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

August 25, 2023 updated by: argenx

A Phase 3, Multicenter, Randomized, Double-Blinded, Placebo-Controlled Trial to Evaluate the Efficacy and the Safety of Efgartigimod (ARGX-113) PH20 Subcutaneous in Adult Patients With Primary Immune Thrombocytopenia

This is a phase 3, multicenter, randomized, double-blinded, placebo-controlled, parallel-group trial to evaluate the efficacy, safety, and effect on QoL/PRO of efgartigimod PH20 SC treatment in adult patients with primary ITP.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

207

Phase

  • Phase 3

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

  • Argentina
      • Buenos Aires, Argentina
        • Investigator Site 0540001
      • Buenos Aires, Argentina
        • Investigator Site 0540004
      • Córdoba, Argentina
        • Investigator Site 0540003
  • Australia
      • Adelaide, Australia
        • Investigator Site 0610009
      • Bedford Park, Australia
        • Investigator Site 0610004
      • Box Hill, Australia
        • Investigator Site 0610002
      • Clayton, Australia
        • Investigator Site 0610010
      • Garran, Australia
        • Investigator Site 0610012
      • Hobart, Australia
        • Investigator Site 0610001
      • Perth, Australia
        • Investigator Site 0610011
      • West Perth, Australia
        • Investigator Site 0610003
      • Westmead, Australia
        • Investigator Site 0610005
  • Bulgaria
      • Plovdiv, Bulgaria
        • Investigator Site 3590017
      • Sofia, Bulgaria
        • Investigator Site 3590015
  • Chile
      • Santiago, Chile
        • Investigator Site 0560002
      • Temuco, Chile
        • Investigator Site 0560004
      • Viña Del Mar, Chile
        • Investigator Site 0560003
  • China
      • Beijing, China
        • Investigator Site 0860003
      • Beijing, China
        • Investigator Site 0860013
      • Bengbu, China
        • Investigator Site 0860008
      • Huizhou, China
        • Investigator Site 0860055
      • Kunming, China
        • Investigator Site 0860009
      • Nanchang, China
        • Investigator Site 0860012
      • Shanxi, China
        • Investigator Site 0860014
      • Shenzhen, China
        • Investigator Site 0860015
      • Tianjin, China
        • Investigator Site 0860001
      • Wenzhou, China
        • Investigator Site 0860006
      • Wuhan, China
        • Investigator Site 0860010
      • Wuxi, China
        • Investigator Site 0860002
      • Zhejiang, China
        • Investigator Site 0860005
      • Zhengzhou, China
        • Investigator Site 0860011
      • Zhenjiang, China
        • Investigator Site 0860058
      • Zhenjiang, China
        • Investigator site 0860062
  • Denmark
      • Roskilde, Denmark
        • Investigator Site 0450005
  • France
      • Créteil, France
        • Investigator Site 0330009
      • Montpellier, France
        • Investigator Site 0330018
  • Georgia
      • Tbilisi, Georgia
        • Investigator Site 9950006
      • Tbilisi, Georgia
        • Investigator Site 9950007
      • Tbilisi, Georgia
        • Investigator Site 9950008
      • Tbilisi, Georgia
        • Investigator Site 9950009
      • Tbilisi, Georgia
        • Investigator Site 9950011
      • Tbilisi, Georgia
        • Investigator Site 9950019
  • Germany
      • Essen, Germany, 45147
        • Investigator Site 0490008
      • Gießen, Germany
        • Investigator Site 0490012
  • Greece
      • Athens, Greece
        • Investigator Site 0300008
      • Athens, Greece
        • Investigator Site 0300010
      • Patra, Greece
        • Investigator Site 0300007
      • Thessaloníki, Greece
        • Investigator Site 0300009
  • Ireland
      • Dublin, Ireland
        • Investigator Site 3530002
      • Dublin, Ireland
        • Investigator Site 3530003
      • Galway, Ireland
        • Investigator Site 3530001
  • Israel
      • Ashkelon, Israel
        • Investigator Site 9720013
      • Haifa, Israel
        • Investigator Site 9720010
      • Haifa, Israel
        • Investigator Site 9720012
      • Jerusalem, Israel
        • Investigator Site 9720008
      • Jerusalem, Israel
        • Investigator Site 9720011
      • Petach Tikva, Israel
        • Investigator Site 9720007
      • Tel Aviv, Israel
        • Investigator Site 9720009
  • Italy
      • Alessandria, Italy
        • Investigator Site 0390037
      • Ferrara, Italy
        • Investigator Site 0390043
      • Meldola, Italy
        • Investigator Site 0390045
      • Milan, Italy, 20122
        • Investigator Site 0390014
      • Milan, Italy
        • Investigator Site 0390032
      • Napoli, Italy
        • Investigator Site 0390041
      • Napoli, Italy
        • Investigator Site 0390044
      • Novara, Italy
        • Investigator Site 0390015
      • Potenza, Italy
        • Investigator Site 0390035
      • Reggio Calabria, Italy
        • Investigator Site 0390011
      • Reggio Emilia, Italy, 42100
        • Investigator Site 0390018
      • Rome, Italy
        • Investigator Site 0390046
      • Terni, Italy
        • Investigator Site 0390033
      • Varese, Italy
        • Investigator Site 0390036
  • Japan
      • Chiba, Japan
        • Investigator Site 0810056
      • Hirakata, Japan
        • Investigator Site 0810015
      • Hiroshima, Japan
        • Investigator Site 0810010
      • Kanagawa, Japan
        • Investigator Site 0810053
      • Kitakyushu, Japan
        • Investigator Site 0810051
      • Kumamoto, Japan
        • Investigator Site 0810054
      • Maebashi, Japan
        • Investigator site 0810018
      • Morioka, Japan
        • Investigator Site 0810057
      • Saitama, Japan
        • Investigator site 0810017
      • Shibukawa, Japan
        • Investigator site 0810016
      • Shimotsuke, Japan
        • Investigator Site 0810023
      • Shinagawa-Ku, Japan
        • Investigator Site 0810039
      • Tama, Japan
        • Investigator Site 0810038
      • Tokyo, Japan
        • Investigator Site 0810052
      • Tsukuba, Japan
        • Investigator Site 0810048
      • Yamanashi, Japan
        • Investigator Site 0810044
      • Ōgaki, Japan
        • Investigator Site 0810012
  • Jordan
      • Amman, Jordan
        • Investigator Site 9620002
      • Irbid, Jordan
        • Investigator Site 9620001
  • Korea, Republic of
      • Seongnam, Korea, Republic of
        • Investigator Site 0820005
      • Seoul, Korea, Republic of
        • Investigator Site 0820003
      • Seoul, Korea, Republic of
        • Investigator Site 0820004
      • Seoul, Korea, Republic of
        • Investigator Site 0820006
      • Seoul, Korea, Republic of
        • Investigator Site 0820007
      • Seoul, Korea, Republic of
        • Investigator Site 0820008
  • Mexico
      • Aguascalientes, Mexico
        • Investigator Site 0520002
      • Chihuahua, Mexico
        • Investigator Site 0520004
      • Mexico, Mexico
        • Investigator Site 0520007
      • Monterrey, Mexico
        • Investigator Site 0520003
      • Oaxaca, Mexico
        • Investigator Site 0520001
  • New Zealand
      • Auckland, New Zealand
        • Investigator Site 0640001
      • Christchurch, New Zealand
        • Investigator Site 0640005
      • Palmerston North, New Zealand
        • Investigator Site 0640002
  • Norway
      • Bergen, Norway
        • Investigator Site 0470002
      • Oslo, Norway
        • Investigator Site 0470003
  • Poland
      • Katowice, Poland, 40519
        • Investigator Site 0480013
      • Lublin, Poland
        • Investigator Site 0480014
      • Nowy Sącz, Poland
        • Investigator site 0480026
      • Skorzewo, Poland
        • Investigator Site 0480037
      • Toruń, Poland
        • Investigator Site 0480039
      • Warszawa, Poland
        • Investigator Site 0480033
  • Portugal
      • Braga, Portugal
        • Investigator Site 3510006
      • Coimbra, Portugal
        • Investigator Site 3510003
      • Lisboa, Portugal
        • Investigator Site 3510002
      • Lisboa, Portugal
        • Investigator Site 3510005
      • Lisboa, Portugal
        • Investigator Site 3510007
      • Porto, Portugal
        • Investigator Site 3510001
      • Porto, Portugal
        • Investigator Site 3510004
  • Romania
      • Bucharest, Romania
        • Investigator Site 0400005
      • Bucuresti, Romania
        • Investigator Site 0400006
      • Bucuresti, Romania
        • Investigator Site 0400009
      • Bucuresti, Romania
        • Investigator Site 0400012
      • Cluj-Napoca, Romania
        • Investigator Site 0400016
      • Craiova, Romania
        • Investigator Site 0400007
      • Sibiu, Romania
        • Investigator Site 0400011
      • Târgu-Mureş, Romania
        • Investigator Site 0400008
  • Russian Federation
      • Kaluga, Russian Federation
        • Investigator site 0070006
      • Kirov, Russian Federation
        • Investigator Site 0070040
      • Moscow, Russian Federation
        • Investigator Site 0070026
      • Nizhny Novgorod, Russian Federation
        • Investigator Site 0070038
      • Novosibirsk, Russian Federation
        • Investigator Site 0070037
      • Pyatigorsk, Russian Federation
        • Investigator Site 0070024
      • Saint Petersburg, Russian Federation
        • Investigator Site 0070025
      • Smolensk, Russian Federation
        • Investigator Site 0070039
      • Syktyvkar, Russian Federation
        • Investigator Site 0070015
      • Tula, Russian Federation
        • Investigator Site 0070012
  • Serbia
      • Belgrade, Serbia
        • Investigator Site 3810006
      • Kragujevac, Serbia
        • Investigator Site 3810008
  • South Africa
      • George, South Africa
        • Investigator Site 0270005
      • Johannesburg, South Africa
        • Investigator Site 0270003
      • Observatory, South Africa
        • Investigator Site 0270004
      • Pretoria, South Africa
        • Investigator Site 0270001
      • Randburg, South Africa
        • Investigator Site 0270002
  • Spain
      • Alava, Spain
        • Investigator Site 0340024
      • Barcelona, Spain
        • Investigator Site 0340006
      • Barcelona, Spain, 08035
        • Investigator Site 0340007
      • Barcelona, Spain
        • Investigator Site 0340023
      • Madrid, Spain
        • Investigator Site 0340037
      • Murcia, Spain
        • Investigator Site 0340022
      • Sabadell, Spain
        • Investigator Site 0340036
      • Sevilla, Spain, 41013
        • Investigator Site 0340013
      • Valencia, Spain
        • Investigator Site 0340004
  • Taiwan
      • New Taipei City, Taiwan
        • Investigator Site 8860001
      • Taoyuan, Taiwan
        • Investigator Site 8860003
  • Thailand
      • Bangkok, Thailand
        • Investigator Site 0660002
      • Bangkok, Thailand
        • Investigator Site 0660003
      • Bangkok, Thailand
        • Investigator Site 0660005
      • Bangkok, Thailand
        • Investigator Site 0660008
      • Bangkok Noi, Thailand
        • Investigator Site 0660001
      • Chiang Mai, Thailand
        • Investigator Site 0660004
      • Khon Kaen, Thailand
        • Investigator Site 0660009
      • Pathum Thani, Thailand
        • Investigator Site 0660006
  • Tunisia
      • Sfax, Tunisia
        • Investigator Site 2160006
      • Sousse, Tunisia
        • Investigator Site 2160001
      • Tunis, Tunisia
        • Investigator Site 2160002
  • Turkey
      • Adapazarı, Turkey
        • Investigator Site 0900007
      • Ankara, Turkey
        • Investigator Site 0900003
      • Ankara, Turkey
        • Investigator Site 0900006
      • Ankara, Turkey
        • Investigator Site 0900008
      • Ankara, Turkey
        • Investigator Site 0900015
      • Edirne, Turkey
        • Investigator Site 0900016
      • Istanbul, Turkey
        • Investigator Site 0900013
      • Kocaeli, Turkey
        • Investigator Site 0900014
      • Malatya, Turkey
        • Investigator Site 0900018
      • Mersin, Turkey
        • Investigator Site 0900010
      • Samsun, Turkey
        • Investigator Site 0900009
      • Tekirdağ, Turkey
        • Investigator Site 0900017
      • Trabzon, Turkey
        • Investigator Site 0900019
      • İzmir, Turkey
        • Investigator Site 0900004
  • United Kingdom
      • Bradford, United Kingdom, BD9 6RJ
        • Investigator site 0440011
      • Coventry, United Kingdom
        • Investigator Site 0440005
      • London, United Kingdom
        • Investigator Site 0440008
      • London, United Kingdom
        • Investigator Site 0440041
      • Truro, United Kingdom
        • Investigator Site 0440014
  • United States
    • Arkansas
      • Springdale, Arkansas, United States, 72758
        • Investigator Site 0010116
    • California
      • Los Angeles, California, United States, 90033
        • Investigator site 0010036
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • Investigator Site 0010045
    • Florida
      • Weston, Florida, United States, 33331
        • Investigator Site 0010104
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Investigator site 0010112
      • Chicago, Illinois, United States, 60637
        • Investigator site 0010193
      • Lisle, Illinois, United States, 60187
        • Investigator Site 0010079
    • Indiana
      • Fort Wayne, Indiana, United States, 46804
        • Investigator Site 0010062
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Investigator Site 0010042
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Investigator Site 0010083
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Investigator Site 0010102
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Investigator Site 0010040
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73142
        • Investigator Site 0010095
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15222
        • Investigator Site 0010115

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:

  • Ability to understand the requirements of the trial and provide written informed consent, willing and able to comply with the trial protocol procedures
  • Is at least the local age of consent for clinical studies when signing the ICF.
  • Confirmed diagnosis of primary ITP made at least 3 months before randomization and based on the American Society of Hematology Criteria, and no known etiology for thrombocytopenia
  • Diagnosis supported by a response to a prior ITP therapy (other than TPO-RAs), in the opinion of the investigator
  • Mean platelet count of <30×10E9/L from at least 3 documented, qualifying counts within the 3 preceding months where at least 2 of the qualifying counts must be taken during the screening period: 1 platelet count collected during the screening period and the predose platelet count on the day of randomization (visit 1). If the third count is not available from the 3 preceding months, this third platelet count can be obtained during the screening period.
  • A documented history of a platelet count of <30×10E9/L before screening
  • At the start of the trial, the participant either takes concurrent ITP treatment(s) and has received at least 1 prior therapy for ITP in the past, or the participant does not take treatment for ITP (see note) but has received at least 2 prior treatments for ITP. Participants receiving permitted concurrent ITP treatment(s) at baseline must have been stable in dose and frequency for at least 4 weeks before randomization.

Permitted concurrent ITP medications include corticosteroids, danazol, vinca alkaloids, oral immunosuppressants, dapsone, fostamatinib, and/or oral TPO-RAs.

-Agree to use contraceptive measures consistent with local regulations and the protocol

Exclusion criteria:

  • Secondary ITP/thrombocytopenia associated with another condition, eg, lymphoma, chronic lymphocytic leukemia, viral infection, hepatitis, induced or alloimmune thrombocytopenia, thrombocytopenia associated with myeloid dysplasia, or hematopoietic stem cell transplant
  • Use of anticoagulants (eg, vitamin K antagonists, direct oral anticoagulants) within 4 weeks prior to randomization
  • Use of any transfusions within 4 weeks prior to randomization
  • Use of Ig (IV, SC, or intramuscular route) or plasmapheresis (PLEX) within 4 weeks prior to randomization
  • Use of romiplostim within 4 weeks prior to randomization
  • Undergone splenectomy less than 4 weeks prior to randomization
  • Use of an investigational product within 3 months or 5 half-lives (whichever is longer) before the first dose of the IMP
  • Use of any monoclonal antibody or Fc fusion proteins, other than those previously indicated, within 6 months before the first dose of the IMP (eg, anti-CD20)
  • At the screening visit, clinically significant laboratory abnormalities as follows: Hemoglobin ≤9 g/dL - OR - International normalized ratio >1.5 or activated partial thromboplastin time >1.5×upper limit of normal - OR - total IgG level <6 g/L
  • History of malignancy unless deemed cured by adequate treatment with no evidence of recurrence for ≥3 years before the first administration of IMP. Participants with the following cancer can be included at any time: Adequately treated basal cell or squamous cell skin cancer, Carcinoma in situ of the cervix, Carcinoma in situ of the breast or Incidental histological finding of prostate cancer (TNM stage T1a or T1b)
  • Uncontrolled hypertension, defined as a repeated elevated blood pressure exceeding 160 mmHg (systolic) and/or 100 mmHg (diastolic) despite appropriate treatments
  • History of any major thrombotic or embolic event (eg, myocardial infarction, stroke, deep venous thrombosis, or pulmonary embolism) within 5 years prior to randomization
  • History of coagulopathy or hereditary thrombocytopenia or a family history of thrombocytopenia
  • Evidence of an active clinically significant bleeding of an organ or internal mucosal bleeding, other than expected in ITP, that warrants emergent treatment or therapeutic procedure based on the investigator's judgment (eg, intracranial hemorrhage, pulmonary hemorrhage, bleeding with ongoing need for packed red blood cell transfusion)
  • Estimated high risk of a clinically significant bleeding of an organ or internal mucosal bleeding, other than expected in ITP, that warrants emergent treatment or therapeutic procedure according to the investigator's judgment
  • Clinical evidence of other significant serious diseases, have had a recent major surgery, or who have any other condition in the opinion of the investigator, that could confound the results of the trial or put the participant at undue risk
  • Positive serum test at screening for an active viral infection with any of the following conditions: Hepatitis B virus (HBV) that is indicative of an acute or chronic infection, unless associated with a negative HBV DNA test, Hepatitis C virus (HCV) based on HCV-antibody assay (unless associated with a negative HCV RNA test), Human immunodeficiency virus (HIV) based on test results that are associated with an acquired immunodeficiency syndrome (AIDS)-defining condition or a CD4 count ≤200 cells/mm3
  • Known hypersensitivity reaction to efgartigimod, rHuPH20, or 1 of its excipients
  • Previously participated in a clinical trial with efgartigimod and have received at least 1 administration of the IMP
  • Pregnant or lactating or intends to become pregnant during the trial
  • Clinically significant uncontrolled active or chronic bacterial, viral, or fungal infection at screening
  • Any other known autoimmune disease that, in the opinion of the investigator, would interfere with an accurate assessment of clinical symptoms of ITP or put the participant at undue risk
  • Clinical evidence of significant unstable or uncontrolled acute or chronic diseases other than ITP (eg, cardiovascular, pulmonary, hematologic, gastrointestinal, endocrine, hepatic, renal, neurological, malignancy, infectious diseases, uncontrolled diabetes) despite appropriate treatments which could put the participant at undue risk
  • Current or history of (ie, within 12 months of screening) alcohol, drug, or medication abuse
  • Received a live/live-attenuated vaccine less than 4 weeks before screening. The receipt of any inactivated, sub-unit, polysaccharide, or conjugate vaccine at any time before screening is not considered an exclusion criterion

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Efgartigimod PH20 SC
Patients receiving efgartigimod PH20 SC treatment
Biological: Efgartigimod PH20 SC
Subcutaneous injection with efgartigimod PH20 SC
Other Names:
  • ARGX-113 PH20 SC
Placebo Comparator: Placebo PH20 SC
Patients receiving placebo PH20 SC treatment
Other: Placebo PH20 SC
Subcutaneous injection with placebo PH20 SC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of patients with chronic ITP with a sustained platelet count response defined as achieving platelet counts of ≥50×10E9/L for at least 4 of the 6 visits between week 19 and week 24 of the trial
Time Frame: Up to 5 weeks (between week 19 -24)
Up to 5 weeks (between week 19 -24)

Secondary Outcome Measures

Outcome Measure
Time Frame
Extent of disease control defined as the number of cumulative weeks over the planned 24-week treatment period with platelet counts of ≥50×10E9/L in the chronic ITP population
Time Frame: Up to 24 weeks
Up to 24 weeks
Proportion of patients in the overall population (chronic and persistent ITP) with a sustained platelet count 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: Up to 5 weeks (between week 19-24)
Up to 5 weeks (between week 19-24)
Proportion of patients in the overall population achieving platelet counts of ≥50×10E9/L for at least 6 of the 8 visits between week 17 and 24 of the trial
Time Frame: Up to 7 weeks (between week 17-24)
Up to 7 weeks (between week 17-24)
Proportion of patients in the overall population with overall platelet response defined as achieving a platelet count of ≥50×10E9/L on at least 4 occasions at any time during the 24-week treatment period
Time Frame: Up to 24 weeks
Up to 24 weeks
Extent of disease control defined as the number of cumulative weeks until week 12 with platelet counts of ≥50×10E9/L in the overall population
Time Frame: Up to 12 weeks
Up to 12 weeks
Proportion of patients in the overall population with overall platelet response defined as achieving a platelet count of ≥50×10E9/L on at least 4 occasions at any time until week 12
Time Frame: Up to 12 weeks
Up to 12 weeks
Mean change from baseline in platelet count at each visit in the overall population
Time Frame: Up to 35 weeks
Up to 35 weeks
Time to response defined as the time to achieve 2 consecutive platelet counts of ≥50×10E9/L in the overall population
Time Frame: Up to 35 weeks
Up to 35 weeks
The number of cumulative weeks over the planned 24-week treatment period with platelet counts of ≥30×10E9/L and ≥20×10E9/L above baseline in the overall population
Time Frame: Up to 24 weeks
Up to 24 weeks
In patients with baseline platelet count of <15×10E9/L, the number of cumulative weeks over the planned 24-week treatment period with platelet counts of ≥30×10E9/L and ≥20×10E9/L above baseline in the overall population
Time Frame: Up to 24 weeks
Up to 24 weeks
Incidence of the World Health Organization (WHO)-classified bleeding events in the overall population
Time Frame: Up to 35 weeks
Up to 35 weeks
Severity of the World Health Organization (WHO)-classified bleeding events in the overall population
Time Frame: Up to 35 weeks
Up to 35 weeks
Incidence and severity of AEs, AEs of special interest (AESIs), and SAEs in the overall population
Time Frame: Up to 35 weeks
Up to 35 weeks
Vital sign measurement: blood pressure in the overall population
Time Frame: Up to 35 weeks
Up to 35 weeks
ECG: PR, QT and QRS interval in the overall population
Time Frame: Up to 35 weeks
Up to 35 weeks
Laboratory assessments: blood and urine analysis in the overall population
Time Frame: Up to 35 weeks
Up to 35 weeks
Rate of receipt of rescue therapy (rescue per patient per month) in the overall population
Time Frame: Up to 35 weeks
Up to 35 weeks
Proportion of patients for whom dose and/or frequency of concurrent ITP therapies have increased at week 12 or later in the overall population
Time Frame: Up to 23 weeks (between week 12-35)
Up to 23 weeks (between week 12-35)
Change from baseline in PRO (Functional Assessment of Chronic Illness Therapy Fatigue Scale [FACIT-Fatigue] at planned visits in the overall population
Time Frame: Up to 24 weeks
Up to 24 weeks
Change from baseline in PRO Functional Assessment of Cancer Therapy questionnaire-Th6 [Fact-Th6]) at planned visits in the overall population
Time Frame: Up to 24 weeks
Up to 24 weeks
Change from baseline in PRO QoL (Short Form-36 [SF-36]) at planned visits in the overall population
Time Frame: Up to 24 weeks
Up to 24 weeks
Incidence of antibodies to efgartigimod and/or rHuPH20 in the overall population
Time Frame: Up to 35 weeks
Up to 35 weeks
Prevalence of antibodies to efgartigimod and/or rHuPH20 in the overall population
Time Frame: Up to 35 weeks
Up to 35 weeks
Titers of antibodies to efgartigimod and/or rHuPH20 in the overall population
Time Frame: Up to 35 weeks
Up to 35 weeks
Presence of neutralizing antibodies (NAb) against efgartigimod and/or rHuPH20, and titers of NAb against efgartigimod and/or rHuPH20 in the overall population
Time Frame: Up to 35 weeks
Up to 35 weeks
Serum efgartigimod concentration observed predose (Ctrough) in the overall population
Time Frame: Up to 35 weeks
Up to 35 weeks
Pharmacodynamics markers: total IgG and antiplatelet antibody levels in the overall population
Time Frame: Up to 35 weeks
Up to 35 weeks
Proportion of patients with an International Working Group (IWG) response
Time Frame: Up to 35 weeks
Up to 35 weeks
Proportion of patients with an International Working Group (IWG) complete response
Time Frame: Up to 35 weeks
Up to 35 weeks
Proportion of patients with an International Working Group (IWG) initial response
Time Frame: Up to 35 weeks
Up to 35 weeks

Collaborators and Investigators

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

Sponsor

argenx

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)

December 11, 2020

Primary Completion (Estimated)

October 1, 2023

Study Completion (Estimated)

October 1, 2023

Study Registration Dates

First Submitted

December 18, 2020

First Submitted That Met QC Criteria

December 23, 2020

First Posted (Actual)

December 29, 2020

Study Record Updates

Last Update Posted (Actual)

August 29, 2023

Last Update Submitted That Met QC Criteria

August 25, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ARGX-113-2004

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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