A study to test the safety of UCB7665 in patients with low levels of platelets.

• Register: EUCTR
• Last refreshed on: 28 February 2019
• Main ID: EUCTR2015-003984-12-BE
• Date of registration: 15/01/2016
• Prospective Registration: Yes
• Primary sponsor: UCB Biopharma SPRL
• Public title: A study to test the safety of UCB7665 in patients with low levels of platelets.
• Scientific title: A MULTICENTER, OPEN-LABEL, MULTIPLE-DOSE STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND EFFICACY OF UCB7665 IN SUBJECTS WITH PRIMARY IMMUNE THROMBOCYTOPENIA
• Date of first enrolment: 22/02/2016
• Target sample size: 66
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-003984-12
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: yes Other specify the comparator: Different dose of the same product Number of treatment arms in the trial: 5
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Australia, Belgium, Bulgaria, Czech Republic, Georgia, Germany, Italy, Lithuania, Moldova, Republic of, Poland, Romania, Spain, United Kingdom

Contacts

• Name: Clin Trial Reg & Results Disclosure
• Affiliation: UCB Biosciences GmbH

• Name: Clin Trial Reg & Results Disclosure
• Affiliation: UCB Biosciences GmbH

Key inclusion & exclusion criteria

Inclusion criteria:
• Subject has a diagnosis of primary immune thrombocytopenia 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 adequate peripheral venous access
• Subject has responded to previous ITP therapy (according to the judgment of the investigator)

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 44
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 22

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
• Subject has planned an elective surgical procedure in the coming 6 months
• Subject has evidence of a secondary cause of immune thrombocytopenia
• 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 or has a history of confirmed, duodenal, gastric or esophageal ulceration in the past 6 months
• Subject has experienced a clinically symptomatic gastrointestinal bleed (positive hemoccult tests without any signs and symptoms of gastrointestinal bleedings will not be considered as “clinically symptomatic”) in the last 6 months prior to Screening Visit and/or has current gastritis or esophagitis and/or has a known risk for clinical relevant gastrointestinal bleeding beyond ITP
• Subject has a medical history of thrombosis within the past 5 years or a history of thrombosis with unknown cause at any time or a significant known risk for 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
• Subject has not completed the washout period for the immune suppressants, biologics and other therapies



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

MedDRA version: 19.1 Level: PT Classification code 10043554 Term: Thrombocytopenia System Organ Class: 10005329 - Blood and lymphatic system disorders

Intervention(s)

Product Name: UCB7665
Product Code: UCB7665
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: UCB7665
CAS Number: 1584645-37-3
Current Sponsor code: UCB7665
Other descriptive name: UCB7665
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 100-

Primary Outcome(s)

Secondary Objective: • To assess the clinical efficacy of UCB7665 as measured by the change in platelet count
• To assess the pharmacodynamic (PD) effect of UCB7665 as measured by the change in total immunoglobulin G (IgG) concentration in serum

Main Objective: To evaluate the safety and tolerability of UCB7665 administered by subcutaneous (sc) infusion in patients with immune thrombocytopenia (ITP)

Primary end point(s): Number of Subjects experiencing at least one Treatment Emergent Adverse Event (TEAE)

Timepoint(s) of evaluation of this end point: From Visit2 (Week1) until End of Study Visit

Secondary Outcome(s)

Secondary end point(s): -

Timepoint(s) of evaluation of this end point: -

Secondary ID(s)

TP0001

2015-003984-12-DE

Source(s) of Monetary Support

UCB Biopharma SPRL

Ethics review

Status: Approved
Approval date:
Contact: