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JOURNAL ONKOLOGIE – STUDIE

Evaluation of Pharmacokinetics, Pharmacodynamics, Efficacy, Safety, and Immunogenicity of Ravulizumab Administered Intravenously in Pediatric Participants With Generalized Myasthenia Gravis (gMG)

Rekrutierend

NCT-Nummer:
NCT05644561

Studienbeginn:
Juni 2023

Letztes Update:
26.03.2024

Wirkstoff:
Ravulizumab

Indikation (Clinical Trials):
Myasthenia Gravis, Muscle Weakness

Geschlecht:
Alle

Altersgruppe:
Alle

Phase:
Phase 3

Sponsor:
Alexion Pharmaceuticals, Inc.

Collaborator:
-

Kontakt

Alexion Pharmaceuticals, Inc. (Sponsor)
Kontakt:
Phone: 1-855-752-2356
E-Mail: clinicaltrials@alexion.com» Kontaktdaten anzeigen

Studienlocations
(3 von 18)

Research Site
94143 San Francisco
United StatesNoch nicht rekrutierend» Google-Maps
Research Site
60611 Chicago
United StatesNoch nicht rekrutierend» Google-Maps
Research Site
2333 ZA Leiden
NetherlandsNoch nicht rekrutierend» Google-Maps
Alle anzeigen

Studien-Informationen

Brief Summary:

The primary purpose of this study is to characterize the pharmacokinetics and

pharmacodynamics of treatment with ravulizumab intravenous infusion in pediatric participants

with gMG.

Ein-/Ausschlusskriterien

Inclusion Criteria:

- Diagnosis of gMG confirmed by a positive serologic test for anti-AChR antibodies (Abs)

obtained at Screening and/or during Screening Period

- Myasthenia Gravis Foundation of America (MGFA) Clinical Classification of Class II to

Class IV at Screening

- Participants receiving treatment must be on a stable dosing regimen of adequate

duration prior to Screening and during the Screening Period.

- Eculizumab-experienced participants must have been enrolled and treated with

eculizumab in Study ECU-MG-303 for at least 6 months (180 days) and must have been on

a stable dose for ≥ 2 months (60 days) prior to Screening.

- All participants must be vaccinated against meningococcal infection

Exclusion Criteria:

Medical Conditions

- Any untreated thymic malignancy, carcinoma, or thymoma.

- Participants with a history of treated benign thymoma

- History of thymectomy, thymomectomy, or any thymic surgery within the 12 months prior

to Screening

- History of N meningitidis infection

- Known to be human immunodeficiency virus (HIV) positive

- History of unexplained infections

- Known or suspected history of drug or alcohol abuse or dependence within 1 year prior

to the start of the Screening Period

Studien-Rationale

Primary outcome:

1. Plasma Concentration of Ravulizumab (Time Frame - Day 1 predose through Week 18 predose)

2. Serum Free C5 Concentration of Ravulizumab (Time Frame - Day 1 predose through Week 18 predose)

Secondary outcome:

1. Change From Baseline in The Quantitative Myasthenia Gravis (QMG) Total Score at Up to Week 18 (Time Frame - Baseline, Up to Week 18)

2. Change From Baseline in Myasthenia Gravis-Activities Of Daily Living (MG-ADL) Total Score at Up to Week 18 (Time Frame - Baseline, Up to Week 18)

3. Change From Baseline in Myasthenia Gravis Composite (MGC) Score at Up to Week 18 (Time Frame - Baseline, Up to Week 18)

4. Change in Status from Week 10 in Myasthenia Gravis Foundation of America Postintervention Status (MGFA-PIS) as Assessed by the Investigator or Neurologist at Up to Week 18 (Time Frame - Week 10, Up to Week 18)

5. Change from Baseline in Neurology Quality of Life (Neuro QoL) Pediatric Fatigue Score at Up to Week 18 (Time Frame - Baseline, Up to Week 18):
Participants ≥8 years of age will be evaluated.

6. Change from Baseline in Patient-reported Outcomes Measurement Information System (PROMIS) Parent Proxy - Fatigue Score at Up to Week 18 (Time Frame - Baseline, Up to Week 18):
Participants <8 years of age will be evaluated.

7. Number of Participants With ≥5-point Reduction Compared to Baseline in the QMG Total Score Over Time Through Week 18 (Time Frame - Baseline through Week 18)

8. Number of Participants With ≥3 point Reduction Compared to Baseline in the MG-ADL Total Score Over Time Through Week 18 (Time Frame - Baseline through Week 18)

9. Number of Participants That Improve or Remain Stable in QMG Total Score at Week 18 Compared to Baseline (Time Frame - Baseline through Week 18):
Stable is defined as a ±5-point change from Baseline.

10. Number of Participants That Improve or Remain Stable in MG ADL Total Score at Week 18 Compared to Baseline (Time Frame - Baseline through Week 18):
Stable is defined as a ±3-point change from baseline.

11. Number of Participants With Treatment Emergent Adverse Events and Serious Adverse Events (Time Frame - Baseline up to Week 126 (8 weeks after last dose of study drug))

12. Number of Participants With Anti-Drug Antibody (ADA) at Week 18 (Time Frame - Baseline through Week 18)

Geprüfte Regime

  • Ravulizumab:
    Ravulizumab will be administered by intravenous (IV) infusion.

Quelle: ClinicalTrials.gov


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