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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04687072




Registration number
NCT04687072
Ethics application status
Date submitted
18/12/2020
Date registered
29/12/2020

Titles & IDs
Public title
A Study to Evaluate the Efficacy and Safety of Efgartigimod PH20 Subcutaneous in Adult Patients With Primary Immune Thrombocytopenia
Scientific title
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
Secondary ID [1] 0 0
ARGX-113-2004
Universal Trial Number (UTN)
Trial acronym
ADVANCE SC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Primary Immune Thrombocytopenia 0 0
Condition category
Condition code
Blood 0 0 0 0
Haematological diseases
Blood 0 0 0 0
Other blood disorders
Inflammatory and Immune System 0 0 0 0
Autoimmune diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Efgartigimod PH20 SC
Other interventions - Placebo PH20 SC

Experimental: Efgartigimod PH20 SC - Patients receiving efgartigimod PH20 SC treatment

Placebo comparator: Placebo PH20 SC - Patients receiving placebo PH20 SC treatment


Treatment: Other: Efgartigimod PH20 SC
Subcutaneous injection with efgartigimod PH20 SC

Other interventions: Placebo PH20 SC
Subcutaneous injection with placebo PH20 SC
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
Timepoint [1] 0 0
Up to 5 weeks (between week 19 -24)
Secondary outcome [1] 0 0
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
Timepoint [1] 0 0
Up to 24 weeks
Secondary outcome [2] 0 0
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
Timepoint [2] 0 0
Up to 5 weeks (between week 19-24)
Secondary outcome [3] 0 0
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
Timepoint [3] 0 0
Up to 7 weeks (between week 17-24)
Secondary outcome [4] 0 0
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
Timepoint [4] 0 0
Up to 24 weeks
Secondary outcome [5] 0 0
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
Timepoint [5] 0 0
Up to 12 weeks
Secondary outcome [6] 0 0
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
Timepoint [6] 0 0
Up to 12 weeks
Secondary outcome [7] 0 0
Mean change from baseline in platelet count at each visit in the overall population
Timepoint [7] 0 0
Up to 35 weeks
Secondary outcome [8] 0 0
Time to response defined as the time to achieve 2 consecutive platelet counts of =50×10E9/L in the overall population
Timepoint [8] 0 0
Up to 35 weeks
Secondary outcome [9] 0 0
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
Timepoint [9] 0 0
Up to 24 weeks
Secondary outcome [10] 0 0
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
Timepoint [10] 0 0
Up to 24 weeks
Secondary outcome [11] 0 0
Incidence of the World Health Organization (WHO)-classified bleeding events in the overall population
Timepoint [11] 0 0
Up to 35 weeks
Secondary outcome [12] 0 0
Severity of the World Health Organization (WHO)-classified bleeding events in the overall population
Timepoint [12] 0 0
Up to 35 weeks
Secondary outcome [13] 0 0
Proportion of patients with an International Working Group (IWG) response
Timepoint [13] 0 0
Up to 35 weeks
Secondary outcome [14] 0 0
Proportion of patients with an International Working Group (IWG) complete response
Timepoint [14] 0 0
Up to 35 weeks
Secondary outcome [15] 0 0
Proportion of patients with an International Working Group (IWG) initial response
Timepoint [15] 0 0
Up to 35 weeks
Secondary outcome [16] 0 0
Incidence and severity of AEs, AEs of special interest (AESIs), and SAEs in the overall population
Timepoint [16] 0 0
Up to 35 weeks
Secondary outcome [17] 0 0
Vital sign measurement: blood pressure in the overall population
Timepoint [17] 0 0
Up to 35 weeks
Secondary outcome [18] 0 0
ECG: PR, QT and QRS interval in the overall population
Timepoint [18] 0 0
Up to 35 weeks
Secondary outcome [19] 0 0
Laboratory assessments: blood and urine analysis in the overall population
Timepoint [19] 0 0
Up to 35 weeks
Secondary outcome [20] 0 0
Rate of receipt of rescue therapy (rescue per patient per month) in the overall population
Timepoint [20] 0 0
Up to 35 weeks
Secondary outcome [21] 0 0
Proportion of patients for whom dose and/or frequency of concurrent ITP therapies have increased at week 12 or later in the overall population
Timepoint [21] 0 0
Up to 23 weeks (between week 12-35)
Secondary outcome [22] 0 0
Change from baseline in PRO (Functional Assessment of Chronic Illness Therapy Fatigue Scale [FACIT-Fatigue] at planned visits in the overall population
Timepoint [22] 0 0
Up to 24 weeks
Secondary outcome [23] 0 0
Change from baseline in PRO Functional Assessment of Cancer Therapy questionnaire-Th6 [Fact-Th6]) at planned visits in the overall population
Timepoint [23] 0 0
Up to 24 weeks
Secondary outcome [24] 0 0
Change from baseline in PRO QoL (Short Form-36 [SF-36]) at planned visits in the overall population
Timepoint [24] 0 0
Up to 24 weeks
Secondary outcome [25] 0 0
Incidence of antibodies to efgartigimod and/or rHuPH20 in the overall population
Timepoint [25] 0 0
Up to 35 weeks
Secondary outcome [26] 0 0
Prevalence of antibodies to efgartigimod and/or rHuPH20 in the overall population
Timepoint [26] 0 0
Up to 35 weeks
Secondary outcome [27] 0 0
Titers of antibodies to efgartigimod and/or rHuPH20 in the overall population
Timepoint [27] 0 0
Up to 35 weeks
Secondary outcome [28] 0 0
Presence of neutralizing antibodies (NAb) against efgartigimod and/or rHuPH20, and titers of NAb against efgartigimod and/or rHuPH20 in the overall population
Timepoint [28] 0 0
Up to 35 weeks
Secondary outcome [29] 0 0
Serum efgartigimod concentration observed predose (Ctrough) in the overall population
Timepoint [29] 0 0
Up to 35 weeks
Secondary outcome [30] 0 0
Pharmacodynamics markers: total IgG and antiplatelet antibody levels in the overall population
Timepoint [30] 0 0
Up to 35 weeks

Eligibility
Key inclusion criteria
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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
11/12/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
9/10/2023
Sample size
Target
Accrual to date
Final
207
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Investigator Site 0610009 - Adelaide
Recruitment hospital [2] 0 0
Investigator Site 0610004 - Bedford Park
Recruitment hospital [3] 0 0
Investigator Site 0610002 - Box Hill
Recruitment hospital [4] 0 0
Investigator Site 0610010 - Clayton
Recruitment hospital [5] 0 0
Investigator Site 0610012 - Garran
Recruitment hospital [6] 0 0
Investigator Site 0610001 - Hobart
Recruitment hospital [7] 0 0
Investigator Site 0610011 - Perth
Recruitment hospital [8] 0 0
Investigator Site 0610003 - West Perth
Recruitment hospital [9] 0 0
Investigator Site 0610005 - Westmead
Recruitment postcode(s) [1] 0 0
- Adelaide
Recruitment postcode(s) [2] 0 0
- Bedford Park
Recruitment postcode(s) [3] 0 0
- Box Hill
Recruitment postcode(s) [4] 0 0
- Clayton
Recruitment postcode(s) [5] 0 0
- Garran
Recruitment postcode(s) [6] 0 0
- Hobart
Recruitment postcode(s) [7] 0 0
- Perth
Recruitment postcode(s) [8] 0 0
- West Perth
Recruitment postcode(s) [9] 0 0
- Westmead
Recruitment outside Australia
Country [1] 0 0
United States of America
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Arkansas
Country [2] 0 0
United States of America
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California
Country [3] 0 0
United States of America
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District of Columbia
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United States of America
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Florida
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Illinois
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Plovdiv
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Sofia
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Santiago
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Tula
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George
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South Africa
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Observatory
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South Africa
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Pretoria
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South Africa
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Randburg
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Alava
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Barcelona
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Spain
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Madrid
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Murcia
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Sabadell
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Spain
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Sevilla
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Spain
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Valencia
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Taiwan
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Taoyuan
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Thailand
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Thailand
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Bangkok
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Thailand
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Chiang Mai
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Thailand
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Khon Kaen
Country [139] 0 0
Thailand
State/province [139] 0 0
Pathum Thani
Country [140] 0 0
Tunisia
State/province [140] 0 0
Sfax
Country [141] 0 0
Tunisia
State/province [141] 0 0
Sousse
Country [142] 0 0
Tunisia
State/province [142] 0 0
Tunis
Country [143] 0 0
Turkey
State/province [143] 0 0
Adapazari
Country [144] 0 0
Turkey
State/province [144] 0 0
Ankara
Country [145] 0 0
Turkey
State/province [145] 0 0
Edirne
Country [146] 0 0
Turkey
State/province [146] 0 0
Istanbul
Country [147] 0 0
Turkey
State/province [147] 0 0
Izmir
Country [148] 0 0
Turkey
State/province [148] 0 0
Kocaeli
Country [149] 0 0
Turkey
State/province [149] 0 0
Malatya
Country [150] 0 0
Turkey
State/province [150] 0 0
Mersin
Country [151] 0 0
Turkey
State/province [151] 0 0
Samsun
Country [152] 0 0
Turkey
State/province [152] 0 0
Tekirdag
Country [153] 0 0
Turkey
State/province [153] 0 0
Trabzon
Country [154] 0 0
United Kingdom
State/province [154] 0 0
Bradford
Country [155] 0 0
United Kingdom
State/province [155] 0 0
Coventry
Country [156] 0 0
United Kingdom
State/province [156] 0 0
London
Country [157] 0 0
United Kingdom
State/province [157] 0 0
Truro

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
argenx
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04687072