About MERIDIAN
MERIDIAN is a Phase 2 clinical trial evaluating the effectiveness and safety of the investigational medication, pegcetacoplan, in adults with sporadic ALS.
Participation in MERIDIAN
Participation in MERIDIAN is expected to last for approximately 2 years and may be followed by a Long-Term Extension Study.
- Year 1: Study participants will be randomly assigned (randomized) to either receive pegcetacoplan or placebo for the first year of the study. There is a 67% (2 in 3) chance of receiving pegcetacoplan, and a 33% (1 in 3) chance of receiving placebo during the first year of the study. Neither the participants nor their study team will know the study treatment group assignment.
- Year 2: All study participants will receive pegcetacoplan during Year 2 of the study.
- Clinic Visits: There are up to 8 in-clinic visits in Year 1 (including screening) and 3 in-clinic visits in Year 2.
- At-Home: Additional assessments will be done at home and via the phone.
Frequently Asked Questions about the MERIDIAN study
What is the investigational medication?
How is the study drug administered?
How long is the study?
Why is there a placebo in MERIDIAN?
Does connecting with a MERIDIAN study clinic require or guarantee participation?
Locations
MERIDIAN is a global clinical trial.
The map below shows the countries and enrolling sites that this website is connected to.
If you do not see a site in your country at this time, you or your physician can email ClinicalTrials@Apellis.com to find out if any sites are enrolling participants in your country.
MERIDIAN Timeline
After Screening, MERIDIAN will take you approximately 2 years to complete. The study is made up of four main periods.
Screening
- To confirm eligibility for the study
- Up to 6 weeks
- Up to 2 in-clinic visits
Randomized Treatment Period Year 1
- To evaluate the safety and effectiveness of pegcetacoplan compared to placebo
- Participants will have a 67% chance of receiving pegcetacoplan and a 33% chance of receiving placebo
- 1 year
- 6 in-clinic visits
- At-home assessments
Open-Label Treatment Period Year 2
- To evaluate the long-term safety and effectiveness of pegcetacoplan
- All participants will receive the investigational medication, pegcetacoplan
- 1 year
- 3 in-clinic visits
- At-home assessments
Follow-Up Period
- To check the health of participants after their last dose of study drug
- No study drug administration
- 6 weeks
- 1 in-clinic visit
Note: After completing Year 2, participants may be able to participate in a Long-Term Extension Study.
About Clinical Trials
What is clinical research and clinical trials?
Clinical research is the process of studying diseases and developing medications to possibly prevent, treat, or help relieve symptoms caused by different medical conditions. Before a medicine can become widely available, it must be tested in a series of clinical trials, or clinical research studies. The medicine being studied or tested in a clinical trial is called an investigational medication.
Clinical trials provide valuable information and may help researchers to understand a condition better and learn how best to treat it, or may lead to new or better treatments being made available. There are usually 3 phases of clinical trials before an investigational medication can be approved for general use:
Phase 1
Healthy volunteers receive the investigational drug to help researchers study the initial safety and understand how the drug is processed by the body. Some phase 1 trials will include people with the disease after initial results are evaluated from healthy volunteers.
Phase 2
The investigational drug is given to a small number of people with the disease to learn more about how safe it is and how it is processed by the body. These trials may also evaluate effectiveness of the drug, and different doses to determine which should be studied further in future trials.
Phase 3
These trials include a larger number of people and are intended to generate enough information to establish whether the investigational medication can safely be administered, and whether it provides sufficient benefit to be made available to the public.
Understanding Clinical Research Terms
Clinical research terminology can be intimidating. We have created this glossary of clinical trial language to help you understand some of the key terms:
Clinical trial participants
Eligibility criteria
Independent ethics committee (IEC) or institutional review board (IRB)
Informed consent form (ICF)
Investigational medication or drug
Study medication or drug
Open-label, open-label extension
Single-blind
Double-blind
Placebo
Protocol
Randomization
Study team, or study site team