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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/18/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/18/2021.

Safety and Efficacy Study of Ravulizumab in Adults With Generalized Myasthenia Gravis

Clinicaltrials.gov identifier NCT03920293

Recruitment Status Recruiting

First Posted April 18, 2019

Last update posted September 25, 2020

Study Description

Brief summary:

The primary purpose of this study is to evaluate the safety and efficacy of ravulizumab for the treatment of participants with generalized myasthenia gravis (gMG).

  • Condition or Disease:Generalized Myasthenia Gravis
  • Intervention/Treatment: Biological: Ravulizumab
    Drug: Placebo
  • Phase: Phase 3
Detailed Description

N/A

Study Design
  • Study Type: Interventional
  • Estimated Enrollment: 160 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Triple (Participant, Care Provider, Investigator)
  • Primary Purpose: Treatment
  • Official Title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Ravulizumab in Complement-Inhibitor-Naïve Adult Patients With Generalized Myasthenia Gravis
  • Actual Study Start Date: March 2019
  • Estimated Primary Completion Date: December 2021
  • Estimated Study Completion Date: December 2023
Arms and interventions
Arm Intervention/treatment
Experimental: Ravulizumab
Participants will receive ravulizumab for the duration of the study.
Biological: Ravulizumab
Concentrated sterile, preservative-free aqueous solution (10 milligrams [mg]/milliliter [mL]) in single-use, 30-mL vial for intravenous (IV) infusion. Single loading dose on Day 1, followed by regular maintenance dosing beginning on Day 15, based on weight.
Placebo Comparator: Placebo
Participants will receive placebo during the 26-week randomized-controlled period of the study, after which they will enter the open-label extension period of the study and receive ravulizumab.
Drug: Placebo
Matching, sterile, preservative-free aqueous solution in single-use, 30-mL vial for IV infusion. Single loading dose on Day 1, followed by regular maintenance dosing beginning on Day 15, based on weight.
Outcome Measures
  • Primary Outcome Measures: 1. Change From Baseline In Myasthenia Gravis-Activities Of Daily Living (MG-ADL) Total Score At Week 26 [ Time Frame: Baseline, Week 26 ]
    To assess the efficacy of ravulizumab compared with placebo in the treatment of gMG based on the improvement in the MG-ADL profile.
  • Secondary Outcome Measures: 1. Change From Baseline In the Revised 15 Component Myasthenia Gravis Quality of Life (MG-QOL15r) At Week 26 [ Time Frame: Baseline, Week 26 ]
    To assess the efficacy of ravulizumab compared with placebo in the treatment of gMG based on the improvement in the MG-QOL15r score
  • 2. Change From Baseline In The Myasthenia Gravis Activities of Daily Living (MG-ADL) Total Score of at least 3 points At Week 26 [ Time Frame: Baseline, Week 26 ]
    To assess the efficacy of ravulizumab compared with placebo in the treatment of gMG based on the improvement in the MG-ADL total score
  • 3. Change From Baseline In the The Quantitative Myasthenia Gravis (QMG) total score by at least 5 points At Week 26 [ Time Frame: Baseline, Week 26 ]
    To assess the efficacy of ravulizumab compared with placebo in the treatment of gMG based on the improvement in the QMG total score
  • 4. Change From Baseline In The Quantitative Myasthenia Gravis (QMG) Total Score At Week 26 [ Time Frame: Baseline, Week 26 ]
    To assess the efficacy of ravulizumab compared with placebo in the treatment of gMG based on the improvement in the QMG total score.
Eligibility Criteria
  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
Criteria

Inclusion Criteria:

1. Diagnosed with Myasthenia Gravis at least 6 months (180 days) prior to the date of the
Screening Visit as confirmed by specific criteria.

2. Myasthenia Gravis Foundation of America Clinical Classification Class II to IV at
screening.

3. MG-ADL profile must be ≥ 6 at screening and randomization (Day 1).

4. Vaccinated against meningococcal infections within 3 years prior to, or at the time
of, initiating study drug to reduce the risk of meningococcal infection (N
meningitidis).

Exclusion Criteria:

Medical Conditions

1. Any active or untreated thymoma. History of thymic carcinoma or thymic malignancy
unless deemed cured by adequate treatment with no evidence of recurrence for ≥ 5 years
before screening.

2. History of thymectomy within the 12 months prior to screening.

3. History of N meningitidis infection.

4. Use of the following within the time period specified below:

- IV immunoglobulin within 4 weeks of randomization

- Use of plasma exchange within 4 weeks of randomization

- Use of rituximab within 6 months of screening

5. Participants who have received previous treatment with complement inhibitors (for
example, eculizumab).

Contacts and Locations
Contacts

Contact: Alexion Pharmaceuticals Inc. 855-752-2356 clinicaltrials@alexion.com

Locations
Show 136 Study Locations
Sponsors and Collaborators

Alexion Pharmaceuticals

More Information
  • Responsible Party: Alexion Pharmaceuticals
  • ClinicalTrials.gov Identifier: NCT03920293 History of Changes
  • Other Study ID Numbers: ALXN1210-MG-306, 2018-003243-39
  • First Posted: April 18, 2019 Key Record Dates
  • Last Update Posted: September 25, 2020
  • Last Verified: September 2020
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: Muscle Weakness Myasthenia Gravis