The study aims to see if a study drug may help maintain strength, sensation, and daily function in adults with Chronic Inflammatory Demyelinating Polyneuropathy(CIDP).
Can I Participate?
You may be eligible to participate in this study if you:
Are 18 years of age or older
Have a diagnosis of typical chronic inflammatory demyelinating polyneuropathy (CIDP), or one of the following variants: multifocal or motor
Have had an episode of worsening of your disease in the past 2 years
Are currently taking a stable dose of IVIg, SCIg, or oral steroids for your CIDP
Other eligibility criteria apply and will be evaluated by a study doctor if you choose to continue screening for the study.
What Should I Know About This Study?
The MAPLE study aims to assess whether a study drug can reduce disease progression and maintain nerve function in individuals with CIDP.
Continue Current CIDP Treatment
Participants will continue to receive their current CIDP medication treatment (IVIg, SCIg, or oral steroids) throughout the first several months of the study.
Close Health Monitoring
The study team will monitor your health closely throughout study participation. If your CIDP relapses, the study team will place you back on your previous treatment for the remaining treatment period.
3 Doses Over a Year
The study drug is given only 3 times over the course of a year during the treatment period.
No Cost to Qualified Participants
The study required procedures and study drug will be provided at no cost to qualified participants.
01
Submit Online Questionnaire
This questionnaire will ask for your contact information and a few questions about your medical history to determine your eligibility.
Then, select a time for a short phone call with PatientWing. Submitting the questionnaire is voluntary and does not require a commitment to participate in the study.
02
Speak With PatientWing
PatientWing is partnering with Amgen to help identify potential individuals who may be interested in the MAPLE Study.
You will have a short call to answer, additional questions about your medical history, and PatientWing will help collect your medical records.
03
Speak With a Research Site
After your conversation with PatientWing you will meet the study team who will review your medical records.
If the research team thinks you are a good fit, they will schedule a screening visit.
The research team will provide more information during your conversations with them. No question is a bad question, so please share your concerns with the team!
04
Study Participation
After you've completed the screening period, the research team will notify you of your eligibility. If you are eligible to move forward, you will be asked to review and sign an informed consent form. This consent is voluntary, and you may withdraw it and stop participating in the study at any time.
If you are enrolled in the study, you will be randomly assigned to receive either the study drug or a placebo three times during the treatment period. A placebo looks just like the study drug but contains no active ingredients.
Study participation lasts approximately 2.5 years and includes up to 20 visits to the research site.
05
Open-Label Period
This study includes a one year optional Open-Label Period (OLP) which occurs after the treatment period of the study.
Open-label means the placebo is removed, and both you and the study team know you’re receiving the study drug. The OLP includes up to 6 visits to the research site.
About CIDP
CIDP is a long-term condition where the immune system attacks the nerves’ protective covering, slowing nerve signals.
Common symptoms of CIDP include:
Weakness
Tingling/ Numbness
Balance Problems
Reflex Lost
Treatment for CIDP focuses on reducing immune system attacks and managing symptoms, using medications like corticosteroids, IVIG, or plasma exchange, along with physical therapy to maintain strength and mobility.
Frequently Asked Questions
Fill out the questionnaire and provide basic information to express interest in the study. You can also email studies@patientwing.com or call 213-459-2979.
You will have up to 20 visits to the research site during the 52-week treatment period, optional open-label period and safety visits.
Yes, this study has a 50% chance of receiving a placebo. The placebo will look and be administered in the same way as the study drug, but it lacks the ingredients of the study drug.
The study team will monitor your health closely throughout study participation. If your CIDP relapses, the study team will place you back on your previous treatment for the remaining treatment period. At the end of the treatment period (52 weeks), you may still be eligible for the open-label period, where you will receive the active study drug.
You’re free to withdraw from the study at any time as study participation is completely voluntary. Withdrawal will not be used against you nor affect your standard medical care in any way. Please contact the study doctor so that they can safely withdraw your participation in the study.
Have Questions?
At PatientWing, we’re here to support you at every step of the study.
You can email, text, call, or fill out the form with any questions.
Phone
213-459-2979
