Multiple SclerosisPhase 2CALLIPERNCT05054140
Study to Evaluate Efficacy, Safety, and Tolerability of IMU-838 in Patients With Progressive Multiple Sclerosis
A Phase 2 study testing IMU-838 in people with Multiple Sclerosis, run by Immunic AG at 73 sites in 12 countries.
Trial summary
Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate Efficacy, Safety, and Tolerability of IMU-838 in Patients with Progressive Multiple Sclerosis - CALLIPER Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- IMU-838
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 450 participants
- Where
- 73 sitesin 12 countries
- Study dates
- 30 Sep 2021to 7 Jan 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients, age 18 to 65 years (inclusive).
- EDSS score at screening between 3.0 to 6.5 (both inclusive)
- No evidence of relapse in the last 24 months before randomization, AND Patients diagnosed according to 2017 revised McDonald Criteria 1 and the 2013 revised classification of disease courses 2 as either
- SPMS inpatients showing evidence of Gd+MRI lesions (active SPMS) or without Gd+MRI lesions (non-active SPMS) in the last 12 months, OR
- PPMS
- Willingness and ability to comply with the protocol.
- Written informed consent given by the patient before the beginning of any study-related procedure.
- Documented evidence of disability progression not temporarily related to a relapse in the last 24 months before randomization, adjudicated by a central independent reviewer
Who cannot join
- Any disease other than MS that may better explain the signs and symptoms, including a history of complete transverse myelitis.
- Clinical signs or presence of laboratory findings suggestive for neuromyelitis optica (NMO) spectrum disorders or myelin oligodendrocyte glycoprotein (MOG)-associated encephalomyelitis (i.e.,presence of anti-NMO [aquaporin-4] antibodies or anti-MOG antibodies).
- Previous or current use of MS treatments lifelong, or within a pre-specified time period.
- 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.
- Positive test for severe acute respiratory syndrome coronavirus 2 (SARS- CoV-2) within14 days before randomization. In case of known SARS-CoV-2 infection, patients should be randomized no earlier than 14 days after 2 consecutive negative tests confirming virus negative status.The screening period can be extended for these patients to accommodate the required virus negativity.
- Positive IFN-gamma release assay (IGRA) for Mycobacterium tuberculosis at SV1.
- Positive hepatitis B virus (HBV) surface antigen, hepatitis B core antibody, positive hepatitis C virus (HCV) antibody, and/or HIV-antigen-antibody test at SV1.
Trial locations and contacts
73 sites in 12 countries.
73 sites in 12 countries
Bulgaria19 sites
MHAT Pulse
Blagoevgrad, 2700
MHAT"Heart and Brain" EAD
Burgas
Dr. Maya Danovska
Pleven, 5800
Dr. Plamen Bozhinov
Pleven, 5804
UMHAT Pulmed
Plovdiv
Dr. Rositsa Krasteva
Rousse, 7003
Dr. Nikolay Georgiev
Shumen, 9700
MHAT Shumen
Shumen, 9705
Dr. Ivan Milanov
Sofia, 1113
MHAT Lyulin
Sofia, 1336
Dr. Rosen Ikonomov
Sofia, 1408
Dr. Penko Shotekov
Sofia, 1431
UMHAT Alexandrovska
Sofia, 1431
Dr. Kana Prinova
Sofia, 1606
Dr. Kosta Kostov
Sofia, 1606
MHAT Sveta Sofia
Sofia
UMHATSM N.I.Pirogov
Sofia
UMHAT Prof. Stoyan Kirkovich
Stara Zagora
Dr. Ara Kaprelyan
Varna, 9010
Poland14 sites
Dr. Robert Bonek
Bydgoszcz, 85-796
Dr. Maciej Maciejowski
Katowice, 40-571
Dr. Janusz Zbrojkiewicz
Katowice, 40-686
Dr. Elzbieta Jasinska
Kielce, 25-726
Indywidualna Praktyka Lekarska Prof. Rejdak
Lublin, 20-016
Dr. Marcin Nastaj
Lublin, 20-640
Instytut Zdrowia
Oświęcim
Dr. Justyna Hryniewicz
Plewiska, 62-064
Clinical Research Center
Poznan
EMC PL Certus
Poznan
NZOZ "Neuro-kard"
Poznan
Dr. Marcin Ratajczak
Szczecin, 70-111
Warszawska Klinika
Warsaw
EMC Instytut Medyczny
Wroclaw
Ukraine11 sites
Chernivtsi Medical Hospital
Chernivtsi
Dr. Olena Moroz
Dnipro, 49000
Dr. Pavlo Khaitov
Dnipro, 49128
Dr. Tamara Mishchenko
Kharkiv, 61068
Dr. Oleksandr Doroschenko
Krykhivtsi, 76493
Dr. Larysa Sokolova
Kyiv, 03037
Dr. Galusha
Kyiv, 04106
Dr. Olga Shulga
Lutsk, 43005
Dr.Tetyana Nehrych
Lviv, 79010
Dr. Svitlana Skhrobot
Ternopil, 46024
Dr. Sergii Moskovko
Vinnytsia, 21050
United States8 sites
University of New Mexico (UNM), MS Specialty Clinic
Albuquerque, New Mexico, 87106
Shepherd Center
Atlanta, Georgia, 30309
Dr. Sonia Kalirao
Coral Springs, Florida, 33067
Dr. Mirela Cerghet
Detroit, Michigan, 48202
Dr. Daniel Becker
Lutherville, Maryland, 21093
Collier Neurologic Specialists
Naples, Florida, 34105
Consultants in Neurology, Ltd.
Northbrook, Illinois, 60062
Prof. James Scott
Ormond Beach, Florida, 32174
Germany4 sites
Datamed GmbH
Cologne, 50935
Klinik und Poliklinik für Neurologie, Universitätsklinikum Dresden
Dresden, 01307
Neuro Centrum Science GmbH
Erbach im Odenwald
Universitätsklinikum Hamburg Eppendorf
Hamburg, 20251
Serbia4 sites
Clinical Hospital Center Zemun
Belgrade
Military Medical Academy
Belgrade
Klinicki Centar Kragujevac
Kragujevac, 34000
Clinical center of Vojvodina
Novi Sad
Moldova3 sites
Dr. Stanislav Groppa
Chisinau, 2004
Dr. Mihail Gavriliuc
Chisinau, 2028
Dr. Olesea Odainic
Chisinau, 2028
North Macedonia3 sites
Dr. Ana Doneva Skopje 1000
Skopje, 1000
Dr. Milcho Demerdziev
Skopje, 1000
Dr. Tatjana Boshkova
Skopje, 1000
Canada2 sites
Montreal Neurological Inst.
Montreal, H3A 2B4
The Ottawa Hospital Research Institute
Ottawa, K1H 8L6
Netherlands2 sites
Dr. Eva Strijibis
Amsterdam, 1081BT
Alrijne ziekenhuis
Leiderdorp
Romania2 sites
Dr. Adriana Dulamea
Bucharest, 22328
Dr. Lacramioara Perju-Dumbrava
Cluj-Napoca, 400013
About this study
Official title: Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate Efficacy, Safety, and Tolerability of IMU-838 in Patients With Progressive Multiple Sclerosis
Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate Efficacy, Safety, and Tolerability of IMU-838 in Patients with Progressive Multiple Sclerosis - CALLIPER
Read the detailed description
This study will be a multicenter, randomized, double-blind, placebo-controlled study with a blinded Main Treatment Period (MT) and an Open Label Period (OLE) to evaluate the efficacy, safety, and tolerability of IMU838 in adult patients with PMS. The study will consist of the following periods:
Screening Period: Approximately 28 days Main Treatment Period: Up to 120 weeks (approximately 2 years) Open Label Extension Period: Up to approximately 8 years
- Conditions
- Multiple Sclerosis
- Being tested
- IMU-838, Placebo matching IMU-838
- Keywords
- Progressive Multiple Sclerosis
- Medical subject headings
- Multiple Sclerosis, Multiple Sclerosis, Chronic Progressive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMU-838Drug
Also called Vidofludimus calcium
IMU-838 tablets
Placebo matching IMU-838Drug
Also called Placebo Arm
Placebo matching IMU-838 tablets
| Study group | Role | What they receive |
|---|---|---|
| IMU-838 | Experimental | IMU-838 as tablet; Administration: Oral - daily Receives: Drug: IMU-838 |
| Placebo | Placebo comparator | Matching placebo as tablet; Administration: Oral - daily Receives: Drug: Placebo matching IMU-838 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of IMU-838 versus placebo
Annualized rate of percent brain volume change (PBVC) during MT period
Measured: 120 weeks
Secondary outcomes (2)
Efficacy of IMU-838 versus placebo
Annualized rate of change in brain parenchymal fraction (BPF) during MT Period
Measured: 120 weeks
Efficacy of IMU-838 versus placebo in terms of disability worsening
Time to 24-week confirmed disability worsening based on expanded disability status scale (EDSS) during MT Period
Measured: 120 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2021
- Study start30 Sep 2021
- Primary completion7 Jan 2025 (estimated)
- Study completion7 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Immunic AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert J. Fox, MD, Principal investigator, Mellen Center for MS, Neurological Institute, Cleveland Clinic, Ohio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05054140
- Sponsor's protocol ID
- P2-IMU-838-PMS
- Acronym
- CALLIPER
- Status last verified
- Apr 2024
- First submitted
- 2 Sep 2021
- Last updated
- 29 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate Efficacy, Safety, and Tolerability of IMU-838 in Patients With Progressive Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT05054140
- Acronym / sponsor ID
- CALLIPER / P2-IMU-838-PMS
- Conditions
- Multiple Sclerosis
- Keywords
- Progressive Multiple Sclerosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Immunic AGIndustry (pharma, biotech, devices)
- Study start
- 30 Sep 2021 (actual)
- Primary completion
- 7 Jan 2025 (estimated)
- Study completion
- 7 Jan 2025 (estimated)
- First posted
- 23 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate Efficacy, Safety, and Tolerability of IMU-838 in Patients with Progressive Multiple Sclerosis - CALLIPER
Detailed description
This study will be a multicenter, randomized, double-blind, placebo-controlled study with a blinded Main Treatment Period (MT) and an Open Label Period (OLE) to evaluate the efficacy, safety, and tolerability of IMU838 in adult patients with PMS. The study will consist of the following periods:
Screening Period: Approximately 28 days Main Treatment Period: Up to 120 weeks (approximately 2 years) Open Label Extension Period: Up to approximately 8 years
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IMU-838 | Experimental | Drug: IMU-838IMU-838 as tablet; Administration: Oral - daily |
| Placebo | Placebo comparator | Drug: Placebo matching IMU-838Matching placebo as tablet; Administration: Oral - daily |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Adult patients, age 18 to 65 years (inclusive).
- EDSS score at screening between 3.0 to 6.5 (both inclusive)
- No evidence of relapse in the last 24 months before randomization, AND Patients diagnosed according to 2017 revised McDonald Criteria 1 and the 2013 revised classification of disease courses 2 as either
- Willingness and ability to comply with the protocol.
- Written informed consent given by the patient before the beginning of any study-related procedure.
Key exclusion criteria (7 listed)
- Any disease other than MS that may better explain the signs and symptoms, including a history of complete transverse myelitis.
- Clinical signs or presence of laboratory findings suggestive for neuromyelitis optica (NMO) spectrum disorders or myelin oligodendrocyte glycoprotein (MOG)-associated encephalomyelitis (i.e.,presence of anti-NMO [aquaporin-4] antibodies or anti-MOG antibodies).
- Previous or current use of MS treatments lifelong, or within a pre-specified time period.
- 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.
- Positive test for severe acute respiratory syndrome coronavirus 2 (SARS- CoV-2) within14 days before randomization. In case of known SARS-CoV-2 infection, patients should be randomized no earlier than 14 days after 2 consecutive negative tests confirming virus negative status.The screening period can be extended for these patients to accommodate the required virus negativity.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IMU-838Also: Vidofludimus calciumIMU-838 tablets | Drug | IMU-838 |
| Placebo matching IMU-838Also: Placebo ArmPlacebo matching IMU-838 tablets | Drug | Placebo |
Primary outcome
Efficacy of IMU-838 versus placebo
Time frame: 120 weeks
Annualized rate of percent brain volume change (PBVC) during MT period
2 secondary outcomes
Efficacy of IMU-838 versus placebo
Time frame: 120 weeks
Efficacy of IMU-838 versus placebo in terms of disability worsening
Time frame: 120 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert J. Fox, MD principal investigator
Mellen Center for MS, Neurological Institute, Cleveland Clinic, Ohio
73 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing IMU-838 in people with Multiple Sclerosis, run by Immunic AG at 73 sites in 12 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 73 sites in Bulgaria, Poland, Ukraine, United States, Germany and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of IMU-838 versus placebo (time frame: 120 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2024.