BridgeMD
An Open-label Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Inebilizumab in Children With gMG
EU CTIS ID: 2025-520993-20-00
What this study is testing
To characterize the pharmacokinetics (PK) of inebilizumab administered in pediatric participants with generalized Myasthenia Gravis (gMG). To characterize the pharmacodynamics (PD) of inebilizumab administered in pediatric participants with gMG. To assess the safety and tolerability of inebilizumab administered in pediatric participants with gMG.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age ≥ 2 to < 18 years of age on the day of enrollment.
- "Diagnosis of gMG defined as: Positive serologic test for anti-AChR or anti-MuSK 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 may enter the study on: (1) Corticosteroids only, with no dose increase within 4 weeks prior to screening, or (2) 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."
You likely can't join if
- Thymectomy within 12 months prior to baseline (day 1) visit or planned thymectomy during the duration of the treatment period.
- Receipt of the following medications or treatments at any time prior to randomization: a) Alemtuzumab b) Total lymphoid irradiation c) Bone marrow transplant d) T-cell vaccination therapy e) Natalizumab
- "Unresected thymoma. Note: Participants with benign thymoma resected > 12 months prior to screening may enroll. Benign is defined as no known metastases and no extension into or beyond the capsule on pathological examination. Imaging to evaluate for thymoma must have been performed prior to screening per standard of care."
- Hospitalization for any reason < 30 days prior to screening.
- Current or recent gMG exacerbation that has not returned to baseline/resolved within at least 30 days prior to screening.
- History of recurrent significant infections (eg, requiring hospitalization or IV antibiotics).
See the full eligibility criteria
Who can join
- Age ≥ 2 to < 18 years of age on the day of enrollment.
- "Diagnosis of gMG defined as: Positive serologic test for anti-AChR or anti-MuSK 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 may enter the study on: (1) Corticosteroids only, with no dose increase within 4 weeks prior to screening, or (2) 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."
What rules you out
- Thymectomy within 12 months prior to baseline (day 1) visit or planned thymectomy during the duration of the treatment period.
- Receipt of the following medications or treatments at any time prior to randomization: a) Alemtuzumab b) Total lymphoid irradiation c) Bone marrow transplant d) T-cell vaccination therapy e) Natalizumab
- "Unresected thymoma. Note: Participants with benign thymoma resected > 12 months prior to screening may enroll. Benign is defined as no known metastases and no extension into or beyond the capsule on pathological examination. Imaging to evaluate for thymoma must have been performed prior to screening per standard of care."
- Hospitalization for any reason < 30 days prior to screening.
- Current or recent gMG exacerbation that has not returned to baseline/resolved within at least 30 days prior to screening.
- History of recurrent significant infections (eg, requiring hospitalization or IV antibiotics).
- "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 mAb or large molecule biologic, including but not limited to FcRn inhibitors, anti-TNF mAbs, anti-JAK Stat mAbs, and complement inhibitors within 6 months prior to screening."
- "Receipt within the 4 weeks prior to screening: a) Live attenuated vaccine (administration of inactivated [killed] vaccine is acceptable); b) Blood transfusion"
- "Participants of childbearing potential unwilling to use protocol-specified method of contraception see (Section 11.5) during treatment and for an additional 6 months after the last dose of investigational product."
The study team makes the final eligibility decision.
Where it's taking place
- United States
- Canada
- United Kingdom
- Brazil
- Argentina
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States; Canada; United Kingdom; Brazil; Argentina. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.