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A Phase 3 Study to Evaluate the Safety and Efficacy of Efgartigimod PH20 Subcutaneous in Adult Patients With Primary Immune Thrombocytopenia (ADVANCE SC+)

Primary Purpose

Primary Immune Thrombocytopenia

Status
Recruiting
Phase
Phase 3
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 Primary Immune Thrombocytopenia

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 and provide written informed consent (including consent for the use and disclosure of research-related health information), willing and able to comply with the trial protocol procedures (including attending the required trial visits).
  2. Participants enrolled in the ARGX-113-2004 trial who completed the 24-week trial period.

Note: If a participant has had an SAE during the ARGX-113-2004 trial, their eligibility should be evaluated by the investigator and the sponsor's trial physician. The decision of enrolling the participant will be evaluated case by case.

3a. Agree to use contraceptives consistent with local regulations regarding the methods of contraception for those participating in clinical trials and the following:

  • Male participants.
  • Female participants of childbearing potential must have a negative urine pregnancy test at baseline before receiving IMP.

In addition to the above criteria, for participants who want to continue receiving efgartigimod during an additional 52-week treatment period (only applicable in case efgartigimod is not yet commercially available for patients with primary ITP or available through another patient program for patients with primary ITP), the following criteria apply:

4. Ability to understand the requirements of the additional 52-week treatment period of the trial, to provide written informed consent (including consent for the use and disclosure of research-related health information), and to comply with the trial protocol procedures (including required trial visits).

5. Participant has completed a 52-week treatment period.

Exclusion criteria:

  1. Introduction or continuation of nonpermitted medications during the ARGX-113-2004 trial (such as anti-CD20 therapy, romiplostim, monoclonal antibodies, Fc fusion proteins, or live/live-attenuated vaccines)
  2. Use of any other investigational drug or participation in any other investigational trial
  3. Known hypersensitivity reaction to efgartigimod PH20 SC or any of its excipients
  4. Pregnant or lactating females and those who intend to become pregnant during the trial or within 90 days after last dose of efgartigimod PH20 SC

Sites / Locations

  • Investigator Site 0010116Recruiting
  • Investigator site 0010045Recruiting
  • Investigator Site 0010062Recruiting
  • Investigator site US0010042Recruiting
  • Investigator Site 0010095Recruiting
  • Investigator Site 0540001
  • Investigator site 540004Recruiting
  • Investigator Site 0610012Recruiting
  • Investigator Site 0610003Recruiting
  • Investigator site 610005Recruiting
  • Investigator Site 3590017Recruiting
  • Investigator site 0560003Recruiting
  • Investigator site 560002Recruiting
  • Investigator site 0560004Recruiting
  • Investigator site 860013Recruiting
  • Investigator Site 0860008Recruiting
  • Investigator site 860055Recruiting
  • Investigator Site 0860015Recruiting
  • Investigator Site 0860001Recruiting
  • Investigator Site 0860010Recruiting
  • Investigator Site 0860002Recruiting
  • Investigator Site 0860011Recruiting
  • Investigator site 860058Recruiting
  • Investigator Site 9950007Recruiting
  • Investigator site 9950009Recruiting
  • Investigator site 9950011Recruiting
  • Investigator site 300008Recruiting
  • Investigator Site 0300009Recruiting
  • Investigator site 3530003Recruiting
  • Investigator site 390043
  • Investigator Site 0390032Recruiting
  • Investigator Site 0390044Recruiting
  • Investigator site 390041
  • Investigator site JP0810015Recruiting
  • Investigator Site 0810017Recruiting
  • Investigator Site 0810053Recruiting
  • Investigator Site 0810051Recruiting
  • Investigator site 0810016Recruiting
  • Investigator site 810023Recruiting
  • Investigator Site 0810038Recruiting
  • Investigator site 9620001Recruiting
  • Investigator site 820004Recruiting
  • Investigator site KO0820007Recruiting
  • Investigator site 520002Recruiting
  • Investigator site 640005Recruiting
  • Investigator site 0470003Recruiting
  • Investigator site PL0480013Recruiting
  • Investigator Site 0480026Recruiting
  • Investigator Site 0480037Recruiting
  • Investigator Site 3510007Recruiting
  • Investigator site 3510004Recruiting
  • Investigator site 3510001Recruiting
  • Investigator Site 0400005Recruiting
  • Investigator site 400012Recruiting
  • Investigator Site 0400007Recruiting
  • Investigator site 0070040Recruiting
  • Investigator Site 0070026
  • Investigator Site 0070038Recruiting
  • Investigator Site 0070037Recruiting
  • Investigator site 270003Recruiting
  • Investigator site 270004Recruiting
  • Investigator site 270001Recruiting
  • Investigator site 270002Recruiting
  • Investigator Site 0660001Recruiting
  • Investigator Site 0660002Recruiting
  • Investigator Site 0660003Recruiting
  • Investigator site 660005Recruiting
  • Investigator site 0660004Recruiting
  • Investigator site TH0660009Recruiting
  • Investigator site 2610001Recruiting
  • Investigator site 2160002Recruiting
  • Investigator Site 0900007Recruiting
  • Investigator Site 0900003Recruiting
  • Investigator Site 0900008Recruiting
  • Investigator Site 0900015Recruiting
  • Investigator site 900004Recruiting
  • Investigator Site 0900014Recruiting
  • Investigator site 900010Recruiting
  • Investigator site 0900017Recruiting
  • Investigator site 900019Recruiting
  • Investigator site 440005Recruiting
  • Investigator site UK044041Recruiting
  • Investigator site UK0440014Recruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

efgartigimod PH20 SC

Arm Description

Patients receiving efgartigimod PH20 SC treatment

Outcomes

Primary Outcome Measures

Incidence, frequency, and severity of adverse events (AEs), AEs of special interest (AESIs), and serious AEs (SAEs)
Vital sign measurement: blood pressure in the overall population
ECG: PR, QT and QRS interval in the overall population
Laboratory safety evaluations: CRP analysis in the overall population

Secondary Outcome Measures

Extent of disease control defined as the percentage of weeks in the trial with platelet counts of ≥50×10E9/L
Proportion of patients with overall platelet count response defined as achieving a platelet count of ≥50×10E9/L on at least 4 occasions at any time during the 52-week treatment period
Mean change from baseline in platelet count at each visit
For patients rolling over from the ARGX-113-2004 trial with a platelet count of <30×10E9/L: time to response defined as the time to achieve 2 consecutive platelet counts of ≥50×10E9/L
The percentage of weeks in the trial with platelet counts of ≥30×10E9/L and ≥20×10E9/L above baseline
In patients with a baseline platelet count of <15×10E9/L in the current trial (ARGX-113-2005), the percentage of weeks in the trial with platelet counts of ≥30×10E9/L and ≥20×10E9/L above baseline
In patients with the first exposure to efgartigimod PH20 SC, the proportion of patients who achieve a sustained platelet response defined as achieving platelet counts of ≥50×10E9/L for at least 4 of the 6 visits between week 19 and week 24
In patients with the first exposure to efgartigimod PH20 SC, the proportion of patients achieving platelet counts of ≥50×10E9/L for at least 6 of the 8 visits between week 17 and week 24
Proportion of patients for whom dose and/or frequency of concurrent ITP therapies have been reduced compared to baseline
Rate of receipt of rescue therapy (rescue per patient per month)
Incidence of the World Health Organization (WHO)-classified bleeding events
Severity of the World Health Organization (WHO)-classified bleeding events
Serum efgartigimod concentration observed predose (Ctrough)
Change from baseline in PRO (Functional Assessment of Chronic Illness Therapy Fatigue Scale [FACIT-fatigue]) at planned visits
Change from baseline in PRO (Functional Assessment of Cancer Therapy questionnaire-Th6 [FACT-Th6]) at planned visits
Change from baseline in PRO (QoL (Short Form-36 [SF-36]) at planned visits
Pharmacodynamics markers: total IgG
Number of patients who performed self-administration at home over time
Percentage of patients who performed self-administration at home over time
Number of caregivers who administered the injection to the patient at home over time
Percentage of caregivers who administered the injection to the patient at home over time
Number of training visits needed for the participant or caregiver to be competent to start administering efgartigimod PH20 SC
Number of self- or caregiver-supported administrations at home
Percentage of self- or caregiver-supported administrations at home
Incidence and prevalence of antibodies to efgartigimod
Titers of antibodies to efgartigimod
Presence of neutralizing antibodies (NAb) against efgartigimod

Full Information

First Posted
March 15, 2021
Last Updated
August 25, 2023
Sponsor
argenx
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1. Study Identification

Unique Protocol Identification Number
NCT04812925
Brief Title
A Phase 3 Study to Evaluate the Safety and Efficacy of Efgartigimod PH20 Subcutaneous in Adult Patients With Primary Immune Thrombocytopenia
Acronym
ADVANCE SC+
Official Title
A Phase 3, Multicenter, Open-Label, Long-Term Trial to Evaluate the Safety and Efficacy of Efgartigimod (ARGX-113) PH20 Subcutaneous in Adult Patients With Primary Immune Thrombocytopenia
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 17, 2021 (Actual)
Primary Completion Date
October 1, 2026 (Anticipated)
Study Completion Date
October 1, 2026 (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
A Phase 3 study to evaluate the safety and efficacy of efgartigimod PH20 subcutaneous in adult patients with primary immune thrombocytopenia

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Immune Thrombocytopenia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
156 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
efgartigimod PH20 SC
Arm Type
Experimental
Arm Description
Patients receiving efgartigimod PH20 SC treatment
Intervention Type
Biological
Intervention Name(s)
efgartigimod PH20 SC
Other Intervention Name(s)
ARGX-113 PH20 SC
Intervention Description
Subcutaneous injection with efgartigimod PH20 SC
Primary Outcome Measure Information:
Title
Incidence, frequency, and severity of adverse events (AEs), AEs of special interest (AESIs), and serious AEs (SAEs)
Time Frame
216 weeks
Title
Vital sign measurement: blood pressure in the overall population
Time Frame
216 weeks
Title
ECG: PR, QT and QRS interval in the overall population
Time Frame
216 weeks
Title
Laboratory safety evaluations: CRP analysis in the overall population
Time Frame
216 weeks
Secondary Outcome Measure Information:
Title
Extent of disease control defined as the percentage of weeks in the trial with platelet counts of ≥50×10E9/L
Time Frame
52 weeks
Title
Proportion of patients with overall platelet count response defined as achieving a platelet count of ≥50×10E9/L on at least 4 occasions at any time during the 52-week treatment period
Time Frame
52 weeks
Title
Mean change from baseline in platelet count at each visit
Time Frame
52 weeks
Title
For patients rolling over from the ARGX-113-2004 trial with a platelet count of <30×10E9/L: time to response defined as the time to achieve 2 consecutive platelet counts of ≥50×10E9/L
Time Frame
52 weeks
Title
The percentage of weeks in the trial with platelet counts of ≥30×10E9/L and ≥20×10E9/L above baseline
Time Frame
52 weeks
Title
In patients with a baseline platelet count of <15×10E9/L in the current trial (ARGX-113-2005), the percentage of weeks in the trial with platelet counts of ≥30×10E9/L and ≥20×10E9/L above baseline
Time Frame
52 weeks
Title
In patients with the first exposure to efgartigimod PH20 SC, the proportion of patients who achieve a sustained platelet response defined as achieving platelet counts of ≥50×10E9/L for at least 4 of the 6 visits between week 19 and week 24
Time Frame
5 weeks (week 19-24)
Title
In patients with the first exposure to efgartigimod PH20 SC, the proportion of patients achieving platelet counts of ≥50×10E9/L for at least 6 of the 8 visits between week 17 and week 24
Time Frame
7 weeks (week 17-24)
Title
Proportion of patients for whom dose and/or frequency of concurrent ITP therapies have been reduced compared to baseline
Time Frame
52 weeks
Title
Rate of receipt of rescue therapy (rescue per patient per month)
Time Frame
52 weeks
Title
Incidence of the World Health Organization (WHO)-classified bleeding events
Time Frame
52 weeks
Title
Severity of the World Health Organization (WHO)-classified bleeding events
Time Frame
52 weeks
Title
Serum efgartigimod concentration observed predose (Ctrough)
Time Frame
52 weeks
Title
Change from baseline in PRO (Functional Assessment of Chronic Illness Therapy Fatigue Scale [FACIT-fatigue]) at planned visits
Time Frame
52 weeks
Title
Change from baseline in PRO (Functional Assessment of Cancer Therapy questionnaire-Th6 [FACT-Th6]) at planned visits
Time Frame
52 weeks
Title
Change from baseline in PRO (QoL (Short Form-36 [SF-36]) at planned visits
Time Frame
52 weeks
Title
Pharmacodynamics markers: total IgG
Time Frame
52 weeks
Title
Number of patients who performed self-administration at home over time
Time Frame
52 weeks
Title
Percentage of patients who performed self-administration at home over time
Time Frame
52 weeks
Title
Number of caregivers who administered the injection to the patient at home over time
Time Frame
52 weeks
Title
Percentage of caregivers who administered the injection to the patient at home over time
Time Frame
52 weeks
Title
Number of training visits needed for the participant or caregiver to be competent to start administering efgartigimod PH20 SC
Time Frame
52 weeks
Title
Number of self- or caregiver-supported administrations at home
Time Frame
52 weeks
Title
Percentage of self- or caregiver-supported administrations at home
Time Frame
52 weeks
Title
Incidence and prevalence of antibodies to efgartigimod
Time Frame
216 weeks
Title
Titers of antibodies to efgartigimod
Time Frame
216 weeks
Title
Presence of neutralizing antibodies (NAb) against efgartigimod
Time Frame
216 weeks

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 and provide written informed consent (including consent for the use and disclosure of research-related health information), willing and able to comply with the trial protocol procedures (including attending the required trial visits). Participants enrolled in the ARGX-113-2004 trial who completed the 24-week trial period. Note: If a participant has had an SAE during the ARGX-113-2004 trial, their eligibility should be evaluated by the investigator and the sponsor's trial physician. The decision of enrolling the participant will be evaluated case by case. 3a. Agree to use contraceptives consistent with local regulations and the following: • Female participants of childbearing potential must have a negative urine pregnancy test at baseline before receiving IMP. In addition to the above criteria, for participants who want to continue receiving efgartigimod during an additional 52-week treatment period (only applicable in case efgartigimod is not yet commercially available for patients with primary ITP or available through another patient program for patients with primary ITP), the following criteria apply: 4. Ability to understand the requirements of the additional 52-week treatment period of the trial, to provide written informed consent (including consent for the use and disclosure of research-related health information), and to comply with the trial protocol procedures (including required trial visits). 5. Participant has completed a 52-week treatment period. Exclusion criteria: Introduction or continuation of nonpermitted medications during the ARGX-113-2004 trial (such as anti-CD20 therapy, romiplostim, monoclonal antibodies, Fc fusion proteins, or live/live-attenuated vaccines) Use of any other investigational drug or participation in any other investigational trial Known hypersensitivity reaction to efgartigimod PH20 SC or any of its excipients Pregnant or lactating females and those who intend to become pregnant during the trial or within 90 days after last dose of efgartigimod PH20 SC
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Ext
+1
Email
clinicaltrials@argenx.com
Facility Information:
Facility Name
Investigator Site 0010116
City
Bentonville
State/Province
Arkansas
ZIP/Postal Code
72758
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Ext
+1
Email
clinicaltrials@argenx.com
Facility Name
Investigator site 0010045
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
clinicaltrials@argenx.com
Facility Name
Investigator Site 0010062
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46804
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Ext
+1
Email
clinicaltrials@argenx.com
Facility Name
Investigator site US0010042
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
Clinicaltrials@argenx.com
Facility Name
Investigator Site 0010095
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73142
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Ext
+1
Email
clinicaltrials@argenx.com
Facility Name
Investigator Site 0540001
City
Buenos Aires
Country
Argentina
Individual Site Status
Active, not recruiting
Facility Name
Investigator site 540004
City
Buenos Aires
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Ext
+1
Email
clinicaltrials@argenx.com
Facility Name
Investigator Site 0610012
City
Garran
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Ext
+1
Email
clinicaltrials@argenx.com
Facility Name
Investigator Site 0610003
City
West Perth
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Ext
+1
Email
clinicaltrials@argenx.com
Facility Name
Investigator site 610005
City
Westmead
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
clinicaltrials@argenx.com
Facility Name
Investigator Site 3590017
City
Plovdiv
Country
Bulgaria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Ext
+1
Email
clinicaltrials@argenx.com
Facility Name
Investigator site 0560003
City
Reñaca
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
clinicaltrials@argenx.com
Facility Name
Investigator site 560002
City
Santiago
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
clinicaltrials@argenx.com
Facility Name
Investigator site 0560004
City
Temuco
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
clinicaltrials@argenx.com
Facility Name
Investigator site 860013
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
clinicaltrials@argenx.com
Facility Name
Investigator Site 0860008
City
Bengbu
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Ext
+1
Email
clinicaltrials@argenx.com
Facility Name
Investigator site 860055
City
Huizhou
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
clinicaltrials@argenx.com
Facility Name
Investigator Site 0860015
City
Shenzhen
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Ext
+1
Email
clinicaltrials@argenx.com
Facility Name
Investigator Site 0860001
City
Tianjin
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Ext
+1
Email
clinicaltrials@argenx.com
Facility Name
Investigator Site 0860010
City
Wuhan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Ext
+1
Email
clinicaltrials@argenx.com
Facility Name
Investigator Site 0860002
City
Wuxi
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Ext
+1
Email
clinicaltrials@argenx.com
Facility Name
Investigator Site 0860011
City
Zhengzhou
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Ext
+1
Email
clinicaltrials@argenx.com
Facility Name
Investigator site 860058
City
Zhenjiang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
clinicaltrials@argenx.com
Facility Name
Investigator Site 9950007
City
Tbilisi
Country
Georgia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Ext
+1
Email
clinicaltrials@argenx.com
Facility Name
Investigator site 9950009
City
Tbilisi
Country
Georgia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
clinicaltrials@argenx.com
Facility Name
Investigator site 9950011
City
Tbilisi
Country
Georgia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
clinicaltrials@argenx.com
Facility Name
Investigator site 300008
City
Athens
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
clinicaltrials@argenx.com
Facility Name
Investigator Site 0300009
City
Thessaloníki
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Ext
+1
Email
clinicaltrials@argenx.com
Facility Name
Investigator site 3530003
City
Dublin
Country
Ireland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
clinicaltrials@argenx.com
Facility Name
Investigator site 390043
City
Ferrara
Country
Italy
Individual Site Status
Completed
Facility Name
Investigator Site 0390032
City
Milan
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Ext
+1
Email
clinicaltrials@argenx.com
Facility Name
Investigator Site 0390044
City
Napoli
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Ext
+1
Email
clinicaltrials@argenx.com
Facility Name
Investigator site 390041
City
Napoli
Country
Italy
Individual Site Status
Completed
Facility Name
Investigator site JP0810015
City
Hirakata
ZIP/Postal Code
5731191
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
Clinicaltrials@argenx.com
Facility Name
Investigator Site 0810017
City
Iruma
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Ext
+1
Email
clinicaltrials@argenx.com
Facility Name
Investigator Site 0810053
City
Kanagawa
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Ext
+1
Email
clinicaltrials@argenx.com
Facility Name
Investigator Site 0810051
City
Kitakyushu
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Ext
+1
Email
clinicaltrials@argenx.com
Facility Name
Investigator site 0810016
City
Shibukawa
ZIP/Postal Code
377-0280
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
Clinicaltrials@argenx.com
Facility Name
Investigator site 810023
City
Shimotsuke
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
clinicaltrials@argenx.com
Facility Name
Investigator Site 0810038
City
Tama
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Ext
+1
Email
clinicaltrials@argenx.com
Facility Name
Investigator site 9620001
City
Irbid
Country
Jordan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
clinicaltrials@argenx.com
Facility Name
Investigator site 820004
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
clinicaltrials@argenx.com
Facility Name
Investigator site KO0820007
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
Clinicaltrials@argenx.com
Facility Name
Investigator site 520002
City
Aguascalientes
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
clinicaltrials@argenx.com
Facility Name
Investigator site 640005
City
Christchurch
Country
New Zealand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
clinicaltrials@argenx.com
Facility Name
Investigator site 0470003
City
Sarpsborg
ZIP/Postal Code
1714
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
Clinicaltrials@argenx.com
Facility Name
Investigator site PL0480013
City
Katowice
ZIP/Postal Code
40-519
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
Clinicaltrials@argenx.com
Facility Name
Investigator Site 0480026
City
Nowy Sącz
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Ext
+1
Email
clinicaltrials@argenx.com
Facility Name
Investigator Site 0480037
City
Skorzewo
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Ext
+1
Email
clinicaltrials@argenx.com
Facility Name
Investigator Site 3510007
City
Lisboa
Country
Portugal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Ext
+1
Email
clinicaltrials@argenx.com
Facility Name
Investigator site 3510004
City
Porto
Country
Portugal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
clinicaltrials@argenx.com
Facility Name
Investigator site 3510001
City
Vila Nova De Gaia
Country
Portugal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
clinicaltrials@argenx.com
Facility Name
Investigator Site 0400005
City
Bucharest
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Ext
+1
Email
clinicaltrials@argenx.com
Facility Name
Investigator site 400012
City
Bucuresti
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
clinicaltrials@argenx.com
Facility Name
Investigator Site 0400007
City
Craiova
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Ext
+1
Email
clinicaltrials@argenx.com
Facility Name
Investigator site 0070040
City
Kirov
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
Clinicaltrials@argenx.com
Facility Name
Investigator Site 0070026
City
Moscow
Country
Russian Federation
Individual Site Status
Completed
Facility Name
Investigator Site 0070038
City
Nizhny Novgorod
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Ext
+1
Email
clinicaltrials@argenx.com
Facility Name
Investigator Site 0070037
City
Novosibirsk
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Ext
+1
Email
clinicaltrials@argenx.com
Facility Name
Investigator site 270003
City
Johannesburg
Country
South Africa
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
clinicaltrials@argenx.com
Facility Name
Investigator site 270004
City
Observatory
Country
South Africa
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
clinicaltrials@argenx.com
Facility Name
Investigator site 270001
City
Pretoria
Country
South Africa
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
clinicaltrials@argenx.com
Facility Name
Investigator site 270002
City
Randburg
Country
South Africa
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
clinicaltrials@argenx.com
Facility Name
Investigator Site 0660001
City
Bangkok Noi
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Ext
+1
Email
clinicaltrials@argenx.com
Facility Name
Investigator Site 0660002
City
Bangkok
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Ext
+1
Email
clinicaltrials@argenx.com
Facility Name
Investigator Site 0660003
City
Bangkok
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Ext
+1
Email
clinicaltrials@argenx.com
Facility Name
Investigator site 660005
City
Bangkok
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
clinicaltrials@argenx.com
Facility Name
Investigator site 0660004
City
Chiang Mai
ZIP/Postal Code
50200
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
Clinicaltrials@argenx.com
Facility Name
Investigator site TH0660009
City
Khon Kaen
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
Clinicaltrials@argenx.com
Facility Name
Investigator site 2610001
City
Sousse
Country
Tunisia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
clinicaltrials@argenx.com
Facility Name
Investigator site 2160002
City
Tunis
Country
Tunisia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
clinicaltrials@argenx.com
Facility Name
Investigator Site 0900007
City
Adapazarı
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Ext
+1
Email
clinicaltrials@argenx.com
Facility Name
Investigator Site 0900003
City
Ankara
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Ext
+1
Email
clinicaltrials@argenx.com
Facility Name
Investigator Site 0900008
City
Ankara
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Ext
+1
Email
clinicaltrials@argenx.com
Facility Name
Investigator Site 0900015
City
Ankara
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Ext
+1
Email
clinicaltrials@argenx.com
Facility Name
Investigator site 900004
City
İzmir
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
clinicaltrials@argenx.com
Facility Name
Investigator Site 0900014
City
Kocaeli
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Ext
+1
Email
clinicaltrials@argenx.com
Facility Name
Investigator site 900010
City
Mersin
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
clinicaltrials@argenx.com
Facility Name
Investigator site 0900017
City
Tekirdağ
ZIP/Postal Code
59100
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
Clinicaltrials@argenx.com
Facility Name
Investigator site 900019
City
Trabzon
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
clinicaltrials@argenx.com
Facility Name
Investigator site 440005
City
Coventry
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
clinicaltrials@argenx.com
Facility Name
Investigator site UK044041
City
London
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
Clinicaltrials@argenx.com
Facility Name
Investigator site UK0440014
City
Penzance
ZIP/Postal Code
TR18 2PF
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
Clinicaltrials@argenx.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

A Phase 3 Study to Evaluate the Safety and Efficacy of Efgartigimod PH20 Subcutaneous in Adult Patients With Primary Immune Thrombocytopenia

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