NCT04486716: OLIKOS

A Single Arm Study Evaluating the Efficacy, Safety and Tolerability of Ofatumumab in Patients With Relapsing Multiple Sclerosis

Completed Phase 3 Results posted Last updated 13 January 2026

What this trial tests

Phase 3 trial testing Ofatumumab in Relapsing Multiple Sclerosis in 111 participants. Completed in 21 October 2024.

Timeline

19 October 2020

Primary endpoint
20 November 2023

21 October 2024

Quick facts

Lead sponsor	Novartis Pharmaceuticals
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	111
Start date	19 October 2020
Primary completion	20 November 2023
Estimated completion	21 October 2024
Sites	20 locations across Puerto Rico, United States

Drugs / interventions tested

• Ofatumumab (OFATUMUMAB) — full drug profile →

Conditions studied

• Relapsing Multiple Sclerosis — all drugs for Relapsing Multiple Sclerosis →

Sponsor

Novartis Pharmaceuticals — full company profile →

Who can join

Adults 18 to 60, any sex, with Relapsing Multiple Sclerosis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage of Participants With no Change or a Reduction From Baseline in the Number of Gadolinium Enhancing (GdE) Lesions at Month 12 Using Non-responder Imputation Primary · Baseline (assessed at screening visit), Month 12

Magnetic Resonance Imaging (MRI) was used to measure presence of new or reduction in number of gadolinium enhancing T1 lesions. Each MRI scan was previewed by a local neuroradiologist. The quality of each scan performed was assessed by a central MRI reading center and evaluated for quality, completeness and adherence to the protocol. A nonresponder imputation (NRI) for missing data approach was applied. NRI assumes that a participant was a treatment failure, i.e. non-responder, if they did not have a valid Month 12 MRI assessment, or if they discontinued the study prematurely and did not have

Group	Value	95% CI
Ofatumumab 20 mg	86.6	78.17 – 92.67

Percentage of Participants With no Change or a Reduction From Baseline in the Number of Gadolinium Enhancing (GdE) Lesions at Month 12 Based on Observed Data Primary · Baseline (assessed at screening visit), Month 12

Magnetic Resonance Imaging (MRI) was used to measure presence of new or reduction in number of gadolinium enhancing T1 lesions. Each MRI scan was previewed by a local neuroradiologist. The quality of each scan performed was assessed by a central MRI reading center and evaluated for quality, completeness and adherence to the protocol. A sensitivity analysis of the primary endpoint was performed based on an observed data approach.

Group	Value	95% CI
Ofatumumab 20 mg	100	95.70 – 100

Number of Participants Who Continued Study Treatment From Baseline to Months 6 and 12 Secondary · Baseline, Month 6, Month 12

Retention on study treatment from baseline to Month 6 and to Month 12 was based on the number of participants who continued study treatment.

Month 6

Group	Value	95% CI
Ofatumumab 20 mg	95

Month 12

Group	Value	95% CI
Ofatumumab 20 mg	89

Change From Baseline in CD19+ B Cell Counts Obtained by FACS Secondary · Baseline, Month 6, Month 12

Changes from baseline in lymphocytes, including total CD19+ B cell counts and CD20+CD3+ T cell counts, were obtained by fluorescence-activated cell sorting (FACS), which is a specific type of flow cytometry.

Month 6

Group	Value	95% CI
Ofatumumab 20 mg	-24.45	± 58.295

Month 12

Group	Value	95% CI
Ofatumumab 20 mg	-17.53	± 52.182

Change From Baseline in CD20+ CD3+ T Cell Counts Obtained by FACS Secondary · Baseline, Month 6, Month 12

Changes from baseline in lymphocytes, including total CD19+ B cell counts and CD20+CD3+ T cell counts, were obtained by fluorescence-activated cell sorting (FACS), which is a specific type of flow cytometry.

Month 6

Group	Value	95% CI
Ofatumumab 20 mg	-11.144	± 39.1520

Month 12

Group	Value	95% CI
Ofatumumab 20 mg	-2.590	± 32.1112

Number of Participants With Suicidal Ideation or Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS) Secondary · Baseline (all prior history), Post-baseline (up to Month 12)

The Columbia-Suicide Severity Rating Scale (C-SSRS) is a questionnaire that assesses suicidal ideation and suicidal behavior. The suicidal ideation section includes 5 items (Categories 1 to 5), and the suicidal behavior section includes 5 items (Categories 6 to 10). Additionally, there is one item about Self-injurious behavior, without suicidal intent. The C-SSRS was given multiple times throughout the study from baseline up to Month 12. The number of participants who answered 'Yes' to any of the items in C-SSRS at baseline and at any timepoint post-baseline is summarized in this record. Bas

Baseline: Any suicidal ideation (Categories 1 to 5)

Group	Value	95% CI
Ofatumumab 20 mg	18

Baseline: Any suicidal behavior (Categories 6 to 10)

Group	Value	95% CI
Ofatumumab 20 mg	6

Baseline: Any suicidal ideation or behavior (Categories 1 to 10)

Group	Value	95% CI
Ofatumumab 20 mg	19

Baseline: Self-injurious behavior, without suicidal intent

Group	Value	95% CI
Ofatumumab 20 mg	4

Post-baseline: Any suicidal ideation (Categories 1 to 5)

Group	Value	95% CI
Ofatumumab 20 mg	4

Post-baseline: Any suicidal behavior (Categories 6 to 10)

Group	Value	95% CI
Ofatumumab 20 mg	0

Post-baseline: Any suicidal ideation or behavior (Categories 1 to 10)

Group	Value	95% CI
Ofatumumab 20 mg	4

Post-baseline: Self-injurious behavior, without suicidal intent

Group	Value	95% CI
Ofatumumab 20 mg	0

Treatment Satisfaction Questionnaire for Medication-9 (TSQM-9) Scores at Baseline, Month 6 and Month 12 Secondary · Baseline, Month 6, Month 12

The Treatment Satisfaction Questionnaire for Medication-9 (TSQM-9) is a 9-item general instrument that measures the major dimensions of satisfaction with a medication. The questionnaire consists of 3 domains: effectiveness (items 1 to 3), convenience (items 4 to 6) and global satisfaction (items 7 to 9). The scores of each domain range from 0 to 100 with higher scores representing higher satisfaction on that domain.

TSQM-9 Effectiveness Score - Baseline

Group	Value	95% CI
Ofatumumab 20 mg	61.11	0.0 – 100.0

TSQM-9 Effectiveness Score - Month 6

Group	Value	95% CI
Ofatumumab 20 mg	66.67	5.6 – 100.0

TSQM-9 Effectiveness Score - Month 12

Group	Value	95% CI
Ofatumumab 20 mg	66.67	11.1 – 100.0

TSQM-9 Convenience Score - Baseline

Group	Value	95% CI
Ofatumumab 20 mg	61.11	22.2 – 100.0

TSQM-9 Convenience Score - Month 6

Group	Value	95% CI
Ofatumumab 20 mg	88.89	50.0 – 100.0

TSQM-9 Convenience Score - Month 12

Group	Value	95% CI
Ofatumumab 20 mg	86.11	50.0 – 100.0

TSQM-9 Global Satisfaction Score - Baseline

Group	Value	95% CI
Ofatumumab 20 mg	63.89	5.6 – 100.0

TSQM-9 Global Satisfaction Score - Month 6

Group	Value	95% CI
Ofatumumab 20 mg	77.78	33.3 – 100.0

Number of Participants With Treatment Emergent Adverse Events (TEAEs) Secondary · From first dose of study drug (Day 1) up to 30 days after last dose (Month 13)

TEAEs are defined as any adverse events (AEs) that started on or after the day of first dose of study drug, or before 30 days after the treatment end date, if severity at baseline was missing or if postbaseline severity was greater than baseline severity.

Participants with AEs (any AE, regardless of seriousness)

Group	Value	95% CI
Ofatumumab 20 mg	86

Participants with serious adverse events (SAEs)

Group	Value	95% CI
Ofatumumab 20 mg	6

Adverse events — posted to ClinicalTrials.gov

Time frame: From first dose (Day 1) through the safety follow-up period, with an average duration of 30 days after last dose (approximately 13 months total) and a maximum follow-up of up to 18 months post-dose (approximately 30 months total).. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Ofatumumab 20 mg

Serious: 6/102 (6%)

Deaths: 0/102

Serious adverse events (8 terms)

Reaction	System	Ofatumumab 20 mg
COVID-19	Infections and infestations	—
Infective myositis	Infections and infestations	—
Urosepsis	Infections and infestations	—
Sciatic nerve injury	Injury, poisoning and procedural complications	—
Vascular graft complication	Injury, poisoning and procedural complications	—
Pain in extremity	Musculoskeletal and connective tissue disorders	—
Cerebrovascular accident	Nervous system disorders	—
Deep vein thrombosis	Vascular disorders	—

Other adverse events (6 terms — click to expand)

Reaction	System	Ofatumumab 20 mg
COVID-19	Infections and infestations	—
Fatigue	General disorders and administration site conditions	—
Headache	Nervous system disorders	—
Urinary tract infection	Infections and infestations	—
Pyrexia	General disorders and administration site conditions	—
Pruritus	Skin and subcutaneous tissue disorders	—

Most-reported serious reactions: COVID-19, Infective myositis, Urosepsis, Sciatic nerve injury, Vascular graft complication, Pain in extremity, Cerebrovascular accident, Deep vein thrombosis.

Data from ClinicalTrials.gov NCT04486716 adverse events section.

Sponsor's own description

A single arm study evaluating the continued efficacy, safety and tolerability of ofatumumab in patients with relapsing multiple sclerosis who are transitioning from aCD20 mAb therapy

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.