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Phase 2 N=66 Randomized Treatment

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

Thrombocytopenia

Enrolled (actual)
66
Serious AEs
6.1%
Results posted
Jan 2024
Primary outcome: Primary: Percentage of Participants Experiencing at Least One Treatment Emergent Adverse Event (TEAE) During the Study — 80.0; 60.0; 58.3; 91.7 percentage of participants

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
UCB7665 (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
UCB Biopharma SRL
Primary completion
Feb 2019

Outcome Measures

OutcomeResultp-value
PRIMARY
Percentage of Participants Experiencing at Least One Treatment Emergent Adverse Event (TEAE) During the Study
80.0; 60.0; 58.3; 91.7; 100

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.

Eligibility 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 =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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02718716). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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