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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 : March 19, 2019
Sponsor:
Collaborator:
Parexel
Information provided by (Responsible Party):
UCB Pharma ( UCB Biopharma S.P.R.L. )

Tracking Information
First Submitted Date  ICMJE March 11, 2016
First Posted Date  ICMJE March 24, 2016
Last Update Posted Date March 19, 2019
Actual Study Start Date  ICMJE March 2016
Actual Primary Completion Date February 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 18, 2016)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Evaluate Safety, Tolerability and Efficacy of UCB7665 in Subjects With Primary Immune Thrombocytopenia
Official Title  ICMJE A Multicenter, Open-label, Multiple-dose Study to Evaluate the Safety, Tolerability, and Efficacy of UCB7665 in Subjects With Primary Immune Thrombocytopenia
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Thrombocytopenia
Intervention  ICMJE Drug: UCB7665
  • Intervention Type: Biological/Vaccine
  • Pharmaceutical Form: Powder for solution for infusion
  • Concentration: 100 mg/ml - Route of Administration:

Subcutaneous infusion

Study Arms  ICMJE
  • Experimental: UCB7665 dose 1
    Subjects in this Arm will receive 5 subcutaneous (sc) doses of UCB7665 at 1-week intervals
    Intervention: Drug: UCB7665
  • Experimental: UCB7665 dose 2
    Subjects in this Arm will receive 3 subcutaneous (sc) doses of UCB7665 dose 2 at 1-week intervals
    Intervention: Drug: UCB7665
  • Experimental: UCB7665 dose 3
    Subjects in this Arm will receive 2 subcutaneous (sc) doses of UCB7665 dose 3 at 1-week intervals
    Intervention: Drug: UCB7665
  • Experimental: UCB7665 dose 4
    Subjects in this Arm will receive 1 subcutaneous (sc) dose of UCB7665 dose 4
    Intervention: Drug: UCB7665
  • Experimental: UCB7665 dose 5
    Subjects in this Arm will receive 1 subcutaneous (sc) dose of UCB7665 dose 5
    Intervention: Drug: UCB7665
Publications * Smith B, Kiessling A, Lledo-Garcia R, Dixon KL, Christodoulou L, Catley MC, Atherfold P, D'Hooghe LE, Finney H, Greenslade K, Hailu H, Kevorkian L, Lightwood D, Meier C, Munro R, Qureshi O, Sarkar K, Shaw SP, Tewari R, Turner A, Tyson K, West S, Shaw S, Brennan FR. Generation and characterization of a high affinity anti-human FcRn antibody, rozanolixizumab, and the effects of different molecular formats on the reduction of plasma IgG concentration. MAbs. 2018 Oct;10(7):1111-1130. doi: 10.1080/19420862.2018.1505464. Epub 2018 Sep 12.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 15, 2018)
66
Original Estimated Enrollment  ICMJE
 (submitted: March 18, 2016)
30
Actual Study Completion Date  ICMJE February 2019
Actual Primary Completion Date February 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Bulgaria,   Czechia,   Georgia,   Germany,   Italy,   Moldova, Republic of,   Poland,   Romania,   Spain,   United Kingdom
Removed Location Countries Belgium,   Czech Republic,   Lithuania
 
Administrative Information
NCT Number  ICMJE NCT02718716
Other Study ID Numbers  ICMJE TP0001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party UCB Pharma ( UCB Biopharma S.P.R.L. )
Study Sponsor  ICMJE UCB Biopharma S.P.R.L.
Collaborators  ICMJE Parexel
Investigators  ICMJE
Study Director: UCB Cares +1-844-599-2273 (UCB)
PRS Account UCB Pharma
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP