A Study to Assess the Safety and Efficacy of a Subcutaneous Formulation of Efgartigimod in Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP, an Autoimmune Disorder That Affects the Peripheral Nerves)
(ADHERE Trial)
Recruiting at391 trial locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Waitlist Available
Sponsor: argenx
Prior Safety Data
Trial Summary
What is the purpose of this trial?
This is a Phase 2 study to evaluate the safety and efficacy of the subcutaneous formulation of efgartigimod in adults with CIDP.
Research Team
Eligibility Criteria
Inclusion Criteria
INCAT score ≥2 at the first run-in visit (for patients entering run-in) or stage A baseline (for treatment-naïve patients with documented evidence for worsening on the total adjusted INCAT disability score within 3 months prior to screening). Patients with an INCAT score of 2 at trial entry must have this score exclusively from the leg disability score; for patients with an INCAT score of ≥3 at trial entry, there are no specific requirements for arm or leg scores.
Currently treated with pulsed corticosteroids, oral corticosteroids equivalent to prednisolone/prednisone ≤10mg/day, and/or IVIg or SCIg, if this treatment has been started within the last 5 years before screening, and the patient is willing to discontinue this treatment at the first run-in visit; or Without previous treatment (treatment-naive); or Treatment with corticosteroids and/or IVIg or SCIg discontinued at least 6 months prior to screening Note: Patients not treated with monthly or daily corticosteroids, IVIg or SCIg for at least 6 months prior to screening are considered as equal to treatment-naïve patients.
You are a woman of childbearing potential.
See 5 more
Treatment Details
Interventions
- efgartigimod PH20 SC (Monoclonal Antibodies)
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: efgartigimod PH20 SCExperimental Treatment1 Intervention
patients receiving efgartigimod PH20 SC in both stage A as stage B
Group II: PlaceboPlacebo Group2 Interventions
patients receiving efgartigimod PH20 SC during stage A and receiving placebo in stage B
Find a Clinic Near You
Who Is Running the Clinical Trial?
argenx
Lead Sponsor
Trials
76
Recruited
11,500+
Tim Van Hauwermeiren
argenx
Chief Executive Officer since 2008
B.Sc. and M.Sc. in Bioengineering from Ghent University, Executive MBA from The Vlerick School of Management
Dr. Peter Ulrichts
argenx
Chief Medical Officer since 2023
MD from Maastricht University, PhD in Molecular Immunology from Maastricht University