A Study to Learn How BIIB141 (Omaveloxolone) Affects the Health of Participants With Friedrich's Ataxia Who Took it During Pregnancy and/or During Breastfeeding and About the Health of Their Babies

Biogen

Status: Enrolling

Conditions: Friedreich Ataxia

Treatments: Drug: Omaveloxolone

Study type: Observational

Funder types: Industry

Identifiers

NCT06628687

EUPAS1000000327 (Other Identifier)

296FA402

Details and patient eligibility

About

In this study, researchers will learn more about the safety of BIIB141, also known as omaveloxolone or SKYCLARYS. This is a drug available for doctors to prescribe for people with Friedrich's Ataxia, also known as FA. This is known as an "observational" study, which collects health information about study participants without changing their medical care. Participants for this study will have taken BIIB141 at any time during pregnancy and/or while breastfeeding or pumping up through the first year after delivery. Participants can join this study on their own or they may be enrolled by their regular doctors. This study is also known as the "SKYCLARYS (Omaveloxolone) Pregnancy and Lactation Surveillance Program."

The main objective of this study is to learn more about how BIIB141 may affect pregnancy, as well as any effects on the health of the mother and of the baby during its first year of life.

The main question researchers want to answer in this study is:

· Does taking BIIB141 during pregnancy or breastfeeding lead to any major birth defects?

Researchers will also learn more about:

• Does taking BIIB141 during pregnancy or breastfeeding lead to any minor birth defects?
• Does taking BIIB141 during pregnancy or breastfeeding affect the following:
• Gestational diabetes, a disease that can happen during pregnancy that affects how your body uses sugar
• Pre-eclampsia, a pregnancy-related high blood pressure disease
• Unborn baby being small for its expected age (usually in weeks)
• Loss of an unborn baby
• Live birth
• Premature birth
• Loss of a newborn
• Growth or developmental delays in the baby
• Serious illness in the baby resulting in hospitalization
• Serious infections in the baby, or ones in babies with a weakened immune system

This study will be done as follows:

• Participants will join the study after signing an informed consent form, also known as an ICF.
• During the study, health information from the participants' regular visits to their doctor will be collected based on whether participant joined the study while pregnant or after the baby is born.
• Each participant will be in the study for up to 1 year after the birth of their child, unless they decide to leave early. Overall, this study is expected to last at least 10 years.

Full description

The objective is to conduct a worldwide descriptive study to collect prospective and retrospective data in women exposed to omaveloxolone during pregnancy and/or lactation to assess risk associated with pregnancy, the maternal complications, and adverse effects on the developing fetus, neonate, and infant (through at least the first year of life) in the post-marketing setting.

Enrollment: 20 estimated patients

Sex: Female

Ages: 16+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Exposure to omaveloxolone for FA at any time during pregnancy (from 12 days prior to conception to pregnancy outcome) and/or at any time during lactation (up to 1 year of infant age or weaning, whichever comes first).

Key Exclusion Criteria:

• Not having exposure to omaveloxolone for FA.

Note: Other protocol-defined Inclusion/Exclusion criteria may apply.

Trial design

20 participants in 1 patient group

Omaveloxolone

Description:

Participants with FA who were exposed to omaveloxolone at any time during pregnancy (from 12 days prior to conception through the end of pregnancy outcome), and/or at any time during lactation (up to 1 year of infant age or weaning, whichever comes first).

Treatment:

Drug: Omaveloxolone