A Phase 3 interventional study of Rozanolixizumab and Placebo in Ocular Myasthenia Gravis, sponsored by UCB Biopharma SRL. Recruiting at 36 sites in 9 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-06.
Sponsored by UCB Biopharma SRL (part of UCB S.A.) · Phase 3, Interventional, and Treatment
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.
330 studies on the registry are indexed under Myasthenia Gravis; 144 are open to participants now.
This study's planned enrollment of 120 is above the median of 44 across 217 interventional studies indexed under Myasthenia Gravis.
Browse Myasthenia Gravis studies →UCB Biopharma SRL is the lead sponsor of 129 studies on the registry; 17 are open to participants now.
Of its 71 completed or terminated interventional studies of FDA-regulated products, 50 (70%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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:
Participant who:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: 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 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.
Drug: Placebo
Rozanolixizumab will be administered by subcutaneous infusion.
Also known as: UCB7665
Placebo will be administered by subcutaneous infusion.
Change from Baseline at Day 43 in (Myasthenia Gravis Impairment Index) MGII ocular score (Patient-Reported Outcome (PRO) part)
MGII is a measure of disease severity based on the signs and symptoms of MG patients. The MGII has 22 patient-reported items and 6 examination items and scores are presented as a sum of all items for a total score but also as an ocular and generalized sub-score. The scoring range is 0 to 84, 0-23 for the ocular score, and 0-61 for the generalized score, where higher scores are indicative of more severe symptoms. The recall period is "the past week" ie, the last 7 days.
Time frame: At Day 43
Change from Baseline at Day 43 in Myasthenia Gravis Symptoms Patient-Reported Outcome (MGSPRO) ocular muscle weakness scale score
The MG symptoms PRO instrument consisted of 42 items across 5 scales: ocular muscle weakness (items 1-5); bulbar muscle weakness (items 6-15); respiratory muscle weakness (items 16-18); physical fatigue (items 19-33) and muscle weakness fatigability (items 34-42). Study participants will be asked to choose response option that best describes how frequently they experienced muscle weakness fatigability (items 34-42) over the past 7 days using a 5-point Likert scale (1="none of the time" to 5="all of the time") for each item.
Time frame: At Day 43
Change from Baseline at Day 43 in Myasthenia Gravis Quality of Life 15-item Scale (revised version) (MG-QoL15r) total score
The MG-QoL15r is a brief survey, completed by the study participant, that is designed to assess some aspects of "quality of life" related to MG. The recall period that will be used is "past 7 days". When completing the 15-item MG-QoL15r, MG study participant should consider only how their MG affects these items.
Time frame: At Day 43
Change from Baseline at Day 43 in Myasthenia Gravis Activities of Daily Living (MG-ADL) ocular subdomain score
The total MG-ADL score is obtained by summing the responses to each individual item (8 items; Grades: 0, 1, 2, 3). The score ranges from 0 to 24, with a higher score indicating more disability. A positive change indicates worsening and a negative change indicates improvement.
Time frame: At Day 43
Change from Baseline at Day 43 in Myasthenia Gravis Impairment Index (MGII) ocular score (Physical Examination part)
MGII is a measure of disease severity based on the signs and symptoms of MG patients. The MGII has 22 patient-reported items and 6 examination items and scores are presented as a sum of all items for a total score but also as an ocular and generalized sub-score. The scoring range is 0 to 84, 0-23 for the ocular score, and 0-61 for the generalized score, where higher scores are indicative of more severe symptoms. The recall period is "the past week" ie, the last 7 days.
Time frame: At Day 43
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.
Time frame: Up to Week 13
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.
Time frame: Up to Week 13
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.
Time frame: Up to Week 13
Plan to share: Yes — 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. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, 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. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available.
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
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.
Data sharing details ↗ · www.vivli.org
No publications or documents are linked to this record.
Started May 2026 (actual). Primary completion is estimated for Dec 2028, 30 months after the start.
Of 43 industry-sponsored phase 3 interventional studies under Myasthenia Gravis, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 39. This study's planned 30 months is above that.
Counting every sponsor, half of 52 studies reached it within 30 months; a quarter within 20 and three quarters within 43.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Rozanolixizumab