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

Thrombocytopenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02718716
• Other study ID #: TP0001
• Status: Completed
• Phase: Phase 2
• Start date: March 2, 2016
• Est. completion date: February 4, 2019

Study information

• Verified date: May 2023
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: February 4, 2019
• Est. primary completion date: February 4, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Purpura, Thrombocytopenic, Idiopathic
• Thrombocytopenia

Intervention

Drug:
• UCB7665
Intervention Type: Biological/Vaccine Pharmaceutical Form: Powder for solution for infusion Concentration: 100 mg/ml - Route of Administration: Subcutaneous infusion

Locations

Country	Name	City	State
Australia	Tp0001 1101	Adelaide
Bulgaria	Tp0001 1302	Pleven
Bulgaria	Tp0001 1301	Sofia
Czechia	Tp0001 203	Olomouc
Czechia	Tp0001 201	Praha 10
Georgia	Tp0001 1201	Tbilisi
Germany	Tp0001 401	Berlin
Germany	Tp0001 403	Dusseldorf
Germany	Tp0001 404	Muenchen
Italy	Tp0001 502	Firenze
Italy	Tp0001 506	Torino
Italy	Tp0001 503	Udine
Italy	Tp0001 505	Vicenza
Moldova, Republic of	Tp0001 601	Chisinau
Poland	Tp0001 702	Bialystok
Poland	Tp0001 703	Gdansk
Poland	Tp0001 701	Lodz
Poland	Tp0001 704	Poznan
Poland	Tp0001 705	Warsaw
Romania	Tp0001 802	Brasov
Romania	Tp0001 801	Bucharest
Romania	Tp0001 803	Craiova
Spain	Tp0001 902	Madrid
Spain	Tp0001 903	Madrid
Spain	Tp0001 901	Valencia
United Kingdom	Tp0001 1001	London
United Kingdom	Tp0001 1002	London
United Kingdom	Tp0001 1003	London
United Kingdom	Tp0001 1004	Truro

Sponsors (2)

Lead Sponsor	Collaborator
UCB Biopharma SRL	Parexel

Countries where clinical trial is conducted

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

References & Publications (1)

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 thr — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Experiencing at Least One Treatment Emergent Adverse Event (TEAE) During the Study	TEAEs were 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.	From Visit 2 (Week 1) until End of Study Visit or Early Termination (up to 12 weeks after the first investigational medicinal product (IMP) administration)

External Links

•   FDA Safety Alerts and Recalls