RECRUITING

Study of Inebilizumab in Pediatric Subjects With Neuromyelitis Optica Spectrum Disorder

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

An Open-Label Multicenter Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of Inebilizumab in Pediatric Subjects With Neuromyelitis Optica Spectrum Disorder

Quick Facts

Study Start:2023-07-03

Study Completion:2027-04-13

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05549258

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:2 Years to 17 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD

Inclusion Criteria	Exclusion Criteria
* Male or female subjects 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.	* Any condition that, in the opinion of the Investigator, would interfere with the evaluation or administration of the Investigational Product or interpretation of subject 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: 1. Alemtuzumab 2. Total lymphoid irradiation 3. Bone marrow transplant 4. 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: 1. Cyclosporine 2. Methotrexate 3. Mitoxantrone 4. Cyclophosphamide 5. Tocilizumab 6. Satralizumab 7. Eculizumab * 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

Inclusion Criteria

Exclusion Criteria

* Male or female subjects 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.

* Any condition that, in the opinion of the Investigator, would interfere with the evaluation or administration of the Investigational Product or interpretation of subject 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:
1. Alemtuzumab
2. Total lymphoid irradiation
3. Bone marrow transplant
4. 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:
1. Cyclosporine
2. Methotrexate
3. Mitoxantrone
4. Cyclophosphamide
5. Tocilizumab
6. Satralizumab
7. Eculizumab
* 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

Contacts and Locations

Study Contact

Amgen Call Center

CONTACT

866-572-6436

medinfo@amgen.com

Principal Investigator

STUDY_DIRECTOR

Amgen

Study Locations (Sites)

Loma Linda University Children's Hospital

Loma Linda, California, 92354

United States

Massachusetts General Hospital

Boston, Massachusetts, 02115

United States

Collaborators and Investigators

Sponsor: Amgen

MD, STUDY_DIRECTOR, Amgen

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-07-03

Study Completion Date2027-04-13

Study Record Updates

Study Start Date2023-07-03

Study Completion Date2027-04-13

Terms related to this study

Additional Relevant MeSH Terms

Neuromyelitis Optica Spectrum Disorder