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Complement Inhibitor

Pegcetacoplan for ALS

Phase 2
Waitlist Available
Research Sponsored by Apellis Pharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
At least 18 years of age
Sporadic ALS diagnosed as definite, probable, or laboratory-supported probable as defined by the revised El Escorial criteria
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to week 104
Awards & highlights

Study Summary

This trial will test if pegcetacoplan is effective and safe in people with ALS. It will last 24 months and will compare pegcetacoplan to a placebo.

Who is the study for?
Adults with ALS who have had symptoms start within the last 18 months, a certain level of lung function, and an ALSFRS-R score of ≥30. They must be vaccinated against specific infections or agree to it. Those with other neuromuscular conditions, on recent investigational drugs, or having significant non-ALS pulmonary disorders cannot join.Check my eligibility
What is being tested?
The MERIDIAN study is testing Pegcetacoplan's effectiveness and safety in treating ALS over 24 months. Participants are randomly assigned to receive either Pegcetacoplan or a placebo without knowing which one they're getting (double-blind).See study design
What are the potential side effects?
Specific side effects for Pegcetacoplan aren't listed here but generally could include reactions at the injection site, potential increased risk of infections due to immunosuppression, and possible allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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My ALS diagnosis is confirmed by specific criteria.
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I have been vaccinated against pneumonia, meningitis, and Hib within the last 5 years or agree to be.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to week 104
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to week 104 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Combined Assessment of Function and Survival (CAFS)
Secondary outcome measures
Change from Baseline in muscle strength
Change from Baseline in percentage of slow vital capacity (%SVC)
Change from Baseline in the Revised ALS Functional Rating scale (ALSFRS-R) score
+3 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: 1,080 mg pegcetacoplan (APL-2)Experimental Treatment1 Intervention
administered subcutaneously twice weekly
Group II: Placebo administered subcutaneously twice weeklyPlacebo Group1 Intervention

Find a Location

Who is running the clinical trial?

Apellis Pharmaceuticals, Inc.Lead Sponsor
24 Previous Clinical Trials
3,776 Total Patients Enrolled

Media Library

Pegcetacoplan (Complement Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04579666 — Phase 2
Amyotrophic Lateral Sclerosis Research Study Groups: Placebo administered subcutaneously twice weekly, 1,080 mg pegcetacoplan (APL-2)
Amyotrophic Lateral Sclerosis Clinical Trial 2023: Pegcetacoplan Highlights & Side Effects. Trial Name: NCT04579666 — Phase 2
Pegcetacoplan (Complement Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04579666 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals are involved in this clinical experiment?

"This clinical trial is not currently accepting patients. It was initially posted on the 30th of September 2020 and last amended on May 27th 2022. However, there are 539 medical trials for lateral sclerosis that are open to enrollment and 10 studies utilizing Pegcetacoplan (APL-2) which require participants."

Answered by AI

What additional research studies have been conducted to assess the efficacy of Pegcetacoplan (APL-2)?

"Pegcetacoplan (APL-2) was introduced to the medical field in 2018 at University's Augenklinik Bonn, with 18329 completed studies as of now. Ten ongoing trials are underway, most notably in Burlington, Vermont."

Answered by AI

What potential consequences should be expected when utilizing Pegcetacoplan (APL-2)?

"Considering the limited evidence of Pegcetacoplan's (APL-2) efficacy, it is rated as a 2 on our team at Power's safety scale."

Answered by AI

Are enrollees being accepted for this scientific investigation?

"At this time, the trial is not currently recruiting. The post date was September 30th 2020 and it has been edited as recently as May 27th 2022. However, if you are looking for other studies related to lateral sclerosis there are 539 open trials right now; alternatively, 10 trials concerning Pegcetacoplan (APL-2) need participants."

Answered by AI

What is the geographical spread of this research project?

"This clinical trial is accepting patients at the University of Vermont Medical Center in Burlington and The Berman Centre located in Minneapolis, as well as 10 other medical sites around the country. Notably, there is a location in Aurora, Colorado at the University of Colorado."

Answered by AI

Does this research represent a pioneering effort in the field?

"First studied in 2018, Pegcetacoplan (APL-2) was sponsored by Apellis Pharmaceuticals after the completion of its initial trial with 600 participants. Subsequently, it received Phase 3 drug approval and is now being assessed at 10 active studies located across 149 cities and 26 countries worldwide."

Answered by AI

Who else is applying?

What state do they live in?
Florida
How old are they?
18 - 65
What site did they apply to?
University of South Florida
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
MERIDIAN: A Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Adults With Amyotrophic Lateral Sclerosis (ALS)
2020. "MERIDIAN: A Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Adults With Amyotrophic Lateral Sclerosis (ALS)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04579666.
~55 spots leftby Apr 2025
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