A Study to Evaluate B Cell Levels in Infants of Lactating Women with Clinically Isolated Syndrome or Multiple sclerosis Receiving Ocrelizumab - The Sopranino Study

Phase 1

• Conditions: Multiple Sclerosis (MS) or Clinically Isolated Syndrome (CIS) [in line with the locally approved indications]; MedDRA version: 20.0Level: PTClassification code 10071068Term: Clinically isolated syndromeSystem Organ Class: 10029205 - Nervous system disorders; MedDRA version: 20.1Level: PTClassification code 10028245Term: Multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2021-000063-79-DE
• Lead Sponsor: F. Hoffmann-La Roche Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-08-25
• Last Update Posted: 21 August 2023

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• An Informed Consent Form (ICF) for participation of the maternal subject and her infant (for collection of blood, infant demographic and AE data) is signed and dated by the subject. Where applicable, the written Informed Consent form (ICF) with respect to the infant is also signed and dated by the holder of parental rights as designated by the maternal subject
• Woman is able and willing to comply with the study protocol, according to the judgment of the Investigator, in particular: 1] Woman is willing to breastfeed (either exclusively, or with formula supplementation) for at least 60 days after the first postpartum ocrelizumab infusion (this decision is to be taken prior to and independent from study participation) 2] Woman is willing to provide breastmilk samples before and after their first and, if applicable, second postpartum ocrelizumab infusion. Exposure to ocrelizumab includes administration of an initial split dose of two 300 mg infusions (in 250 mL 0.9% sodium chloride) separated by 14 days for women initiating treatment with ocrelizumab, or a single 600 mg infusion (in 500 mL 0.9% sodium chloride) for women already on treatment with ocrelizumab.
• Woman is between 18 and 40 years of age at screening
• Woman has a diagnosis of MS or CIS (in line with the locally approved indications)
• Woman has delivered a healthy term singleton infant (>=37 weeks gestation)
• Infant is between 2-24 weeks of age at the time of the mother’s first postpartum dose of ocrelizumab
• For women who received commercial ocrelizumab (OCREVUS) before enrolment: documentation that last exposure ocrelizumab occurred more than 3 months before the last menstrual period (LMP) (i.e. excluded a potential fetal exposure) and was given at the approved dose of 2x300 mg or 1x600 mg
• Woman agrees to use acceptable contraceptive methods or alternative methods during the study
Are the trial subjects under 18? yes
Number of subjects for this age range: 10
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Exclusions related to the mother
• Hypersensitivity to ocrelizumab or to any of its excipients
• Woman received last dose of ocrelizumab <3 months before the LMP or during pregnancy (i.e. there was a potential fetal exposure to ocrelizumab)
• Active infections (note: the woman may be included once the infection is treated and is resolved; women with bilateral mastitis infection should not have samples collected until the infection is completely resolved)
• Prior or current history of primary or secondary immunodeficiency, or woman in an otherwise severely immunocompromised state. Woman may be re-screened and included if condition resolves
• Woman with known active malignancies or being actively monitored for recurrence of malignancy including solid tumors and hematological malignancies (except basal cell and in situ squamous cell carcinomas of the skin). Women with high risk of breast malignancies undergoing prophylactic treatment with drugs such as tamoxifen are excluded
• Woman has history of breast implants, breast augmentation, breast reduction surgery or mastectomy
• Woman has prior or current history of chronic alcohol abuse or drug abuse
• Woman has any medical, obstetrical or psychiatric condition that, in the opinion of the Investigator, would compromise the woman's ability to participate in this study
• Treatment with a disease-modifying therapy (DMT) for CIS or MS during pregnancy and/or first weeks postpartum, with the exception of formulations of interferon-beta, glatiramer acetate or pulsed corticosteroids
• Drugs known to transfer to the breastmilk and with established or potential deleterious effects for the infant, including but not limited to aspirin (risk of Reye’s syndrome), tetracyclines or fluoroquinolones
• Treatment with any investigational agent within 6 months or five half-lives of the investigational drug (whichever is longer) prior to the LMP, unless the investigational agent is ocrelizumab administered >3 months prior to the LMP in the context of a study or registry sponsored by Roche

Exclusions related to the infant
• Infant is >24 weeks of age at the time of the mother’s first postpartum dose of ocrelizumab
• Infant has any abnormality that may interfere with breastfeeding or milk absorption, including but not limited to cleft palate and/or lip, congenital diaphragmatic hernia and esophageal atresia
• Infant has an active infection. Infant may be included once the infection resolves
• Infant has any other medical condition or abnormality that, in the opinion of the investigator, could compromise the infant’s ability to participate in this study, including interference with the interpretation of study results
• Infant has at least one documented brief resolved unexplained event (BRUE), as defined by the 2016 Guidelines of the American Academy of Pediatrics

Exclusions Related to Laboratory Findings
• Mother with any abnormal screening laboratory value that is clinically relevant should be retested only once in order to rule out any progressive or uncontrolled underlying condition. The last value before study entry must meet study criteria
• Mother with positive screening tests for hepatitis B, determined by a positive hepatitis B surface antigen (HBsAg) result (current infection) or positive hepatitis B core antibody (HBcAb) titers (previous infection) will be excluded. Women with documented history of hepatitis B virus (HBV) vaccination or positive hepatitis B surface antibody (HBsAb) titers are eligibl

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified