Study to test IMU-838 in patients with progressive multiple sclerosis
- Conditions
- Progressive forms of Multiple SclerosisMedDRA version: 21.1Level: PTClassification code 10053395Term: Progressive multiple sclerosisSystem Organ Class: 10029205 - Nervous system disordersTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2021-000048-23-PL
- Lead Sponsor
- Immunic AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 450
1. Adult patients, age 18 to 65 years (inclusive).
2. No evidence of relapse in the last 24 months before randomization, AND
Patients diagnosed with either
a)SPMS, in patients showing evidence of Gd+ MRI lesions (active SPMS) in the brain or spinal cord, or without Gd+ MRI lesions (non-active SPMS) in the last 12 months, OR
b) PPMS
according to 2017 revised McDonald Criteria and the 2013 revised
classification of disease courses with a disease duration of the
progressive disease of =10 years
3. EDSS score at screening between 3.0 to 6.5 (both inclusive).
4. Evidence of disability worsening not temporarily related to a relapse
in the last 24 months before randomization, adjudicated by a central
independent reviewer, and documented as:
a) An increase of EDSS of at least 1.0 point with Screening EDSS of up to
5.5 (inclusive) and 0.5 point for Screening EDSS 6.0 or 6.5 (as
documented in patient files in the last 24 months before randomization),
OR
b) A 20% worsening (or more) in 25-foot walk time or 9-hole peg test
time in either hand (as documented in patient files in the last 24 months
before randomization),
OR
c) A written summary of the clinical evidence of disability worsening in
the previous 24 months before randomization through a retrospective
assessment of disease worsening from patient files.
5. 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
cause), or
b) If of childbearing potential, must have a negative pregnancy test at
SV1 (blood test) and before the first IMP intake at Day 1 (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 study consent and 30 days after
the last intake of the IMP.
c) Highly effective forms of birth control are those with a failure rate of
less than 1% per year and include:
i) Oral, intravaginal, or transdermal combined (estrogen and
progestogen containing) hormonal contraceptives associated with
inhibition of ovulation.
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 study. And is the sole sexual partner of the female patient during
the clinical study).
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:
i) Condom.
ii) Occlusive cap (diaphragm or cervical/vault caps) with spermicidal
gel/film/cream/suppository.
6. Male patients must agree not to father a child or to donate sperm
starting at SV1, throughout the clinical study, 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 contracept
MS-related exclusion criteria:
1. Any disease other than MS that may better explain the signs and
symptoms, including a history of complete transverse myelitis.
2. Clinical signs or presence of laboratory findings suggestive for
neuromyelitis optica spectrum disorders (NMOSD) or myelin
oligodendrocyte glycoprotein (MOG)-associated encephalomyelitis (i.e.,
presence of aquaporin-4 antibodies or anti-MOG antibodies).
3. Any MRI finding, atypical for MS, including but not limited to a
longitudinally extensive spinal cord lesion.
4. Any active and uncontrolled coexisting autoimmune disease, other
than MS (except for type 1 diabetes mellitus and inflammatory bowel
disease).
Therapy-related exclusion criteria:
5. Any previous or current use of the following MS treatments:
a) alemtuzumab or belimumab, including their biosimilars,
b) cladribine,
c) total lymphoid irradiation, and
d) bone marrow or stem cell transplantation.
6. Any use of the following MS treatments before the date of randomization (see table in study protocol)
7. Any use of adrenocorticotrophic hormone (ACTH) or occasional use of
systemic corticosteroids (oral or intravenous) 30 days before SV2.
8. Use of any investigational product within 8 weeks or 5× the respective
PK half-life before the date of informed consent, whichever is longer,
and throughout the study. For some investigational products, prolonged
biological effects beyond 8 weeks should be considered.
For more information, please refer to Clinical Study Protocol.
Exclusion Criteria for the OLE Period:
Patients meeting any of the following criteria will be ineligible to
participate in the OLE
Period of the study:
1. Any ongoing, clinically significant (as assessed by the Investigator)
treatment-emergent AE or laboratory abnormality (including blood
biochemistry and urinalysis) that can jeopardize the patient's safety, in
agreement with the medical monitor.
2. Significant study or treatment non-compliance (<80% or >125%)
during the MT period, and/or inability or unwillingness to follow
instructions by study personnel.
3. The lack of interpretable BL or EoMT MRI or the omission of more than
one other MRI during the MT.
4. Use of experimental/investigational drug (except for COVID-19
vaccines approved by emergency use authorization or similar expanded
access schemes) and/or participation in another clinical study of an
investigational drug throughout the duration of the OLE treatment
period.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method