ABOUT THE ADHERE STUDY

This study will evaluate the effectiveness, safety, and tolerability of the investigational study drug, efgartigimod, in adults with CIDP.

AM I ELIGIBLE?

You may be eligible to participate in this study if you are at least 18 years of age or older and have been diagnosed with CIDP. Additional eligibility requirements apply.

Your personal information will be kept confidential, will not be shared without your permission except as required by law, and will only be used for the purpose of this study. Our full privacy policy can be viewed here: Privacy Policy 

Efgartigimod is an investigational study drug that is currently being studied in multiple disease states. Efgartigimod is an investigational study drug that is not currently approved for use by any regulatory agency as efficacy and safety have not been established.

Watch our video about the ADHERE CIDP Study. 

Am I Eligible?

These are some of the requirements to participate in the study.

Be at least 18 years old

Be diagnosed with probable or definite CIDP, your study physician will determine this diagnosis

Not be pregnant or nursing

Be willing to travel to the study location on a regular basis

Meet other criteria that the study staff will discuss

There are additional study requirements that patients must meet in order to take part in this study. A study representative will discuss them with you.

More about the ADHERE study

ADHERE Study Goals

The ADHERE study is designed to assess how effective and safe the investigational study drug, efgartigimod, is for adults living with chronic inflammatory demyelinating polyneuropathy (CIDP).

What to expect during the ADHERE study

INFORMED CONSENT

To participate in this study, patients will be asked to read and sign an Informed Consent Form (ICF). The form explains:

 

  • The purpose of the study
  • Study visits and procedures
  • Potential risks and benefits
  • Confidentiality
  • Information on how to withdraw from the study

SCREENING

During screening, patients will be evaluated to see if they meet the study criteria. The screening period can last up to 28 days.

RUN-IN PERIOD

Patients who are currently on medication for their CIDP, will also be asked to join a run-in period where they are to stop taking the medication until a clinically meaningful deterioration occurs. If that deterioration occurs, they may be eligible to join Stage A of the study.

ADHERE STUDY TREATMENT PERIOD

The ADHERE study treatment period will include Stage A and Stage B. Approximately 360 adults in countries around the world will be enrolled in the first part of the treatment period (Stage A). The second treatment period (Stage B) will include a maximum of 180 adults who improved on their CIDP symptoms in Stage A.

 

Stage A of the ADHERE study will typically last up to 12 weeks, with one extra week in certain circumstances, in case an improvement of your symptoms appears only in week 12 of Stage A. During this time, you will receive the investigational study drug weekly, at the site location. It will be administered as a short subcutaneous (under the skin) injection in the abdomen, which will take approximately 1-2 minutes to complete.

 

If your CIDP symptoms improve during Stage A, you may proceed to Stage B. Stage B of the ADHERE study will last up to 48 weeks. You will be placed into 1 of 2 groups, where half will receive the investigational study drug while the other half will receive the placebo (drug with no active ingredient) during this part of the study. Mandatory study site visits are every 4 weeks. Each site has its own arrangement on how to administer the investigational study drug in between mandatory visits. This will be explained to you by the study doctor. Neither you nor the study team will know which treatment you are receiving.

 

This trial has been designed so patients receiving the investigational study drug, efgartigimod, or the placebo, will continue to do so if they are positively responding to treatment.

STUDY LENGTH

Patients will be enrolled in the ADHERE study for up to 80 weeks (though the study may be shorter). If all criteria are met, at the conclusion of the study, you will be given the opportunity to join an open-label extension study where everyone participating may receive efgartigimod with planned treatment cycles, each that last 48 weeks.

INFORMED CONSENT FORM

SCREENING

<28 DAYS

RUN-IN

<12 WEEKS

STAGE A

≤ 12 WEEKS

STAGE B

≤ 48 WEEKS

OPEN-LABEL EXTENSION

<48 WEEKS PER CYCLE

Efgartigimod is an investigational study drug that is currently being studied in multiple disease states. Efgartigimod is an investigational study drug that is not currently approved for use by any regulatory agency as efficacy and safety have not been established.

More About Chronic Inflammatory
Demyelinating Polyneuropathy (CIDP)

CIDP is a rare, chronic, autoimmune disease where damage to peripheral nerves, in which antibodies are thought to play a key role, often results in progressive weakness and a loss of feeling in the arms and legs.1

In an autoimmune disease, the body attacks its own tissues. In the case of CIDP, the body attacks the myelin sheaths which are the fatty coverings on the fibers that insulate and protect the nerves. When the myelin sheath is damaged or removed, electrical impulses can be slowed or lost, and messages transmitted from or to the brain can be disrupted. 1

[1] https://www.cedars-sinai.org/health-library/diseases-and-conditions/c/chronic-inflammatory-demyelinating-polyradiculoneuropathy.html#:~:text=Chronic%20inflammatory%20demyelinating%20polyradiculoneuropathy%20(CIDP,insulate%20and%20protect%20the%20nerves.

Frequently Asked Questions

What is a clinical study?

Clinical studies are research studies that evaluate the effect of an intervention on specified outcomes. In a clinical study, volunteer participants receive specific interventions according to the research plan or protocol. These interventions may be medical products, such as drugs or devices, procedures, or changes to participants’ behavior, such as diet.[1]

 

Clinical trials used in drug development are sometimes described by phase. These phases are defined by the Food and Drug Administration (FDA). Each phase has a different purpose and helps researchers answer different questions.[2]

  • Phase 1: Researchers test a drug or treatment in a small group of people for the first time. The purpose is to study the drug or treatment to learn about safety and identify side effects.
  • Phase 2: The new drug or treatment is given to a larger group of people to determine its effectiveness and to further study its safety.
  • Phase 3: The new drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it with standard or similar treatments, and collect information that will allow the new drug or treatment to be used safely.
  • Phase 4: After a drug is approved by the FDA and made available to the public, researchers track its safety in the general population, seeking more information about a drug or treatment’s benefits and optimal use.

[1] https://clinicaltrials.gov/ct2/about-studies/learn#WhatIs

[2] https://www.nih.gov/health-information/nih-clinical-research-trials-you/basics

What is an investigational study drug?

An investigational study drug has not been approved by the U.S. Food and Drug Administration (FDA) or any other regulating body but is allowed to be administered to people for research purposes.

What is Efgartigimod?

Efgartigimod is the investigational study drug that is being tested in this clinical research study. Efgartigimod is being evaluated for the treatment of patients with autoimmune diseases with confirmed presence of IgG, where a severe unmet medical need exists, such as with CIDP.

 

Refer to the argenx website for more information.

What is a placebo?

A placebo has no active ingredient and is used to compare the effects of the investigational study drug. The placebo will look like the investigational study drug and will be administered the same way to make sure that no one, not even the study doctor, will know which drug has been assigned to whom.

How is COVID-19 expected to affect the trial?

During the COVID-19 pandemic, it may not be possible to perform all assessments as planned for this trial. With this possibility in mind, processes and procedures have been developed to provide patients with CIDP the opportunity to continue the study during the COVID-19 pandemic. If you have any additional questions or concerns related to the COVID-19 pandemic, please speak with your study doctor.

Can participants withdraw from the clinical trial after they have started?

Taking part in a clinical research study is entirely voluntary. Participants can withdraw at any time for any reason. Your standard care by your primary doctor will not change.

What are my responsibilities while participating in this study?

You are asked to follow, without exception, the rules and instructions listed within the Informed Consent Form (ICF) for the study. If you do not follow these rules and instructions, you may be withdrawn from the study.

 

To provide maximum protection for your health, the study is conducted under the direct supervision of the study doctor, who is assisted by trained healthcare personnel. You will need to provide all information about your current and past health (medical history) at the Screening Visit and at each Follow-Up Visit, including your participation in any other research studies. This information is to protect your health.

 

If you have a primary doctor, it is strongly recommended that you inform them of your interest to participate in this research study.

Will compensation be provided?

You will not be paid to take part in this study, but you may be compensated for study-related travel costs and meal expenses. The Sponsor (argenx) will pay for all study-related drugs, tests, examinations, and medical care related to the study. You or your health insurance company will be responsible for the cost of standard of care treatment when you exit the study. A study representative can answer any questions you may have about compensation and travel concierge services.

How can I learn more about the investigational study drug and this global study?

More information on this clinical research study can be found here:

www.clinicaltrials.gov [NCT 04281472]

 

More information about argenx (the company conducting this trial) can be found here: www.argenx.com

 

For additional information, including site locations, please refer to

www.clinicaltrials.gov/ct2/show/NCT04281472?term=NCT+04281472&draw=2&rank=1

Help spread awareness of the ADHERE study by sharing with others! To share this study information via email, click here.

Interested patients should refer to clinicaltrials.gov to see participating sites and contact them for more information.

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