Is NCT05549258 recruiting in Dallas, TX?

Yes, NCT05549258 is currently recruiting participants at its Dallas, TX location. This neuromyelitis optica clinical trial is actively enrolling qualified participants.

How do I join the neuromyelitis optica clinical trial in Dallas?

To join this clinical trial in Dallas, 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 Dallas 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.

Neuromyelitis Optica Clinical Trial in Dallas, TX

About This Neuromyelitis Optica Study in Dallas

A Phase 2, open-label, multicenter study to evaluate the pharmacokinetics (PK), pharmacodynamics (PD), and safety of inebilizumab in eligible pediatric participants 2 to \< 18 years of age with recently active neuromyelitis optica spectrum disorder (NMOSD) who are seropositive for autoantibodies against aquaporin-4 (AQP4-immunoglobulin \[Ig\]G).

Sponsor: Amgen

Who Can Participate

Inclusion Criteria

Male or female participants, minimum body weight of 15 kg, age 2 to \< 18 years at the time of screening.

Positive serum anti-AQP4-IgG result at screening and diagnosed with NMOSD according to the criteria of Wingerchuk et al, 2015.

Documented history of one or more NMOSD acute relapses within the last year, or 2 or more NMOSD acute relapses within 2 years prior to screening.

Exclusion Criteria

Any condition that, in the opinion of the Investigator, would interfere with the evaluation or administration of the Investigational Product or interpretation of participant safety or study results.

Concurrent/previous enrollment in another clinical study involving an investigational treatment within 4 weeks or 5 published half-lives of the investigational treatment, whichever is the longer, prior to Day 1.

Evidence of significant hepatic, renal, or metabolic dysfunction or significant hematological abnormality (one repeat test may be conducted to confirm results within the same screening period).

B-cell counts \< one-half of the lower limit of normal (LLN) for age according to the central laboratory.

Receipt of the following at any time prior to Day 1:

Alemtuzumab

Total lymphoid irradiation

Bone marrow transplant

T-cell vaccination therapy

Receipt of rituximab or any experimental B-cell depleting agent within 6 months prior to screening unless B-cell counts have returned to ≥ one-half the LLN.

Receipt of intravenous immunoglobulin (IVIG) within one month prior to Day 1.

Receipt of any of the following within 2 months prior to Day 1:

Cyclosporine

Methotrexate

Mitoxantrone

Cyclophosphamide

Tocilizumab

Satralizumab

Receipt of natalizumab (Tysabri®) within 6 months prior to Day 1.

Severe drug allergic history or anaphylaxis to 2 or more food products or medicine (including known sensitivity to acetaminophen/paracetamol, diphenhydramine or equivalent antihistamine, and methylprednisolone or equivalent glucocorticoid).

Diagnosed with a concurrent autoimmune disease that is uncontrolled (unless approved by the medical monitor).

Recent receipt of live/attenuated vaccine or blood transfusion. Receipt of any of the following:

Any live or attenuated vaccine within 4 weeks prior to Day 1 (administration of killed vaccines and nucleoside-modified mRNA-based vaccines is acceptable; the Sponsor recommends that Investigators ensure all participants are up to date on required vaccinations prior to study entry).

Bacillus Calmette Guérin vaccine within one year of screening.

Blood transfusion within 4 weeks prior to screening or during screening.

Clinically significant serious active or chronic viral, bacterial, or fungal infection that requires treatment with anti-infectives, hospitalization, or, in the Investigator's opinion, represents an additional risk to the participant, within 2 months prior to Day 1.

Known history of congenital or acquired immunodeficiency (e.g., due to human immunodeficiency virus \[HIV\] infection, splenectomy, immunosuppression-related or idiopathic T-cell deficiencies) that predisposes the participant to infection.

Positive test for chronic hepatitis B infection at screening, defined as either: a. Positive hepatitis B surface antigen (HBsAg), or b. Positive hepatitis B core (HBc) antibody (anti-HBc) plus negative hepatitis B surface (HBs) antibody (anti-HBs).

Positive test for hepatitis C virus antibody.

Negative test for varicella zoster virus (VZV)-IgG.

History of cancer, apart from squamous cell or basal cell carcinoma of the skin treated with documented success of curative therapy \> 3 months prior to Day 1.

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. Participants with latent TB or a positive QuantiFERON®-TB Gold test who are actively on anti-TB treatment can enroll if they have completed at least one month of anti-TB treatment and intend to complete the full course of anti-TB treatment. Participants with an indeterminate QuantiFERON®-TB Gold test result can enroll if a repeat QuantiFERON®-TB Gold test is negative or a tuberculin skin test is negative.

For participants who may undergo MRI scans:

Unable to undergo an MRI scan (e.g., hypersensitivity to Gd-containing MRI contrast agents, implanted pacemakers, defibrillators, or other metallic objects on or inside the body that limit performing MRI scans), or

Unable to tolerate or comply with the MRI procedure.

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 Dallas?

Yes, this clinical trial (NCT05549258) has an active research site in Dallas, 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.

Neuromyelitis Optica Treatment Options in Dallas, TX

If you're searching for neuromyelitis optica treatment options in Dallas, TX, this clinical trial (NCT05549258) 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 Dallas research site is actively enrolling participants for this phase 2 clinical trial. You'll receive care from experienced neuromyelitis optica 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 neuromyelitis optica clinical trials near you to find additional studies recruiting in your area.

Neuromyelitis Optica Clinical Trial in Dallas, TX

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