NCT07043946 A Phase 1b/2a Study of Budoprutug in Subjects With Immune Thrombocytopenia (ITP)
| NCT ID | NCT07043946 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Climb Bio, Inc. |
| Condition | Immune Thrombocytopenia (ITP) |
| Study Type | INTERVENTIONAL |
| Enrollment | 24 participants |
| Start Date | 2025-06-30 |
| Primary Completion | 2027-08 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 24 participants in total. It began in 2025-06-30 with a primary completion date of 2027-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The main objective is to assess the safety and tolerability of budoprutug in adults with ITP. Pharmacokinetics, pharmacodynamics, and preliminary clinical efficacy will also be assessed.
Eligibility Criteria
Inclusion Criteria: 1. Aged 18 years at the time of consent. 2. Platelet count \< 30,000/µL despite an adequate trial of at least one prior therapeutic attempt. Platelet counts of \< 30,000/µL must be confirmed on 2 occasions at least 5 days apart, but no more than 14 days apart. 3. Partial thromboplastin time \< 1.5 x upper limit of normal (ULN), prothrombin time \< 1.5 x ULN, total bilirubin \< 1.5 x ULN unless due to Gilbert's syndrome, or an international normalized ratio \< 1.5 at screening. Exclusion Criteria: 1. CD19+ B cell count \< 80 cells/µL at Screening, or \< 40 cells/µL if B-cell depleting therapy was received within 24 weeks to 2 years prior. 2. Diagnosis of paroxysmal nocturnal hemoglobinuria, Evan's Syndrome, or other bleeding disorders affecting safety or data integrity. 3. Prior B-cell depleting therapy (e.g., rituximab) within 24 weeks before first dose or planned during the study. 4. Chronic use of anticoagulants or antiplatelet agents (e.g., aspirin, NSAIDs, thienopyridines) within 14 days before dosing through follow-up. Intermittent NSAID use is allowed. 5. Immunosuppressants (excluding corticosteroids) within 30 days or 5× half-life before Screening; alkylating agents within 180 days. 6. IVIg treatment within 90 days prior to Screening. 7. Active ITP treatment (other than steroids or TPO agonists) within 30 days or 5× half-life before first dose, unless approved by Medical Monitor. 8. Active, chronic, or latent infections including hepatitis B/C or HIV. 9. Active TB or high TB risk.
Contact & Investigator
Study Director
STUDY DIRECTOR
Climb Bio, Inc.
Frequently Asked Questions
Who can join the NCT07043946 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Immune Thrombocytopenia (ITP). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07043946 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07043946 currently recruiting?
Yes, NCT07043946 is actively recruiting participants. Contact the research team at clinicaltrials@climbbio.com for enrollment information.
Where is the NCT07043946 trial being conducted?
This trial is being conducted at Plovdiv, Bulgaria, Plovdiv, Bulgaria, Sofia, Bulgaria, Athens, Greece and 11 additional locations.
Who is sponsoring the NCT07043946 clinical trial?
NCT07043946 is sponsored by Climb Bio, Inc.. The principal investigator is Study Director at Climb Bio, Inc.. The trial plans to enroll 24 participants.