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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 : May 10, 2024
Sponsor:
Information provided by (Responsible Party):
Alexion Pharmaceuticals, Inc.

Tracking Information
First Submitted Date  ICMJE September 23, 2022
First Posted Date  ICMJE September 27, 2022
Last Update Posted Date May 10, 2024
Actual Study Start Date  ICMJE November 21, 2022
Estimated Primary Completion Date August 5, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 23, 2022)		 Change From Baseline in Myasthenia Gravis-Activities of Daily Living (MG-ADL) Total Score at Week 26 [ Time Frame: Baseline, Week 26 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 22, 2024)
  • Change From Baseline in Quantitative Myasthenia Gravis (QMG) Total Score at Week 26 [ Time Frame: Baseline, Week 26 ]
  • 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.
  • 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
  • Change From Baseline in Myasthenia Gravis Composite (MGC) Total Score at Week 26 [ Time Frame: Baseline, Week 26 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 23, 2022)
  • Change From Baseline in Quantitative Myasthenia Gravis (QMG) Total Score at Week 26 [ Time Frame: Baseline, Week 26 ]
  • Percentage of Responders Based on Reduction of the MG-ADL Total Score at Week 26 [ Time Frame: Baseline up to Week 26 ]
    Responders based on reduction by >= 3 points in the change from baseline in the MG-ADL total score at Week 26
  • Percentage of Responders based on Reduction of the QMG Total Score at Week 26 [ Time Frame: Baseline up to Week 26 ]
    Responders based on reduction by >= 5 points in the change from baseline in the QMG total score at Week 26
  • Change From Baseline in Myasthenia Gravis Composite (MGC) Total Score at Week 26 [ Time Frame: Baseline, Week 26 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of ALXN1720 in Adults With Generalized Myasthenia Gravis
Official Title  ICMJE 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
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE 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
Condition  ICMJE Generalized Myasthenia Gravis
Intervention  ICMJE
  • Combination Product: ALXN1720
    Combination product consisting of syringe prefilled with ALXN1720.
  • Combination Product: Placebo
    Combination product consisting of syringe prefilled with placebo.
Study Arms  ICMJE
  • 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.
    Intervention: Combination Product: 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.
    Intervention: Combination Product: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 27, 2023)		 254
Original Estimated Enrollment  ICMJE
 (submitted: September 23, 2022)		 200
Estimated Study Completion Date  ICMJE July 7, 2027
Estimated Primary Completion Date August 5, 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Alexion Pharmaceuticals, Inc. (Sponsor) 1-855-752-2356 clinicaltrials@alexion.com
Listed Location Countries  ICMJE Argentina,   Austria,   Brazil,   Canada,   China,   Denmark,   France,   Germany,   Israel,   Italy,   Japan,   Korea, Republic of,   Netherlands,   Poland,   Portugal,   Serbia,   Spain,   Switzerland,   Taiwan,   Turkey,   United Kingdom,   United States
Removed Location Countries Australia,   Belgium,   Czechia,   Hungary
 
Administrative Information
NCT Number  ICMJE NCT05556096
Other Study ID Numbers  ICMJE ALXN1720-MG-301
2022-000460-21 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE
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.
Current Responsible Party Alexion Pharmaceuticals, Inc.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Alexion Pharmaceuticals, Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Alexion Pharmaceuticals, Inc.
Verification Date May 2024

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP