ADHERE
Research type
Research Study
Full title
A Phase 2 Trial to Investigate the Efficacy, Safety, and Tolerability of Efgartigimod PH20 SC in Adult Patients With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
IRAS ID
1003108
Contact name
Simon Rinaldi
Contact email
Eudract number
2019-003076-39
Research summary
This is a study for patients with chronic inflammatory demyelinating polyneuropathy
(CIDP). CIDP is a rare autoimmune disease in which antibodies (proteins that normally
fight infections) attack the insulating layer around the nerves. This causes weakness and
loss of function in the limbs.
A new drug called ‘efgartigimod’ will be tested in this trial. Efgartigimod has already
been used in studies with healthy volunteers and in studies on patients with other autoimmune
diseases. The studies showed that efgartigimod could lower the amount of
antibodies that cause these diseases.
In this trial, efgartigimod will be given as a subcutaneous injection. Therefore, an
ingredient called rHuPH20 (recombinant human hyaluronidase PH20) will be added to
the drug to make the injection easier.
The purpose of this study is to assess how effective the drug called ‘efgartigimod’ is in
treating patients with CIDP, how safe and tolerable (acceptable) the new drug is. Other
purposes of the study are to see how the body reacts to efgartigimod and how
efgartigimod acts on the body. To make the results of the study reliable, a dummy drug
(placebo) will be used to compare the treatment with efgartigimod.
First, the patient will be screened and will enter a run-in period (maximum 12 weeks) in
which the patient will not be treated for CIDP. After the run-in period, the participant
will enter stage A of the study in which all participants receive the study drug (maximum
12 weeks). Participants with improved symptoms then enter stage B of the trial. In stage
B, the study drug is compared to the dummy drug (maximum 48 weeks). The maximum
duration of the complete study is 81 weeks.
Under certain conditions, participants can choose to go to the open-label extension study
ARGX-113-1902. In that trial, all participants will receive the study drug.REC name
HSC REC A
REC reference
20/NI/0045
Date of REC Opinion
7 May 2020
REC opinion
Further Information Favourable Opinion