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 is expected to last for approximately 2 years and may be followed by a Long-Term Extension Study.
Pegcetacoplan (peg-set-a-koé-plan), also known as APL-2, is the investigational medication being evaluated in this study. It has been designed to target C3, a central protein in the complement cascade. Increased levels of C3 have been found at the motor end plate (also called the neuromuscular junction) where nerves and muscles meet. It is thought that reducing the activation of C3 may result in less C3 depositing at the motor end plate, which may reduce inflammation, and this may slow the progression of ALS.
Investigational means that pegcetacoplan is not approved by any health authority for the treatment of ALS.
It is given as a subcutaneous (under the skin) infusion twice a week. Study participants and/or their care partner(s) will be taught how to administer the study drug at home.
After completing the Screening period, participation will last for up to 2 years and includes 9 in-clinic visits, and at-home and phone assessments.
After completing Year 2, participants may be able to participate in a Long-Term Extension Study. The study team can discuss the potential of this with you in more detail.
This is the first clinical trial evaluating the investigational medication, pegcetacoplan, in adults with ALS. To determine if pegcetacoplan is effective and safe, it must be compared to placebo.
No, connecting with a site does not obligate you to participate, nor does it guarantee your eligibility to participate in the study. Participating in this or any clinical trial is completely voluntary. If you decide to participate in a research study, you are always free to withdraw at any time without any penalty or effect on your future medical care.
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.
After Screening, MERIDIAN will take you approximately 2 years to complete. The study is made up of four main periods.
Note: After completing Year 2, participants may be able to participate in a Long-Term Extension Study.
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:
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.
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.
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.
Clinical research terminology can be intimidating. We have created this glossary of clinical trial language to help you understand some of the key terms:
People who voluntarily consent to take part in a clinical trial and who meet all of the eligibility criteria.
The requirements for who can participate in a clinical trial. These can include age, diagnosis, current and previous treatments, allergies, and other conditions.
Independent committees made up of medical experts and the general public who review, approve, and monitor all aspects of clinical research studies involving people. These groups ensure study protocols adhere to all relevant regulations, and that the rights and welfare of all participants are protected.
An important written document that is part of a larger consent process discussion with the study team. The ICF describes the study, including potential risks. By signing the ICF, patients agree to participate. Parents or guardians must sign for minors to participate in a clinical trial, however the child may be asked to sign a simplified “Assent Form” to show they understand and are participating voluntarily.
The drug or medicine being studied in a clinical trial. Typically, this medication is not yet approved for general use for the condition being studied.
This term may be used to describe the investigational medication or other study treatment (such as placebo) that a participant may receive while in the study.
In an open-label study, or open-label extension (continuation of the study) both the study team and the participant know which treatment group they have been assigned to, or which study treatment is being administered.
In a single-blind study, the study participant does not know the study treatment group they have been assigned to, but the study team does.
In a double-blind study, neither the participant nor the study team knows which study treatment group the participant has been assigned to, but the study team can find out in case of an emergency.
A substance that looks like the investigational medication but has no active medicinal ingredients. Placebos are used to compare the effectiveness of the investigational medication against no treatment. This is important to correct for the “placebo effect” when people feel better because they think they’re taking a medicine, even if the medicine does not do anything.
A detailed plan describing the purpose of a study, how the study will be conducted, who can participate, the investigational medication that will be administered, and how the effects will be monitored.
Randomized clinical trials assign participants at random to groups (also called cohorts) within the trial, with each cohort receiving a different study treatment regimen. The different regimens may include the investigational medication, a placebo, an alternative therapy, or some combination of them.
Randomization is important in gathering clear, unbiased results. Not all studies involve placebos, alternative therapies, or randomization. If a particular study is randomized, patients will be made aware before agreeing to participate.
The doctors, nurses, and other professionals who are conducting a study at a particular clinic or hospital. The doctors may also be referred to as “investigators” for the study.