Austin, TXNCT06987539Now EnrollingIRB Ready

Generalized Myasthenia Gravis Clinical Trial in Austin, TX

Access cutting-edge generalized myasthenia gravis treatment through this clinical trial at a research site in Austin. Study-provided care at no cost to qualified participants.

Sponsored by Amgen

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Expert Care in Austin

Access generalized myasthenia gravis specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related generalized myasthenia gravis treatment provided free

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Check if you qualify for this generalized myasthenia gravis clinical trial in Austin, TX

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Why Participate?

  • No-Cost Study Care

  • Local to Austin

    Convenient for TX residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Austin site if eligible
  4. 4Begin participation

About This Generalized Myasthenia Gravis Study in Austin

The primary objectives of this study are to characterize the pharmacokinetics (PK) and pharmacodynamics (PD) of inebilizumab administered in pediatric participants with gMG, and to assess the safety and tolerability of inebilizumab administered in pediatric participants with gMG.

Sponsor: Amgen

Who Can Participate

Inclusion Criteria

Participant's legally authorized representative has provided informed consent when the participant is legally too young to provide informed consent and the participant has provided written assent based on local regulations and/or guidelines before any study-specific activities/procedures being initiated.
Age ≥ 2 to \< 18 years of age on the day of enrollment.
Diagnosis of gMG defined as:
Positive serologic test for anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody (Ab) titers as confirmed at screening (1 retest allowed), and
At least 1 of the following:
History of abnormal neuromuscular transmission test results demonstrated by single-fiber electromyography or repetitive nerve stimulation; or
History of positive anticholinesterase test (eg, edrophonium chloride test); or
Participant demonstrated improvement in gMG signs on oral cholinesterase inhibitors, as assessed by the treating physician; or
Clinical syndrome consistent with a diagnosis of gMG, and not otherwise explained by another condition.
Myasthenia Gravis Foundation of America Clinical Classification Class II, III, or IV at the time of screening.
Participants must be on:
Corticosteroids only, with no dose increase within 4 weeks prior to screening, or
One allowed non-steroidal immunosuppressive therapies (IST) (azathioprine, mycophenolate mofetil, or mycophenolic acid) with continuous use for at least 6 months prior to screening and no dose increase within 4 months prior to screening, or
Combination of (1) corticosteroids with no dose increase within 4 weeks prior to screening and (2) one allowed non-steroidal IST with continuous use for at least 6 months prior to screening and no dose increase within 4 months prior to screening. Tacrolimus is allowed in Japan only, with continued use for ≥ 6 months prior to screening and no dose increase within 4 months prior to screening.
Participants may enter the study on a stable dose of acetylcholinesterase inhibitors (pyridostigmine dose). The acetylcholinesterase inhibitor dose must have been stable for at least 2 weeks prior to enrollment.
Vital signs and laboratory parameters within the normal ranges at screening, or, if outside normal ranges, deemed not clinically significant by the investigator.

Exclusion Criteria

Employees of the Sponsor, contract research organization (CRO), site staff, and their family members.
Thymectomy within 12 months prior to baseline (Day 1) visit or planned thymectomy during the duration of the treatment period.
Unresected thymoma- Participants with benign thymoma resected \> 12 months prior to screening may enroll.
History of recurrent significant infections.
Known immunodeficiency disorder, including current infection or positive test for human immunodeficiency virus (HIV).
Positive test for chronic hepatitis B infection at screening.
History of untreated hepatitis C infection, or positive antibody test for hepatitis C virus (HCV).
History of active or latent tuberculosis (TB), or a positive QuantiFERON®-TB Gold test at screening, unless treatment for TB was completed per local guidelines.
History of progressive multifocal leukoencephalopathy.
Participants diagnosed with congenital myasthenic syndromes.
Receipt of any biologic B-cell-depleting therapy (eg, rituximab, ocrelizumab, obinutuzumab, ofatumumab, inebilizumab) or any experimental B-cell-depleting agent in the 6 months prior to screening.
Receipt of any other monoclonal antibody (mAb) or large molecule biologic, including but not limited to FcRn inhibitors, anti-TNF mAbs, anti-janus kinase (JAK) Stat mAbs, and complement inhibitors within 6 months prior to screening.
Receipt of the following medications or treatments at any time prior to randomization: alemtuzumab, total lymphoid irradiation, bone marrow transplant, T-cell vaccination therapy, natalizumab.
Participants who are pregnant or breastfeeding or planning to get pregnant.

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 Austin?

Yes, this clinical trial (NCT06987539) has an active research site in Austin, TX 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.

Generalized Myasthenia Gravis Treatment Options in Austin, TX

If you're searching for generalized myasthenia gravis treatment options in Austin, TX, this clinical trial (NCT06987539) 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 Austin research site is actively enrolling participants for this clinical trial. You'll receive care from experienced generalized 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 generalized myasthenia gravis clinical trials near you to find additional studies recruiting in your area.

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