Study on Long-term Safety and Efficacy of Efgartigimod PH20 SC in Adults with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

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What is this study about?

This clinical trial is focused on studying the long-term safety and effectiveness of a treatment for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), which is an autoimmune disorder affecting the peripheral nerves. The treatment being investigated is called efgartigimod, specifically in a form that is injected under the skin. This study aims to understand how well patients tolerate this treatment over an extended period.

Participants in the study will receive efgartigimod injections and will be monitored for any side effects or changes in their condition. The study will also include a comparison with a placebo to evaluate the treatment’s effectiveness. Throughout the study, various health assessments will be conducted to track the participants’ progress and any potential improvements in their symptoms.

The study is designed to gather information on how efgartigimod affects patients with CIDP over time, including any changes in their ability to perform daily activities and their overall quality of life. The goal is to determine if this treatment can provide a safe and effective option for managing this condition in the long term.

1 joining the trial

Upon joining the trial, you will be required to provide written consent, confirming your understanding of the trial requirements and your willingness to comply with the procedures.

You will need to confirm your eligibility, which includes having completed certain stages of a previous trial or being offered participation due to specific circumstances.

2 initial assessment

An initial assessment will be conducted to ensure you meet all necessary criteria, including a negative pregnancy test for women of childbearing potential.

You will be informed about the importance of using an acceptable method of contraception during the trial.

3 medication administration

You will receive the medication efgartigimod PH20 SC, which is a solution for injection administered subcutaneously (under the skin).

The frequency and dosage will be determined by the trial protocol, and you will be informed about the schedule for your injections.

4 regular study visits

You will attend regular study visits where various assessments will be conducted, including blood sampling to monitor for any significant laboratory abnormalities.

During these visits, your health and response to the medication will be closely monitored.

5 monitoring and assessments

Throughout the trial, the incidence of any adverse events will be recorded, and your overall health will be assessed.

You will be asked to complete questionnaires about your quality of life, pain levels, treatment satisfaction, and any feelings of anxiety or depression.

6 self-administration training

You may be trained to self-administer the medication, or a caregiver may be instructed on how to assist you with the injections.

The percentage of patients performing self-administration will be monitored over time.

7 completion of trial

Upon completion of the trial, a final assessment will be conducted to evaluate your overall health and the effects of the medication.

You will be informed about any follow-up procedures or additional steps required after the trial ends.

Who Can Join the Study?

  • The patient must be able to understand the trial requirements and agree to participate by signing a consent form. This includes agreeing to share health information related to the research.
  • The patient must be willing and able to follow the trial procedures, including attending required trial visits.
  • The patient must be either male or female.
  • The patient must have one of the following conditions:
    • Completed the Week-48 visit of Stage B of a previous trial and be eligible for treatment in this study.
    • Experienced worsening of their condition during Stage B of a previous trial and be eligible for treatment in this study.
    • Been offered participation in this study due to early termination of a previous trial and be eligible for treatment.
    • Completed the Week-48 visit of a previous cycle of this study and be eligible to continue treatment.
  • Women of childbearing potential (women who can become pregnant) must have a negative pregnancy test before starting the trial medication.
  • Women of childbearing potential must use an acceptable method of birth control from the time they sign the consent form until the last dose of the trial medication.

Who Cannot Join the Study?

  • Patients with any other serious health conditions that might interfere with the study.
  • Patients who are pregnant or breastfeeding.
  • Patients who have a history of allergic reactions to the study medication or similar drugs.
  • Patients who are currently participating in another clinical trial.
  • Patients who have had a major surgery within the last 3 months.
  • Patients with uncontrolled high blood pressure or other significant heart problems.
  • Patients with active infections that require treatment.
  • Patients with a history of substance abuse or alcohol dependency.
  • Patients who have received any live vaccines within the last 4 weeks.
  • Patients with autoimmune diseases that are not stable or controlled.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Medical University Of Vienna Vienna Austria
Azienda Ospedaliero Universitaria Careggi Florence Italy
Katholieke Universiteit te Leuven Leuven Belgium
Galen Clinic Lublin Poland
Centre Hospitalier Universitaire De Bordeaux Bordeaux France

Other Sites

Site Name City Country Status
Centre Hospitalier Universitaire De Nantes Nantes France
Centre Hospitalier Universitaire De Nice Nice France
Hopital Beaujon Clichy France
A.O.U. Policlinico G. Martino Di Messina Messina Italy
Centre Hospitalier Regional De La Citadelle Liege Belgium
Cvmhvjios Uvnngteruzolco Swigrcpce Woluwe-Saint-Lambert Belgium
Horsviub Vzau dxvkmqga Barcelona Spain
Dqflmkgveuygcgqfuxyelbz cjfowl “ddfutyyoshlaptz Epnh Sofia Bulgaria
Uqqzwhcuni Hcxhwwpb Cndtgmt Cologne Germany
Oqsldr Usmguldsiz Hndavbxl Odense Denmark
Fjcmpnkewp Ibajv Cd Gztvdu Oiisvjtr Mzzxuieb Psivcyhtbol Milan Italy
Efwcawp Udfpuljaftyy Mpfhofv Cfawlkl Rbyyqfjkm (lspiclt Mtb Rotterdam The Netherlands
Hlfdrnql Csmsvua Sgl Crulsc Madrid Spain
Appsnnq Onwzinbriof Ukfckmgdysoyk Clwcvxmzvrki Dwhzw Sbhfxu E Dywzu Sdoxpvt Dd Trhpef Turin Italy
Jwqzlndm Kgfqaj Uktzilthhg Linz Austria
Rnsrxnpcfdruvy Copenhagen Denmark
Hkbqchae Dr Lg Snxgu Cnqk I Sttx Pmv Barcelona Spain
Upspikmvft Op Awxojnr Edegem Belgium
Ucpecilgnakuzquextizq Sfumjslfcoetnosslr Aha Kiel Germany
Uknnubvohi Dmkxt Sdmqo Dh Breramt Brescia Italy
Fawngxbbmr Iybvnkcujo Iqqvqxja Nkprpewakkj Bjnzk Milan Italy
Hixlftsb Uiohhpztxnrqlr Schloaoghy &xthlpa Hpwlzkx dl Hsswbwitnsi STRASBOURG, Alsace France
Dcuffywullh Akb Cczxblaertti Ckhttz Cdapyh Lmmd Sofia Bulgaria
Sdaeocgr Cfbipx Jqepoxkj Dw Uzdrahk Phzv Bvqzekf Timisoara Romania
Neklvhede Slvuza Bucharest Romania
Tpi Hyzttf Sohr Brasov Romania
Caxiray Nnyvujhkye Kcwtlhcyg Silijk Lodz Poland
Muganhtml i Pjjokojln Llwylji Sdccum Pfhrutcwufb Cracow Poland
Cekrjr Hprdmatiygq Eq Untdrualptfnu Dh Lfvijuf Limoges France
Aroqpd Ucrzkrjewn Hszwkrwc Aarhus Denmark
Ulvwewddgfsmktngw Dn Palb Pisa Italy
Aqlmypyyg Uqu Amsterdam The Netherlands
Mulurrwb Mjdhbjt Awspmlk Pleven Bulgaria
Cjn Gryeaeqlfvqazhpc Clermont Ferrand France
Srz Jscpafpomhenca Bochum Germany

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Austria Austria
Recruiting
29.05.2020
Belgium Belgium
Recruiting
29.05.2020
Bulgaria Bulgaria
Recruiting
29.05.2020
Denmark Denmark
Recruiting
29.05.2020
France France
Recruiting
29.05.2020
Germany Germany
Not recruiting
29.05.2020
Italy Italy
Recruiting
29.05.2020
Poland Poland
Recruiting
29.05.2020
Romania Romania
Recruiting
29.05.2020
Spain Spain
Recruiting
29.05.2020
The Netherlands The Netherlands
Recruiting
29.05.2020

Trial locations

Investigated Drugs:

Efgartigimod PH20 SC is a medication being studied for its long-term safety and effectiveness in treating a condition called Chronic Inflammatory Demyelinating Polyneuropathy (CIDP). This condition affects the nerves and can cause weakness and numbness. Efgartigimod PH20 SC is designed to be given as an injection under the skin. It combines two components: efgartigimod, which helps to reduce the harmful antibodies that attack the nerves, and recombinant human hyaluronidase PH20, which helps the medication spread more easily under the skin. This combination aims to provide relief from the symptoms of CIDP by targeting the underlying cause of the nerve damage.

Chronic Inflammatory Demyelinating Polyneuropathy – Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) is a neurological disorder characterized by progressive weakness and impaired sensory function in the legs and arms. It is caused by damage to the myelin sheath, the protective covering of the nerves. The disease progresses slowly, with symptoms that may include tingling or numbness, muscle weakness, and loss of deep tendon reflexes. Over time, these symptoms can lead to difficulty walking and performing daily activities. CIDP can vary greatly in its progression, with some individuals experiencing periods of improvement and others having a steady decline in function.

Trial ID:
2023-507885-21-00
Protocol code:
ARGX-113-1902
NCT ID:
NCT04280718
Trial Phase:
Therapeutic exploratory (Phase II)

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