Current Clinical Trials

ADHERE+: A Study to Assess the Long-term 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)
  1. Samir Macwan, MD
    Samir Macwan, MD
  2. for people 18 Years and up (full criteria)
  3. Rancho Mirage, CA
  4. study started July 2022
  5. Samir Macwan, MD
  6. Accepting new patients

Description

Summary

This is an open-label extension of the ARGX-113-1802 trial to investigate the long-term safety, tolerability, and efficacy of efgartigimod PH20 SC in patients aged 18 years and older with CIDP. Patients will be given the opportunity to continue efgartigimod PH20 SC treatment in this OLE trial in the event any of the following 4 conditions are occurring, provided the patient has not permanently discontinued IMP: The patient experiences a clinical deterioration (ie, increase [worsening] in adjusted Inflammatory Neuropathy Cause and Treatment [INCAT] disability score) in Stage B of ARGX-113-1802 as described in the ARGX-113-1802 protocol. The patient completes the week-48 visit of Stage B of the ARGX-113-1802 trial without any clinical deterioration. The patient is in Stage A or Stage B of the ARGX-113-1802 trial at the time sufficient events for the primary endpoint analysis of that trial have been reached and it is stopped. The patient completes the week-48 visit of this OLE trial (the patient can then start a new treatment cycle of 48 weeks).

Official Title

ADHERE+: Open-label Extension of the ARGX-113-1802 Trial to Investigate the Long-term Safety, Tolerability, and Efficacy of Efgartigimod PH20 SC in Patients With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

Keywords

Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

Eligibility

for people 18 Years and up
Inclusion Criteria: Ability to understand the requirements of the trial, provide written informed consent (including consent for the use and disclosure of research-related health information), willingness and ability to comply with the trial protocol procedures (including required trial visits) of this trial. Male or female patient with one of the following options: Have completed the Week-48 visit of Stage B of the ARGX-113-1802 trial and are considered to be eligible for treatment with efgarti... more
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Inclusion Criteria: Ability to understand the requirements of the trial, provide written informed consent (including consent for the use and disclosure of research-related health information), willingness and ability to comply with the trial protocol procedures (including required trial visits) of this trial. Male or female patient with one of the following options: Have completed the Week-48 visit of Stage B of the ARGX-113-1802 trial and are considered to be eligible for treatment with efgartigimod PH20 SC; or Have deteriorated during Stage B of the ARGX-113-1802 trial and are considered to be eligible for treatment with efgartigimod PH20 SC, or Have been offered the participation in the OLE trial due to early termination of the ARGX-113-1802 trial (because sufficient events for the primary endpoint analysis of the that trial have been reached and it is stopped) and are considered to be eligible for treatment with efgartigimod PH20 SC treatment; or Have completed the Week-48 visit of the previous cycle of the OLE trial and are considered to be eligible to continue with efgartigimod PH20 SC treatment. Women of childbearing potential who have a negative urine pregnancy test at baseline before IMP administration. Women of childbearing potential must use an acceptable method of contraception from signing the ICF until the date of the last administration of IMP. Exclusion Criteria: Week-48/ED visit in the ARGX-113-1802 trial or the Week-48 visit of the previous OLE participation occurred more than 14 days prior to SD1 of the OLE trial or the start of a new treatment cycle in the OLE trial and more than 21 days since the last dose of IMP. Pregnant and lactating women and those intending to become pregnant during the trial. Patients with clinical evidence of other significant serious disease or patients who underwent a recent or have a planned major surgery, or patients who (intend to) use prohibited medications (see protocol) and therapies during the trial, or any other reason which could confound the results of the trial or put the patient at undue risk.

Lead Scientists at Eisenhower Health

Samir Macwan, MD
Dr. Samir Macwan served as a section chief of Neurology at Eisenhower Medical Center between 2012 to 2015. He is Board Certified in Neurology and Neuromuscular Medicine.  Prior to completing an Internal Medicine internship at New York Medical College Dr. Macwan did a research fellowship in Headache/Cranial Neuralgia at University of Southern California. He performed a Neurology residency and Clinical Neurophysiology fellowship at University of Kansas Medical Center. He has been trained u... more
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Dr. Samir Macwan served as a section chief of Neurology at Eisenhower Medical Center between 2012 to 2015. He is Board Certified in Neurology and Neuromuscular Medicine. 

Prior to completing an Internal Medicine internship at New York Medical College Dr. Macwan did a research fellowship in Headache/Cranial Neuralgia at University of Southern California. He performed a Neurology residency and Clinical Neurophysiology fellowship at University of Kansas Medical Center. He has been trained under internationally acclaimed neuromuscular expert Dr. Richard Barohn. 

Dr. Macwan has been practicing Neuromuscular Medicine in the Greater Palm Springs area for 10 years. He is a member of MG care as well a speaker at the national meeting of Myasthenia Gravis Foundation of America. He is also on the advisory board member of Myasthenia Gravis Foundation of California. He has been involved in research of Myasthenia Gravis as well as Immune Mediated Polyneuropathy in Diabetes and Small Fiber Neuropathy. Dr. Macwan moderates and speaks at support groups for MG patients and caregivers. 

Dr. Macwan is professionally trained in performing botulinum toxin injections in cervical dystonia/focal dystonias, chronic migraine, muscle spasticity, sialorrhea and facial spasm.

Co-Investigators

  1. Seymour Young, MD

Clinical Study Details

  1. Accepting new patients
  2. study started July 2022
  3. Interventional
  4. March 06, 2024