The AMPLIFI CIDP clinical study
The AMPLIFI study is evaluating the safety and effectiveness of a new investigational drug called IMVT-1402, administered as weekly subcutaneous (SC) injections using an autoinjector in people with Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP).
Why is this clinical study being done?
Antibodies are molecules in the blood that are produced to combat infections. In people with CIDP, the body produces abnormal antibodies that attack its own nerves rather than defending against infections. As a result, muscles become weaker and get tired more quickly than normal. This study will evaluate a new investigational treatment for CIDP, called IMVT-1402, that potentially works by reducing the level of antibodies, including these abnormal antibodies.
This study will evaluate how well IMVT-1402 treatment works for people with CIDP. The study will randomly assign study participants to receive either IMVT-1402 or a placebo. The placebo is a look-alike substance that does not have the active ingredient, IMVT-1402, in it. Neither study participants nor the study doctor/staff will know who received IMVT-1402 or placebo.
What will happen during this study?
Participants will be in this study for up to 89 weeks. Study doctor/staff will perform monthly checkups to monitor your progress and see how the study treatment works for you. This study has 4 parts: Screening, Period 1, Period 2, and Follow-up.
- Screening: Study doctor/staff will check if potential participants are eligible to enter the study. Participants on oral steroids may need to slowly decrease their dose during this period. Participants will take their last dose of pulsed corticosteroids, intravenous immunoglobulin (Ig), or subcutaneous Ig about 1 week before the end of the Screening period, if applicable.
- Period 1: A 24-week main investigational treatment period. Participants will be randomly assigned, by chance, to receive either IMVT-1402 or placebo weekly.
- Period 2: An optional 52-week treatment period. All participants who complete Period 1 will be eligible to enter this Period and receive IMVT-1402 weekly.
- Follow-up: Participants will have a follow-up visit 4 weeks after the last dose of study treatment.
Who can take part in this clinical study?
To be considered for this study, you must:
- Be 18 years of age or older
- Have been diagnosed with CIDP or a CIDP variant (multifocal or motor)
- Have been receiving CIDP treatment for at least 3 months prior to joining this study, including:
- Corticosteroids OR
- Immunoglobulin therapy (IVIg or SCIg)
- Be willing to attend study clinic visits and be available for phone calls from the study doctor/staff
Want to learn more about this study?
If you would like to learn more about our study you may email clinicaltrials@immunovant.com or visit https://clinicaltrials.gov/study/NCT07032662
If you would like to learn more about Immunovant’s values and our commitment to patients and caregivers, please visit https://www.immunovant.com/patients-caregivers/our-commitment
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