A Study to Evaluate the Efficacy and Safety of Orelabrutinib in Adult Patients With Immune Thrombocytopenia

NCT05232149 | Unknown Phase 2

• 1 other identifier: ICP-CL-00116
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 9

Brief Summary

The study is designed to be a randomized, open, multi-center, phase IIa/IIb seamless adaptive trial. Phase IIa: The study consists of a screening period, a core treatment period, an open label extension period, and a safety follow-up period Phase IIb: At present, a preliminary exploratory study (i.e., phase IIa study) will be conducted first. The design of the phase IIb study (including the selection of populations) will be clarified after a relatively clear understanding of the therapeutic effect, value, risks and benefits of the BTK inhibitor for ITP is obtained.

Conditions

Primary Immune Thrombocytopenia

Keywords

Persistent or chronic

Outcome Measures

Primary Outcomes (1)

• Proportion of subjects with the platelet count of ≥ 50 × 109/L after 12 weeks of treatment

  12 weeks

Secondary Outcomes (2)

• Proportion of subjects who achieve a complete response (CR) over treatment time. CR is defined as a post-treatment platelet count of ≥100 × 109/L

  25 weeks

• Occurrence of treatment emergent adverse events (TEAE) and treatment-related adverse events (TRAE) were evaluated according to severity

  25 weeks

Other Outcomes (1)

• Cmax

  25 weeks

Study Arms (2)

Lower Dose

EXPERIMENTAL

Orelabrutinib is a white, round, uncoated tablet

Drug: Orelabrutinib( lower dose)

Higher Dose

EXPERIMENTAL

Orelabrutinib is a white, round, uncoated tablet

Drug: Orelabrutinib( higher dose)

Interventions

Orelabrutinib( lower dose) DRUG

Orelabrutinib is a white, round, uncoated tablet, will be taken lower dose QD by patients with persistent or chronic primary immune thrombocytopenia

Lower Dose

Orelabrutinib( higher dose) DRUG

Orelabrutinib is a white, round, uncoated tablet, will be taken higher dose QD by patients with persistent or chronic primary immune thrombocytopenia

Higher Dose

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects have had a detailed understanding of the nature, significance, possible benefits, possible inconveniences, and potential risks of the trial, understood the study procedures, and voluntarily signed a written ICF before the study.
• Males or females aged from 18 to 80 years (including the marginal values).
• With a body weight of ≥ 35 kg at screening.
• Diagnostic criteria:the diagnosis of persistent (3-12 months) or chronic (≥ 12 months) ITP is met
• Patients who have failed at least 1 prior first-line standard therapy for ITP, or who have failed to tolerate a standard therapy.
• Women of childbearing potential must take a complementary barrier method of contraception in combination with a highly effective method of contraception at screening, throughout the trial, and within 90 days after the last dose of the investigational drug.
• The mean of two platelet counts is less than 30 × 109/L and no platelet count is greater than 35 × 109/L during the screening visit and/or before the first dose.

You may not qualify if:

• Severe hemorrhage occurred within 4 weeks prior to screening.
• Subjects suffer from severe ITP at screening
• Subjects have other diseases which mention in protocol
• Subjects develop intracranial hemorrhage within 6 months prior to screening.
• Active and uncontrollable infection
• Subjects have a history of coagulopathy other than ITP
• Subjects with a history of malignancies.
• History of major organ transplantation or hematopoietic stem cell/bone marrow transplantation.
• Subjects with a known history of hypersensitivity to the investigational drug as described in the Protocol, or any ingredients.
• Subjects with a Medication history and surgical history which mention in protocol
• Subjects do not meet the criterion of the laboratory test in protocol

Sponsors & Collaborators

• Beijing InnoCare Pharma Tech Co., Ltd.: lead

Study Sites (9)

Hainan People's Hospital

Haikou, Hainan, 570100, China

RECRUITING

Henan Tumor Hospital

Zhengzhou, Henan, 450000, China

RECRUITING

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450000, China

RECRUITING

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430000, China

RECRUITING

Yichang Central People's Hospital

Yichang, Hubei, 443000, China

RECRUITING

Wuxi People's Hospital

Wuxi, Jiangsu, 214000, China

RECRUITING

Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, 221000, China

RECRUITING

First Hospital of Nanchang University

Nanchang, Jiangxi, 330000, China

RECRUITING

QiLu Hospital of Shandong University

Jinan, Shandong, 250012, China

RECRUITING

Related Publications (1)

• Yan S, Zhou H, Huang R, Wang F, Mei H, Lin L, Guo J, Zhou X, Li Z, Liu Y, Li S, Zhou W, Hou Y, Hou M. A phase 2 trial of orelabrutinib showing promising efficacy and safety in patients with persistent or chronic primary immune thrombocytopenia. Am J Hematol. 2024 Jul;99(7):1392-1395. doi: 10.1002/ajh.27303. Epub 2024 Mar 28. No abstract available.

  PMID: 38546375 DERIVED

MeSH Terms

Conditions

Purpura, Thrombocytopenic, Idiopathic; Bronchiolitis Obliterans Syndrome

Interventions

orelabrutinib

Condition Hierarchy (Ancestors)

Purpura, Thrombocytopenic; Purpura; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Thrombotic Microangiopathies; Thrombocytopenia; Blood Platelet Disorders; Cytopenia; Hemorrhagic Disorders; Autoimmune Diseases; Immune System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease

Central Study Contacts

Ming Hou, PhD

CONTACT

18560087007; houming@medmail.com.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2021
• First Posted: February 9, 2022
• Study Start: February 21, 2022
• Primary Completion: December 30, 2023
• Study Completion: December 30, 2024
• Last Updated: January 12, 2023

Record last verified: 2023-01

Locations

CN (9)