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

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: NCT04579666
Recruitment Status : Recruiting
First Posted : October 8, 2020
Last Update Posted : October 8, 2020
Sponsor:
Information provided by (Responsible Party):
Apellis Pharmaceuticals, Inc.

Tracking Information
First Submitted Date  ICMJE September 22, 2020
First Posted Date  ICMJE October 8, 2020
Last Update Posted Date October 8, 2020
Actual Study Start Date  ICMJE September 30, 2020
Estimated Primary Completion Date September 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 1, 2020)
Combined Assessment of Function and Survival (CAFS) [ Time Frame: Week 52 ]
Efficacy
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: October 1, 2020)
  • Incidence and severity of treatment-emergent adverse events (TEAEs) [ Time Frame: Up to Week 104 ]
    Safety
  • Number of participants with positive responses (yes) to the Columbia Suicide Severity Rating Scale (C-SSRS) [ Time Frame: Up to Week 104 ]
  • Change from Baseline in the Revised ALS Functional Rating scale (ALSFRS-R) score [ Time Frame: Baseline, Week 52 ]
    Minimum score of 0 and maximum of 48, with higher values representing better function
  • Change from Baseline in percentage of slow vital capacity (%SVC) [ Time Frame: Baseline, Week 52 ]
  • Change from Baseline in muscle strength [ Time Frame: Baseline, Week 52 ]
  • Time to death, permanent tracheostomy, or permanent assisted ventilation [ Time Frame: Up to Week 52 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE MERIDIAN: A Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Adults With Amyotrophic Lateral Sclerosis (ALS)
Official Title  ICMJE A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Subjects With Amyotrophic Lateral Sclerosis (ALS)
Brief Summary 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)
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Amyotrophic Lateral Sclerosis
  • Motor Neuron Disease
Intervention  ICMJE
  • Drug: Pegcetacoplan (APL-2)
    Complement (C3) Inhibitor
  • Other: Placebo
    Sterile solution of equal volume to active arm
Study Arms  ICMJE
  • Experimental: 1,080 mg pegcetacoplan (APL-2)
    administered subcutaneously twice weekly
    Intervention: Drug: Pegcetacoplan (APL-2)
  • Placebo Comparator: Placebo administered subcutaneously twice weekly
    Intervention: Other: 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: October 1, 2020)
228
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2023
Estimated Primary Completion Date September 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • At least 18 years of age
  • Sporadic ALS diagnosed as definite, probable, or laboratory-supported probable as defined by the revised El Escorial criteria
  • Slow vital capacity (SVC) ≥60% of the predicted value at screening
  • Onset of ALS symptoms within 72 weeks (18 months) prior to screening
  • Total ALSFRS-R score of ≥30 at screening
  • Have vaccination within 5 years against Streptococcus pneumoniae, Neisseria meningitidis (types A, C, W, Y, and B), and Haemophilus influenzae (type B) or agree to receive vaccination

Exclusion Criteria:

  • Confirmed or suspected other causes of neuromuscular weakness
  • Diagnosed with another neurodegenerative disease (examples include Parkinson's disease and Huntington's disease)
  • Significant pulmonary disorder not attributed to ALS (eg, chronic obstructive pulmonary disease, pulmonary fibrosis, cystic fibrosis, pulmonary arterial hypertension)
  • If taking riluzole, participant must be on a stable dose for 30 days prior to the start of the screening period. Use of riluzole is not required for participation.
  • If taking edaravone, participant must be on a stable dose for 60 days prior to the start of the screening period. Use of edaravone is not required for participation.
  • Participation in any other investigational drug trial or exposure to other investigational agent, device, or procedure within 30 days or within 5-half lives of the treatment (whichever is longer) prior to the start of the screening period or during study participation
  • Use of any other complement inhibitor within 30 days or within 5-half lives of the treatment (whichever is longer) prior to the start of the screening period or during study participation
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: Apellis Clinical Trial Information Line 617-977-5700 clinicaltrials@apellis.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04579666
Other Study ID Numbers  ICMJE APL2-ALS-206
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: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Apellis Pharmaceuticals, Inc.
Study Sponsor  ICMJE Apellis Pharmaceuticals, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Apellis Pharmaceuticals, Inc.
Verification Date October 2020

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