Multiple SclerosisPhase 4KATHAROSNCT06444113
Concentration of Ofatumumab in the Breast Milk of Lactating Women With Relapsing Forms of Multiple Sclerosis
A Phase 4 study testing Ofatunumab in people with Multiple Sclerosis, run by Novartis Pharmaceuticals at 15 sites in 5 countries.
Trial summary
This study will evaluate whether ofatumumab is excreted at quantifiable levels and at which concentrations in breast milk of lactating women with RMS). The study will include lactating mothers who plan to breastfeed and initiate/re-initiate ofatumumab 2-24 weeks post-partum. Read more about this study
- Who is it for?
- Ages 18 to 100 years, women only
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Ofatunumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 15 sitesin 5 countries
- Study dates
- 25 Nov 2024to 29 Oct 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 100 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent must be obtained before any study assessment is performed.
- Participant is female with a relapsing form of MS and at least 18 years of age at the time of providing consent.
- Participant must be postpartum at the time of enrollment, plan to be exclusively breastfeeding and willing to provide breast milk samples.
- Participant has delivered term infant (at least 37 weeks gestation).
- Participant must plan to initiate or re-initiate or have initiated or re-initiated treatment with ofatumumab between 2 to 24 weeks postpartum. The decision to be treated with ofatumumab and to breastfeed is made in accordance with the treating physician and must be completely independent of the decision to participate in this study.
Who cannot join
- Use of any investigational drugs within 5 half-lives of enrollment, or within 30 days or until the expected pharmacodynamic effect has returned to baseline, whichever is longer.
- Participant taking medications prohibited by the study protocol at screening.
- Pregnant woman, confirmed by positive serum pregnancy test during screening.
- Female of childbearing potential should use effective contraception as per local label.
- Participant has history of chronic alcohol abuse or drug abuse in the last year.
- Participant has any medical, obstetrical, psychiatric or other medical condition that, in the opinion of the Investigator, can jeopardize or would compromise the subject's ability to participate in this study or confound the study assessment.
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- Participant has history of breast implants, breast augmentation, or breast reduction surgery.
- Participant has received anti-CD20 agents during the second and third trimesters of pregnancy.
- Active infections, including mastitis (participant may be included once the infection is resolved).
- Prior or current history of primary or secondary immunodeficiency, or participant in an otherwise severely immunocompromised state.
- Participant with active hepatitis B disease prior to the initiation or re-initiation of ofatumumab. (Participant with positive hepatitis B serology should consult a liver disease medical standards to prevent hepatitis B reactivation.)
- History of malignancy of any organ system (other than localized basal cell carcinoma of the skin or in situ cervical cancer), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
- Any contraindication as per local label.
- Participant who has an infant with any abnormality that may interfere with breastfeeding or confound the study assessment in the opinion of the Investigator.
Trial locations and contacts
15 sites in 5 countries.
15 sites in 5 countries
United States4 sites
UC Health Neuroscience Ctr
Aurora, Colorado, 80045
Brigham and Womens Hospital
Brookline, Massachusetts, 02445
UCSF
San Francisco, California, 94115
Northwestern Medicine Northwestern University
Winfield, Illinois, 60190
Germany4 sites
Novartis Investigative Site
Bochum, 44791
Novartis Investigative Site
Hamburg, 22179
Novartis Investigative Site
Munich, Bavaria, 81377
Novartis Investigative Site
Tübingen, 72076
United Kingdom4 sites
Novartis Investigative Site
Cambridge, CB2 0QQ
Novartis Investigative Site
London, NW1 2BU
Novartis Investigative Site
Oxford, OX3 9DU
Novartis Investigative Site
Salford, M6 8HD
Poland2 sites
Novartis Investigative Site
Bialystok, 15 276
Novartis Investigative Site
Kielce, 25-726
About this study
Official title: A Phase IV, Prospective, Multicenter, Open-label, Mother-milk Study to Evaluate Ofatumumab Concentration in the Breast Milk of Lactating Women With Relapsing Forms of Multiple Sclerosis Receiving Ofatumumab
This study will evaluate whether ofatumumab is excreted at quantifiable levels and at which concentrations in breast milk of lactating women with RMS). The study will include lactating mothers who plan to breastfeed and initiate/re-initiate ofatumumab 2-24 weeks post-partum.
Read the detailed description
This is a Phase IV study in which breastfeeding mothers treated with ofatumumab and their babies are taking part for up to 1 year. The study consists of a Core Part and a Safety Follow-up Part. The Core Part includes a Screening period and a Sampling period. During the Screening period (up to 4 weeks), the study doctor will assess if mothers can join the study. The Sampling period, during which milk samples and a blood sample will be collected, will last for up to 12 weeks. The Safety Follow-up Part will last for about 9 months, to follow up on health and safety of mothers and their babies.
- Conditions
- Multiple Sclerosis
- Being tested
- Ofatunumab
- Keywords
- Lactating women,, multiple sclerosis (MS), ofatumumab, milk concentration, breastfed infant
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OfatunumabDrug
No study-treatment is provided for this study. Study participants will be treated with commercially available ofatumumab according to the local label.
| Study group | Role | What they receive |
|---|---|---|
| Ofatunumab | Experimental | Recommended dose as per ofatumumab label. Injection at weeks 0,1,2 and monthly starting at week 4. Receives: Drug: Ofatunumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of ofatumumab in breast milk.
Quantification of ofatumumab concentration in breast milk of lactating women with RMS who have initiated or re-initiated ofatumumab treatment post-partum.
Measured: (pre-dose) on the day of second (or subsequent) maintenance dose, then 7, 14, 21, 28 days after the second (or subsequent) maintenance dose"
Secondary outcomes (6)
Evaluate other PK parameters of ofatumumab in breast milk and plasma of lactating women with RMS who have initiated or re-initiated ofatumumab treatment post-partum
proportion of at least one sample with quantifiable concentration; Maximum concentration; exposure (Area under curve); milk/plasma ratio
Measured: 28 days after second(or subsequent) maintenance dose.
Estimation of relative infant dose of ofatumumab
Estimated relative infant dose (RID, %) over 28 days after the lactating mother receives second or subsequent maintenance dose
Measured: 28 days after second (or subsequent) maintenance dose.
Safety data collected in lactating women receiving ofatumumab and their breastfed infants
Rate and nature of adverse events in the mothers treated with ofatumumab to up to 12 months after ofatumumab treatment initiation/re-initiation Rate and nature of serious adverse events and any infection adverse events in the breastfed infants of mothers up to 12 months after ofatumumab treatment initiation/re-initiation
Measured: Upto 12 months
Plasma Pharmacokinetics of OMB157(Cmax)
Maximum concentration (Cmax) of ofatumumab in breast milk over 28 days after the second (or any subsequent) maintenance dose.
Measured: over 28 days after the second (or any subsequent) maintenance dose.
Plasma Pharmacokinetics of OMB157(AUC)
The exposure (area under the curve (AUC) of ofatumumab in milk over 28 days (from the second or any subsequent maintenance dose to the next maintenance dose after initiation or re-initiation of ofatumumab post-partum)
Measured: over 28 days
Plasma Pharmacokinetics of OMB157 (M/P Ratio)
Milk/Plasma (M/P) ratio of ofatumumab at 28 days after the second or any subsequent maintenance dose.
Measured: at 28 days after the second or any subsequent maintenance dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2024
- Study start25 Nov 2024
- Primary completion20 Feb 2026
- Study completion29 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06444113
- Sponsor's protocol ID
- COMB157G2410
- Other IDs
- 2023-505283-11-00, 2023
- Acronym
- KATHAROS
- Status last verified
- Aug 2026
- First submitted
- 30 May 2024
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IV, Prospective, Multicenter, Open-label, Mother-milk Study to Evaluate Ofatumumab Concentration in the Breast Milk of Lactating Women With Relapsing Forms of Multiple Sclerosis Receiving Ofatumumab
- ClinicalTrials.gov ID
- NCT06444113
- Acronym / sponsor ID
- KATHAROS / COMB157G2410
- Conditions
- Multiple Sclerosis
- Keywords
- Lactating women,, multiple sclerosis (MS), ofatumumab, milk concentration, breastfed infant
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 25 Nov 2024 (actual)
- Primary completion
- 20 Feb 2026 (actual)
- Study completion
- 29 Oct 2026 (estimated)
- First posted
- 5 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate whether ofatumumab is excreted at quantifiable levels and at which concentrations in breast milk of lactating women with RMS). The study will include lactating mothers who plan to breastfeed and initiate/re-initiate ofatumumab 2-24 weeks post-partum.
Detailed description
This is a Phase IV study in which breastfeeding mothers treated with ofatumumab and their babies are taking part for up to 1 year. The study consists of a Core Part and a Safety Follow-up Part. The Core Part includes a Screening period and a Sampling period. During the Screening period (up to 4 weeks), the study doctor will assess if mothers can join the study. The Sampling period, during which milk samples and a blood sample will be collected, will last for up to 12 weeks. The Safety Follow-up Part will last for about 9 months, to follow up on health and safety of mothers and their babies.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ofatunumab | Experimental | Drug: OfatunumabRecommended dose as per ofatumumab label. Injection at weeks 0,1,2 and monthly starting at week 4. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Written informed consent must be obtained before any study assessment is performed.
- Participant is female with a relapsing form of MS and at least 18 years of age at the time of providing consent.
- Participant must be postpartum at the time of enrollment, plan to be exclusively breastfeeding and willing to provide breast milk samples.
- Participant has delivered term infant (at least 37 weeks gestation).
- Participant must plan to initiate or re-initiate or have initiated or re-initiated treatment with ofatumumab between 2 to 24 weeks postpartum. The decision to be treated with ofatumumab and to breastfeed is made in accordance with the treating physician and must be completely independent of the decision to participate in this study.
Key exclusion criteria (14 listed)
- Use of any investigational drugs within 5 half-lives of enrollment, or within 30 days or until the expected pharmacodynamic effect has returned to baseline, whichever is longer.
- Participant taking medications prohibited by the study protocol at screening.
- Pregnant woman, confirmed by positive serum pregnancy test during screening.
- Female of childbearing potential should use effective contraception as per local label.
- Participant has history of chronic alcohol abuse or drug abuse in the last year.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OfatunumabNo study-treatment is provided for this study. Study participants will be treated with commercially available ofatumumab according to the local label. | Drug | Ofatunumab |
Primary outcome
Concentration of ofatumumab in breast milk.
Time frame: (pre-dose) on the day of second (or subsequent) maintenance dose, then 7, 14, 21, 28 days after the second (or subsequent) maintenance dose"
Quantification of ofatumumab concentration in breast milk of lactating women with RMS who have initiated or re-initiated ofatumumab treatment post-partum.
6 secondary outcomes
Evaluate other PK parameters of ofatumumab in breast milk and plasma of lactating women with RMS who have initiated or re-initiated ofatumumab treatment post-partum
Time frame: 28 days after second(or subsequent) maintenance dose.
Estimation of relative infant dose of ofatumumab
Time frame: 28 days after second (or subsequent) maintenance dose.
Safety data collected in lactating women receiving ofatumumab and their breastfed infants
Time frame: Upto 12 months
Plasma Pharmacokinetics of OMB157(Cmax)
Time frame: over 28 days after the second (or any subsequent) maintenance dose.
Plasma Pharmacokinetics of OMB157(AUC)
Time frame: over 28 days
Plasma Pharmacokinetics of OMB157 (M/P Ratio)
Time frame: at 28 days after the second or any subsequent maintenance dose.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
15 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ofatunumab in people with Multiple Sclerosis, run by Novartis Pharmaceuticals at 15 sites in 5 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 5 inclusion and 14 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: under way, not looking for participants, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States, Germany, United Kingdom, Poland, 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Concentration of ofatumumab in breast milk. (time frame: (pre-dose) on the day of second (or subsequent) maintenance dose, then 7, 14, 21, 28 days after the second (or subsequent) maintenance dose"). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Aug 2026.