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

May 15, 2023 updated by: UCB Biopharma SRL

A Multicenter, Open-label, Multiple-dose Study to Evaluate the Safety, Tolerability, and Efficacy of UCB7665 in Subjects With Primary Immune Thrombocytopenia

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

66

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Adelaide, Australia
        • Tp0001 1101
  • Bulgaria
      • Pleven, Bulgaria
        • Tp0001 1302
      • Sofia, Bulgaria
        • Tp0001 1301
  • Czechia
      • Olomouc, Czechia
        • Tp0001 203
      • Praha 10, Czechia
        • Tp0001 201
  • Georgia
      • Tbilisi, Georgia
        • Tp0001 1201
  • Germany
      • Berlin, Germany
        • Tp0001 401
      • Dusseldorf, Germany
        • Tp0001 403
      • Muenchen, Germany
        • Tp0001 404
  • Italy
      • Firenze, Italy
        • Tp0001 502
      • Torino, Italy
        • Tp0001 506
      • Udine, Italy
        • Tp0001 503
      • Vicenza, Italy
        • Tp0001 505
  • Moldova, Republic of
      • Chisinau, Moldova, Republic of
        • Tp0001 601
  • Poland
      • Bialystok, Poland
        • Tp0001 702
      • Gdańsk, Poland
        • Tp0001 703
      • Lodz, Poland
        • Tp0001 701
      • Poznan, Poland
        • Tp0001 704
      • Warsaw, Poland
        • Tp0001 705
  • Romania
      • Brasov, Romania
        • Tp0001 802
      • Bucharest, Romania
        • Tp0001 801
      • Craiova, Romania
        • Tp0001 803
  • Spain
      • Madrid, Spain
        • Tp0001 902
      • Madrid, Spain
        • Tp0001 903
      • Valencia, Spain
        • Tp0001 901
  • United Kingdom
      • London, United Kingdom
        • Tp0001 1001
      • London, United Kingdom
        • Tp0001 1002
      • London, United Kingdom
        • Tp0001 1003
      • Truro, United Kingdom
        • Tp0001 1004

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:

  • 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

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: UCB7665 4 mg/kg
Participants in this arm received 5 subcutaneous (sc) doses of UCB7665 (rozanolixizumab) 4 milligram per kilograms (mg/kg) 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

Other Names:
  • rozanolixizumab
Experimental: UCB7665 7 mg/kg
Participants in this arm received 3 sc doses of UCB7665 (rozanolixizumab) 7 mg/kg 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

Other Names:
  • rozanolixizumab
Experimental: UCB7665 10 mg/kg
Participants in this arm received 2 sc doses of UCB7665 (rozanolixizumab) 10 mg/kg 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

Other Names:
  • rozanolixizumab
Experimental: UCB7665 15 mg/kg
Participants in this arm received 1 sc dose of UCB7665 (rozanolixizumab) 15 mg/kg.
Drug: UCB7665
  • Intervention Type: Biological/Vaccine
  • Pharmaceutical Form: Powder for solution for infusion
  • Concentration: 100 mg/ml - Route of Administration:

Subcutaneous infusion

Other Names:
  • rozanolixizumab
Experimental: UCB7665 20 mg/kg
Participants in this arm received 1 sc dose of UCB7665 (rozanolixizumab) 20 mg/kg.
Drug: UCB7665
  • Intervention Type: Biological/Vaccine
  • Pharmaceutical Form: Powder for solution for infusion
  • Concentration: 100 mg/ml - Route of Administration:

Subcutaneous infusion

Other Names:
  • rozanolixizumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Experiencing at Least One Treatment Emergent Adverse 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 investigational medicinal product (IMP) administration)
TEAEs were 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.
From Visit 2 (Week 1) until End of Study Visit or Early Termination (up to 12 weeks after the first investigational medicinal product (IMP) administration)

Collaborators and Investigators

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

Sponsor

UCB Biopharma SRL

Collaborators

Parexel

Investigators

  • Study Director: UCB Cares, 001 844 599 2273 (UCB)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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)

March 2, 2016

Primary Completion (Actual)

February 4, 2019

Study Completion (Actual)

February 4, 2019

Study Registration Dates

First Submitted

March 11, 2016

First Submitted That Met QC Criteria

March 18, 2016

First Posted (Estimated)

March 24, 2016

Study Record Updates

Last Update Posted (Estimated)

January 29, 2024

Last Update Submitted That Met QC Criteria

May 15, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TP0001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

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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