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

UCB

Status and phase: Completed; Phase 2

Conditions: Thrombocytopenia

Treatments: Drug: UCB7665

Study type: Interventional

Funder types: Industry

Identifiers

NCT02718716

TP0001

Details and patient eligibility

About

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.

Enrollment: 66 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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66 participants in 5 patient groups

UCB7665 4 mg/kg

Experimental group

Description:

Participants in this arm received 5 subcutaneous (sc) doses of UCB7665 (rozanolixizumab) 4 milligram per kilograms (mg/kg) at 1-week intervals.

Treatment:

Drug: UCB7665

UCB7665 7 mg/kg

Experimental group

Description:

Participants in this arm received 3 sc doses of UCB7665 (rozanolixizumab) 7 mg/kg at 1-week intervals.

Treatment:

Drug: UCB7665

UCB7665 10 mg/kg

Experimental group

Description:

Participants in this arm received 2 sc doses of UCB7665 (rozanolixizumab) 10 mg/kg at 1-week intervals.

Treatment:

Drug: UCB7665

UCB7665 15 mg/kg

Experimental group

Description:

Participants in this arm received 1 sc dose of UCB7665 (rozanolixizumab) 15 mg/kg.

Treatment:

Drug: UCB7665

UCB7665 20 mg/kg

Experimental group

Description:

Participants in this arm received 1 sc dose of UCB7665 (rozanolixizumab) 20 mg/kg.

Treatment:

Drug: UCB7665