Primary Immune Thrombocytopenia (ITP)Phase 3NCT07559331
High-Dose Dexamethasone Combined With Orelabrutinib Versus High-Dose Dexamethasone Combined With Placebo in Adult Patients With Newly Diagnosed Primary Immune Thrombocytopenia
A Phase 3 study testing High-Dose Dexamethasone Combined with Orelabrutinib in people with Primary Immune Thrombocytopenia (ITP), run by Shandong University at 1 site in China.
Trial summary
This is a randomized controlled study of high-dose Dexamethasone combined with Orelabrutinib versus high-dose Dexamethasone combined with placebo in adult patients with newly diagnosed Primary Immune Thrombocytopenia. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Primary Immune Thrombocytopenia (ITP)
- What is being tested?
- High-Dose Dexamethasone Combined with Orelabrutinib
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 86 participants
- Where
- 1 siteChina
- Study dates
- 8 Apr 2026to 31 Dec 2028
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must thoroughly understand the nature, significance, potential benefits, possible inconveniences, and potential risks of the trial prior to enrollment. They must understand the study procedures and voluntarily sign the informed consent form.
- Male or female subjects aged 18-80 years (inclusive).
- Body weight ≥35 kg at screening.
- Adult patients with newly diagnosed, untreated primary ITP, with platelet count (PLT) <30×10⁹/L and no active bleeding in vital organs.
- Subjects who responded to prior treatment with oral dexamethasone 40 mg/day for 4 days, defined as meeting all three of the following criteria on any day between Day 5 and Day 7 post-treatment: ① PLT ≥30×10⁹/L; ② ≥2-fold increase from baseline; and ③ no active bleeding. Between Week 2 and Week 12, any abnormal PLT result meeting any of the following criteria must be confirmed by repeat testing at Qilu Hospital within 24-48 hours: ① PLT <30×10⁹/L; ② <2-fold increase from baseline; or ③ active bleeding.
- Women of childbearing potential must use an effective method of contraception during the screening period, throughout the entire trial, and for 90 days following the last dose of study medication.
Who cannot join
- Subjects with severe ITP at screening (e.g., life-threatening thrombocytopenia, major bleeding events, or requiring urgent treatment including intravenous immunoglobulin, high-dose glucocorticoids, or plasma exchange), whom the investigator anticipates will require rescue treatment within 2 weeks after enrollment.
- Subjects with autoimmune systemic diseases other than ITP, unless the investigator determines that such conditions will not affect the evaluation of study outcomes.
- Subjects who failed to respond to prior treatment with oral dexamethasone 40 mg/day for 4 days, defined as meeting any of the following criteria on any day between Day 5 and Day 7 post-treatment: ① PLT <30×10⁹/L; ② <2-fold increase from baseline; or ③ active bleeding.
- History of intracranial hemorrhage within 6 months prior to screening.
- Subjects with a history of coagulation disorders other than ITP, such as disseminated intravascular coagulation, hemolytic uremic syndrome, or thrombotic thrombocytopenic purpura.
- Subjects with a known hypersensitivity to any component of the study drugs described in this protocol.
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- Known human immunodeficiency virus (HIV) infection, or positive serologic test results.
- Subjects with positive tuberculosis screening test (based on interferon-gamma release assay, including T-SPOT®, etc.), or active, latent, or incompletely appropriately treated tuberculosis at screening.
- Activated partial thromboplastin time (aPTT) ≥1.5× upper limit of normal (ULN) or international normalized ratio (INR) ≥1.5 at screening.
- Organ dysfunction, with the following laboratory findings at screening: Absolute neutrophil count (ANC) <1.5×10⁹/L; hemoglobin <90 g/L; lymphocyte count <0.8×10⁹/L. Total bilirubin >1.2×ULN; aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >ULN. Amylase or lipase >2×ULN. Estimated glomerular filtration rate (eGFR) <40 mL/min/1.73 m² calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula. Immunoglobulin IgG <6 g/L.
- Pregnant or lactating women.
- Subjects unable to undergo blood collection, or with contraindications to phlebotomy.
- Any other condition that the investigator considers unsuitable for participation in this trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Qilu Hospital of Shandong University
Jinan, Shandong
About this study
Official title: A Randomized Controlled Study of High-Dose Dexamethasone Combined With Orelabrutinib Versus High-Dose Dexamethasone Combined With Placebo in Adult Patients With Newly Diagnosed Primary Immune Thrombocytopenia
This is a randomized controlled study of high-dose Dexamethasone combined with Orelabrutinib versus high-dose Dexamethasone combined with placebo in adult patients with newly diagnosed Primary Immune Thrombocytopenia.
- Conditions
- Primary Immune Thrombocytopenia (ITP)
- Being tested
- High-Dose Dexamethasone Combined with Orelabrutinib, High-Dose Dexamethasone Combined with Placebo
- Medical subject headings
- Purpura, Thrombocytopenic, Idiopathic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-Dose Dexamethasone Combined with OrelabrutinibDrug
Orelabrutinib 50 mg once daily (QD) (for 3 consecutive months) combined with Dexamethasone 40 mg/day for 4 days
High-Dose Dexamethasone Combined with PlaceboDrug
Placebo 50 mg once daily (QD) (for 3 consecutive months) combined with Dexamethasone 40 mg/day for 4 days
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | Dexamethasone plus Placebo Group Receives: Drug: High-Dose Dexamethasone Combined with Placebo |
| Experimental Group | Experimental | High-Dose Dexamethasone Combined with Orelabrutinib Receives: Drug: High-Dose Dexamethasone Combined with Orelabrutinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate (ORR)
Measured: Throughout the study period, an average of 6 months
Secondary outcomes (1)
Overall Response Rate (ORR)
Measured: Throughout the study period, an average of 1/2/3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2026
- Study start8 Apr 2026
- Primary completion8 Apr 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Immune Thrombocytopenia (ITP)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ming Hou, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07559331
- Sponsor's protocol ID
- KYLL-2026-02-006-1
- Status last verified
- Apr 2026
- First submitted
- 23 Apr 2026
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No