New combo therapy aims to boost platelets in ITP patients
NCT ID NCT07669675
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase 2 trial tests whether adding baricitinib to standard TPO-RA therapy helps adults with immune thrombocytopenia (ITP) who did not respond to TPO-RA alone. One hundred participants will be randomly assigned to receive either baricitinib plus TPO-RA or TPO-RA alone for 14 days. The main goal is to see if the combination leads to a better platelet count response without needing rescue treatment.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Baricitinib (a JAK inhibitor) plus a TPO-RA (hetrombopag or eltrombopag)
- What this could lead to
- If it works, this could offer a new combination treatment option for people with immune thrombocytopenia who do not respond to standard TPO-RA therapy alone.
- What could go wrong
- This is a small, early-phase trial (phase 2) with only 100 participants, so results may not apply to everyone. Baricitinib can increase infection risk and other side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 100 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jul 2026
An estimate. Start dates often move.
- Expected to finish
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Aug 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. ≥18 years old; 2. Patients diagnosed with primary ITP who failed to achieve a response after 14 days of full-dose TPO-RA therapy; 3. Patients with baseline platelet count less than 30×10⁹/L, or those with baseline platelet count ranging from 30×10⁹/L to 50×10⁹/L accompanied by clinically significant bleeding (WHO bleeding score ≥2). Exclusion Criteria: * Pregnant or lactating women, and who were possibly pregnant, planning to become pregnant, or who had partners planning to become pregnant; * With active malignancy or a history of malignant tumor; * Having experienced severe bacterial, viral, fungal or parasitic infection within the past 4 weeks; * With a history of symptomatic herpes zoster infection within 12 weeks prior to screening; * Active or chronic HBV, HCV or HIV infection; * Evidence of active tuberculosis; or previous evidence of active tuberculosis without appropriate and documented treatment; or household contact with patients with active tuberculosis without appropriate and documented tuberculosis prophylaxis; * Receipt of live vaccines within the past 12 weeks, or planned live vaccination during the study period; * Prior baricitinib therapy; * History of solid organ transplant or planned surgery; * Myelodysplastic syndrome, aplastic anemia or myelofibrosis; * Patients with other diseases were undergoing treatment with immunosuppressants; * Clinically significant thromboembolic events within the past 24 weeks, or ongoing anticoagulant treatment, who are deemed ineligible for the study by the investigator; * History or presence of myocardial infarction, unstable ischemic heart disease, stroke, or NYHA Class IV heart failure; * History or active manifestations of severe or unstable cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, neurological, neuropsychiatric, or other medical conditions that, in the investigator's judgment, could confer unacceptable safety risks with the investigational product or confound the interpretation of study data; * AST \> 2 times the upper limit of normal (ULN), ALT \> 2×ULN, TBIL ≥ 1.5×ULN; * eGFR \< 50 mL/min/1.73m²; * Other patients deemed unsuitable for enrollment in this study by the investigator.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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Other studies related to the condition(s) this trial covers.
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- Promising ITP drug trial pulled before it even started