MERIDIAN: A Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Adults With Amyotrophic Lateral Sclerosis (ALS)

Part of paid clinical trials in Los Angeles, California.

Sponsor
Apellis Pharmaceuticals, Inc.
Study ID
NCT04579666
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pegcetacoplan (APL-2) — DRUG
    Complement (C3) Inhibitor
  • Placebo — OTHER
    Sterile solution of equal volume to active arm

Study Details

This is a 24-month, Phase 2, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of pegcetacoplan in subjects with amyotrophic lateral sclerosis (ALS)

Key Dates

First listed
Oct 8, 2020
Start date
Sep 30, 2020
Status verified
Apr 2025
Primary completion
Mar 31, 2023
Completion
Jul 13, 2023

Study Design

Enrollment
249 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 1,080 mg pegcetacoplan (APL-2)
    administered subcutaneously twice weekly
  • Placebo Comparator: Placebo administered subcutaneously twice weekly

Primary Outcome Measure

OLP: Number of Participants With Treatment-emergent Adverse Events and Treatment-emergent Serious Adverse Events [ Time Frame: From first dose of study drug (Week 52) up to 56 days post last dose of study drug, approximately 60 weeks ]

Locations (10)

FacilityCityStateZIPSite coordinators
Cedars-Sinai Medical CenterLos AngelesCalifornia90048-
University of ColoradoAuroraColorado80045-
University of South FloridaTampaFlorida33612-
Augusta UniversityAugustaGeorgia30912-
Indiana UniversityIndianapolisIndiana46202-
Johns HopkinsBaltimoreMaryland21205-
The Berman CenterMinneapolisMinnesota55415-
Hospital for Special SurgeryNew YorkNew York10021-
Austin Neuromuscular CenterAustinTexas78756-
University of Vermont Medical CenterBurlingtonVermont05401-

Related coverage on Hipa.ai

Find similar trials in Los Angeles, CA

By research site
Cedars-Sinai Medical Center· Los Angeles, CAUniversity of Colorado· Aurora, COUniversity of South Florida· Tampa, FLAugusta University· Augusta, GAIndiana University· Indianapolis, INJohns Hopkins· Baltimore, MD

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