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Safety and Efficacy of ALXN1720 in Adults With Generalized Myasthenia Gravis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05556096
Recruitment Status : Recruiting
First Posted : September 27, 2022
Last Update Posted : April 26, 2024
Sponsor:
Information provided by (Responsible Party):
Alexion Pharmaceuticals, Inc.

Study Description
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Brief Summary:
The purpose of this study is to evaluate the safety and efficacy of ALXN1720 for the treatment of generalized MG (gMG) in adults with autoantibodies against acetylcholine receptor (AChR).

Condition or disease Intervention/treatment Phase
Generalized Myasthenia Gravis Combination Product: ALXN1720 Combination Product: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 254 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This is a treatment study with 2 parallel intervention groups. The study is blinded for sponsor staff, sponsor designees, investigative site personnel, other staff directly associated with the conduct of the study, and study participants.
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel, Multicenter Study to Evaluate the Safety and Efficacy of ALXN1720 in Adults With Generalized Myasthenia Gravis
Actual Study Start Date : November 21, 2022
Estimated Primary Completion Date : August 5, 2025
Estimated Study Completion Date : July 7, 2027

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Arms and Interventions
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Arm Intervention/treatment
Experimental: ALXN1720
Participants will receive a weight-based initial (loading) dose of ALXN1720 on Day 1, followed by weight-based maintenance treatment with ALXN1720 on Day 8 and once every week (Q1W) thereafter for a total of 26 weeks. Following this randomized controlled treatment (RCT) period, all participants will receive ALXN1720 in an open-label extension (OLE) period of 105 weeks.
 Combination Product: ALXN1720
Combination product consisting of syringe prefilled with ALXN1720.
Placebo Comparator: Placebo
Participants will receive placebo during the 26-week RCT period, after which they will enter the OLE period of the study and receive ALXN1720.
 Combination Product: Placebo
Combination product consisting of syringe prefilled with placebo.


Outcome Measures
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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 ]

Secondary Outcome Measures :
  1. Change From Baseline in Quantitative Myasthenia Gravis (QMG) Total Score at Week 26 [ Time Frame: Baseline, Week 26 ]
  2. Percentage of Responders Based on Reduction of the MG-ADL Total Score at Week 26 [ Time Frame: Baseline up to Week 26 ]
    Response is defined as reduction of the MG-ADL total score by >= 3 points from baseline at Week 26.

  3. Percentage of Responders based on Reduction of the QMG Total Score at Week 26 [ Time Frame: Baseline up to Week 26 ]
    Response is defined as reduction of the QMG total score by >= 5 points from baseline at Week 26

  4. Change From Baseline in Myasthenia Gravis Composite (MGC) Total Score at Week 26 [ Time Frame: Baseline, Week 26 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of MG with generalized muscle weakness meeting the clinical criteria defined by Myasthenia Gravis Foundation of America (MGFA) Class II, III or IV
  • Positive serological test for autoantibodies against AChR

Exclusion Criteria:

  • History of thymectomy, or any other thymic surgery within 12 months prior to Screening
  • Untreated thymic malignancy, carcinoma, or thymoma
  • History of Neisseria meningitidis infection
  • Pregnancy, breastfeeding, or intention to conceive during the course of the study
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05556096


Contacts
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Contact: Alexion Pharmaceuticals, Inc. (Sponsor) 1-855-752-2356 clinicaltrials@alexion.com

Locations
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Sponsors and Collaborators
Alexion Pharmaceuticals, Inc.
More Information
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Responsible Party: Alexion Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT05556096    
Other Study ID Numbers: ALXN1720-MG-301
2022-000460-21 ( EudraCT Number )
First Posted: September 27, 2022    Key Record Dates
Last Update Posted: April 26, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Alexion has a public commitment to allow requests for access to study data and will be supplying a protocol, CSR, and plain language summaries.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Alexion Pharmaceuticals, Inc.:
ALXN1720
anti-acetylcholine receptor antibody-positive
acetylcholine receptor
AChR
generalized myasthenia gravis
myasthenia gravis
 MG
gMG
complement component 5
C5
VHH antibody
Additional relevant MeSH terms:
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Myasthenia Gravis
Muscle Weakness
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Pathologic Processes
Paraneoplastic Syndromes, Nervous System
Nervous System Neoplasms
 Neoplasms by Site
Neoplasms
Paraneoplastic Syndromes
Autoimmune Diseases of the Nervous System
Neurodegenerative Diseases
Neuromuscular Junction Diseases
Neuromuscular Diseases
Autoimmune Diseases
Immune System Diseases