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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02718716
• Date of registration: 11/03/2016
• Prospective Registration: No
• Primary sponsor: UCB Biopharma S.P.R.L.
• Public title: Study to Evaluate Safety, Tolerability and Efficacy of UCB7665 in Subjects With Primary Immune Thrombocytopenia
• 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: March 2016
• Target sample size: 66
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02718716
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

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

Contacts

• Name: UCB Cares
• Affiliation: [phone] (UCB)

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Thrombocytopenia

Intervention(s)

Drug: UCB7665

Primary Outcome(s)

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)]

Secondary ID(s)

TP0001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Parexel