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Study to Evaluate Safety, Tolerability and Efficacy of UCB7665 in Subjects With Primary Immune Thrombocytopenia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02718716
Recruitment Status : Completed
First Posted : March 24, 2016
Last Update Posted : December 1, 2020
Sponsor:
Collaborator:
Parexel
Information provided by (Responsible Party):
UCB Pharma ( UCB Biopharma S.P.R.L. )

Study Description
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Brief Summary:
The primary objective of the study is to check if an subcutaneous (sc) infusion of UCB7665 is safe and tolerated in subjects with primary immune thrombocytopenia.

Condition or disease Intervention/treatment Phase
Thrombocytopenia Drug: UCB7665 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Open-label, Multiple-dose Study to Evaluate the Safety, Tolerability, and Efficacy of UCB7665 in Subjects With Primary Immune Thrombocytopenia
Actual Study Start Date : March 2016
Actual Primary Completion Date : February 2019
Actual Study Completion Date : February 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: UCB7665 dose 1
Subjects in this Arm will receive 5 subcutaneous (sc) doses of UCB7665 at 1-week intervals
 Drug: UCB7665
  • Intervention Type: Biological/Vaccine
  • Pharmaceutical Form: Powder for solution for infusion
  • Concentration: 100 mg/ml - Route of Administration:

Subcutaneous infusion
Experimental: UCB7665 dose 2
Subjects in this Arm will receive 3 subcutaneous (sc) doses of UCB7665 dose 2 at 1-week intervals
 Drug: UCB7665
  • Intervention Type: Biological/Vaccine
  • Pharmaceutical Form: Powder for solution for infusion
  • Concentration: 100 mg/ml - Route of Administration:

Subcutaneous infusion
Experimental: UCB7665 dose 3
Subjects in this Arm will receive 2 subcutaneous (sc) doses of UCB7665 dose 3 at 1-week intervals
 Drug: UCB7665
  • Intervention Type: Biological/Vaccine
  • Pharmaceutical Form: Powder for solution for infusion
  • Concentration: 100 mg/ml - Route of Administration:

Subcutaneous infusion
Experimental: UCB7665 dose 4
Subjects in this Arm will receive 1 subcutaneous (sc) dose of UCB7665 dose 4
 Drug: UCB7665
  • Intervention Type: Biological/Vaccine
  • Pharmaceutical Form: Powder for solution for infusion
  • Concentration: 100 mg/ml - Route of Administration:

Subcutaneous infusion
Experimental: UCB7665 dose 5
Subjects in this Arm will receive 1 subcutaneous (sc) dose of UCB7665 dose 5
 Drug: UCB7665
  • Intervention Type: Biological/Vaccine
  • Pharmaceutical Form: Powder for solution for infusion
  • Concentration: 100 mg/ml - Route of Administration:

Subcutaneous infusion


Outcome Measures
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Primary Outcome Measures :
  1. Subjects experiencing at least one Treatment Emergent Event (TEAE) during the study [ Time Frame: From Visit 2 (Week 1) until End of Study Visit or Early Termination (up to 12 weeks after the first IMP administration) ]
    TEAEs are defined as Adverse Events starting after the time of first Investigational Medicinal Product (IMP) administration up to and including 8 weeks after the final dose.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject has a diagnosis of primary immune thrombocytopenia (ITP) for a minimum of 3 months prior to Screening Visit
  • Subject has a platelet count <30x10^9/L at Screening and <35x10^9/L at Baseline (Visit 2)
  • Subject has a current or history of a peripheral blood smear consistent with ITP
  • Subject has responded to previous ITP therapy (according to the judgment of the investigator)

Exclusion Criteria:

  • Subject has an immunoglobulin G (IgG) level <=6g/L at Screening Visit
  • Subject has a partial thromboplastin time (PTT) >=1.5x upper limit of normal (ULN) or International Normalized Ratio (INR) >=1.5 at Screening Visit

  • Subject has renal and/or liver impairment defined as:

    • Serum creatinine level of >=1.4 mg/dL for females and >=1.5 mg/dL for males at Screening Visit
  • Subject has planned an elective surgical procedure in the coming 6 months
  • Subject has evidence of a secondary cause of primary immune thrombocytopenia purpura
  • Subject has a history of clinically relevant ongoing chronic infections
  • Subject has a family history of primary immunodeficiency
  • Subject has a clinically relevant active infection or has had a serious infection within 6 weeks prior to the first dose of IMP
  • Subject has a history of known inflammatory bowel disease, diverticular disease, and gastric or esophageal ulceration
  • Subject has experienced gastrointestinal bleed in the last 6 months prior to Screening Visit and/or has current gastritis or esophagitis
  • Subject has a medical history of thrombosis
  • Subject has a history of coagulopathy disorders other than ITP
  • Subject has received a live vaccination within 8 weeks prior to the Baseline Visit; or intends to have a live vaccination during the course of the study or within 7 weeks following the final dose of IMP
  • Subject has had prior treatment with rituximab in the 6 months prior to the Baseline Visit
  • Subject has not completed the washout period for the immunosuppressants, biologics and other therapies
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02718716


Locations
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Sponsors and Collaborators
UCB Biopharma S.P.R.L.
Parexel
Investigators
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Study Director: UCB Cares +1-844-599-2273 (UCB)
More Information
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Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: UCB Biopharma S.P.R.L.
ClinicalTrials.gov Identifier: NCT02718716    
Other Study ID Numbers: TP0001
First Posted: March 24, 2016    Key Record Dates
Last Update Posted: December 1, 2020
Last Verified: November 2020
Keywords provided by UCB Pharma ( UCB Biopharma S.P.R.L. ):
ITP
Additional relevant MeSH terms:
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Thrombocytopenia
Purpura, Thrombocytopenic, Idiopathic
Blood Platelet Disorders
Hematologic Diseases
Purpura, Thrombocytopenic
Purpura
Blood Coagulation Disorders
Thrombotic Microangiopathies
Hemorrhagic Disorders
 Autoimmune Diseases
Immune System Diseases
Hemorrhage
Pathologic Processes
Skin Manifestations
Rozanolixizumab
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs