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

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

Sponsors

Lead Sponsor: UCB Biopharma S.P.R.L.

Collaborator: Parexel

Source UCB Pharma
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.

Overall Status Completed
Start Date March 2016
Completion Date February 2019
Primary Completion Date February 2019
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Subjects experiencing at least one Treatment Emergent Event (TEAE) during the study From Visit 2 (Week 1) until End of Study Visit or Early Termination (up to 12 weeks after the first IMP administration)
Enrollment 66
Condition
Intervention

Intervention Type: Drug

Intervention Name: UCB7665

Description: Intervention Type: Biological/Vaccine Pharmaceutical Form: Powder for solution for infusion Concentration: 100 mg/ml - Route of Administration: Subcutaneous infusion

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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
UCB Cares Study Director +1-844-599-2273 (UCB)
Location
Facility:
Tp0001 1101 | Adelaide, Australia
Tp0001 1302 | Pleven, Bulgaria
Tp0001 1301 | Sofia, Bulgaria
Tp0001 203 | Olomouc, Czechia
Tp0001 201 | Praha 10, Czechia
Tp0001 1201 | Tbilisi, Georgia
Tp0001 401 | Berlin, Germany
Tp0001 403 | Dusseldorf, Germany
Tp0001 404 | Muenchen, Germany
Tp0001 502 | Firenze, Italy
Tp0001 506 | Torino, Italy
Tp0001 503 | Udine, Italy
Tp0001 505 | Vicenza, Italy
Tp0001 601 | Chisinau, Moldova, Republic of
Tp0001 702 | Bialystok, Poland
Tp0001 703 | Gdańsk, Poland
Tp0001 701 | Lodz, Poland
Tp0001 704 | Poznan, Poland
Tp0001 705 | Warsaw, Poland
Tp0001 802 | Brasov, Romania
Tp0001 801 | Bucharest, Romania
Tp0001 803 | Craiova, Romania
Tp0001 902 | Madrid, Spain
Tp0001 903 | Madrid, Spain
Tp0001 901 | Valencia, Spain
Tp0001 1001 | London, United Kingdom
Tp0001 1002 | London, United Kingdom
Tp0001 1003 | London, United Kingdom
Tp0001 1004 | Truro, United Kingdom
Location Countries

Australia

Bulgaria

Czechia

Georgia

Germany

Italy

Moldova, Republic of

Poland

Romania

Spain

United Kingdom

Verification Date

March 2019

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 5
Arm Group

Label: UCB7665 dose 1

Type: Experimental

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

Label: UCB7665 dose 2

Type: Experimental

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

Label: UCB7665 dose 3

Type: Experimental

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

Label: UCB7665 dose 4

Type: Experimental

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

Label: UCB7665 dose 5

Type: Experimental

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

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov