive Gd+ MRI scan (brain and/or spine) in the last 12 months
- •prior to randomization.
- •(a) Relapses and/or Gd+ MRI lesions must have been assessed and documented by a physician in the patient files.
- •5. EDSS score between 0 and 5.5 (inclusive) at SV1.
- •Female patients:
- •a. must be of non-childbearing potential, i.e., surgically sterilized
- •(hysterectomy, bilateral salpingectomy, bilateral oophorectomy at least
- •6 weeks before SV1) or postmenopausal (where postmenopausal is
- •defined as no menses for 12 months without an alternative medical
- •b. if of childbearing potential, must have a negative pregnancy test at
- •SV1 (blood test) and before the first IMP intake (Day 1 blood or urine
- •test). They must agree not to attempt to become pregnant, must not
- •donate ova, and must use a highly effective contraceptive method (see
- •below) together with a barrier method between trial consent and 30 days after the last intake of the IMP.
- •c.highly effective forms of birth control are those with a failure rate less
- •than 1% per year and include:
- •i.oral, intravaginal, or transdermal combined (estrogen and progestogen
- •containing) hormonal contraceptives associated with inhibition of
- •ii.oral, injectable, or implantable progestogen-only hormonal
- •contraceptives associated with inhibition of ovulation.
- •iii.intrauterine device or intrauterine hormone-releasing system.
- •iv.bilateral tubal occlusion.
- •v.vasectomized partner (i.e., the patient's male partner underwent
- •effective surgical sterilization before the female patient entered the
- •clinical trial. and is the sole sexual partner of the female patient during the clinical trial).
- •vi.sexual abstinence (acceptable only if it is the patient's usual form of
- •birth control/lifestyle choice; periodic abstinence [e.g., calendar,
- •ovulation, symptothermal, postovulation methods] and withdrawal are
- •not acceptable methods of contraception).
- •d.Barrier methods of contraception include:
- •ii.occlusive cap (diaphragm or cervical/vault caps) with spermicidal
- •gel/film/cream/suppository.
- •7. Male patients must agree not to father a child or to donate sperm
- •starting at SV1, throughout the clinical trial, and for 30 days after the
- •last intake of the IMP. Male patients must also:
- •a. abstain from sexual intercourse with a female partner (acceptable
- •only if it is the patient's usual form of birth control/lifestyle choice), or
- •b. use adequate barrier contraception during treatment with the IMP and
- •until at least 30 days after the last intake of the IMP, and
- •c. if they have a female partner of childbearing potential, the partner
- •should use a highly effective contraceptive method as outlined in
- +2 more not shown
Exclusion Criteria
- •Exclusion Criteria for the Main Period of the Trial:
- •1. Patients with non-active secondary progressive MS and primary
- •progressive MS.
- •2. Any disease other than MS that may better explain the signs and
- •symptoms, including history of complete transverse myelitis.
- •3. Clinical signs or presence of laboratory findings suggestive for
- •neuromyelitis optica (NMO) spectrum disorders or myelin
- •oligodendrocyte glycoprotein (MOG)-IgG-associated encephalomyelitis.
- •4. Any MRI finding, which puts in question the MS diagnosis, including
- •but not limited to a longitudinally extensive spinal cord lesion.
- •5. History of malignancy of any organ system (other than localized basal
- •cell carcinoma of the skin or adequately treated cervical cancer), treated
- •or untreated, within the past 5 years, regardless of whether there is
- •evidence of full remission at the current time.
- •6. Any active and uncontrolled coexisting autoimmune disease, other
- •than MS (except for type 1 diabetes mellitus and inflammatory bowel
- •7. An MS relapse ending within 30 days before SV1 and/or during the
- •Screening Period (until Day 1).
- •8. Any corticosteroid treatment for relapse given within 30 days before SV2.
- •Exclusion Criteria for the Extension Period of the Trial, Open-Label
- •1.Any ongoing, clinically significant (as assessed by the investigator)
- •TEAE (started after intake of IMP) or laboratory abnormality (including
- •blood chemistry and urinalysis) that, upon discretion of the investigator,
- •should prohibit further treatment with trial medication in this trial(a).
- •2.Significant treatment non-compliance (defined as having taken <70%
- •of trial medication) or trial non-compliance during the MP (as
- •assessed by the investigator, in consultation with the medical monitor),
- •and/or inability or unwillingness to follow instructions by trial
- •3.Multiple significant protocol deviations during the MP that are
- •assessed by the investigator, in consultation with the medical monitor,
- •to negatively affect further patient cooperation in this trial.
- •4.Use of experimental/investigational drug (with the exception of
- •COVID-19 vaccines approved by emergency use authorization) and/or
- •participation in another clinical trial of an investigational drug
- •throughout the duration of the EP open-label treatment period.
- •5. Any treatment mentioned in the Therapy Exclusion Criteria 9, 10, 11, 12, and 13.
- •(a) If a TEAE(s) is the reason for exclusion from the EP open-label
- •treatment period, the eligibility can be re-assessed up to 12 weeks
- •following the last treatment in the MP.
Investigators
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