ABOUT THE ADHERE STUDY
This study will evaluate the effectiveness, safety, and tolerability of the investigational study drug, efgartigimod, in adults with CIDP.
This study will evaluate the effectiveness, safety, and tolerability of the investigational study drug, efgartigimod, in adults with CIDP.
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.
These are some of the requirements to participate in the study.
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).
To participate in this study, patients will be asked to read and sign an Informed Consent Form (ICF). The form explains:
During screening, patients will be evaluated to see if they meet the study criteria. The screening period can last up to 28 days.
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.
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.
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.
<28 DAYS
<12 WEEKS
≤ 12 WEEKS
≤ 48 WEEKS
<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.
[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.