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Immune ThrombocytopeniaPhase 2NCT05932524

Low-dose Baricitinib Plus High-dose Dexamethasone for Patients With Newly Diagnosed Immune Thrombocytopenia

A Phase 2 study testing Baricitinib 2 MG and Dexamethasone in people with Immune Thrombocytopenia, run by Peking University People's Hospital at 10 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

A randomized, open-label, multicenter, phase 2 trial to compare the efficacy and safety of baricitinib plus high-dose dexamethasone compared to high-dose dexamethasone monotherapy for the first-line treatment of adults with primary immune thrombocytopenia (ITP). Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Immune Thrombocytopenia
What is being tested?
Baricitinib 2 MG and Dexamethasone
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
132 participants
Where
10 sitesChina
Study dates
7 Jul 2023to Jun 2025
Phase
Phase 2
Are there results?
None posted in the registry

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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Confirmed newly-diagnosed, treatment-naive ITP;
  • A platelet count <30,000/μL, or a platelet count <50,000/μL with clinically significant bleeding symptoms (WHO bleeding scale 2 or above) at the enrollment;
  • Willing and able to sign written informed consent.

Who cannot join

  • Received chemotherapy or anticoagulants or other drugs affecting the platelet counts within 6 months before the screening visit;
  • Have a known diagnosis of other autoimmune diseases, established in the medical history and laboratory findings with positive results for the determination of antinuclear antibodies, anti-cardiolipin antibodies, lupus anticoagulant or direct Coombs test;
  • Active or a history of malignancy;
  • Pregnancy or lactation;
  • Received first-line and second-line ITP-modifying therapy;
  • Previously received corticosteroids or immunosuppressive agents for non-ITP diseases within 6 months before enrollment;
Show all 17Show fewer
  • A history of clinically significant adverse reactions to previous corticosteroid therapy;
  • Unstable or uncontrolled disease or condition related to or impacting cardiac function (e.g., unstable angina, congestive heart failure, uncontrolled hypertension or cardiac arrhythmia);
  • Current or recent (<4 weeks prior to screening) clinically serious viral, bacterial, fungal, or parasitic infection;
  • A history of symptomatic herpes zoster infection within 12 weeks prior to screening;
  • Active or chronic viral infection from hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV);
  • Have evidence of active tuberculosis (TB), or have previously had evidence of active TB and did not receive appropriate and documented treatment, or have had household contact with a person with active TB and did not receive appropriate and documented prophylaxis for TB;
  • Have experienced a clinically significant thrombotic event within 24 weeks of screening or are on anticoagulants and in the opinion of the investigator are not well controlled;
  • Myocardial infarction (MI), unstable ischemic heart disease, stroke, or New York Heart Association Stage IV heart failure;
  • A history or presence of cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, neurological, or neuropsychiatric disorders or any other serious and/or unstable illness that, in the opinion of the investigator, could constitute an unacceptable risk when taking investigational product or interfere with the interpretation of data;
  • Any of the following specific abnormalities on screening laboratory tests:
  • 1) ALT or AST >2 x ULN, or total bilirubin ≥1.5 x ULN 2) hemoglobin <9 g/dL, or total white blood cell (WBC) count <2,500/µL, or neutropenia (absolute neutrophil count <1,200/µL), or lymphopenia (lymphocyte count <750/µL) 3) eGFR <50 mL/min/1.73 m^2.

Trial locations and contacts

10 sites in 1 country.

Xiaohui Zhang contact

+8613522338836

zhangxh@bjmu.edu.cn

Peng Zhao contact

+8618810323668

zpeng702@163.com

10 sites in 1 country

China10 sites, 10 recruiting

  • Peking University Insititute of Hematology, Peking University People's Hospital

    Beijing, 100044

    Xiaohui Zhang, MD, +8613522338836, zhangxh@bjmu.edu.cn

    Peng Zhao, MD, +8618810323668, zpeng702@163.com

    Recruiting

  • Beijing Friendship Hospital

    Beijing

    Zhao Wang, MD, +861088324672, wangliru2019@126.com

    Recruiting

  • Beijing Hospital

    Beijing

    Hui Liu, MD, +861088324672, fengru2019@126.com

    Recruiting

  • Beijing Luhe Hospital

    Beijing

    He Bing Zhou, MD, +861088324672, zhouhebing2019@126.com

    Recruiting

  • Beijing Tsinghua Changgeng Hospital

    Beijing

    Li Hong Li, MD, +861088324672, 1510301227@bjmu.edu.cn

    Recruiting

  • China-Japan Friendship Hospital

    Beijing

    Zhen Ling Li, MD, +861088324672, Lizhenling1994@163.com

    Recruiting

  • Chinese PLA General Hospital

    Beijing

    Dai Hong Liu, MD, +861088326666, 1510301227@bjmu.edu.cn

    Recruiting

  • Peking University First Hospital

    Beijing

    Yu Jun Dong, MD, +861088324577, 1510301227@bjmu.edu.cn

    Recruiting

  • Peking University Third Hospital

    Beijing

    Hong Mei Jing, MD, +861088324672, 1510301227@bjmu.edu.cn

    Recruiting

  • The Sixth Medical Center of PLA General Hospital

    Beijing

    Yi Liu, MD, +861088324577, drliuyi@126.com

    Recruiting

Other trials in China

About this study

Official title: Low-dose Baricitinib Plus High-dose Dexamethasone as First-line Treatment for Patients With Newly Diagnosed Immune Thrombocytopenia: a Multicenter, Open-label, Randomized, Controlled, Phase 2 Trial

A randomized, open-label, multicenter, phase 2 trial to compare the efficacy and safety of baricitinib plus high-dose dexamethasone compared to high-dose dexamethasone monotherapy for the first-line treatment of adults with primary immune thrombocytopenia (ITP).

Read the detailed description

This is a parallel group, multicenter, randomized, controlled trial of patients with ITP in China. Patients were randomly assigned to receive baricitinib plus high-dose dexamethasone or high-dose dexamethasone monotherapy. Treatment will be discontinued if very severe or life-threatening adverse events developed or at the patients' request. The primary endpoint is durable response, defined as the maintenance of platelet count ≥30,000/μL and at least 2-fold increase of the baseline count, the absence of bleeding, and no need for rescue medication at the 6-month follow-up.

Being tested
Baricitinib 2 MG, Dexamethasone
Keywords
Baricitinib, High-dose dexamethasone
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.

  • Baricitinib 2 MGDrug

    Also called Olumiant

    Baricitinib 2 mg q.d., p.o., for 6 consecutive months.

  • DexamethasoneDrug

    Also called HD-DXM

    Dexamethasone 40 mg q.d. for 4 consecutive days (the 4-day course of dexamethasone will be repeated in the case of lack of response by day 10)

Study groups in NCT05932524
Study groupRoleWhat they receive
Low-dose baricitinib plus high-dose dexamethasoneExperimentalOral baricitinib is given at a dose of 2 mg daily for 6 consecutive months. Dexamethasone is administrated at 40 mg per day for 4 consecutive days (the 4-day course of dexamethasone will be repeated in the case of lack of response by day 10). Treatment will be discontinued if very severe or life-threatening adverse events developed or at the patients' request.
Receives: Drug: Baricitinib 2 MG; Drug: Dexamethasone
High-dose dexamethasoneActive comparatorDexamethasone is administrated at 40 mg per day for 4 consecutive days (the 4-day course of dexamethasone will be repeated in the case of lack of response by day 10). Treatment will be discontinued if very severe or life-threatening adverse events developed or at the patients' request.
Receives: Drug: Dexamethasone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Durable response

    The maintenance of a platelet count ≥30,000/μL, at least 2-fold increase of the baseline count, the absence of bleeding, and no need for rescue medication at the 6-month follow-up.

    Measured: 6 months

Secondary outcomes (9)

  1. Complete response (CR)

    A platelet count over 100,000/μL and absence of bleeding.

    Measured: 1 month

  2. Response (R)

    A platelet count over 30,000/μL and at least 2-fold increase of the baseline count and absence of bleeding.

    Measured: 1 month

  3. Time to response

    The time from starting treatment to time of achievement of CR or R.

    Measured: 6 months

  4. Duration of response

    Duration of response at 6-month follow up.

    Measured: 6 months

  5. Early response

    Achievement of CR or R at day 7

    Measured: 7 days

  6. Initial response

    Achievement of CR or R at day 28

    Measured: 28 days

  7. Bleeding events

    Clinically significant bleeding as assessed using the world health organization (WHO) bleeding scale.

    Measured: From the start of study treatment (Day 1) to the end of week 26

  8. Health-related quality of life (HRQoL)

    ITP-PAQ is used to assess the Health Related Quality of Life (HRQoL) before and after treatment.

    Measured: From the start of study treatment (Day 1) to the end of week 26

  9. Adverse events

    Adverse events (AEs) are reported and graded in accordance with the Common Terminology Criteria for Adverse Events (CTCAE), version 5.0.

    Measured: From the start of study treatment (Day 1) to the end of week 26

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jul 2023
  2. Study start7 Jul 2023
  3. Primary completionJun 2024 (estimated)
  4. Study completionJun 2025 (estimated)

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Patients are randomly assigned at a 1:1 ratio to receive baricitinib plus high-dose dexamethasone or high-dose dexamethasone alone. Each group requires 66 patients (considering 10% drop-off).
Masking
None (open label)
Enrolment
132 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05932524
Sponsor's protocol ID
PKU-BAITP-03
Status last verified
Jul 2023
First submitted
28 Jun 2023
Last updated
12 Jul 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Baricitinib 2 MG and Dexamethasone in people with Immune Thrombocytopenia, run by Peking University People's Hospital at 10 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 12 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Xiaohui Zhang (+8613522338836, zhangxh@bjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Durable response (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05932524.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2023.

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