Recruiting
Phase 3

Rozanolixizumab

Sponsor:

UCB Biopharma SRL

Code:

NCT07463521

Conditions

Ocular Myasthenia Gravis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Rozanolixizumab

Placebo

Study Details

Brief summary:

The purpose of the study is to demonstrate the efficacy, safety and tolerability of rozanolixizumab compared with placebo in the treatment of adult study participants with Ocular Myasthenia Gravis.

Conditions

Ocular Myasthenia Gravis

Study ID

NCT07463521

Start date

May 27, 2026

Status verified date

Aug, 2026

Completion date

Jan 22, 2029

Anticipated

Primary completion date

Dec 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Participant must be a minimum of 18 years of age inclusive at the time of signing the informed consent form (ICF)
  • Participant has Myasthenia Gravis Foundation of America (MGFA) Class I with any ocular weakness at Screening through Baseline. The participant may have weakness in muscles of eye (ie, extraocular muscles that move the eyeball, including the medial rectus, lateral rectus, superior rectus, inferior rectus, superior oblique, and inferior oblique, orbicularis oculi muscles, and levator palpebrae superioris) but must have normal strength in all other facial, bulbar, and limb muscles.
  • Study participant has been diagnosed with Ocular Myasthenia Gravis (oMG) with consistent ocular clinical features at Screening and supported by:
  • Documented presence of autoantibodies against acetylcholine receptor (AChR) or muscle-specific kinase (MuSK), OR
  • Documented absence of autoantibodies against AChR or MuSK; in this case, documented abnormal repetitive nerve stimulation (RNS) or single fiber electromyography (SFEMG) (as defined in the adjudication manual) and at least 1 of the following should be met:

  • Documented positive ice test (Ptosis recovers with the ice test \[applied 2 minutes (min) to the ptotic lid\] with >2mm improvement)
  • History of positive edrophonium chloride (Tensilon) test (or equivalent tests used to establish oMG diagnostic as per current practice)
  • Demonstrated objective improvement in oMG signs with acetylcholinesterase inhibitor (AChEIs), plasma exchange (PLEX), intravenous immunoglobulin (IVIg), subcutaneous immunoglobulin (SCIg) or corticosteroids (CSs)
  • Participant has an Myasthenia Gravis Impairment Index (MGII) ocular score (Patient-Reported Outcome (PRO) part) ≥6 with at least 2 ocular items with a score of ≥2 at both Screening and Baseline visits.
  • Participant reported ocular symptom(s) onset <3 years before Screening or ≥3 years provided they have demonstrated response (ie, improvement in ptosis or diploplia) to treatment (IVIg, PLEX, SCIg, pyridostigmine, and/or CSs) in the past year.
  • Participant has no pupillary abnormality except those resulting from prior localized eye disease or surgical intervention.
  • Participant who:

  • is currently receiving background treatment for oMG symptoms at the time of Screening and has been receiving treatment for oMG with a stable dose for at least 30 days prior to Screening, OR
  • is not receiving any background treatment at the time of Screening
  • Participant has a body weight ≥35kg at Baseline.

Exclusion Criteria:

  • Participant has any clinically significant medical or psychiatric condition (including an alcohol or drug use disorder), recent major surgery (including thymectomy \[within 3 months of Screening\], solid organ, stem cell or marrow transplant), planned major surgery (including thymectomy) during study participation, and/or significant laboratory abnormality that, in the opinion of the investigator, could jeopardize or would compromise the study participant's ability to participate in this study.
  • Participant has been diagnosed with other diseases that lead to eyelid dropping, peripheral muscle weakness, or diplopia, including other autoimmune diseases that would interfere with an accurate assessment of the oMG clinical symptoms or other neurological diseases, such as congenital myasthenic syndromes, mitochondrial diseases, and muscular dystrophies.
  • Participant has a known hypersensitivity to other anti-Fc receptor (FcRn) medications, to any components of the study medication (including the excipient polysorbate 80) or has a known history of hyperprolinemia, since L-proline is a constituent of the rozanolixizumab formulation.
  • Participant has active neoplastic disease or has received treatment for neoplastic disease within 5 years of study entry (except for basal or squamous cell carcinoma of the skin, carcinoma in situ of the uterine cervix, carcinoma in situ of the breast, or incidental histological findings of prostate cancer \[Tumor, Node, Metastasis (TNM) stage T1a or T1b\] that has been definitely treated with standard of care approaches).
  • Participant has a clinically relevant active infection (eg, tuberculosis (TB) infection) or a history of serious infection (resulting in hospitalization or requiring intravenous (iv) antibiotic treatment) within 6 weeks before the Baseline Visit.
  • Participant has renal impairment, defined as glomerular filtration rate less than 30milliliter/min/1.73m2 at Screening.
  • Participant has been previously treated with FcRn inhibitors.
  • Participant has been treated with any of the immunosuppressive medications, biologics, or other therapies, in the specified prohibitive timeframe.

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Rozanolixizumab

After the Screening Period, participants will enter the study Intervention Period and will be administered study drug for up to 6 weeks. Prior to entering the Intervention Period, study participants will be randomized at a 1:1 ratio and will receive rozanolixizumab. At the End of Treatment Visit, participants will enter an Observation Period of 4 to 7 weeks with an opportunity to transition to an open-label extension study.

placebo comparator: Placebo

After the Screening Period, participants will enter the study Intervention Period and will be administered study drug for up to 6 weeks. Prior to entering the Intervention Period, study participants will be randomized at a 1:1 ratio and will receive placebo. At the End of Treatment Visit, participants will enter an Observation Period of 4 to 7 weeks with an opportunity to transition to an open-label extension study.

Interventions

Rozanolixizumab

Rozanolixizumab will be administered by subcutaneous infusion.

Placebo

Placebo will be administered by subcutaneous infusion.

Primary outcome measure

  • Change from Baseline at Day 43 in (Myasthenia Gravis Impairment Index) MGII ocular score (Patient-Reported Outcome (PRO) part) [ Time Frame: At Day 43 ]

Central Contacts and Locations

Central contacts

UCB Cares

+18445992273ucbcares@ucb.com

UCB Cares

00184459922733 (UCB)ucbcares@ucb.com

Locations

Mg0038 10104

Recruiting

Scottsdale, Arizona, United States, 85251

Mg0038 10105

Recruiting

O'Fallon, Illinois, United States, 62269

Mg0038 10106

Recruiting

Amherst, New York, United States, 14226

Mg0038 10103

Recruiting

Columbus, Ohio, United States, 43210

Mg0038 10108

Recruiting

Greenfield, Wisconsin, United States, 53228

Mg0038 10201

Recruiting

Montreal, Canada

More Information

Sponsor

UCB Biopharma SRL

Last update posted

Aug 24, 2026

Last verified

Aug, 2026

Keywords

  • Ocular Myasthenia Gravis
  • Phase 3
  • rozanolixizumab

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by UCB Biopharma SRL on 2026-08-24.