Is NCT07463521 recruiting in Amherst, NY?

Yes, NCT07463521 is currently recruiting participants at its Amherst, NY location. This ocular myasthenia gravis clinical trial is actively enrolling qualified participants.

How do I join the ocular myasthenia gravis clinical trial in Amherst?

To join this clinical trial in Amherst, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Amherst clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Ocular Myasthenia Gravis Clinical Trial in Amherst, NY

Who Can Participate

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.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Amherst?

Yes, this clinical trial (NCT07463521) has an active research site in Amherst, NY that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Ocular Myasthenia Gravis Treatment Options in Amherst, NY

If you're searching for ocular myasthenia gravis treatment options in Amherst, NY, this clinical trial (NCT07463521) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Amherst research site is actively enrolling participants for this clinical trial. You'll receive care from experienced ocular myasthenia gravis specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all ocular myasthenia gravis clinical trials near you to find additional studies recruiting in your area.

Ocular Myasthenia Gravis Clinical Trial in Amherst, NY

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