Iguratimod Plus Low-dose Rituximab vs Low-dose Rituximab in Corticosteroid-resistant or Relapsed ITP

NCT07057778 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: Pku-IGU-ITP-03
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Randomized, open-label, multicentre study to assess the efficacy and safety of the combination of low-dose rituximab and Iguratimod in patients with steroid-resistant/relapsed ITP.

Conditions

Immune Thrombocytopenia (ITP)

Keywords

Iguratimod

Outcome Measures

Primary Outcomes (1)

• overall response

  The number of participants (responders) with platelet count \>=30x10\^9/L and at least a 2-fold increase in the baseline count (PR) or a platelet count \>=100x10\^9/L (CR) and the absence of bleeding, without rescue medication at 1-year follow-up.

  From the start of study treatment (Day 1) up to the end of Year 1

Secondary Outcomes (7)

• sustained response

  From the start of study treatment (Day 1) up to the end of Year 1

• complete response

  From the start of study treatment (Day 1) up to the end of Year 1

• time to response

  From the start of study treatment (Day 1) up to the end of Year 1

• duration of response

  From the start of study treatment (Day 1) up to the end of Year 1

• incidence of adverse events

  All patients were assessed for adverse events every week during the first 4 weeks of treatment, and at 2-weeks interval for the following 5 months, and monthly thereafter. Adverse events were scaled according to CTCAE 5.0

Study Arms (2)

Iguratimod plus low-dose rituximab

EXPERIMENTAL

Low-dose rituximab was used in combination with Iguratimod

Drug: Iguratimod; Drug: low-dose rituximab

Low-dose rituximab

ACTIVE COMPARATOR

Low-dose rituximab alone

Drug: low-dose rituximab

Interventions

Iguratimod DRUG

oral iguratimod at 25mg twice daily for 26 weeks

Iguratimod plus low-dose rituximab

low-dose rituximab DRUG

rituximab 100mg once weekly for 6 weeks

Iguratimod plus low-dose rituximab; Low-dose rituximab

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ITP confirmed by excluding other supervened causes of thrombocytopenia;
• Platelet count of less than 30×10\^9/L at enrollment;
• Patients who did not achieve a sustained response to treatment with full dose corticosteroids for a minimum duration of 4 weeks or who relapsed during steroid-tapering or after its discontinuation;

You may not qualify if:

• Secondary immune thrombocytopenia (e.g., patients with HIV, HCV, Helicobacter pylori infection or patients with systemic lupus erythematosus);
• Congestive heart failure;
• Severe arrhythmia;
• Nursing or pregnant women;
• Aspartate aminotransferase and alanine transaminase levels ≥ 3×the upper limit of the normal threshold criteria;
• Creatinine or serum bilirubin levels each 1•5 times or more than the normal range;
• Active or previous malignancy;
• Patients with other diseases were undergoing treatment with immunosuppressants;
• Patients with ITP had received rituximab;

Sponsors & Collaborators

• Peking University People's Hospital: lead
• Beijing Hospital: collaborator
• Beijing Friendship Hospital: collaborator
• Navy General Hospital, Beijing: collaborator
• Beijing Tongren Hospital: collaborator

Study Sites (1)

Peking University Insititute of Hematology

Beijing, China

Location

MeSH Terms

Conditions

Purpura, Thrombocytopenic, Idiopathic

Interventions

iguratimod; Rituximab

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

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Xiaohui Zhang

  Peking University Institute of Hematology, Peking University People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaohui Zhang

CONTACT

+8613522338836; zhangxh@bjmu.edu.cn

Qiusha Huang

CONTACT

+8613051816058; huangfuqs@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice president of Peking Univeristy Institute of Hematology

Model Details: Patients are randomly assigned at a 1:1 ratio to receive Iguratimod plus low-dose rituximab or high-dose rituximab alone. Each group requires 60 patients.

Study Record Dates

• First Submitted: June 30, 2025
• First Posted: July 10, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): July 1, 2027
• Last Updated: July 10, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)