BUDOPRUTUG for Immune thrombocytopenia (ITP)|Primary immune thrombocytopenia

Inclusion criteria

• {"criterion_text":"- 1. Aged > 18 years at the time of informed consent.\n- 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.\n- 3. Partial thromboplastin time < 1.5 × upper limit of normal (ULN), prothrombin time < 1.5 × ULN, total bilirubin < 1.5 × ULN unless due to Gilbert’s syndrome, or an international normalized ratio < 1.5 at screening.\n- 4. Adequate hematologic, hepatic, and renal function\n- 5. If being treated with corticosteroids or thrombopoietin (TPO) agonists, subjects must be on a stable dose (< 20% change in dose over the 14 days prior to the first dose of study drug). Corticosteroid treatment should not be > 1 mg/kg methylprednisolone (or equivalent) for 2 weeks prior to the first dose of study drug.\n- 6. Diagnosed with primary ITP"}

Exclusion criteria

• {"criterion_text":"- 1. CD19+ B-cell count < 80 cells/μL at Screening or < 40 cells/μL if B-cell depleting treatment was received within 24 weeks to 2 years prior to Screening.\n- 2. Diagnosis of paroxysmal nocturnal hemoglobinuria, Evan’s Syndrome, or any other bleeding disorder that could confound results and impact patient safety.\n- 3. Prior treatment with rituximab or other B-cell depleting agents within 24 weeks prior to the first dose of study drug or plan to receive B-cell depleting agents during the study.\n- 4. Current or planned treatment with any chronic anticoagulants or platelet aggregation-inhibiting drugs such as aspirin, nonsteroidal anti-inflammatory drugs, or thienopyridines within 14 days of planned dosing through the end of follow-up. Symptom-based intermittent dosing of nonsteroidal anti-inflammatory drugs is permitted.\n- 5. Prior treatment with immunosuppressants (other than corticosteroids) within 30 days or 5 times the elimination half-life (whichever is longer) of the Screening Visit (e.g., calcineurin inhibitors, mycophenolate mofetil, azathioprine), or alkylating agents within 180 days of the Screening Visit.\n- 6. Active or uncontrolled infection at the time of informed consent or study drug initiation.\n- 7. Recent hospitalization for any reason within 14 days prior to Screening, unless approved by the Medical Monitor.\n- 8. Receipt of a live vaccine within 28 days prior to the first dose of study drug or during the study. All other vaccines must be completed within 21 days prior to the first dose of study drug.\n- 9. Secondary cause of ITP (e.g., malignancy, hepatitis B or C, HIV, or other autoimmune diseases [e.g., thyroiditis], or drug-induced ITP)."}

Primary endpoints

• {"endpoint_text":"- 1. Incidence, relatedness, severity, and duration of treatment-emergent adverse events (TEAEs) and dose-limiting toxicities (DLTs).","definition_or_measurement_approach":""}

Secondary endpoints

• {"endpoint_text":"- 1. Budoprutug PK parameters (including area under the concentration-time curve, time to maximum observed concentration, terminal half-life, apparent clearance, and volume of distribution).","definition_or_measurement_approach":"PK parameters as listed (AUC, Tmax, terminal half-life, apparent clearance, volume of distribution) to be determined from plasma concentration-time data."}
• {"endpoint_text":"- 2. The change from baseline in absolute peripheral cluster of differentiation (CD)20+ B-cell count.","definition_or_measurement_approach":"Change from baseline in absolute peripheral CD20+ B-cell count measured over time."}
• {"endpoint_text":"- 3. The change in platelet count observed with budoprutug over time in subjects with ITP.","definition_or_measurement_approach":"Absolute platelet count change from baseline measured at scheduled timepoints."}
• {"endpoint_text":"- 4. The percentage of subjects with ITP who achieve a stable, partial, and complete response by Week 12. Note: A stable, partial, and complete response is defined as a platelet count ≥ 30,000/μL, ≥ 50,000/μL, or ≥ 100,000/μL, respectively, on at least 2 occasions at least 7 days apart within a 30-day time frame.","definition_or_measurement_approach":"Responder rates by Week 12 using platelet count thresholds with requirement of ≥2 measurements at least 7 days apart within 30 days as defined in the endpoint."}
• {"endpoint_text":"- 5. The change in serum IgG, IgM, and IgA from baseline over time.","definition_or_measurement_approach":"Change from baseline in serum immunoglobulin (IgG, IgM, IgA) concentrations measured over time."}
• {"endpoint_text":"- 6. The incidence of subjects who develop ADAs at any time after study drug administration.","definition_or_measurement_approach":"Incidence of anti-drug antibodies (ADAs) measured post-dose at designated timepoints."}
• {"endpoint_text":"- 7. The percentage of subjects on a steroid at baseline who are able to stop steroid treatment.","definition_or_measurement_approach":"Proportion of baseline steroid-treated subjects who discontinue steroid therapy during follow-up."}

Bulgaria

Earliest CTIS Part Ii Submission Date

12-06-2025

Latest Decision Or Authorization Date

27-06-2025

Processing Time Days

15

Number Of Sites

3

Number Of Participants

3

Greece

Earliest CTIS Part Ii Submission Date

28-03-2025

Latest Decision Or Authorization Date

27-06-2025

Processing Time Days

91

Number Of Sites

4

Number Of Participants

4

Spain

Earliest CTIS Part Ii Submission Date

30-05-2025

Latest Decision Or Authorization Date

23-06-2025

Processing Time Days

24

Number Of Sites

6

Number Of Participants

6

Primary sponsor

Full Name

Climb Bio Inc.

Organisation Type

Pharmaceutical company

Country Of Registered Address

United States

Contract research organisations

Name

PPD Global Ltd.

Responsibilities

codes: 1; 12; 2 (operational/study management and associated duties as listed)

Name

PPD Development LP

Responsibilities

codes: 1; 12; 2; 5; 8 (operational/study management, regulatory and pharmacovigilance roles as listed)

Name

PPD Global Central Labs

Responsibilities

B-cell subsets flow cytometry assay validation and sample analysis; code 4

Third parties

• {"country":"United States","full_name":"Bioagilytix Labs LLC","duties_or_roles":"PK and ADA assay validation and sample analysis - bioanalytical; code 4","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Merative US LP","duties_or_roles":"code 7","organisation_type":"Hospital/Clinic/Other health care facility"}
• {"country":"Greece","full_name":"PPD Global Ltd.","duties_or_roles":"codes: 1; 12; 2","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Mayo Collaborative Services LLC","duties_or_roles":"Anti Platelet AB Screen; code 4","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"Belgium","full_name":"MEDPACE LABORATORIES","duties_or_roles":"code 4","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United States","full_name":"Arup Laboratories Inc.","duties_or_roles":"Testing for Measles, Mumps, Rubella, Tetanus, Pneumococcus; code 4","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United States","full_name":"PPD Development LP","duties_or_roles":"codes: 1; 12; 2; 5; 8","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"PPD Development LP","duties_or_roles":"code 8","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Datafy Clinical LLC","duties_or_roles":"code 6","organisation_type":"Pharmaceutical company"}
• {"country":"Belgium","full_name":"PPD Global Central Labs","duties_or_roles":"B-cell subsets flow cytometry assay validation and sample analysis; code 4","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Llx Solutions LLC","duties_or_roles":"code 10","organisation_type":"Pharmaceutical company"}