Efficacy and Safety of QL0911 in Adult Patients With Chronic Primary Immune Thrombocytopenia

NCT05621330 | Completed Phase 3

• 1 other identifier: QL0911-003
• Study Type: interventional
• Target: 216
• Locations: 1 country
• Sites: 1

Brief Summary

QL0911, a recombinant human thrombopoietin mimetic peptide-Fc fusion protein for injection, is a romiplostim (Nplate®) biosimilar for the treatment of primary immune thrombocytopenia (ITP). This phase III study aimed to assess the efficacy and safety of QL0911 in adult patients with primary chronic ITP.

Conditions

Primary Immune Thrombocytopenia

Outcome Measures

Primary Outcomes (1)

• proportion of patients achieving durable platelet response at week 24 during the double-blind treatment period

  24weeks

Secondary Outcomes (2)

• proportion of patients with weekly platelet responses within 24 weeks of treatment;

  24weeks

• Proportion of patients who achieved platelet count ≥ 30 × 10^9/L at least a two-fold increase from baseline platelet count without bleeding during the 24-week double-blind period;

  24weeks

Study Arms (2)

QL0911

EXPERIMENTAL

Drug: QL0911

Placebo

PLACEBO COMPARATOR

Drug: Placebo comparator

Interventions

QL0911 DRUG

The study in a 2:1 randomization ratio(144 subjects to QL0911). Qilu investigational product (QL0911 or placebo) will be administered in the clinic by a qualified healthcare provider as a subcutaneous injection.

QL0911

Placebo comparator DRUG

The study in a 2:1 randomization ratio(72 subjects to Placebo ). Qilu investigational product (QL0911 or placebo) will be administered in the clinic by a qualified healthcare provider as a subcutaneous injection.

Placebo

Eligibility Criteria

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

You may qualify if:

• Aged ≥18 years old;
• Diagnosed primary ITP for at least 12 months;
• Had received at least one first-line ITP treatment with no response or recurrence after treatment;
• Had a platelet count \<30×10\^9/L within 48 hours before the first dose;
• Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2;
• Fully understand and comply with the requirements of this study, and voluntarily sign the informed consent form.

You may not qualify if:

• Had a history of bone marrow stem cell abnormalities or myelodysplastic syndrome other than ITP-specific changes.
• Had arterial thrombosis, or venous thromboembolism; severe cardiovascular diseases; malignant tumors; secondary thrombocytopenia caused by autoimmune diseases.
• Underwent splenectomy within 12 weeks before the first dose;
• Had received ITP treatments (including rescue treatment) within 2 weeks before the first dose;
• Had received romiplostim (Nplate®) or eltrombopag (Revolade®), rhTPO or other agents that stimulate TPO receptors (also known as c-Mpl), and hematopoietic growth factors (HGFs) within 4 weeks before the first dose;
• Had received antineoplastic agents within 8 weeks before the first administration, but when treating ITP with hypomethylating agents (HMA) such as decitabine, a 4-week washout period was acceptable, as judged by the investigator;
• Had received antibody-based therapies within 14 weeks before the first dose; 8) had serum creatinine or total bilirubin \>1.5 upper limit of normal (ULN), alanine transaminase (ALT) or aspartate transaminase (AST) \>3 ULN, hemoglobin \< 100g/L, absolute neutrophil count \<1.5x10\^9/L;
• Had prothrombin time (PT) or prothrombin time-international normalized ratio (PT-INR) or activated partial thromboplastin time (APTT) exceeded 20% of the reference range of normal values.

Sponsors & Collaborators

• Qilu Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Qilu Hospital of Shandong University

Shandong, China

Location

Related Publications (1)

• Zhou H, Han S, Jin J, Huang R, Guo X, Shen X, Wang B, Wang X, Yao H, Du X, Huang M, Ran X, Wang W, Yang T, Zhang F, Zheng C, Zuo X, Fu R, Gao D, Ge Z, Han Y, Li Y, Kang X, Shi Y, Hou M. Efficacy and safety of QL0911 in adult patients with chronic primary immune thrombocytopenia: A multicenter, randomized, double-blind, placebo-controlled, phase III trial. J Transl Int Med. 2023 Dec 20;11(4):423-432. doi: 10.2478/jtim-2023-0106. eCollection 2023 Dec.

  PMID: 38130645 DERIVED

MeSH Terms

Conditions

Purpura, Thrombocytopenic, Idiopathic

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2022
• First Posted: November 18, 2022
• Study Start: October 18, 2019
• Primary Completion: December 13, 2021
• Study Completion: December 16, 2021
• Last Updated: November 23, 2022

Record last verified: 2022-11

Locations

CN (1)