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

• Sponsor: UCB Biopharma S.P.R.L. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02718716
• Collaborator: Parexel (Industry)
• Enrollment: 66
• Locations: 29
• Arms: 5
• Actual Duration (Months): 35.1
• Patients Per Site: 2.3
• Patients Per Site Per Month: 0.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Thrombocytopenia	Drug: UCB7665	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 66 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Multicenter, Open-label, Multiple-dose Study to Evaluate the Safety, Tolerability, and Efficacy of UCB7665 in Subjects With Primary Immune Thrombocytopenia
• Actual Study Start Date: Mar 1, 2016
• Actual Primary Completion Date: Feb 1, 2019
• Actual Study Completion Date: Feb 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: UCB7665 dose 1 Subjects in this Arm will receive 5 subcutaneous (sc) doses of UCB7665 at 1-week intervals	Drug: UCB7665; Intervention Type: Biological/Vaccine Pharmaceutical Form: Powder for solution for infusion Concentration: 100 mg/ml - Route of Administration: Subcutaneous infusion
Experimental: UCB7665 dose 2 Subjects in this Arm will receive 3 subcutaneous (sc) doses of UCB7665 dose 2 at 1-week intervals	Drug: UCB7665; Intervention Type: Biological/Vaccine Pharmaceutical Form: Powder for solution for infusion Concentration: 100 mg/ml - Route of Administration: Subcutaneous infusion
Experimental: UCB7665 dose 3 Subjects in this Arm will receive 2 subcutaneous (sc) doses of UCB7665 dose 3 at 1-week intervals	Drug: UCB7665; Intervention Type: Biological/Vaccine Pharmaceutical Form: Powder for solution for infusion Concentration: 100 mg/ml - Route of Administration: Subcutaneous infusion
Experimental: UCB7665 dose 4 Subjects in this Arm will receive 1 subcutaneous (sc) dose of UCB7665 dose 4	Drug: UCB7665; Intervention Type: Biological/Vaccine Pharmaceutical Form: Powder for solution for infusion Concentration: 100 mg/ml - Route of Administration: Subcutaneous infusion
Experimental: UCB7665 dose 5 Subjects in this Arm will receive 1 subcutaneous (sc) dose of UCB7665 dose 5	Drug: UCB7665; Intervention Type: Biological/Vaccine Pharmaceutical Form: Powder for solution for infusion Concentration: 100 mg/ml - Route of Administration: Subcutaneous infusion

Outcome Measures

Primary Outcome Measures

1. 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)]

   TEAEs are 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tp0001 1101	Adelaide		Australia
2	Tp0001 1302	Pleven		Bulgaria
3	Tp0001 1301	Sofia		Bulgaria
4	Tp0001 203	Olomouc		Czechia
5	Tp0001 201	Praha 10		Czechia
6	Tp0001 1201	Tbilisi		Georgia
7	Tp0001 401	Berlin		Germany
8	Tp0001 403	Dusseldorf		Germany
9	Tp0001 404	Muenchen		Germany
10	Tp0001 502	Firenze		Italy
11	Tp0001 506	Torino		Italy
12	Tp0001 503	Udine		Italy
13	Tp0001 505	Vicenza		Italy
14	Tp0001 601	Chisinau		Moldova, Republic of
15	Tp0001 702	Bialystok		Poland
16	Tp0001 703	Gdańsk		Poland
17	Tp0001 701	Lodz		Poland
18	Tp0001 704	Poznan		Poland
19	Tp0001 705	Warsaw		Poland
20	Tp0001 802	Brasov		Romania
21	Tp0001 801	Bucharest		Romania
22	Tp0001 803	Craiova		Romania
23	Tp0001 902	Madrid		Spain
24	Tp0001 903	Madrid		Spain
25	Tp0001 901	Valencia		Spain
26	Tp0001 1001	London		United Kingdom
27	Tp0001 1002	London		United Kingdom
28	Tp0001 1003	London		United Kingdom
29	Tp0001 1004	Truro		United Kingdom

Sponsors and Collaborators

• UCB Biopharma S.P.R.L.
• Parexel

Investigators

• Study Director: UCB Cares, [phone] (UCB)

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: UCB Biopharma S.P.R.L.
• ClinicalTrials.gov Identifier: NCT02718716
• Other Study ID Numbers: TP0001
• First Posted: Mar 24, 2016
• Last Update Posted: Dec 1, 2020
• Last Verified: Nov 1, 2020

• Keywords provided by UCB Biopharma S.P.R.L.: ITP
• Additional relevant MeSH terms: Thrombocytopenia; Purpura, Thrombocytopenic, Idiopathic; Rozanolixizumab

Study Results

No Results Posted as of Dec 1, 2020