A Study to Evaluate The Long-Term Safety And Efficacy of Rozanolixizumab in Adult Participants With Ocular Myasthenia Gravis

NCT07465289 | Not Yet Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: MG0039
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of the study is to assess the long-term safety and efficacy of rozanolixizumab in adult study participants with ocular myasthenia gravis.

Conditions

Ocular Myasthenia Gravis

Keywords

Phase 3; oMG; rozanolixizumab

Outcome Measures

Primary Outcomes (3)

• Incidence of treatment-emergent adverse events (TEAEs)

  Treatment Emergent Adverse Events (TEAEs) are any untoward medical incidence in a participant after the administration of study treatment, whether or not these events are related to study treatment.

  Up to 2 years

• Incidence of treatment-emergent serious adverse events (TESAEs)

  An SAE is defined as any untoward medical occurrence that, at any dose, meets 1 or more of the criteria listed: * Results in death * Is life-threatening * Requires inpatient hospitalization or prolongation of existing hospitalization * Results in persistent or significant disability/incapacity * Is a congenital anomaly/birth defect * Other important medical events which based on medical or scientific judgement may jeopardize the patients or may require medical or surgical intervention to prevent any of the above.

  Up to 2 years

• Incidence of TEAEs leading to permanent withdrawal of study treatment

  Treatment Emergent Adverse Events (TEAEs) are any untoward medical incidence in a participant after the administration of study treatment, whether or not these events are related to study treatment. This measure considers any TEAE leading to permanent withdrawal from study.

  Up to 2 years

Secondary Outcomes (7)

• Change from Baseline at Day 43 in (Myasthenia Gravis Impairment Index) MGII ocular score (Patient-Reported Outcome part)

  At Day 43 (of the first 3 Symptom-driven Cycles)

• Change from Baseline at Day 43 in Myasthenia Gravis Activities of Daily Living (MG-ADL) ocular score

  At Day 43 (of the first 3 Symptom-driven Cycles)

• Change from Baseline at Day 43 in Myasthenia Gravis Symptoms Patient-Reported Outcome (MGSPRO) ocular muscle weakness scale score

  At Day 43 (of the first 3 Symptom-driven Cycles)

• Change from Baseline at Day 43 in Myasthenia Gravis Quality of Life 15-item Scale (revised version) (MG-QoL15r) total score

  At Day 43 (of the first 3 Symptom-driven Cycles)

• Study participant who generalizes to Myasthenia Gravis Foundation of America (MGFA) class ≥2 over time

  Up to 2 years

Study Arms (1)

Rozanolixizumab

EXPERIMENTAL

The study is composed of Extended Observation Period(s) and Symptom-driven Cycle(s). Based on their clinical need for treatment, study participants will be able to start the study with either an Extended Observation Period or a Symptom-driven Cycle. A Symptom-driven Cycle will be initiated based on disease worsening and participants will receive rozanolixizumab based on investigator's medical judgement.

Drug: Rozanolixizumab

Interventions

Rozanolixizumab DRUG

Rozanolixizumab will be administered by subcutaneous infusion.

Also known as: UCB7665

Rozanolixizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant must be a minimum of 18 years of age inclusive at the time of signing the informed consent form (ICF)
• Participant must have received at least 1 dose of investigational medicinal product (IMP) (rozanolixizumab or placebo) in MG0038
• Participant for whom the investigator considers a favorable benefit/risk for participation
• Participant who, alone or with assistance of the caregiver, is considered reliable and capable of adhering to the protocol visit schedule or medication intake according to the judgement of the investigator
• Male or female
• A female participant is eligible to participate if she is not, not breastfeeding (including pumping breastmilk to feed a child), and at least 1 of the following conditions applies:
• Not a woman of childbearing potential (WOCBP)
• A WOCBP who agrees to follow the contraceptive guidance for the entire study period
• Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in the protocol

You may not qualify if:

• Participant meets any of the withdrawal criteria defined in MG0038
• Participant has a clinically relevant active infection (resulting in hospitalization or requiring intravenous (IV) antibiotic treatment) within 6 weeks before study entry.
• Participant intends to have a live vaccination during the study or within 8 weeks following the final dose of rozanolixizumab
• Participant has been administered with the prohibited immunosuppressive medications, biologics, or other therapies
• Participant has planned use of prohibited medications

Sponsors & Collaborators

• UCB Biopharma SRL: lead

MeSH Terms

Conditions

Myasthenia Gravis

Interventions

rozanolixizumab

Condition Hierarchy (Ancestors)

Paraneoplastic Syndromes, Nervous System; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Paraneoplastic Syndromes; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Neurodegenerative Diseases; Neuromuscular Junction Diseases; Neuromuscular Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

UCB Cares

CONTACT

+18445992273; ucbcares@ucb.com

UCB Cares

CONTACT

00184459922733 (UCB); ucbcares@ucb.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2026
• First Posted: March 11, 2026
• Study Start (Estimated): July 27, 2026
• Primary Completion (Estimated): January 23, 2031
• Study Completion (Estimated): January 23, 2031
• Last Updated: March 11, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe or global development is discontinued, and 18 months after trial completion.
• Access Criteria: Qualified researchers may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal.