Clinical trial • Phase II • Immunology | Neurology
CC-97489 for Multiple sclerosis (spasticity)
Phase II trial of CC-97489 for Multiple sclerosis (spasticity).
Overview
- Trial Therapeutic Area
- Immunology | Neurology
- Trial Disease
- Multiple sclerosis (spasticity)
- Trial Stage
- Phase II
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 29-05-2025
- First CTIS Authorization Date
- 08-09-2025
Trial design
Randomised, placebo (cc-97489 1mg , cc-97489 3mg); dose and schedule not specified in provided data-controlled Phase II trial across 21 sites in Czechia, Germany, Poland.
- Randomised
- Yes
- Comparator
- Placebo (CC-97489 1mg , CC-97489 3mg); dose and schedule not specified in provided data
- Single Multiple Or Escalation Dose Combined
- Yes
- Target Sample Size
- 100
Eligibility
Recruits 100 No vulnerable population selected (populationOfTrialSubjects.isVulnerablePopulationSelected = false). Participants must be adults aged 18-70, so informed consent is provided by the participant (no assent procedures described)..
- Vulnerable Population
- No vulnerable population selected (populationOfTrialSubjects.isVulnerablePopulationSelected = false). Participants must be adults aged 18-70, so informed consent is provided by the participant (no assent procedures described).
Inclusion criteria
- {"criterion_text":"- Participants must be 18-70 years old who have a multiple sclerosis (MS) diagnosis.\n- Participants must have a history of spasticity due to MS for at least 6 months prior to Visit 1 (Screening).\n- Participants must have a modified Ashworth Scale (mAS) score ≥2 in each of 2 muscle groups (at least one muscle group in the leg, excluding ankle plantar flexors) at Visit 1.\n- Participants must have an Expanded Disability Status Scale (EDSS) score 3.0-6.5 (meaning moderate-significant disability) at Visit 1."}
Exclusion criteria
- {"criterion_text":"- Participants must not have had any concomitant disease or disorder that has symptoms of spasticity or that may influence the participant’s level of spasticity.\n- Participants must not have an acute MS exacerbation/relapse requiring treatment or alteration in disease modifying drug dose within 3 months of Visit 1 or Visit 2 (Randomization).\n- Participants must not have a history of any substance abuse disorder. Participants must not be currently taking a medication for spasticity that cannot be discontinued and washed out by Visit 2.\n- Participants must not have used cannabinoid-related products (including cannabis, CBD, or THC) within 30 days prior to Visit 1. Other protocol defined Inclusion/Exclusion criteria apply."}
Endpoints
Primary endpoints
- {"endpoint_text":"- The way we are measuring the main study goals (the main trial endpoint) is by looking at how much the stiffness in the person's most affected leg changes from the start of the study to the end of Week 6. We will use a tool called the Total Numeric-transformed Modified Ashworth Scale-Most Affected Lower Limb (TNmAS-MALL) to measure this","definition_or_measurement_approach":"Change in stiffness in the participant's most affected leg from baseline to end of Week 6 measured using the Total Numeric-transformed Modified Ashworth Scale - Most Affected Lower Limb (TNmAS-MALL)."}
Secondary endpoints
- {"endpoint_text":"- The secondary trial endpoints include the Numeric Rating Scale-Spasticity (NRS-S), which is a question answered every day using an eDiary provided to the participant.\n- Other secondary endpoints include the MS Spasticity Scale (MSSS-88), a set of questions asking about spasticity in the participant’s daily life, the Timed 25-Foot Walk (T25FW) test, a test to see how long it takes the participant to walk 25 feet, and the Clinical Global Impression of Severity, a question for the investigator to determine how severe the participant’s condition is.","definition_or_measurement_approach":"NRS-S: daily patient-reported numeric rating of spasticity recorded in an eDiary. MSSS-88: patient-reported questionnaire on spasticity impact in daily life. T25FW: timed performance measure of time to walk 25 feet. Clinical Global Impression of Severity: investigator-rated severity assessment."}
Recruitment
- Planned Sample Size
- 100
- Recruitment Window Months
- 16
- Consent Approach
- Informed consent obtained from participants (adults aged 18–70). Subject information and informed consent forms are available in local languages (documents present for Czech, German and Polish: e.g. L1_SIS and ICF Main_CZ_Redacted; L1_ICF Main_Clean_DE_redacted; L1_SIS and ICF main_PL_redacted). No assent procedures or vulnerable-population-specific consent described.
Geography
- Total Number Of Sites
- 21
- Total Number Of Participants
- 100
Czechia
- Earliest CTIS Part Ii Submission Date
- 13-06-2025
- Latest Decision Or Authorization Date
- 08-09-2025
- Processing Time Days
- 87
- Number Of Sites
- 6
- Number Of Participants
- 36
Sites
- Site Name
- Nemocnice Pardubickeho kraje a.s.
- Department Name
- Neurologie/MS centrum
- Principal Investigator Name
- Miroslav Mares
- Principal Investigator Email
- miroslav.mares@nempk.cz
- Contact Person Name
- Miroslav Mares
- Contact Person Email
- miroslav.mares@nempk.cz
- Site Name
- Fakultni Nemocnice Hradec Kralove
- Department Name
- Neurologicka klinika/MS centrum
- Principal Investigator Name
- Zbysek Pavelek
- Principal Investigator Email
- zbysekpavelek@email.cz
- Contact Person Name
- Zbysek Pavelek
- Contact Person Email
- zbysekpavelek@email.cz
- Site Name
- Vseobecna Fakultni Nemocnice V Praze
- Department Name
- Neurologicka klinika/RS centrum
- Principal Investigator Name
- Ivana Kovarova
- Principal Investigator Email
- Ivana.kovarova@vfn.cz
- Contact Person Name
- Ivana Kovarova
- Contact Person Email
- Ivana.kovarova@vfn.cz
- Site Name
- Fakultni Nemocnice U Sv Anny V Brne
- Department Name
- I. neurologicka klinika
- Principal Investigator Name
- Martin Pail
- Principal Investigator Email
- martin.pail@fnusa.cz
- Contact Person Name
- Martin Pail
- Contact Person Email
- martin.pail@fnusa.cz
- Site Name
- Krajska zdravotni a.s.
- Department Name
- Neurologicke oddeleni
- Principal Investigator Name
- Marta Vachova
- Principal Investigator Email
- marta.vachova@kzcr.eu
- Contact Person Name
- Marta Vachova
- Contact Person Email
- marta.vachova@kzcr.eu
- Site Name
- Fakultni Thomayerova nemocnice
- Department Name
- Neurologicka klinika
- Principal Investigator Name
- Marketa Grunermelova
- Principal Investigator Email
- marketa.grunermelova@ftn.cz
- Contact Person Name
- Marketa Grunermelova
- Contact Person Email
- marketa.grunermelova@ftn.cz
Germany
- Earliest CTIS Part Ii Submission Date
- 26-08-2025
- Latest Decision Or Authorization Date
- 12-09-2025
- Processing Time Days
- 17
- Number Of Sites
- 8
- Number Of Participants
- 34
Sites
- Site Name
- Neurozentrum Bielefeld
- Department Name
- Zentrum für klinische Studien
- Principal Investigator Name
- Matthias Böhringer
- Principal Investigator Email
- matthias_boehringer@yahoo.de
- Contact Person Name
- Matthias Böhringer
- Contact Person Email
- matthias_boehringer@yahoo.de
- Site Name
- Klinikum Wuerzburg Mitte gGmbH
- Department Name
- Klinik für Neurologie
- Principal Investigator Name
- Mathias Mäurer
- Principal Investigator Email
- mathias.maeurer@kwm-klinikum.de
- Contact Person Name
- Mathias Mäurer
- Contact Person Email
- mathias.maeurer@kwm-klinikum.de
- Site Name
- Universitaetsklinikum Jena KöR
- Department Name
- Klinik für Neurologie
- Principal Investigator Name
- Matthias Schwab
- Principal Investigator Email
- matthias.schwab@med.uni-jena.de
- Contact Person Name
- Matthias Schwab
- Contact Person Email
- matthias.schwab@med.uni-jena.de
- Site Name
- Universitaetsklinikum Muenster AöR
- Department Name
- Klinik für Neurologie mit Institut für Translationale Neurologie
- Principal Investigator Name
- Luisa Klotz
- Principal Investigator Email
- luisa.klotz@ukmuenster.de
- Contact Person Name
- Luisa Klotz
- Contact Person Email
- luisa.klotz@ukmuenster.de
- Site Name
- Universitaetsklinikum Essen AöR
- Department Name
- Klinik für Neurologie
- Principal Investigator Name
- Refik Pul
- Principal Investigator Email
- refik.pul@uk-essen.de
- Contact Person Name
- Refik Pul
- Contact Person Email
- refik.pul@uk-essen.de
- Site Name
- Neurologische Gemeinschaftspraxis Kassel und Vellmar
- Department Name
- Studien Abteilung
- Principal Investigator Name
- Christoph Lassek
- Principal Investigator Email
- studien@neurologie-kasselvellmar.de
- Contact Person Name
- Christoph Lassek
- Contact Person Email
- studien@neurologie-kasselvellmar.de
- Site Name
- Katholisches Klinikum Bochum gGmbH
- Department Name
- Klinik für Neurologie
- Principal Investigator Name
- Simon- Faissner
- Principal Investigator Email
- simon.faissner@ruhr-uni-bochum.de
- Contact Person Name
- Simon- Faissner
- Contact Person Email
- simon.faissner@ruhr-uni-bochum.de
- Site Name
- Technische Universitaet Dresden
- Department Name
- Zentrum für Klinische Neurowissenschaften/ Multiple Sklerose Zentrum Dresden
- Principal Investigator Name
- Tjalf Ziemssen
- Principal Investigator Email
- tjalf.ziemssen@ukdd.de
- Contact Person Name
- Tjalf Ziemssen
- Contact Person Email
- tjalf.ziemssen@ukdd.de
Poland
- Earliest CTIS Part Ii Submission Date
- 12-08-2025
- Latest Decision Or Authorization Date
- 06-02-2026
- Processing Time Days
- 178
- Number Of Sites
- 7
- Number Of Participants
- 30
Sites
- Site Name
- Pratia S.A.
- Department Name
- -
- Principal Investigator Name
- Paulina Kaczmarska
- Principal Investigator Email
- paulina.kaczmarska@pratia.com
- Contact Person Name
- Paulina Kaczmarska
- Contact Person Email
- paulina.kaczmarska@pratia.com
- Site Name
- Neuroprotect Sp. z o.o.
- Department Name
- -
- Principal Investigator Name
- Anna Karlinska
- Principal Investigator Email
- anna.karlinska@neuroprotect.pl
- Contact Person Name
- Anna Karlinska
- Contact Person Email
- anna.karlinska@neuroprotect.pl
- Site Name
- Centrum Medyczne Neuromed Sp. z o.o.
- Department Name
- -
- Principal Investigator Name
- Pawel Lisewski
- Principal Investigator Email
- 0@0
- Contact Person Name
- Pawel Lisewski
- Contact Person Email
- 0@0
- Site Name
- Ma-Lek Clinical Sp. z o.o.
- Department Name
- -
- Principal Investigator Name
- Katarzyna Maciejowska
- Principal Investigator Email
- rejestracja@centrumterapiism.pl
- Contact Person Name
- Katarzyna Maciejowska
- Contact Person Email
- rejestracja@centrumterapiism.pl
- Site Name
- Szpital Uniwersytecki w Krakowie
- Department Name
- Poradnia Neurologiczna
- Principal Investigator Name
- Agnieszka Slowik
- Principal Investigator Email
- neurologiabk@su.krakow.pl
- Contact Person Name
- Agnieszka Slowik
- Contact Person Email
- neurologiabk@su.krakow.pl
- Site Name
- Instytut Zdrowia Dr Boczarska-Jedynak Sp. z o.o. S.K.
- Department Name
- -
- Principal Investigator Name
- Magdalena Boczarska-Jedynak
- Principal Investigator Email
- m.boczarska@instytutboczarska.pl
- Contact Person Name
- Magdalena Boczarska-Jedynak
- Contact Person Email
- m.boczarska@instytutboczarska.pl
- Site Name
- Miejskie Centrum Medyczne Im. Dr. Karola Jonschera W Lodzi
- Department Name
- -
- Principal Investigator Name
- Tomasz Berkowicz
- Principal Investigator Email
- berkowt@gmail.com
- Contact Person Name
- Tomasz Berkowicz
- Contact Person Email
- berkowt@gmail.com
Sponsor
Primary sponsor
- Full Name
- Celgene Corp.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Contract research organisations
- Name
- Iqvia Inc.
- Responsibilities
- Investigator Grant Payments
- Name
- Labcorp Central Laboratory Services LP
- Responsibilities
- Database Construction Services, Investigator Training, Collection Services, Transpotation Services, Laboratory Services, Data Services, Clinical Trial Management, Specimen Management, Sample Storage
Third parties
- {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"Database Construction Services, Investigator Training, Collection Services, Transpotation Services, Laboratory Services, Data Services, Clinical Trial Management, Specimen Management, Sample Storage","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Iqvia Inc.","duties_or_roles":"Investigator Grant Payments","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"Data Management Platform","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Signant Health Global LLC","duties_or_roles":"eCOA, PRO/COA","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- CC-97489
- Active Substance
- CC-97489
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- ORAL USE
- Investigational Product Name
- CC-97489 1mg , CC-97489 3mg
- Modality
- Other
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