Ofatumumab for Relapsing multiple sclerosis

Inclusion criteria

• {"criterion_text":"- 1. Written informed consent must be obtained before any study assessment is performed."}
• {"criterion_text":"- 2. Participant is female with a relapsing form of MS and at least 18 years of age at the time of providing consent."}
• {"criterion_text":"- 3. Participant must be postpartum at the time of enrollment, plan to be exclusively breastfeeding and willing to provide breast milk samples."}
• {"criterion_text":"- 4. Participant has delivered term infant (at least 37 weeks gestation)."}
• {"criterion_text":"- 5.\tParticipant 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."}

Exclusion criteria

• {"criterion_text":"- 1. 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."}
• {"criterion_text":"- 9. Active infections, including mastitis (participant may be included once the infection is resolved)."}
• {"criterion_text":"- 11. 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 expert before the start of treatment and should be monitored and managed following local medical standards to prevent hepatitis B reactivation.)"}
• {"criterion_text":"- 12. 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."}
• {"criterion_text":"- 13. Any contraindication as per local label."}
• {"criterion_text":"- 14. Participant who has an infant with any abnormality that may interfere with breastfeeding or confound the study assessment in the opinion of the Investigator."}
• {"criterion_text":"- 10. Prior or current history of primary or secondary immunodeficiency, or participant in an otherwise severely immunocompromised state."}
• {"criterion_text":"- 2. Participant taking medications prohibited by the protocol (see Section 6.6.2) at screening."}
• {"criterion_text":"- 3. Pregnant woman, confirmed by positive serum pregnancy test during screening."}
• {"criterion_text":"- 4. Females of childbearing potential should use effective contraception as per local label."}
• {"criterion_text":"- 5. Participant has history of chronic alcohol abuse or drug abuse in the last year."}
• {"criterion_text":"- 6. 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."}
• {"criterion_text":"- 7. Participant has history of breast implants, breast augmentation, or breast reduction surgery."}
• {"criterion_text":"- 8. Participant has received anti-CD20 agents during the second and third trimesters of pregnancy."}

Primary endpoints

• {"endpoint_text":"- The concentration of ofatumumab in breast milk at the following timepoints: (pre-dose) on the day of the second (or any subsequent) maintenance dose, then 7, 14, 21 and (pre-dose) 28 days after the second (or any subsequent) maintenance dose.","definition_or_measurement_approach":"Quantification of ofatumumab concentration in breast milk measured at specified timepoints: pre-dose on day of second (or any subsequent) maintenance dose, and at 7, 14, 21 and pre-dose 28 days after that maintenance dose."}

Secondary endpoints

• {"endpoint_text":"- Proportion of participants with at least 1 sample with quantifiable ofatumumab concentrations in breast milk","definition_or_measurement_approach":"Proportion of participants having at least one breast milk sample with ofatumumab concentration above the assay quantification limit."}
• {"endpoint_text":"- Maximum concentration (Cmax) of ofatumumab in breast milk over 28 days after the second (or any subsequent) maintenance dose.","definition_or_measurement_approach":"Measurement of Cmax in breast milk within 28 days following the second (or subsequent) maintenance dose."}
• {"endpoint_text":"- 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)","definition_or_measurement_approach":"Calculation of AUC (0–28 days) for ofatumumab concentrations in breast milk from the second (or subsequent) maintenance dose to the next maintenance dose."}
• {"endpoint_text":"- Milk/Plasma (M/P) ratio of ofatumumab at 28 days after the second or any subsequent maintenance dose.","definition_or_measurement_approach":"Ratio of concentration of ofatumumab in milk versus plasma at 28 days after the second (or any subsequent) maintenance dose."}
• {"endpoint_text":"- Estimated relative infant dose (RID, %) over 28 days after the lactating mother receives second or subsequent maintenance dose","definition_or_measurement_approach":"Estimated relative infant dose (%) calculated over 28 days after the mother receives the second or subsequent maintenance dose, based on measured milk concentrations and standard infant milk intake assumptions."}
• {"endpoint_text":"- Rate and nature of adverse events in the mothers treated with ofatumumab up to 12 months after ofatumumab treatment initiation/re-initiation","definition_or_measurement_approach":"Collection and tabulation of adverse events (frequency, severity, relationship) in mothers up to 12 months after ofatumumab initiation/re-initiation."}
• {"endpoint_text":"- Rate and nature of serious adverse events and any infections in the breast-fed infants of mothers up to 12 months after ofatumumab treatment initiation/re-initiation","definition_or_measurement_approach":"Collection and tabulation of serious adverse events and infections in breastfed infants up to 12 months after maternal ofatumumab initiation/re-initiation."}

France

Earliest CTIS Part Ii Submission Date

18-04-2024

Latest Decision Or Authorization Date

06-06-2024

Processing Time Days

49

Number Of Sites

4

Number Of Participants

6

Germany

Earliest CTIS Part Ii Submission Date

08-05-2024

Latest Decision Or Authorization Date

06-06-2024

Processing Time Days

29

Number Of Sites

4

Number Of Participants

3

Italy

Earliest CTIS Part Ii Submission Date

28-02-2025

Latest Decision Or Authorization Date

19-05-2025

Processing Time Days

80

Number Of Sites

3

Number Of Participants

2

Poland

Earliest CTIS Part Ii Submission Date

12-05-2025

Latest Decision Or Authorization Date

08-06-2025

Processing Time Days

27

Number Of Sites

5

Number Of Participants

4

Primary sponsor

Full Name

Novartis Pharma AG

Organisation Type

Pharmaceutical company

Country Of Registered Address

Switzerland

Contract research organisations

Name

Syneos Health Inc.

Responsibilities

sponsorDuties code: 1

Name

IQVIA Limited

Responsibilities

sponsorDuties code: 1

Name

Parexel International (IRL) Limited

Responsibilities

sponsorDuties code: 12

Name

Icon Clinical Research Limited

Responsibilities

sponsorDuties code: 1

Name

Labcorp Early Development Laboratories Limited

Responsibilities

sponsorDuties code: 4

Name

Q Squared Solutions LLC

Responsibilities

sponsorDuties code: 7

Third parties

• {"country":"United Kingdom","full_name":"Medical Equipment Supplies And Management Limited","duties_or_roles":"Medical Equipment Supplies and Management Limited (MESM): Industry pharmaceutical company - providing breast pumps, sterilizer kits and user guides for patients on study","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Syneos Health Inc.","duties_or_roles":"sponsorDuties code: 1","organisation_type":"Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"sponsorDuties code: 1","organisation_type":"Pharmaceutical company"}
• {"country":"Ireland","full_name":"Parexel International (IRL) Limited","duties_or_roles":"sponsorDuties code: 12","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Q Squared Solutions LLC","duties_or_roles":"sponsorDuties code: 7","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United Kingdom","full_name":"Q Squared Solutions Limited","duties_or_roles":"Specimen management – preparing lab kits and storing extra lab samples.","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"Labcorp Early Development Laboratories Limited","duties_or_roles":"sponsorDuties code: 4","organisation_type":"Pharmaceutical company"}
• {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"sponsorDuties code: 1","organisation_type":"Pharmaceutical company"}