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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT03102593
Date of registration: 14/03/2017
Prospective Registration: Yes
Primary sponsor: argenx
Public title: A Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of ARGX-113 in Patients With ITP
Scientific title: A Randomized, Double-blind, Placebo-controlled, Phase II Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of ARGX-113 in Patients With Primary Immune Thrombocytopenia
Date of first enrolment: March 13, 2017
Target sample size: 38
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT03102593
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).  
Phase:  Phase 2
Countries of recruitment
Austria Belgium Czech Republic Czechia France Germany Hungary Poland
Spain Ukraine United Kingdom
Contacts
Name:     Adrian Newland
Address: 
Telephone:
Email:
Affiliation:  Barts Hospital, Cancer Centre in London
Key inclusion & exclusion criteria

Inclusion Criteria:

1. Male or female patients aged = 18 to = 85 years.

2. Must receive SoC treatment for ITP that has been stable in dose and frequency for at
least 4 weeks prior to Screening. SoC may include oral corticosteroids and/or
permitted oral immunosuppressants and/or TPO-R agonist.

3. Confirmed diagnosis of ITP with blood platelet counts < 30 × 109/L and who have not
experienced major bleeding in the last 4 weeks prior to Screening.

Exclusion Criteria:

1. Use of anticoagulants, or any drug with antiplatelet effect within 3 weeks prior to
Screening.

2. Patients who have received any blood support or transfusion within 4 weeks prior to
Screening.

3. Use of Intravenous immunoglobulin G (IVIg) or anti-D immunoglobulin treatment within 4
weeks prior to screening.

4. Use of recombinant thrombopoietin at any time.

5. Use of rituximab within 6 months prior to Screening. Use of any anti-CD20 other than
rituximab at any time is not permitted.

6. Use of immunosuppressants is not permitted within 4 weeks prior to Screening, with the
exception of the following oral immunosuppressants: azathioprine, danazol,
mycophenolate mofetil, mycophenolate sodium which must have been stable for at least 4
weeks prior to Screening.

7. Use of any other biological therapy or investigational drug than those previously
indicated within 3 months or 5 half-lives of the drug (whichever is longer) prior to
Screening.

8. Received vaccinations within 4 weeks prior to Screening or planned during the study.

9. At Screening, have clinically significant laboratory abnormalities

10. History of any thrombotic or embolic event within 12 months prior to Screening.

11. Known auto-immune disease other than ITP.



Age minimum: 18 Years
Age maximum: 85 Years
Gender: All
Health Condition(s) or Problem(s) studied
Primary Immune Thrombocytopenia
Intervention(s)
Drug: ARGX-113
Other: Placebo
Primary Outcome(s)
Incidence and severity of serious adverse events (SAEs). [Time Frame: After the first administration of Investigational Medicinal Product day 1 to 30 days of a patient's last visit.]
Secondary Outcome(s)
Frequency and proportion of patients with initial response [Time Frame: Over the study period (up to 13 weeks).]
Secondary ID(s)
2016-003038-26
ARGX-113-1603.
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Quintiles, Inc.
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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