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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+)

Primary Purpose

Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Efgartigimod PH20 SC
Sponsored by
argenx
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 a highly effective or acceptable method of contraception from baseline to 90 days after the last administration of IMP.
  5. Male patients agree not to donate sperm during the trial period and 90 days thereafter.

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 or within 90 days after last IMP administration.
  3. Patients with clinical evidence of other significant serious disease or patients who underwent a recent or have a planned major surgery, or any other reason which could confound the results of the trial or put the patient at undue risk.

Sites / Locations

  • Investigator site 0010065
  • Investigator site 0010013
  • Investigator site 0010055
  • Investigator site 0010032
  • Investigator site 10190
  • Investigator site 0010160
  • Investigator site 0010071
  • Investigator site 0010057
  • Investigator site 0010072
  • Investigator site 0010144
  • Investigator site 0010023
  • Investigator site 0010068
  • Investigator site 0010059
  • Investigator site 0010006
  • Investigator site 0010011
  • Investigator site 0010015
  • Investigator site 10147
  • Investigator site 10168
  • Investigator site 0010003
  • Investigator site 0010064
  • Investigator site 0010007
  • Investigator site 0010047
  • Investigator Site 0010066
  • Investigator site 0010009
  • Investigator site 0010061
  • Investigator site 0430007
  • Investigator site 0430008
  • Investigator site 0430005
  • Investigator site 0320016
  • Investigator site 0320009
  • Investigator site 320024
  • Investigator site 320022
  • Investigator site 3590007
  • Investigator site 3590005
  • Investigator site 3590008
  • Investigator site 3590006
  • Investigator site 0860033
  • Investigator site 860041
  • Investigator site 0860036
  • Investigator site 860049
  • Investigator site 0860038
  • Investigator site 0860050
  • Investigator site 0860032
  • Investigator site 0860045
  • Investigator site 0860035
  • Investigator site 860035
  • Investigator site 0860031
  • Investigator site 0860040
  • Investigator site 0860043
  • Investigator site 0860028
  • Investigator site 860047
  • Investigator site 0860042
  • Investigator site 0860034
  • Investigator site 0860029
  • Investigator site 0860048
  • Investigator site 0860054
  • Investigator site 4200010
  • Investigator site 0450002
  • Investigator site 0450001
  • Investigator site 0450003
  • Investigator site 00330034
  • Investigator site 0330013
  • Investigator site 330033
  • Investigator site 0330023
  • Investigator site 0330024
  • Investigator site 330022
  • Investigator site 0330021
  • Investigator site 0330035
  • Investigator site 0330020
  • Investigator site 9950020
  • Investigator site 9950004
  • Investigator site 9950005
  • Investigator site 9950002
  • Investigator Site 9950003
  • Investigator site 490044
  • Investigator site 490045
  • Investigator site 490021
  • Investigator site 0490016
  • Investigator site 0490013
  • Investigator site 0490019
  • Investigator site 9720004
  • Investigator site 0390022
  • Investigator site 390029
  • Investigator site 0390024
  • Investigator site 390027
  • Investigator site 0390026
  • Investigator site 0390003
  • Investigator site 0390023
  • Investigator site 0390008
  • Investigator site 0390042
  • Investigator site 0810035
  • Investigator site 0810002
  • Investigator site 0810030
  • Investigator site 0810031
  • Investigator site 0810065
  • Investigator site 0810066
  • Investigator site 0810058
  • Investigator site 0810036
  • Investigator site 0810029
  • Investigator site 0810026
  • Investigator site 810061
  • Investigator site 0810027
  • Investigator site 0810032
  • Investigator site 0810003
  • Investigator site 0810007
  • Investigator site 0810063
  • Investigator site 0810064
  • Investigator site 0810060
  • Investigator site 31
  • Investigator site 0310010
  • Investigator site 0310011
  • Investigator site 0480024
  • Investigator site 0480018
  • Investigator Site 0480017
  • Investigator site 0480022
  • Investigator site 0480020
  • Investigator site 040002
  • Investigator site 040001
  • Investigator site 040004
  • Investigator site 040003
  • Investigator site 070017
  • Investigator site 0070023
  • Investigator site 0070020
  • Investigator site 70021
  • Investigator site 0070019
  • Investigator site 0070014
  • Investigator site 0070021
  • Investigator site 3810001
  • Investigator site 3810003
  • Investigator site 3810004
  • Investigator site 0340021
  • Investigator site 0340038
  • Investigator site 0340018
  • Investigator site 8860013
  • Investigator site 8860012
  • Investigator site 8860016
  • Investigator site 8860017
  • Investigator site 900025
  • Investigator site 900021
  • Investigator site 900022
  • Investigator Site 3800012
  • Investigator Site 3800010
  • Investigator site 3100013
  • Investigator site 3800008
  • Investigator site 3800011
  • Investigator site 440026
  • Investigator site 0440016
  • Investigator site 0440018

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

efgartigimod PH20 SC

Arm Description

Patients treated with efgartigimod PH20 SC

Outcomes

Primary Outcome Measures

Incidence of treatment-emergent adverse events and serious adverse events

Secondary Outcome Measures

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

Full Information

First Posted
February 20, 2020
Last Updated
August 3, 2023
Sponsor
argenx
search

1. Study Identification

Unique Protocol Identification Number
NCT04280718
Brief Title
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)
Acronym
ADHERE+
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 18, 2020 (Actual)
Primary Completion Date
March 1, 2027 (Anticipated)
Study Completion Date
March 1, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
argenx

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
226 (Actual)

8. Arms, Groups, and Interventions

Arm Title
efgartigimod PH20 SC
Arm Type
Experimental
Arm Description
Patients treated with efgartigimod PH20 SC
Intervention Type
Biological
Intervention Name(s)
Efgartigimod PH20 SC
Other Intervention Name(s)
ARGX-113
Intervention Description
Subcutaneous administration of efgartigimod
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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
Title
Percentage of patients with titers of binding antibodies towards efgartigimod and the presence of neutralizing antibodies against efgartigimod.
Time Frame
Up to 51 weeks
Title
Efgartigimod serum concentrations
Time Frame
Up to 51 weeks
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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

10. Eligibility

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

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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)

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