A Phase 4 interventional study of Ofatumumab and mRNA COVID-19 vaccine in Relapsing Multiple Sclerosis (RMS), sponsored by Novartis Pharmaceuticals. Terminated at 7 sites in United States. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2025-05-16.
Sponsored by Novartis Pharmaceuticals · Phase 4, Interventional, and Treatment
This study evaluated if relapsing multiple sclerosis (MS) participants treated with ofatumumab 20 mg subcutaneous (s.c.) administered once monthly could develop an adequate immune response to the COVID-19 mRNA vaccine compared to participants on an interferon or glatiramer acetate.
This was a six-cohort, multicenter, prospective study planned for up to 88 relapsing multiple sclerosis (MS) participants. The study was intended to address two questions: 1) Can participants treated with ofatumumab develop an immune response if receiving a COVID-19 mRNA vaccine two weeks prior to ofatumumab start? 2) If receiving COVID-19 mRNA vaccine after introduction of ofatumumab treatment, can participants develop an immune response? Cohort 1: participants received an mRNA COVID-19 vaccine at least two weeks prior to ofatumumab start. Cohort 2: participants received an mRNA COVID-19 vaccine at least four weeks after beginning ofatumumab. Cohort 3: participants on an interferon or glatiramer acetate who received COVID-19 mRNA vaccine. Cohort 4: participants fully vaccinated with an RNA COVID-19 vaccine at least four weeks after ofatumumab start. Cohort 5: participants vaccinated with an RNA COVID-19 vaccine, with or without a booster dose, and on interferon or glatiramer acetate. Cohort 6: participants fully vaccinated with an RNA COVID-19 vaccine who received a booster dose at least four weeks after ofatumumab start. Participants obtained the COVID-19 mRNA vaccine from their HCP (private insurance) or appropriate federal, state or local program.
Participants in Cohort 1 received loading doses of ofatumumab and subsequent dosing was 20 mg s.c. administered monthly. All other cohorts continued current dosing schedule of either ofatumumab, glatiramer acetate or interferon. Participation in trial was maximum of 421 days which was dependent on the Cohort.
7,638 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's enrollment of 24 is below the median of 100 across 4,098 interventional studies indexed under COVID-19.
Browse COVID-19 studies →Novartis Pharmaceuticals is the lead sponsor of 2,673 studies on the registry; 228 are open to participants now.
Of its 576 completed or terminated interventional studies of FDA-regulated products, 431 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants received non-live COVID-19 mRNA vaccine at least two weeks prior to start of ofatumumab (OMB157) (20 mg subcutaneous).
Drug: Ofatumumab · Biological: mRNA COVID-19 vaccine
Participants received non-live COVID-19 mRNA vaccine at least four weeks after start of ofatumumab (OMB157) (20 mg subcutaneous).
Drug: Ofatumumab · Biological: mRNA COVID-19 vaccine
Participants will receive non-live COVID-19 mRNA vaccine at least 4 weeks after start of prescribed interferon or glatiramer acetate
Biological: mRNA COVID-19 vaccine · Drug: interferon or glatiramer acetate
Participants fully vaccinated with a non-live COVID mRNA vaccine and on ofatumumab for at least 4 weeks (20 mg subcutaneous)
Drug: Ofatumumab · Biological: mRNA COVID-19 vaccine
Participants fully vaccinated with a non-live COVID mRNA vaccine, without or without a booster, and on interferon or glatiramer acetate for at least 4 weeks.
Biological: mRNA COVID-19 vaccine · Drug: interferon or glatiramer acetate
Participants fully vaccinated with a non-live COVID mRNA vaccine with a booster and on ofatumumab for at least 4 weeks (20 mg subcutaneous)
Drug: Ofatumumab · Biological: mRNA COVID-19 vaccine
3 loading doses followed by monthly administrations
Pfizer or Moderna mRNA Vaccine
iDMT
Percentage of Participants With Response by SARS-CoV-2 Qualitative IgG Antibody Assay at 14 Days Post-vaccination by Cohort Group and Overall, Non-response Imputation Approach (Safety Analysis Set)
An immune response is defined as a positive SARS-CoV-2 qualitative IgG antibody assay ≥14 days after full course \[2 doses\] vaccination to non live mRNA COVID-19 vaccine, Participants with a negative or borderline result were considered non-responders, as well as participants with a missing or invalid immune response assessment at 14 days post-vaccination (imputed as non-responders).
Time frame: Cohorts 1 - 3: >=14 days after vaccination: Day 36 (Pfizer) or Day 43 (Moderna); Cohorts 4-6: Day 1
Percentage of Patients With an Immune Response by SARS-CoV-2 Qualitative IgG Antibody Assay by Time Point, Cohort Group and Overall, Non-response Imputation Approach (Safety Analysis Set)
An immune response is defined as a positive SARS-CoV-2 qualitative IgG antibody assay ≥14 days after full course \[2 doses\] vaccination to non live mRNA COVID-19 vaccine, Participants with a negative or borderline result were considered non-responders, as well as participants with a missing or invalid immune response assessment at 14 days post-vaccination (imputed as non-responders).
Time frame: Vaccination up to 70, 180, 270 and 360 days
Percentage of Participants Achieving Immune Conversion by Individual Cohort Group and Overall, Non-response Imputation Approach (Safety Analysis Set)
Immune conversion was defined as (i) pre-vaccination absence of SARS-CoV-2 qualitative IgG antibody with any post-vaccination positive SARS-CoV-2 qualitative IgG antibody assay (Cohorts 1-3 only); or (ii) pre vaccination presence of SARS-CoV-2 quantitative IgG antibody (i.e., pre vaccination value ≥0.80 U/mL) with any post-vaccination ≥4-fold increase in SARS-CoV-2 quantitative IgG antibody titer (Cohorts 1-3 only); or (iii) initial negative SARS-CoV-2 nucleocapsid antibody assay with any post-vaccination positive SARS-CoV-2 qualitative IgG antibody assay (Cohorts 4 and 5 only). There was no baseline for Cohort 6 because there was no blood collection prior to vaccination.
Time frame: Cohorts 1 - 3: >=14 days after vaccination: Day 36 (Pfizer) or Day 43 (Moderna); Cohorts 4-5: Day 1
| Milestone | C1: VN - Plan to Start OMB157 | C2: VN - on OMB157 >=4 WKs | C3: VN - INFy or GA >=4 WKs | C4: FV - OMB157 >=4 WKs | C5: FV - INFy or GA >=4 WKs | C6: FV - on OMB157 >=4 WKs + Booster |
|---|---|---|---|---|---|---|
| Started | 5 | 2 | 0 | 1 | 11 | 5 |
| Completed | 4 | 2 | 0 | 0 | 1 | 0 |
| Not completed | 1 | 0 | 0 | 1 | 10 | 5 |
| Withdrew: Lost to follow-up | 0 | 0 | 0 | 1 | 0 | 1 |
| Withdrew: Protocol deviation | 1 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Study terminated by sponsor | 0 | 0 | 0 | 0 | 9 | 4 |
| Withdrew: Subject decision | 0 | 0 | 0 | 0 | 1 | 0 |
An immune response is defined as a positive SARS-CoV-2 qualitative IgG antibody assay ≥14 days after full course \[2 doses\] vaccination to non live mRNA COVID-19 vaccine, Participants with a negative or borderline result were considered non-responders, as well as participants with a missing or invalid immune response assessment at 14 days post-vaccination (imputed as non-responders).
| Percentage of participants | C1: VN - Plan to Start OMB157 | C2: VN - on OMB157 >=4 WKs | C3: VN - INFy or GA >=4 WKs | C4: FV - OMB157 >=4 WKs | C5: FV - INFy or GA >=4 WKs | C6: FV - on OMB157 >=4 WKs + Booster | Overall |
|---|---|---|---|---|---|---|---|
| Percentage of Participants With Response by SARS-CoV-2 Qualitative IgG Antibody Assay at 14 Days Post-vaccination by Cohort Group and Overall, Non-response Imputation Approach (Safety Analysis Set) | 100.0 (47.8 to 100.0) | 100.0 (15.8 to 100.0) | — | 0.0 (0.0 to 97.5) | 100.0 (69.2 to 100.0) | 50.0 (6.8 to 93.2) | 86.4 (65.1 to 97.1) |
An immune response is defined as a positive SARS-CoV-2 qualitative IgG antibody assay ≥14 days after full course \[2 doses\] vaccination to non live mRNA COVID-19 vaccine, Participants with a negative or borderline result were considered non-responders, as well as participants with a missing or invalid immune response assessment at 14 days post-vaccination (imputed as non-responders).
| Percentage of participants | C1: VN - Plan to Start OMB157 | C2: VN - on OMB157 >=4 WKs | C3: VN - INFy or GA >=4 WKs | C4: FV - OMB157 >=4 WKs | C5: FV - INFy or GA >=4 WKs | C6: FV - on OMB157 >=4 WKs + Booster | Overall |
|---|---|---|---|---|---|---|---|
| 70 days post-vaccination n=5,0,0,0,0,0,5 | 100.0 (47.8 to 100.0) | — | — | — | — | — | 100.0 (47.8 to 100.0) |
| 180 days post-vaccination, n=5,2,0,1,10,4,22 | 80.0 (28.4 to 99.5) | 0.0 (0.0 to 84.2) | — | 100.0 (2.5 to 100.0) | 90.0 (55.5 to 99.7) | 25.0 (0.6 to 80.6) | 68.2 (45.1 to 86.1) |
| 270 days post-vaccination n=5,2,0,1,10,4,22 | 60.0 (14.7 to 94.7) | 0.0 (0.0 to 70.8) | — | 0.0 (0.0 to 97.5) | 60.0 (26.2 to 87.8) | 50.0 (6.8 to 93.2) | 50.0 (28.2 to 71.8) |
| 360 days post-vaccination n=5,2,0,1, 10, 4,22 | 60.0 (14.7 to 94.7) | 0.0 (0.0 to 84.2) | — | 0.0 (0.0 to 97.5) | 10.0 (0.3 to 44.5) | 0.0 (0.0 to 60.2) | 18.2 (5.2 to 40.3) |
Immune conversion was defined as (i) pre-vaccination absence of SARS-CoV-2 qualitative IgG antibody with any post-vaccination positive SARS-CoV-2 qualitative IgG antibody assay (Cohorts 1-3 only); or (ii) pre vaccination presence of SARS-CoV-2 quantitative IgG antibody (i.e., pre vaccination value ≥0.80 U/mL) with any post-vaccination ≥4-fold increase in SARS-CoV-2 quantitative IgG antibody titer (Cohorts 1-3 only); or (iii) initial negative SARS-CoV-2 nucleocapsid antibody assay with any post-vaccination positive SARS-CoV-2 qualitative IgG antibody assay (Cohorts 4 and 5 only). There was no baseline for Cohort 6 because there was no blood collection prior to vaccination.
| Percentage of participants | C1: VN - Plan to Start OMB157 | C2: VN - on OMB157 >=4 WKs | C3: VN - INFy or GA >=4 WKs | C4: FV - OMB157 >=4 WKs | C5: FV - INFy or GA >=4 WKs | Overall |
|---|---|---|---|---|---|---|
| Pre-vac absence and post vac positive n=5,2, 0,0,0,7 | 80.0 (28.4 to 99.5) | 50.0 (1.3 to 98.7) | — | — | — | 71.4 (29.0 to 96.3) |
| Pre-vac presence and post vac ≥4-fold increase n=5,2,0,0,0,7 | 0 (0.0 to 52.2) | 0.0 (0.0 to 84.2) | — | — | — | 0.0 (0.0 to 41.0) |
| Initial negative SARS nucleocapsid with post-vac positive SARS n=0,0,0,1,1,2 | — | — | — | 0.0 (0.0 to 97.5) | 0.0 (0.0 to 97.5) | 0.0 (0.0 to 84.2) |
| Immune conversion n=5,2,0,1,1,9 | 80.0 (28.4 to 99.5) | 50.0 (1.3 to 98.7) | — | 0.0 (0.0 to 97.5) | 0.0 (0.0 to 97.5) | 55.6 (21.2 to 86.3) |
Collected over Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cohort 1 | 0/5 (0%) | 0/5 (0%) | 5/5 (100%) |
| Cohort 2 | 0/2 (0%) | 0/2 (0%) | 1/2 (50%) |
| Cohort 3 | — | — | — |
| Cohort 4 | 0/1 (0%) | 0/1 (0%) | 0/1 (0%) |
| Cohort 5 | 0/11 (0%) | 1/11 (9.1%) | 2/11 (18.2%) |
| Cohort 6 | 0/5 (0%) | 1/5 (20%) | 2/5 (40%) |
| Event | Cohort 1 | Cohort 2 | Cohort 3 | Cohort 4 | Cohort 5 | Cohort 6 |
|---|---|---|---|---|---|---|
| Foot fractureInjury, poisoning and procedural complications | 0/5 | 0/2 | — | 0/1 | 0/11 | 1/5 |
| Deep vein thrombosisVascular disorders | 0/5 | 0/2 | — | 0/1 | 1/11 | 0/5 |
| Event | Cohort 1 | Cohort 2 | Cohort 3 | Cohort 4 | Cohort 5 | Cohort 6 |
|---|---|---|---|---|---|---|
| VertigoEar and labyrinth disorders | 0/5 | 1/2 | — | 0/1 | 0/11 | 0/5 |
| FatigueGeneral disorders | 0/5 | 1/2 | — | 0/1 | 0/11 | 0/5 |
| Blood pressure increasedInvestigations | 0/5 | 1/2 | — | 0/1 | 0/11 | 0/5 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 0/5 | 1/2 | — | 0/1 | 0/11 | 0/5 |
| Limb discomfortMusculoskeletal and connective tissue disorders | 0/5 | 1/2 | — | 0/1 | 0/11 | 0/5 |
| Muscle discomfortMusculoskeletal and connective tissue disorders | 0/5 | 1/2 | — | 0/1 | 0/11 | 0/5 |
| Musculoskeletal discomfortMusculoskeletal and connective tissue disorders | 0/5 | 1/2 | — | 0/1 | 0/11 | 0/5 |
| MyalgiaMusculoskeletal and connective tissue disorders | 0/5 | 1/2 | — | 0/1 | 0/11 | 0/5 |
| Pain in extremityMusculoskeletal and connective tissue disorders | 0/5 | 1/2 | — | 0/1 | 0/11 | 0/5 |
| HeadacheNervous system disorders | 1/5 | 1/2 | — | 0/1 | 0/11 | 0/5 |
There were no participants enrolled in Cohort 3.
| Age, Categorical(Participants) | C1: VN - Plan to Start OMB157 | C2: VN - on OMB157 >=4 WKs | C3: VN - INFy or GA >=4 WKs | C4: FV - OMB157 >=4 WKs | C5: FV - INFy or GA >=4 WKs | C6: FV - on OMB157 >=4 WKs + Booster | Total |
|---|---|---|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 5 | 2 | 0 | 1 | 11 | 5 | 24 |
| >=65 years | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | C1: VN - Plan to Start OMB157 | C2: VN - on OMB157 >=4 WKs | C3: VN - INFy or GA >=4 WKs | C4: FV - OMB157 >=4 WKs | C5: FV - INFy or GA >=4 WKs | C6: FV - on OMB157 >=4 WKs + Booster | Total |
|---|---|---|---|---|---|---|---|
| Female | 5 | 1 | 0 | 0 | 8 | 5 | 19 |
| Male | 0 | 1 | 0 | 1 | 3 | 0 | 5 |
| Race/Ethnicity, Customized(Participants) | C1: VN - Plan to Start OMB157 | C2: VN - on OMB157 >=4 WKs | C3: VN - INFy or GA >=4 WKs | C4: FV - OMB157 >=4 WKs | C5: FV - INFy or GA >=4 WKs | C6: FV - on OMB157 >=4 WKs + Booster | Total |
|---|---|---|---|---|---|---|---|
| White | 3 | 2 | — | 1 | 10 | 4 | 20 |
| Black or African American | 2 | 0 | — | 0 | 1 | 0 | 3 |
| Missing | 0 | 0 | — | 0 | 0 | 1 | 1 |
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Plan to share: 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 https://www.clinicalstudydatarequest.com/.
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