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) (ADHERE+)

August 3, 2023 updated by: argenx

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)

This is the open-label extension study of phase II ARGX-113-1802 to evaluate the long-term safety and efficacy of the subcutaneous formulation of efgartigimod in adults with CIDP.

Patients already stabilized on efgartigimod PH20 SC will also have the opportunity to participate in a sub study to explore less frequent dosing of efgartigimod PH20 SC.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

226

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Austria
      • Innsbruck, Austria
        • Investigator site 0430007
      • Linz, Austria, 4021
        • Investigator site 0430008
      • Wien, Austria, 1090
        • Investigator site 0430005
  • Belgium
      • Edegem, Belgium
        • Investigator site 0320016
      • Leuven, Belgium, 3000
        • Investigator site 0320009
      • Liège, Belgium, 4000
        • Investigator site 320024
      • Woluwe-Saint-Lambert, Belgium, 1200
        • Investigator site 320022
  • Bulgaria
      • Pleven, Bulgaria, 5800
        • Investigator site 3590007
      • Sofia, Bulgaria, 1113
        • Investigator site 3590005
      • Sofia, Bulgaria, 1431
        • Investigator site 3590008
      • Sofia, Bulgaria, 1680
        • Investigator site 3590006
  • China
      • Beijing, China
        • Investigator site 0860033
      • Changsha, China
        • Investigator site 860041
      • Chengdu, China
        • Investigator site 0860036
      • Chifeng, China, 024000
        • Investigator site 860049
      • Fuzhou, China
        • Investigator site 0860038
      • Guangzhou, China, 510120
        • Investigator site 0860050
      • Guanzhou, China
        • Investigator site 0860032
      • Guiyang, China
        • Investigator site 0860045
      • Hangzhou, China
        • Investigator site 0860035
      • Hangzhou, China
        • Investigator site 860035
      • Jinan, China, 250012
        • Investigator site 0860031
      • Nanchang, China, 33008
        • Investigator Site 0860040
      • Nanjing, China
        • Investigator site 0860043
      • Shanghai, China
        • Investigator site 0860028
      • Shanghai, China
        • Investigator site 860047
      • Tianjin, China
        • Investigator site 0860042
      • Wuhan, China, 430040
        • Investigator site 0860034
      • Wuhan, China, 430060
        • Investigator site 0860029
      • Xi'an, China, 710038
        • Investigator site 0860048
      • Xianyang, China, 712000
        • Investigator site 0860054
  • Czechia
      • Hradec Králové, Czechia, 500-03
        • Investigator site 4200010
  • Denmark
      • Aarhus, Denmark, 8200
        • Investigator site 0450002
      • Copenhagen, Denmark, 2100
        • Investigator site 0450001
      • Odense, Denmark, 5000
        • Investigator site 0450003
  • France
      • Angers, France
        • Investigator site 00330034
      • Bordeaux, France, 33076
        • Investigator site 0330013
      • Clermont-Ferrand, France, 63003
        • Investigator site 330033
      • Le Kremlin-Bicêtre, France, 94275
        • Investigator site 0330023
      • Limoges, France, 87042
        • Investigator site 0330024
      • Nantes, France, 44093
        • Investigator site 330022
      • Nice, France, 06202
        • Investigator site 0330021
      • Paris, France
        • Investigator site 0330035
      • Strasbourg, France, 67098
        • Investigator site 0330020
  • Georgia
      • Kutaisi, Georgia, 4600
        • Investigator site 9950020
      • Tbilisi, Georgia, 0112
        • Investigator site 9950005
      • Tbilisi, Georgia
        • Investigator Site 9950002
      • Tbilisi, Georgia
        • Investigator Site 9950003
      • Tbilisi, Georgia, 0112
        • Investigator Site 9950004
  • Germany
      • Bochum, Germany, 44791
        • Investigator site 490044
      • Essen, Germany, 45147
        • Investigator site 490045
      • Göttingen, Germany, 37075
        • Investigator site 490021
      • Kiel, Germany, 24105
        • Investigator site 0490016
      • Köln, Germany
        • Investigator site 0490013
      • Potsdam, Germany
        • Investigator site 0490019
  • Israel
      • Tel Aviv, Israel, 6423906
        • Investigator site 9720004
  • Italy
      • Brescia, Italy
        • Investigator site 0390022
      • Firenze, Italy, 50139
        • Investigator site 390029
      • Genova, Italy, 16132
        • Investigator site 0390024
      • Messina, Italy, 98125
        • Investigator site 390027
      • Milan, Italy, 20122
        • Investigator site 0390003
      • Milano, Italy
        • Investigator site 0390026
      • Pisa, Italy, 56125
        • Investigator site 0390023
      • Roma, Italy, 00189
        • Investigator site 0390008
      • Torino, Italy
        • Investigator site 0390042
  • Japan
      • Bunkyō-Ku, Japan
        • Investigator site 0810035
      • Chiba, Japan
        • Investigator site 0810002
      • Fuchū, Japan, 183-0042
        • Investigator site 0810030
      • Fukuoka, Japan, 812-8582
        • Investigator site 0810031
      • Ginowan, Japan
        • Investigator site 0810065
      • Hakodate, Japan
        • Investigator site 0810066
      • Hiroshima, Japan
        • Investigator site 0810058
      • Itabashi, Japan, 173-8606
        • Investigator site 0810036
      • Kawagoe, Japan
        • Investigator site 0810029
      • Kodaira, Japan, 187-8551
        • Investigator site 0810026
      • Kyoto-shi, Japan, 616-8255
        • Investigator site 810061
      • Mibu, Japan, 321-0293
        • Investigator site 0810027
      • Nagoya, Japan, 466-8560
        • Investigator site 0810032
      • Osaka, Japan, 565-0871
        • Investigator site 0810003
      • Osaka, Japan, 589-8511
        • Investigator site 0810007
      • Suita, Japan, 565-0871
        • Investigator site 0810063
      • Tokushima, Japan
        • Investigator site 0810064
      • Yokohama, Japan
        • Investigator site 0810060
  • Latvia
      • Riga, Latvia, 1038
        • Investigator Site 31
  • Netherlands
      • Amsterdam, Netherlands, 1105
        • Investigator site 0310010
      • Rotterdam, Netherlands, 3015
        • Investigator site 0310011
  • Poland
      • Kraków, Poland, 31-202
        • Investigator site 0480024
      • Kraków, Poland, 31-539
        • Investigator site 0480018
      • Lublin, Poland, 20-093
        • Investigator site 0480017
      • Warszawa, Poland, 07-097
        • Investigator site 0480022
      • Łódź, Poland, 90-324
        • Investigator site 0480020
  • Romania
      • Braşov, Romania, 500299
        • Investigator site 040002
      • Bucharest, Romania, 011302
        • Investigator site 040001
      • Constanţa, Romania, 900591
        • Investigator site 040004
      • Timişoara, Romania, 300723
        • Investigator site 040003
  • Russian Federation
      • Kazan, Russian Federation, 420097
        • Investigator site 0070023
      • Kazan, Russian Federation, 420021
        • Investigator site 070017
      • Moscow, Russian Federation, 117186
        • Investigator site 0070020
      • Moscow, Russian Federation, 117186
        • Investigator site 70021
      • Rostov-on-Don, Russian Federation, 344022
        • Investigator site 0070019
      • Saint Petersburg, Russian Federation, 194354
        • Investigator site 0070014
      • Saransk, Russian Federation, 430032
        • Investigator site 0070021
  • Serbia
      • Belgrade, Serbia, 11000
        • Investigator site 3810001
      • Belgrade, Serbia, 11000
        • Investigator site 3810003
      • Kragujevac, Serbia
        • Investigator site 3810004
  • Spain
      • Badalona, Spain, 08035
        • Investigator site 0340021
      • Barcelona, Spain
        • Investigator site 0340038
      • Madrid, Spain, 28040
        • Investigator site 0340018
  • Taiwan
      • Tainan, Taiwan, 701
        • Investigator site 8860013
      • Taipei, Taiwan, 116
        • Investigator site 8860012
      • Taipei, Taiwan, 116
        • Investigator site 8860016
      • Taoyuan, Taiwan, 333
        • Investigator site 8860017
  • Turkey
      • Bursa, Turkey, 16059
        • Investigator site 900025
      • Samsun, Turkey, 55239
        • Investigator site 900022
      • İzmir, Turkey
        • Investigator site 900021
  • Ukraine
      • Dnipro, Ukraine, 49069
        • Investigator site 3800012
      • Ivano-Frankivs'k, Ukraine, 76008
        • Investigator site 3800010
      • Kyiv, Ukraine, 02000
        • Investigator site 3100013
      • Luts'k, Ukraine, 43024
        • Investigator site 3800008
      • Zaporizhzhya, Ukraine, 69068
        • Investigator site 3800011
  • United Kingdom
      • London, United Kingdom
        • Investigator site 440026
      • Oxford, United Kingdom
        • Investigator site 0440016
      • Sheffield, United Kingdom
        • Investigator site 0440018
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233-2110
        • Investigator site 0010065
    • Arizona
      • Phoenix, Arizona, United States, 85018
        • Investigator site 0010013
      • Scottsdale, Arizona, United States, 85028
        • Investigator site 0010055
    • California
      • Carlsbad, California, United States, 92011
        • Investigator Site 0010032
      • Pomona, California, United States, 91767-2009
        • Investigator site 10190
      • Rancho Mirage, California, United States, 92270-4150
        • Investigator site 0010160
      • San Francisco, California, United States, 94109
        • Investigator site 0010071
    • Colorado
      • Centennial, Colorado, United States, 80112
        • Investigator site 0010057
    • Florida
      • Boca Raton, Florida, United States, 33487
        • Investigator site 0010072
      • Coral Springs, Florida, United States, 33067-4640
        • Investigator site 0010144
      • Jacksonville, Florida, United States, 32209
        • Investigator site 0010023
      • Maitland, Florida, United States, 32751
        • Investigator Site 0010068
      • Miami, Florida, United States, 33136
        • Investigator site 0010059
      • Tampa, Florida, United States, 33612
        • Investigator site 0010006
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Investigator site 0010011
    • Kansas
      • Fairway, Kansas, United States, 66205
        • Investigator site 0010015
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • Investigator site 10147
    • New York
      • New York, New York, United States, 10016
        • Investigator site 10168
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27517
        • Investigator site 0010003
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Investigator site 0010064
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Investigator site 0010007
      • Philadelphia, Pennsylvania, United States, 19126
        • Investigator site 0010047
    • Texas
      • Austin, Texas, United States, 78756
        • Investigator site 0010066
      • San Antonio, Texas, United States, 78229
        • Investigator site 0010009
    • Virginia
      • Richmond, Virginia, United States, 23298
        • Investigator site 0010061

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. 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.

  2. 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.
  3. Women of childbearing potential who have a negative urine pregnancy test at baseline before IMP administration.
  4. 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:

  1. 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.
  2. Pregnant and lactating women and those intending to become pregnant during the trial.
  3. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: efgartigimod PH20 SC
Patients treated with efgartigimod PH20 SC
Biological: Efgartigimod PH20 SC
Subcutaneous administration of efgartigimod
Other Names:
  • ARGX-113

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of treatment-emergent adverse events and serious adverse events
Time Frame: Up to 48 weeks per cycle (each cycle is 48 weeks) until the end of the study
Up to 48 weeks per cycle (each cycle is 48 weeks) until the end of the study

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from baseline over time of the adjusted INCAT score
Time Frame: Up to 48 weeks per cycle (each cycle is 48 weeks) until the end of the study
Up to 48 weeks per cycle (each cycle is 48 weeks) until the end of the study
Change from baseline over time of the MRC Sum score
Time Frame: Up to 48 weeks per cycle (each cycle is 48 weeks) until the end of the study
Up to 48 weeks per cycle (each cycle is 48 weeks) until the end of the study
Change from baseline over time of I-RODS disability scores
Time Frame: Up to 48 weeks per cycle (each cycle is 48 weeks) until the end of the study
Up to 48 weeks per cycle (each cycle is 48 weeks) until the end of the study
Change from baseline over time of mean grip strength
Time Frame: Up to 48 weeks per cycle (each cycle is 48 weeks) until the end of the study
Up to 48 weeks per cycle (each cycle is 48 weeks) until the end of the study
Change from baseline over time of TUG score
Time Frame: Up to 48 weeks per cycle (each cycle is 48 weeks) until the end of the study
Up to 48 weeks per cycle (each cycle is 48 weeks) until the end of the study
Percentage of patients without clinical deterioration over time, defined by adjusted INCAT deterioration ≥1 point compared to baseline.
Time Frame: Up to 48 weeks per cycle (each cycle is 48 weeks) until the end of the study
Up to 48 weeks per cycle (each cycle is 48 weeks) until the end of the study
Percentage of patients with titers of binding antibodies towards efgartigimod and the presence of neutralizing antibodies against efgartigimod.
Time Frame: Up to 51 weeks
Up to 51 weeks
Efgartigimod serum concentrations
Time Frame: Up to 51 weeks
Up to 51 weeks
Changes from baseline over time of serum IgG levels (total)
Time Frame: Up to 48 weeks per cycle (each cycle is 48 weeks) until the end of the study
Up to 48 weeks per cycle (each cycle is 48 weeks) until the end of the study
Change from baseline over time in EQ-5D-5L
Time Frame: Up to 48 weeks per cycle (each cycle is 48 weeks) until the end of the study
Up to 48 weeks per cycle (each cycle is 48 weeks) until the end of the study
Change from baseline over time in BPI SF
Time Frame: Up to 48 weeks per cycle (each cycle is 48 weeks) until the end of the study
Up to 48 weeks per cycle (each cycle is 48 weeks) until the end of the study
Change from baseline over time in TSQM-9
Time Frame: Up to 48 weeks per cycle (each cycle is 48 weeks) until the end of the study
Up to 48 weeks per cycle (each cycle is 48 weeks) until the end of the study
Change from baseline over time in RT-FSS
Time Frame: Up to 48 weeks per cycle (each cycle is 48 weeks) until the end of the study
Up to 48 weeks per cycle (each cycle is 48 weeks) until the end of the study
Change from baseline over time in HADS
Time Frame: Up to 48 weeks per cycle (each cycle is 48 weeks) until the end of the study
Up to 48 weeks per cycle (each cycle is 48 weeks) until the end of the study
Percentage of patients performing self-administration over time
Time Frame: Up to 48 weeks per cycle (each cycle is 48 weeks) until the end of the study
Up to 48 weeks per cycle (each cycle is 48 weeks) until the end of the study
Percentage of patients with treatment administered by caregiver over time.
Time Frame: Up to 48 weeks per cycle (each cycle is 48 weeks) until the end of the study
Up to 48 weeks per cycle (each cycle is 48 weeks) until the end of the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

argenx

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 18, 2020

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2027

Study Registration Dates

First Submitted

February 20, 2020

First Submitted That Met QC Criteria

February 20, 2020

First Posted (Actual)

February 21, 2020

Study Record Updates

Last Update Posted (Actual)

August 4, 2023

Last Update Submitted That Met QC Criteria

August 3, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ARGX-113-1902
  • 2019-003107-35 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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