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Multiple SclerosisPhase 3STHENOSNCT04788615

Open Label Randomized Multicenter to Assess Efficacy & Tolerability of Ofatumumab 20mg vs. First Line DMT in RMS

A Phase 3 study testing Ofatumumab and First line DMT in people with Multiple Sclerosis, run by Novartis Pharmaceuticals at 41 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This study will compare ofatumumab vs. European approved platform first line self-administered disease modifying therapy (DMT) in newly diagnosed MS patients Read more about this study

Who is it for?
Ages 18 to 55 years
Conditions the study is for
Multiple Sclerosis
What is being tested?
Ofatumumab and First line DMT
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
185 participants
Where
41 sitesin 4 countries
Study dates
23 Jul 2021to 4 Nov 2025
Phase
Phase 3
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 55 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Written informed consent obtained before any assessment
  • Male/female patients, 18 through 55 (inclusive) years of age.
  • Diagnosis of MS according to the 2017 revised McDonald criteria (Thompson et al 2018).
  • Relapsing MS: relapsing-course (RMS), as defined by Lublin et al 2014.
  • Treatment Naïve patients, ≤ 5 years since first MS symptom.
  • EDSS score 0-4.0 (inclusive).
Show all 49Show fewer
  • Patient must be suitable to be treated with one of first line self-administered DMT-physician's choice (glatiramer acetate, IFNs, teriflunomide, DMF, diroximel fumarate according to EMA SmPC) or ofatumumab depending on randomization and physician's choice
  • At least 1 relapse or 1 Gd+ enhanced lesion on T1 in 1 year prior to Screening.
  • Able to obtain MRI assessment.
  • Neurologically stable within 1 month prior to first study drug administration Exclusion Criteria
  • <!-- -->
  • Diseases other than multiple sclerosis responsible for the clinical or MRI presentation
  • Progressive MS phenotypes: Patients with primary progressive MS (Polman et al 2011) or SPMS (Lublin et al 2014).
  • Use of other experimental or investigational drugs at the time of enrollment (Screening) or within the prior 30 days, or 5 elimination half-lives, or until the expected pharmacodynamics effect has returned to baseline, whichever is longer
  • Relapse between Screening and Baseline visits
  • Pregnancy or breastfeeding
  • Patients suspected of not being able or willing to cooperate or comply with study protocol requirements in the opinion of the Investigator
  • Women of childbearing potential defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception (methods that result in less than 1% pregnancy rates) while receiving ofatumumab and for 6 months after the last administration. The requirements for contraception for the comparators should also be taken into consideration according to their SmPC.
  • Highly effective methods of contraception include:
  • Total abstinence (when this is in line with the preferred and usual lifestyle of the participant). Sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the participant. Periodic abstinence (e.g. calendar, ovulation, symptothermal, postovulation methods) and withdrawal are not acceptable methods of contraception.
  • Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy), total hysterectomy, or bilateral tubal ligation at least six weeks before taking study treatment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment.
  • Male sterilization (at least 6 months prior to screening). For female participants on the study, the vasectomized male partner should be the sole partner for that participant.
  • (Vasectomized partner is a highly effective birth control method provided that partner is the sole sexual partner of the WOCBP trial participant and that the vasectomized partner has received medical assessment of the surgical success.) - Use of combined, estrogen and progesterone containing (oral, intravaginal, transdermal), hormonal methods of contraception or use of progesterone-only (oral, injectable, implantable) hormonal methods of contraception or placement of an intrauterine device (IUD) or intrauterine system (IUS), or other forms of hormonal contraception that have comparable efficacy (failure rate <1%), for example hormone vaginal ring or transdermal hormone contraception. In case of use of oral contraception women should have been stable on the same pill for a minimum of 3 months before taking study treatment. Women are considered post-menopausal if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate history of vasomotor symptoms). Women are considered not of childbearing potential if they are post-menopausal or have had surgical bilateral oophorectomy (with or without hysterectomy), total hysterectomy or bilateral tubal ligation at least six weeks ago. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of childbearing potential. If local regulations deviate from the contraception methods listed above to prevent pregnancy, local regulations apply and will be described in the ICF.
  • Patients with an active chronic disease (or stable but treated with immune therapy) of the immune system other than MS (e.g. rheumatoid arthritis, scleroderma, Sjögren's syndrome, Crohn's disease, ulcerative colitis, etc.) or with immunodeficiency syndrome (hereditary immune deficiency, drug-induced immune deficiency)
  • Patients with an active infection (bacterial, fungal, or viral like hepatitis, HIV or COVID), until the infection is resolved. Where local regulation requires it, Sars-Cov-19 must be ruled out by the PCR test.
  • Patients with neurological findings consistent with Progressive Multifocal Leukoencephalopathy (PML), or confirmed PML
  • Positive results at Screening for serological markers for hepatitis (H) B and C indicating acute or chronic infection:
  • Hepatitis B virus (HBV) screening should be performed before initiation of treatment.
  • At a minimum, screening should include hepatitis B surface antigen (HBsAg) and hepatitis B core antibody (HBcAb) testing. These can be complemented with other appropriate markers as per local guidelines. Patients with positive hepatitis B serology (either HBsAg or HBcAb) should consult a liver disease expert before the start of treatment and should be monitored and managed following local medical standards to prevent hepatitis B reactivation.
  • Hepatitis C risk must be ruled out via anti-HC IgG (if positive IgG, HCV-RNA PCR will be performed and if negative, patient can be enrolled) NOTE: If the Investigator suspects false positive hepatitis serology results such as an antibody pattern indicating acute hepatitis infection but no corresponding elevated liver enzymes and no signs or symptoms of liver disease, an infectious disease expert may be consulted. In the case the patient has a record of vaccination including HB, and there is no evidence of acute or chronic hepatitis infection (confirmed by an infectious disease expert), the Investigator must document (in source data and as a comment in the electronic Case Report Form (eCRF) that the serology results are considered false positive and may then enroll the subject.
  • Have received any live or live-attenuated vaccines within 4 weeks prior to first study drug administration
  • Any other disease or condition that could interfere with participation in the study according to the study protocol, or with the ability of the patients to cooperate or comply with the study procedures
  • Any of the following conditions or treatments that may impact the safety of the patient:
  • History of, or current, significant cardiac disease including cardiac failure (NYHA functional class II-IV), myocardial infarction (within 6 months prior to screening), unstable angina (within 6 months prior to screening), transient ischemic attack (within 6 months prior to screening), stroke, cardiac arrhythmias requiring treatment or uncontrolled arterial hypertension
  • Concomitant clinically significant cardiac arrhythmias, e.g. sustained ventricular tachycardia and clinically significant second or third degree AV block without a pacemaker on screening electrocardiogram (ECG)
  • History of or active severe respiratory disease, including Chronic Obstructive Pulmonary Disease, interstitial lung disease or pulmonary fibrosis
  • Patients with asthma requiring regular treatment with oral steroids
  • Severe hepatic impairment (Child-Pugh class C) or any chronic liver or biliary disease
  • Patients with severe renal impairment (glomerular filtration rate < 30 ml/min/1.73 m2)
  • Any medically unstable condition as determined by the Investigator
  • Any of the following abnormal laboratory values prior to first study drug administration:
  • Total bilirubin greater than 3 times upper limit of normal (ULN) range, unless in the context of Gilbert's syndrome
  • Alkaline phosphatase (ALP) greater than 5 times the ULN range
  • Serum IgG < 500mg/dL (according to central laboratory range)
  • Any other clinically significant laboratory assessment as determined by the Investigator (e.g. significant anemia, neutropenia, thrombocytopenia, signs of impaired bone marrow function)
  • Patients with severe hypoproteinemia e.g. in nephrotic syndrome
  • Patients with any of the following neurologic/psychiatric disorders prior to first study drug administration: - Score "yes" on item 4 or item 5 of the Suicidal Ideation section of the Columbia- Suicide Severity Rating Scale (CSSRS) if this ideation occurred in the past 6 months OR
  • "yes" on any item of the Suicidal Behavior section, except for the "Non-Suicidal Self- Injurious Behavior" (item also included in the Suicidal Behavior section) if this behavior occurred in the past 2 years.
  • History of hypersensitivity to the study drug or any of the excipients or to drugs of similar chemical classes

Who cannot join

None listed.

Trial locations and contacts

41 sites in 4 countries.

41 sites in 4 countries

France13 sites

  • Novartis Investigative Site

    Amiens, 80054

  • Novartis Investigative Site

    Bayonne, Bayonne Cedex, 64109

  • Novartis Investigative Site

    Bordeaux, 33076

  • Novartis Investigative Site

    Clermont-Ferrand, 63003

  • Novartis Investigative Site

    Créteil, 94010

  • Novartis Investigative Site

    Gonesse, 95500

  • Novartis Investigative Site

    Grenoble, 38043

  • Novartis Investigative Site

    Montpellier, 34090

  • Novartis Investigative Site

    Nice, 06202

  • Novartis Investigative Site

    Nîmes, 30029

  • Novartis Investigative Site

    Poissy, 78303

  • Novartis Investigative Site

    Rennes, 35033

  • Novartis Investigative Site

    Strasbourg, 67000

Other trials in France

Germany11 sites

  • Novartis Investigative Site

    Bayreuth, 95445

  • Novartis Investigative Site

    Berlin, 12101

  • Novartis Investigative Site

    Berlin, 13353

  • Novartis Investigative Site

    Bielefeld, 33647

  • Novartis Investigative Site

    Cologne, North Rhine-Westphalia, 50937

  • Novartis Investigative Site

    Dortmund, 44137

  • Novartis Investigative Site

    Frankfurt am Main, Hesse, 60590

  • Novartis Investigative Site

    Heidelberg, 69120

  • Novartis Investigative Site

    Siegen, 57076

  • Novartis Investigative Site

    Ulm, 89073

  • Novartis Investigative Site

    Westerstede, Lower Saxony, 26655

Other trials in Germany

Spain11 sites

  • Novartis Investigative Site

    Barakaldo, Vizcaya, 48903

  • Novartis Investigative Site

    Barcelona, 08035

  • Novartis Investigative Site

    El Palmar, Murcia, 30120

  • Novartis Investigative Site

    Madrid, 28009

  • Novartis Investigative Site

    Madrid, 28034

  • Novartis Investigative Site

    Madrid, 28040

  • Novartis Investigative Site

    Málaga, 29010

  • Novartis Investigative Site

    Salt, Girona, 17190

  • Novartis Investigative Site

    Santiago Compostela, A Coruna, 15706

  • Novartis Investigative Site

    Seville, 41009

  • Novartis Investigative Site

    Valencia, 46026

Other trials in Spain

Italy6 sites

  • Novartis Investigative Site

    Milan, MI, 20132

  • Novartis Investigative Site

    Montichiari, BS, 25018

  • Novartis Investigative Site

    Naples, 80131

  • Novartis Investigative Site

    Orbassano, TO, 10043

  • Novartis Investigative Site

    Roma, RM, 00133

  • Novartis Investigative Site

    Roma, RM, 00189

Other trials in Italy

About this study

Official title: Open-Label Rater-Blind Randomized Multi-Center Parallel-Arm Active- Comparator Study to Assess the Efficacy and Tolerability of Ofatumumab 20mg SC Monthly vs. First Line DMT - Physician's Choice in the Treatment of Newly Diagnosed RMS

This study will compare ofatumumab vs. European approved platform first line self-administered disease modifying therapy (DMT) in newly diagnosed MS patients

Read the detailed description

The study is a randomized (1:1), open-label, rater-blind, multi-center, prospective, parallel-arm, active comparator study which will consist of 15 months treatment period and a 6 months observational safety extension period, for patients who withdraw ofatumumab for any reason, in 186 total patients with early relapsing multiple sclerosis (RMS) RMS patients are patients who are newly diagnosed or have never been on active treatment at the time of study entry with ≤ 5 years from first MS symptoms.

There is a screening period and patients are randomized to either ofatumumab or first line DMT at baseline. Patients will be treated until the end of study (EOS) or for a maximum duration of 15 months. Patients who prematurely discontinue study drug or comparator will have their end of treatment (EOT) visit and assessments at the time of discontinuation. After ofatumumab or the standard of care comparator (DMT) discontinuation, patients may initiate alternative MS therapy according to local standard of care, if clinically indicated.

Patients who for any reason withdraw from ofatumumab during treatment will be invited to participate in the observational extension safety period for 6 months or until patient re-starts MS treatment with a new DMT treatment. During this period, clinical efficacy after ofatumumab withdrawal will be assessed.

Being tested
Ofatumumab, First line DMT
Keywords
Ofatumumab, relapsing multiple sclerosis, relapsing-remitting MS, MS therapy, RMS, Relapsing MS, Glatiramer acetate, IFNβ-1b, IFNβ-1a, peg-IFNβ-1a, Teriflunomide, Dimethyl fumarate, Diroximel fumarate, OMB157, adult
Medical subject headings
Multiple Sclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OfatumumabDrug

    Also called OMB157

    20mg Subcutaneous injection

  • First line DMTDrug

    Also called Glatiramer acetate or Interferon or Peg-Interferon beta-1a or Teriflunomide or Dimethyl fumarate or Diroximel fumarate

    any one of these based on availability at country given as First line DMT Glatiramer acetate 20mg or 40mg or Interferon 22µg or 0.25mg or Peg-Interferon beta-1a 63µg or 125µg or Teriflunomide 14mg or Dimethyl fumarate 120mg or 240mg or Diroximel fumarate 231mg or 462mg

Study groups in NCT04788615
Study groupRoleWhat they receive
ofatumumabExperimentalOftatumumab 20mg auto injector syringes for subcutaneous injection on Day 1, Week 1 and 2, followed by subsequent monthly dosing, starting at Month 1.
Receives: Drug: Ofatumumab
First line DMTActive comparator1. Glatiramer acetate minimum dose 20mg or maximum dose 40mg twice a day or three times a week or 2. Interferon minimum dose 22µg or maximum dose of 0.25mg 3 times a week or once a week or Every second week depending on preparation or 3. Peg-Interferon beta-1a minimum dose of 63µg or maximum dose of 125µg every 2 weeks (14 days) or 4. Teriflunomide 14 mg once a day or 5. Dimethyl fumarate minimum dose of 120mg or maximum dose of 240mg twice a day 6. Diroximel fumarate minimum dose of 231mg or maximum dose of 462mg twice a day
Receives: Drug: First line DMT

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants with no evidence of disease activity (NEDA-3)

    NEDA-3 (yes/no) is defined as:

    1. Absence of confirmed clinical relapse
    2. Absence of new MRI activity (Gd+ T1 lesion or new/enlarged T2 lesion) with MRI re-baselined at Month 3
    3. Absence of 3-month confirmed disability worsening

    Measured: Baseline to 15 month

Secondary outcomes (17)

  1. Number of relapses

    Number of relapses will be summarized descriptively

    Measured: Baseline to Month 15

  2. Annual relapse rate

    Annual relapse rate will be analyzed by treatment group using negative binomial regression model with log-link and patient's time in study will be used as an offset.

    Measured: Baseline to Month 15

  3. Percentage of relapse-free patients and proportion of relapse free patients with MRI activity free

    Proportion of relapse-free patients and proportion of relapse-free patients with MRI activity free at Month 3, 9 and 15 will be summarized descriptively at each timepoint.

    Measured: Month 3, Month 9 and Month 15

  4. Time to 3 month Confirmed Disability Worsening (CDW) and time to 6-month Confirmed Disability Worsening (CDW)

    Time to 3 month Confirmed Disability Worsening (CDW) and time to 6-month CDW will be assessed by EDSS (Expanded disability status scale) score

    Measured: Baseline to Month 3 and to Month 6

  5. Change in expanded disability status scale (EDSS)

    Change in expanded disability status scale (EDSS) from baseline to end of study will be summarized descriptively based on the expanded disability status scale (EDSS) score

    Measured: Baseline to Month 15

  6. Percentage of disability-progression free patients

    Proportion of disability-progression free patients at end of study will be summarized descriptively

    Measured: Baseline to Month 15

  7. Number of Gd+ T1 lesions of brain

    Number of Gd+ T1 lesions of brain will be summarized descriptively.

    Measured: Baseline to Month 15

  8. The number and percentage of patients with Treatment emergent adverse events (TEAE) or adverse events reports

    Adverse will be collected at each patients visit including any clinically significant safety assessments determined to be an adverse event by the investigator

    Measured: Baseline to Month 15 and 6 months safety follow-up

  9. Volume of Gd+ T1 lesions of brain

    Volume of Gd+ T1 lesions of brain will be summarized descriptively.

    Measured: Baseline to Month 15

  10. Number of new/enlarging T2 lesions of brain

    Number of new/enlarging T2 lesions of brain will be summarized descriptively.

    Measured: Baseline to Month 15

  11. Volume of new enlarging T2 lesions of brain

    Volume of new enlarging T2 lesions of brain will be summarized descriptively.

    Measured: Baseline to Month 15

  12. Mean time to first relapse

    Mean time to first relapse will be summarized descriptively

    Measured: Baseline to Month 15

  13. Percentage of SAEs, and SAEs with hospitalizations

    Proportion of SAEs, and SAEs with hospitalizations between ofatumumab 20 mg s.c. and first line self-administered DMTs

    Measured: Baseline to Month 15 and 6 months safety follow-up

  14. Percentage of treatment compliance of participants

    Treatment compliance will be assessed by review of participant diary entries and counts of treatment (dispensed and returned)

    Measured: Baseline to Month 15

  15. Percentage of patient with AEs

    Proportion of patients with adverse events, including injection related reactions

    Measured: Baseline to Month 15 and 6 months safety follow-up

  16. Percentage of withdrawn patients

    Proportion of patients who withdrew due to abnormal lab values

    Measured: Baseline to Month 15

  17. Percentage of treatment discontinuation or interruptions

    Proportion of treatment discontinuation or interruptions for safety/ tolerability reason

    Measured: Baseline to Month 15

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Mar 2021
  2. Study start23 Jul 2021
  3. Primary completion4 Nov 2025
  4. Study completion4 Nov 2025

Resources

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
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
185 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04788615
Sponsor's protocol ID
COMB157G3301
Other IDs
2020-004505-32
Acronym
STHENOS
Status last verified
Feb 2026
First submitted
8 Mar 2021
Last updated
3 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ofatumumab and First line DMT in people with Multiple Sclerosis, run by Novartis Pharmaceuticals at 41 sites in 4 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 49 inclusion and 0 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: finished, as of the sponsor's last update on 3 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 41 sites in France, Germany, Spain, Italy. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Number of participants with no evidence of disease activity (NEDA-3) (time frame: Baseline to 15 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04788615.

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 3 Mar 2026.

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STHENOS Clinical Trial NCT04788615 | AzTrials