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

Primary Purpose

Thrombocytopenia

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
UCB7665
Sponsored by
UCB Biopharma S.P.R.L.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thrombocytopenia focused on measuring ITP

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Tp0001 1101
  • Tp0001 1302
  • Tp0001 1301
  • Tp0001 203
  • Tp0001 201
  • Tp0001 1201
  • Tp0001 401
  • Tp0001 403
  • Tp0001 404
  • Tp0001 502
  • Tp0001 506
  • Tp0001 503
  • Tp0001 505
  • Tp0001 601
  • Tp0001 702
  • Tp0001 703
  • Tp0001 701
  • Tp0001 704
  • Tp0001 705
  • Tp0001 802
  • Tp0001 801
  • Tp0001 803
  • Tp0001 902
  • Tp0001 903
  • Tp0001 901
  • Tp0001 1001
  • Tp0001 1002
  • Tp0001 1003
  • Tp0001 1004

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

UCB7665 dose 1

UCB7665 dose 2

UCB7665 dose 3

UCB7665 dose 4

UCB7665 dose 5

Arm Description

Subjects in this Arm will receive 5 subcutaneous (sc) doses of UCB7665 at 1-week intervals

Subjects in this Arm will receive 3 subcutaneous (sc) doses of UCB7665 dose 2 at 1-week intervals

Subjects in this Arm will receive 2 subcutaneous (sc) doses of UCB7665 dose 3 at 1-week intervals

Subjects in this Arm will receive 1 subcutaneous (sc) dose of UCB7665 dose 4

Subjects in this Arm will receive 1 subcutaneous (sc) dose of UCB7665 dose 5

Outcomes

Primary Outcome Measures

Subjects experiencing at least one Treatment Emergent Event (TEAE) during the study
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.

Secondary Outcome Measures

Full Information

First Posted
March 11, 2016
Last Updated
November 26, 2020
Sponsor
UCB Biopharma S.P.R.L.
Collaborators
Parexel
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1. Study Identification

Unique Protocol Identification Number
NCT02718716
Brief Title
Study to Evaluate Safety, Tolerability and Efficacy of UCB7665 in Subjects With Primary Immune Thrombocytopenia
Official Title
A Multicenter, Open-label, Multiple-dose Study to Evaluate the Safety, Tolerability, and Efficacy of UCB7665 in Subjects With Primary Immune Thrombocytopenia
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
March 2016 (Actual)
Primary Completion Date
February 2019 (Actual)
Study Completion Date
February 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UCB Biopharma S.P.R.L.
Collaborators
Parexel

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thrombocytopenia
Keywords
ITP

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
66 (Actual)

8. Arms, Groups, and Interventions

Arm Title
UCB7665 dose 1
Arm Type
Experimental
Arm Description
Subjects in this Arm will receive 5 subcutaneous (sc) doses of UCB7665 at 1-week intervals
Arm Title
UCB7665 dose 2
Arm Type
Experimental
Arm Description
Subjects in this Arm will receive 3 subcutaneous (sc) doses of UCB7665 dose 2 at 1-week intervals
Arm Title
UCB7665 dose 3
Arm Type
Experimental
Arm Description
Subjects in this Arm will receive 2 subcutaneous (sc) doses of UCB7665 dose 3 at 1-week intervals
Arm Title
UCB7665 dose 4
Arm Type
Experimental
Arm Description
Subjects in this Arm will receive 1 subcutaneous (sc) dose of UCB7665 dose 4
Arm Title
UCB7665 dose 5
Arm Type
Experimental
Arm Description
Subjects in this Arm will receive 1 subcutaneous (sc) dose of UCB7665 dose 5
Intervention Type
Drug
Intervention Name(s)
UCB7665
Intervention Description
Intervention Type: Biological/Vaccine Pharmaceutical Form: Powder for solution for infusion Concentration: 100 mg/ml - Route of Administration: Subcutaneous infusion
Primary Outcome Measure Information:
Title
Subjects experiencing at least one Treatment Emergent Event (TEAE) during the study
Description
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.
Time Frame
From Visit 2 (Week 1) until End of Study Visit or Early Termination (up to 12 weeks after the first IMP administration)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
UCB Cares
Organizational Affiliation
+1-844-599-2273 (UCB)
Official's Role
Study Director
Facility Information:
Facility Name
Tp0001 1101
City
Adelaide
Country
Australia
Facility Name
Tp0001 1302
City
Pleven
Country
Bulgaria
Facility Name
Tp0001 1301
City
Sofia
Country
Bulgaria
Facility Name
Tp0001 203
City
Olomouc
Country
Czechia
Facility Name
Tp0001 201
City
Praha 10
Country
Czechia
Facility Name
Tp0001 1201
City
Tbilisi
Country
Georgia
Facility Name
Tp0001 401
City
Berlin
Country
Germany
Facility Name
Tp0001 403
City
Dusseldorf
Country
Germany
Facility Name
Tp0001 404
City
Muenchen
Country
Germany
Facility Name
Tp0001 502
City
Firenze
Country
Italy
Facility Name
Tp0001 506
City
Torino
Country
Italy
Facility Name
Tp0001 503
City
Udine
Country
Italy
Facility Name
Tp0001 505
City
Vicenza
Country
Italy
Facility Name
Tp0001 601
City
Chisinau
Country
Moldova, Republic of
Facility Name
Tp0001 702
City
Bialystok
Country
Poland
Facility Name
Tp0001 703
City
Gdańsk
Country
Poland
Facility Name
Tp0001 701
City
Lodz
Country
Poland
Facility Name
Tp0001 704
City
Poznan
Country
Poland
Facility Name
Tp0001 705
City
Warsaw
Country
Poland
Facility Name
Tp0001 802
City
Brasov
Country
Romania
Facility Name
Tp0001 801
City
Bucharest
Country
Romania
Facility Name
Tp0001 803
City
Craiova
Country
Romania
Facility Name
Tp0001 902
City
Madrid
Country
Spain
Facility Name
Tp0001 903
City
Madrid
Country
Spain
Facility Name
Tp0001 901
City
Valencia
Country
Spain
Facility Name
Tp0001 1001
City
London
Country
United Kingdom
Facility Name
Tp0001 1002
City
London
Country
United Kingdom
Facility Name
Tp0001 1003
City
London
Country
United Kingdom
Facility Name
Tp0001 1004
City
Truro
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
32886753
Citation
Robak T, Kazmierczak M, Jarque I, Musteata V, Trelinski J, Cooper N, Kiessling P, Massow U, Woltering F, Snipes R, Ke J, Langdon G, Bussel JB, Jolles S. Phase 2 multiple-dose study of an FcRn inhibitor, rozanolixizumab, in patients with primary immune thrombocytopenia. Blood Adv. 2020 Sep 8;4(17):4136-4146. doi: 10.1182/bloodadvances.2020002003.
Results Reference
result
PubMed Identifier
30130439
Citation
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.
Results Reference
derived

Learn more about this trial

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

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