Relapsing Multiple SclerosisPhase 3NCT05147220
Efficacy and Safety of Remibrutinib Compared to Teriflunomide in Participants With Relapsing Multiple Sclerosis (RMS) (REMODEL-1)
A Phase 3 study testing Remibrutinib and Teriflunomide in people with Relapsing Multiple Sclerosis, run by Novartis Pharmaceuticals at 200 sites in 34 countries.
Trial summary
To compare the efficacy and safety of remibrutinib versus teriflunomide in patients with relapsing multiple sclerosis (RMS) Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Relapsing Multiple Sclerosis
- What is being tested?
- Remibrutinib and Teriflunomide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 200 sitesin 34 countries
- Study dates
- 16 Dec 2021to 30 Oct 2030
- Phase
- Phase 3
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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 18 to 55 years of age
- Diagnosis of RMS according to the 2017 McDonald diagnostic criteria
- At least: 1 documented relapse within the previous year. OR 2 documented relapses within the previous 2 years, OR 1 active Gadolinium (Gd)-enhancing lesion in the 12 months.
- EDSS score of 0 to 5.5 (inclusive)
- Neurologically stable within 1 month
- Participants who complete the Core Part of the study on double-blind study treatment and conduct the Accelerated Elimination Procedure (AEP)
- Other inclusion and exclusion criteria may apply
Who cannot join
- Diagnosis of primary progressive multiple sclerosis (PPMS)
- Disease duration of more than 10 years in participants with EDSS score of 2 or less at screening
- History of clinically significant CNS disease other than MS
- Ongoing substance abuse (drug or alcohol)
- History of malignancy of any organ system (other than complete resection of localized basal cell carcinoma of the skin or in situ cervical cancer),
- Participants with history of confirmed Progressive Multifocal Leukoencephalopathy (PML) or Neurological symptoms consistent with PML
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- suicidal ideation or behavior
- Evidence of clinically significant cardiovascular, neurological, psychiatric, pulmonary , renal, hepatic, endocrine, metabolic, hematological disorders or gastrointestinal disease that can interfere with interpretation of the study results or protocol adherence
- Participants who have had a splenectomy
- Active clinically significant systemic bacterial, viral, parasitic or fungal infections
- Positive results for syphilis or tuberculosis testing
- Uncontrolled disease states, such as asthma, or inflammatory bowel disease, where flares are commonly treated with oral or parenteral corticosteroids
- Active, chronic disease of the immune system (including stable disease treated with immune therapy (e.g. Leflunomide, Methotrexate)) other than MS (e.g. rheumatoid arthritis, systemic lupus erythematosus, etc.) with the exception of well-controlled diabetes or thyroid disorder.
- Participants with a known immunodeficiency syndrome (AIDS, hereditary immune deficiency, drug induced immune deficiency), or tested positive for HIV antibody
- History or current treatment for hepatic disease including but not limited to acute or chronic hepatitis, cirrhosis (including all Child-Pugh classes) or hepatic failure or any chronic liver or biliary disease.
- History of severe renal disease or creatinine level
- Participants at risk of developing or having reactivation of hepatitis
- Hematology parameters at screening:
- Hemoglobin: < 10 g/dl (<100g/L)
- Platelets: < 100000/mm3 (<100 x 109/L)
- Absolute lymphocyte count < 800/mm3 (<0.8 x 109/L)
- White blood cells: <3 000/mm3 (<3.0 x 109/L)
- Neutrophils: < 1 500/mm3 (<1.5 x 109/L)
- B-cell count < 50% lower limit of normal (LLN) or total IgG \& total IgM < LLN (only required for participants who had a history of receiving B-cell therapies, such as rituximab, ocrelizumab or ofatumumab, prior to screening)
- History or current diagnosis of significant ECG abnormalities
- Resting QTcF ≥450 msec (male) or ≥460 msec (female) at pre-treatment as per central ECG reading at screening visit
- Use of other investigational drugs
- Requirement for anticoagulant medication or use of dual anti-platelet therapy Significant bleeding risk or coagulation disorders,
- History of gastrointestinal bleeding
- Major surgery within 8 weeks prior to screening
- History of hypersensitivity to any of the study drugs or excipients
- Pregnant or nursing (lactating) female participants, prior to randomization
- Women of childbearing potential not using highly effective contraception
- Sexually active males not agreeing to use condom
- Have received any live or live-attenuated vaccines within 6 weeks of randomization or requirement to receive these vaccinations during study
- Use of strong CYP3A4 inhibitors or use of moderate or strong CYP3A4 inducers within two weeks prior to randomization
Trial locations and contacts
200 sites in 34 countries.
200 sites in 34 countries
United States52 sites
Neurology of Central FL Res Ctr
Altamonte Springs, Florida, 32714
The Research and Education Inst of Alta Bates Summit Med Grp
Berkeley, California, 94705
American Oncology Partners PA Center for Cancer and Blood Disorders
Bethesda, Maryland, 20817
SCL Health
Billings, Montana, 59101
Alpine Clinical Research Center
Boulder, Colorado, 80301
The Neurological Institute PA
Charlotte, North Carolina, 28204
Rush University Medical Center
Chicago, Illinois, 60612
The Neuron Clinic
Chula Vista, California, 91910
Texas Neurology
Dallas, Texas, 75206
Arrow Clinical Trials
Daytona Beach, Florida, 32117
Wayne State University Multiple Sclerosis Clinic
Detroit, Michigan, 48201
The Belinga Clinic
Fort Smith, Arkansas, 72916
IU Health Inc
Fort Wayne, Indiana, 46815
John Peter Smith Hospital
Fort Worth, Texas, 76104
Neurology Center of New England PC
Foxborough, Massachusetts, 02035
Glendale Adventist Medical Center
Glendale, California, 91206
Homestead Assoc In Research Inc
Homestead, Florida, 33033
Neuro Eye Clinical Trials Inc
Houston, Texas, 77074
Neurological Associates of Long Island PC
Lake Success, New York, 11042
Norton Neurology MS Services
Louisville, Kentucky, 40207
University of Wisconsin Madison
Madison, Wisconsin, 53792
DHR Health Institute
McAllen, Texas, 78504
Reliant Medical Research
Miami, Florida, 33165
Neuroscience Group
Neenah, Wisconsin, 54956
Jersey Shore University Medical Ctr
Neptune City, New Jersey, 07753
NYU Langone Med Center CV Research
New York, New York, 10016
Christiana Care Health Services
Newark, Delaware, 19713
Hoag Health System
Newport Beach, California, 92663
Multiple Sclerosis Center of Excellence of OMRF
Oklahoma City, Oklahoma, 73104
Neurological Services of Orlando PA
Orlando, Florida, 32806
Orlando Health Clinical Trials
Orlando, Florida, 32806
Comprehensive Neurology Clinic
Orlando, Florida, 32825
Neurology Associates of Ormond Beach
Ormond Beach, Florida, 32174
College Park Family Care Center
Overland Park, Kansas, 66210
SC3 Research Pasadena
Pasadena, California, 91105
AZ Integrated Neuro and Spine
Phoenix, Arizona, 85037
University Of Pittsburgh Medical Ctr Magee-Womens Hospital
Pittsburgh, Pennsylvania, 15213
Saturn Research Solutions LLC
Plano, Texas, 75024
Neuro Center
Pomona, California, 91767
Neurostudies Inc
Port Charlotte, Florida, 33952
Providence St Vincent Med Center
Portland, Oregon, 97225
Velocity Clinical Research
Raleigh, North Carolina, 27607
Reading Hospital
Reading, Pennsylvania, 19611
Accel Research Sites St Pete-Largo
Seminole, Florida, 33777
The MS Center for Innovation in Care
St Louis, Missouri, 63131
Palmetto Clinical Research
Summerville, South Carolina, 29485
University Of South Florida
Tampa, Florida, 33612
Center for Neurosciences
Tucson, Arizona, 85718
MS Center of Greater Washington, P.C.
Vienna, Virginia, 22182
Washington Hospital Center
Washington D.C., District of Columbia, 20010
Columbus Neuroscience
Westerville, Ohio, 43082
Conquest Research
Winter Park, Florida, 32789
Spain20 sites
Novartis Investigative Site
A Coruña, 15006
Novartis Investigative Site
Alcorcón, Madrid, 28922
Novartis Investigative Site
Barcelona, Barcelona, 08035
Novartis Investigative Site
Cadiz, Andalusia, 11009
Novartis Investigative Site
Castilleja de la Cuesta, Sevilla, 41950
Novartis Investigative Site
Córdoba, 14004
Novartis Investigative Site
El Palmar, Murcia, 30120
Novartis Investigative Site
Getafe, Madrid, 28905
Novartis Investigative Site
Las Palmas GC, 35010
Novartis Investigative Site
León, 24080
Novartis Investigative Site
Madrid, 28006
Novartis Investigative Site
Madrid, 28034
Novartis Investigative Site
Madrid, 28040
Novartis Investigative Site
Majadahonda, Madrid, 28222
Novartis Investigative Site
Málaga, 29010
Novartis Investigative Site
Salt, Girona, 17190
Novartis Investigative Site
Sant Joan Despí, Barcelona, 08970
Novartis Investigative Site
Seville, Andalusia, 41014
Novartis Investigative Site
Valladolid, 47011
Novartis Investigative Site
Vigo, Pontevedra, 36212
China11 sites
Novartis Investigative Site
Baotou, Inner Mongolia, 014040
Novartis Investigative Site
Beijing, 100053
Novartis Investigative Site
Beijing, 100730
Novartis Investigative Site
Changchun, Jilin, 130021
Novartis Investigative Site
Changsha, Hunan, 410008
Novartis Investigative Site
Chongqing, 400016
Novartis Investigative Site
Guangzhou, Guangdong, 510030
Novartis Investigative Site
Hohhot, Inner Mongolia, 010017
Novartis Investigative Site
Nanchang, Jiangxi, 330006
Novartis Investigative Site
Tianjin, 300052
Novartis Investigative Site
Zhengzhou, Henan, 450003
Poland10 sites
Novartis Investigative Site
Bydgoszcz, Woj Kujawsko Pomorskie, 85-796
Novartis Investigative Site
Kielce, 25 726
Novartis Investigative Site
Lodz, 90 324
Novartis Investigative Site
Lodz, 93-113
Novartis Investigative Site
Lublin, 20-410
Novartis Investigative Site
Piotrkow Trybunalski, 97-300
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Poznan, 60-693
Novartis Investigative Site
Rzeszów, 35-323
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Szczecin, 70-111
Novartis Investigative Site
Wroclaw, Lower Silesian Voivodeship, 52-416
India9 sites
Novartis Investigative Site
Chandigarh, Punjab, 160012
Novartis Investigative Site
Dehradun, Uttarakhand, 248001
Novartis Investigative Site
Lucknow, Uttar Pradesh, 226014
Novartis Investigative Site
Ludhiana, Punjab, 141008
Novartis Investigative Site
Mangalore, Karnataka, 575003
Novartis Investigative Site
Mangalore, Karnataka, 575018
Novartis Investigative Site
Mumbai, Maharashtra, 400008
Novartis Investigative Site
Nashik, Maharashtra, 422005
Novartis Investigative Site
New Delhi, National Capital Territory of Delhi, 110017
Argentina7 sites
Novartis Investigative Site
Buenos Aires, C1055AAF
Novartis Investigative Site
Caba, C1182
Novartis Investigative Site
Caba, C1424BYD
Novartis Investigative Site
Capital Federal, Buenos Aires, 1424
Novartis Investigative Site
Capital Federal, C1023AAB
Novartis Investigative Site
Rosario, Santa Fe Province, 2000
Novartis Investigative Site
Santiago del Estero, Santiago del Estero Province, 4200
Georgia7 sites
Novartis Investigative Site
Tbilisi, 0100
Novartis Investigative Site
Tbilisi, 0114
Novartis Investigative Site
Tbilisi, 0159
Novartis Investigative Site
Tbilisi, 0178
Novartis Investigative Site
Tbilisi, 0179
Novartis Investigative Site
Tbilisi, 0192
Novartis Investigative Site
Tbilisi, 172
Turkey (Türkiye)7 sites
Novartis Investigative Site
Ankara, Bilkent-Cankaya, 06800
Novartis Investigative Site
Ankara, Yenimahalle, 06500
Novartis Investigative Site
Istanbul, Sultangazi, 34295
Novartis Investigative Site
Istanbul, 34147
Novartis Investigative Site
Izmir, Karsiyaka, 35575
Novartis Investigative Site
Izmir, 35100
Novartis Investigative Site
Mersin, Yenisehir, 33110
Brazil6 sites
Novartis Investigative Site
Porto Alegre, Porto Alegre RS, 90610 000
Novartis Investigative Site
Santo André, São Paulo, 09040 010
Novartis Investigative Site
São Paulo, São Paulo, 01244-030
Novartis Investigative Site
São Paulo, São Paulo, 04076-004
Novartis Investigative Site
São Paulo, 01321001
Novartis Investigative Site
São Paulo, 04550-000
Colombia6 sites
Novartis Investigative Site
Bogotá, 111411
Novartis Investigative Site
Cali, Valle del Cauca Department, 760001
Novartis Investigative Site
Cali, Valle del Cauca Department, 760032
Novartis Investigative Site
Medellín, 050001
Novartis Investigative Site
Medellín, 050034
Novartis Investigative Site
Puerto Colombia, Atlántico, 080012
Italy6 sites
Novartis Investigative Site
Milan, MI, 20132
Novartis Investigative Site
Novara, 28100
Novartis Investigative Site
Roma, RM, 00133
Novartis Investigative Site
Roma, RM, 00168
Novartis Investigative Site
Roma, RM, 00189
Novartis Investigative Site
Verona, VR, 37134
Belgium5 sites
Novartis Investigative Site
Bruges, 8000
Novartis Investigative Site
Brussels, Brussels Capital, 1070
Novartis Investigative Site
Edegem, 2650
Novartis Investigative Site
Melsbroek, 1820
Novartis Investigative Site
Overpelt, 3900
Israel5 sites
Novartis Investigative Site
Ashkelon, 7830604
Novartis Investigative Site
Hadera, 3820302
Novartis Investigative Site
Haifa, 3109601
Novartis Investigative Site
Jerusalem, 9112001
Novartis Investigative Site
Sefad, 1311300
Bulgaria4 sites
Novartis Investigative Site
Pleven, 5800
Novartis Investigative Site
Sofia, 1113
Novartis Investigative Site
Sofia, 1431
Novartis Investigative Site
Sofia, 1680
Croatia4 sites
Novartis Investigative Site
Osijek, 31000
Novartis Investigative Site
Rijeka, 51000
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Zagreb, Croatia, 10000
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Zagreb, 10000
Malaysia4 sites
Novartis Investigative Site
Kuala Lumpur, Kuala Lumpur, 50586
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Kuala Terengganu, Terengganu, 20400
Novartis Investigative Site
Kuching, Sarawak, 93586
Novartis Investigative Site
Seberang Jaya, Pulau Pinang, 13700
Slovakia4 sites
Novartis Investigative Site
Bratislava, Slovakia, 826 06
Novartis Investigative Site
Košice, 041 90
Novartis Investigative Site
Nitra, 950 01
Novartis Investigative Site
Trnava, Slovakia, 917 02
Taiwan4 sites
Novartis Investigative Site
Kaohsiung City, 83301
Novartis Investigative Site
Tainan, 704302
Novartis Investigative Site
Taipei, 11220
Novartis Investigative Site
Taoyuan, 33305
Lebanon3 sites
Novartis Investigative Site
Beirut, 166830
Novartis Investigative Site
El Chouf, LBN, 1503-2010
Novartis Investigative Site
Tripoli, 1434
Mexico3 sites
Novartis Investigative Site
Guadalajara, Jalisco, 44600
Novartis Investigative Site
San Pedro G G, 66278
Novartis Investigative Site
Veracruz, 91900
United Kingdom3 sites
Novartis Investigative Site
Glasgow, Scotland, G51 4TF
Novartis Investigative Site
Westbruy on Trym, Bristol, BS10 5NB
Novartis Investigative Site
Winchester, Hampshire, SO23 8SR
Austria2 sites
Novartis Investigative Site
Linz, Upper Austria, 4020
Novartis Investigative Site
Linz, 4020
Chile2 sites
Novartis Investigative Site
Santiago, Santiago Metropolitan, 7650568
Novartis Investigative Site
Santiago, Santiago Metropolitan, 8431657
Ireland2 sites
Novartis Investigative Site
Dublin, Ireland, D03 VX82
Novartis Investigative Site
Dublin, DO4
Latvia2 sites
Novartis Investigative Site
Riga, LV, LV-1005
Novartis Investigative Site
Riga, LV 1002
Lithuania2 sites
Novartis Investigative Site
Klaipėda, LT-92288
Novartis Investigative Site
Šiauliai, LTU, 76231
Switzerland2 sites
Novartis Investigative Site
Basel, 4031
Novartis Investigative Site
Bern, 3010
United Arab Emirates2 sites
Novartis Investigative Site
Abu Dhabi
Novartis Investigative Site
Dubai
Netherlands1 site
Novartis Investigative Site
Rotterdam, South Holland, 3079 DZ
About this study
Official title: A Randomized, Double-blind, Double-dummy, Parallel-group Study, Comparing the Efficacy and Safety of Remibrutinib Versus Teriflunomide in Participants With Relapsing Multiple Sclerosis, Followed by Extended Treatment With Open-label Remibrutinib
To compare the efficacy and safety of remibrutinib versus teriflunomide in patients with relapsing multiple sclerosis (RMS)
Read the detailed description
The study CLOU064C12301 consists of an initial Core Part (CP) (maximum duration per participant of up to 30 months), followed by an Extension Part (EP, of up to 5 years duration) for eligible participants.
The Core Part is a randomized, double-blind, double-dummy, active comparator-controlled, fixed-dose, parallel-group, multi-center study in approximately 800 participants with relapsing multiple sclerosis (RMS).
The Extension Part is an open-label, single-arm, fixed-dose design in which eligible participants are treated with remibrutinib for up to 5 years.
A second study of identical design (CLOU064C12302) will be conducted simultaneously. Both studies will be conducted globally and data from the two studies will be pooled for some of the endpoints.
- Conditions
- Relapsing Multiple Sclerosis
- Being tested
- Remibrutinib, Teriflunomide
- Keywords
- MS, RMS, RRMS, active secondary progressive multiple sclerosis SPMS, remibrutinib, LOU064, teriflunomide, adult, relapse, Expanded Disability Status Scale, T2 lesions, T1 lesions, GD- enhancing MRI, Neurofilament light chain, McDonald diagnostic criteria
- Medical subject headings
- Recurrence, Charcot-Marie-Tooth disease, Type 1F
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RemibrutinibDrug
Also called LOU064
tablet taken orally
TeriflunomideDrug
capsule taken orally
| Study group | Role | What they receive |
|---|---|---|
| Remibrutinib - Core | Experimental | Remibrutinib tablet and matching placebo of teriflunomide capsule Receives: Drug: Remibrutinib |
| Teriflunomide - Core | Active comparator | Teriflunomide capsule and matching placebo remibrutinib tablet Receives: Drug: Teriflunomide |
| Remibrutinib - Extension | Experimental | Participants on remibrutinib in Core will continue on remibrutinib tablet Receives: Drug: Remibrutinib |
| Remibrutinib - Extension (on teriflunomide in Core) | Experimental | Participants on teriflunomide in Core will switch to remibrutinib tablet Receives: Drug: Remibrutinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Annualized relapse rate (ARR) of confirmed relapses [Core Part]
ARR is the average number of confirmed MS relapses in a year
Measured: From Baseline, up to 30 months
Secondary outcomes (24)
Time to 3-month confirmed disability progression (3mCDP) on Expanded Disability Status Scale (EDSS) [Core Part] (pooled data)
Time to 3-month confirmed disability progression (3mCDP) is defined as an increase in Expanded Disability Status Scale (EDSS) which is sustained for at least 3 months
Measured: Baseline up to 30 months
Time to 6-month confirmed disability progression (6mCDP) on EDSS [Core Part] (pooled data)
Time to 6-month confirmed disability progression (6mCDP) is defined as an increase in Expanded Disability Status Scale (EDSS) which is sustained for at least 6 months
Measured: Baseline up to 30 months
Annualized rate of new or enlarging T2 lesion [Core Part]
Number of new/newly enlarged T2 lesions per year
Measured: Baseline up to 30 months
Neurofilament light chain (Nfl) [Core Part]
Neurofilament light chain (NfL) concentration in serum
Measured: Baseline up to 30 months
Number of Gd-enhancing T1 lesions per MRI scan [Core Part]
Average number of Gd-enhancing T1 lesions per scan
Measured: Baseline up to 30 months
Percentage of participants with No Evidence of Disease Activity-3 (NEDA-3) [Core Part] (pooled data)
Percentage of participants with No Evidence of Disease Activity-3 (NEDA-3), as assessed by absence of confirmed MS relapses, 6mCDP and new/enlarging T2 lesions on MRI
Measured: Baseline up to 30 months
Time to first confirmed relapse [Core Part]
Change in the Expanded Disability Status Scale (EDSS), an increase of at least 0.5 points on the EDSS (total) score, or an increase of at least 1 point on at least two functional scores (FSs), or an increase of at least 2 points on at least one FS, excluding changes involving bowel/bladder or cerebral FS, compared to the previous available rating.
Measured: Baseline up to 30 months
Time to 6-month confirmed disability improvement (6mCDI) on EDSS [Core Part] (pooled data)
Decrease in Expanded Disability Status Scale Score (EDSS) which is sustained for at least 6 months
Measured: Baseline up to 30 months
Time to 3-months confirmed disability progression (3mCDP) and 6-month confirmed disability progression (6mCDP) independent of relapse activity (PIRA) [Core Part] (pooled data)
Time to 3-month confirmed disability progression (3mCDP) and 6-month confirmed disability progression (6mCDP) is defined as an increase in Expanded Disability Status Scale (EDSS) which is sustained for at least 3 months or 6 months, respectively, without an on-study relapse before or on the day of a progression event.
Measured: Baseline up to 30 months
Change from baseline in the Symbol Digit Modalities Test (SDMT) [Core Part] (pooled data)
Symbol Digit Modalities Test (SDMT), an array of symbols paired with empty spaces, measures processing in speed; participants verbally match the number for each symbol as rapidly as possible. The score is the number of correctly coded items in 90 seconds. Higher scores indicate improvement. Lower scores indicate worsening
Measured: Baseline up to 30 months
Time to 6-month confirmed worsening by at least 20% in the Timed 25-foot walk test (T25FW) [Core Part] (pooled data)
The patient walking speed to cover 25-foot distance is recorded in seconds. Longer time indicates poorer lower limb function. 20% worsening is defined as 20% increase from baseline T25FW score
Measured: Baseline, up to 30 months
Time to 6-month confirmed worsening by at least 20% in the Timed 9-hole peg test (9HPT) (pooled data) [Core Part] (pooled data)
The patient's right and left arm function to peg 9 holes measured in seconds. Longer time indicates poorer upper limb function. 20% worsening is defined as 20% increase from baseline 9HPT score in at least one hand (average of two trials per hand)
Measured: Baseline up to 30 months
Time to composite 6-month confirmed disability Progression (CDP) [Core Part] (pooled data)
The composite involves CDP and worsening by at least 20% in T25FW and 9HPT
Measured: Baseline up to 30 months
Change from Baseline in T2 lesion volume [Core Part]
Change from baseline in total T2 lesion volume.
Measured: Baseline up to 30 months
Change from baseline in Multiple Sclerosis Impact Scale (MSIS-29) [Core Part]
29-item, self-administered questionnaire that includes 2 domains, physical and psychological. Responses are captured on a 4-point scale ranging from "not at all" (1) to "extremely" (4), where higher scores reflect greater impact on day to day life
Measured: Baseline up to 30 months
Number of participants with Adverse events and Serious adverse events(SAE) [Core Part]
Adverse events and SAEs including clinically significant , laboratory data, vital signs, electrocardiogram (ECG), Columbia Suicide Severity Rating
Measured: Baseline up to 30 months
Pharmacokinetics of remibrutinib [Core Part]
Blood concentrations of remibrutinib
Measured: Month 1, Month 6
Number of participants with Adverse events and Serious adverse events (SAE) [Extension Part]
Adverse events and SAEs including clinically significant, laboratory data, vital signs, electrocardiogram (ECG), Columbia Suicide Severity Rating
Measured: Day 1 Extension up to 5 years
Annualized relapse rate (ARR) of confirmed relapses [Extension Part]
ARR is the average number of confirmed MS relapses in a year
Measured: Day 1 Extension up to 5 years
Annualized rate of new or enlarging T2 lesion [Extension Part]
Number of new/newly enlarged T2 lesions per year
Measured: Day 1 Extension up to 5 years
Time to 6-month confirmed disability progression (6mCDP) on EDSS [Extension Part]
Time to 6-month confirmed disability progression (6mCDP) is defined as an increase in Expanded Disability Status Scale (EDSS) which is sustained for at least 6 months
Measured: Day 1 Extension up to 5 years
Change from baseline in the Symbol Digit Modalities Test (SDMT) [Extension Part]
Symbol Digit Modalities Test (SDMT), an array of symbols paired with empty spaces, measures processing in speed; participants verbally match the number for each symbol as rapidly as possible. The score is the number of correctly coded items in 90 seconds. Higher scores indicate improvement. Lower scores indicate worsening
Measured: Day 1 Extension up to 5 years
Neurofilament light chain (NfL) [Extension Part]
Neurofilament light chain (NfL) concentration in serum
Measured: Day 1 Extension up to 5 years
Change from baseline in Multiple Sclerosis Impact Scale (MSIS-29) [Extension Part]
29-item, self-administered questionnaire that includes 2 domains, physical and psychological. Responses are captured on a 4-point scale ranging from "not at all" (1) to "extremely" (4), where higher scores reflect greater impact on day to day life
Measured: Day 1 Extension up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2021
- Study start16 Dec 2021
- Primary completion21 Jul 2026
- Study completion30 Oct 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsing Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Eligible participants will be randomized in a 1:1 ratio
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05147220
- Sponsor's protocol ID
- CLOU064C12301
- Other IDs
- 2020-005899-36
- Status last verified
- May 2026
- First submitted
- 24 Nov 2021
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com