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A Study to Investigate OCS Tapering in Adult Participants With Generalized Myasthenia Gravis Treated With Ravulizumab

ConditionsGeneralized Myasthenia GravisgMG
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorAlexion Pharmaceuticals, Inc.

About this trial

This is a prospective, multicenter single arm study designed to evaluate the effectiveness and safety of a predefined oral corticosteroids (OCS) tapering schedule to reduce OCS use in adult participants with acetylcholine receptor positive (AChR+) generalized myasthenia gravis (gMG) being treated with intravenous ravulizumab.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged greater than 18 years and male or female

Clinical diagnosis of gMG

Receiving ravulizumab treatment prior to enrollment

Receipt of OCS therapy equivalent to a daily dose ≥ 7.5 mg of prednisone/prednisolone for ≥ 4 continuous weeks directly preceding enrollment

Disqualifiers

Concurrent participation in an interventional clinical trial.

History of chronic hypoadrenalism (ie, Addison's disease).

Use of concomitant OCS for comorbid conditions other than gMG

Receipt of a biologic for gMG (e.g., efgartigimod, rozanolixizumab, inebilizumab, rituximab, intravenous immunoglobulin) within 5 half-lives of enrollment

Trial design

Design model

Single group

Treatments tested in this trial

  • Oral Corticosteroid Tapering Schedule

    Procedure/Surgery

    During the tapering period, participant will follow an Oral Corticosteroid tapering schedule as applicable to the participant. The oral corticosteroid (prednisone/prednisolone) is provided as per standard medical care.

  • Ravulizumab

    Drug

    Patients being treated with intravenous ravulizumab as part of their standard medical care.

  • Prednisone/Prednisolone

    Drug

    Participants will continue with or be switched to prednisone/prednisolone as per standard medical care.

Treatment groups

75 Participants
are divided into 1 treatment group
Group A: Oral Corticosteroid Tapering ScheduleExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Proportion of Adult Participants With gMG Who Either: Discontinue Oral Corticosteroids (OCS) or Reduce Their Daily OCS Dosage ≤ 5 mg/day and Maintain this Status for ≥ 4 Weeks Without Clinical Deterioration of gMG

Time frame
Up to approximately 32 weeks

Secondary outcomes

1

Proportion of Adult Participants with gMG Who Discontinue OCS (0 mg/day), Sustained ≥ 4 Weeks Without Clinical Deterioration of gMG

Time frame
Up to approximately 32 weeks
2

Percentage Change From Daily OCS Dose (mg/day) at Baseline

Time frame
Baseline, Up to approximately 32 weeks
3

Change from Baseline in the Myasthenia Gravis Quality of Life-15 Revised (MG-QoL-15r) Score in Adult Participants with gMG

Time frame
Baseline, Up to approximately 32 weeks
4

Change from Baseline in the Myasthenia Gravis-Activities of Daily Living (MG-ADL) Total Score in Adult Participants with gMG

Time frame
Baseline, Up to approximately 32 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Alexion Pharmaceuticals, Inc.

Lead sponsor

Source ClinicalTrials.gov
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