Background: Immune thrombocytopenia (ITP) is an autoimmune bleeding disorder. Corticosteroids are first-line therapy, but about one-third of patients relapse or are refractory. Eltrombopag (a TPO-RA) promotes platelet production, yet some patients show no response or relapse upon discontinuation. Telitacicept, a TACI-Fc fusion protein, dual-targets BAFF and APRIL, inhibiting B cell and plasma cell function and reducing autoantibody production, potentially providing synergistic immunomodulatory benefit.
Objective: To evaluate the sustained response rate of eltrombopag plus telitacicept vs. eltrombopag alone in patients with steroid-refractory/relapsed ITP.
Design: Randomized, open-label, controlled, exploratory Phase II study. 40 patients planned (20 combination, 20 monotherapy). Combination group: eltrombopag + telitacicept . Monotherapy group: eltrombopag alone for 12 weeks. Monotherapy patients with no response after 4 weeks may cross over to the combination group. After 12 weeks, treatment is stopped and patients are followed until Week 24.
Primary endpoint: Proportion of patients maintaining platelet count ≥30×10⁹/L with no bleeding at 24 weeks post-treatment. Secondary endpoints include platelet response rates during 12 weeks, safety, bleeding events, etc.
Expected results: The combination group is expected to have a significantly higher proportion of patients achieving the primary endpoint without increased adverse events.
Population: Age ≥18, diagnosed ITP ≥3 months, baseline platelets \<30×10⁹/L, prior corticosteroid failure.
Safety: Monitoring for bleeding, infection, thrombosis, cytopenia, etc., with dose adjustment/cessation as per protocol.
Conclusion: This study explores whether dual-targeting (platelet production + autoimmune suppression) with eltrombopag and telitacicept can provide more durable remission for steroid-refractory/relapsed ITP patients.
Age ≥18 years, regardless of sex.
Clinically diagnosed with immune thrombocytopenia for at least 3 months prior to enrollment. Platelet count <30×10⁹/L within 48 hours before the first dose of study drug.
Previous failure (ineffective, unable to maintain response, or relapse) to first-line standard corticosteroid therapy for ITP as recommended by guidelines.
Any prior emergency treatment for ITP (e.g., corticosteroids, platelet transfusion, intravenous immunoglobulin) must have been completed at least 2 weeks before the first dose.
Received anti-CD20 antibody therapy within 3 months.
Uncontrolled primary disease of vital organs, such as malignant tumors, liver failure, heart failure, renal failure, etc.
Positive for HIV.
Uncontrolled active viral or bacterial infections, including positive for hepatitis B, hepatitis C, cytomegalovirus, Epstein-Barr virus, or syphilis.
Parallel
Eltrombopag
Drugeltrombopag plus telitacicept vs. eltrombopag alone
Sustained Response Comparison
To compare the sustained response rate of eltrombopag combined with telitacicept versus eltrombopag monotherapy in patients with immune thrombocytopenia who are refractory or relapsed to prior corticosteroid therapy.
Platelet Response Within 12 Weeks
Percentage of subjects achieving at least one platelet count ≥30×10⁹/L with an increase of ≥2-fold from baseline within 12 weeks of first dose, without receiving rescue therapy.
Platelet ≥50×10⁹/L at Week 12
Proportion of patients with platelet count ≥50×10⁹/L at Week 12 of treatment.
Platelet ≥100×10⁹/L at Week 12
Proportion of patients with platelet count ≥100×10⁹/L at Week 12 of treatment.
Time to First Platelet Response
Time to first platelet count ≥30×10⁹/L with an increase of ≥2-fold from baseline.
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