A Study of Pirtobrutinib in Participants With Immune Thrombocytopenia

Part of paid clinical trials in Los Angeles, California.

Sponsor
Eli Lilly and Company
Study ID
NCT06721013
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Immune Thrombocytopenia (ITP)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pirtobrutinib — DRUG
    Administered orally
  • Placebo — DRUG
    Administered orally

Study Details

The purpose of the phase 1 part of this study is to evaluate how well pirtobrutinib is tolerated and what side effects may occur. The phase 2 part of the study will further investigate efficacy and safety of multiple pirtobrutinib dosages versus placebo. The study drug will be administered orally in participants with Primary Immune Thrombocytopenia (ITP). Blood tests will be performed to check how much pirtobrutinib gets into the bloodstream and how long it takes the body to eliminate it. The study will last up to approximately 16 weeks for phase 1 dose-escalation and 28 weeks for phase 2 dose-optimization, excluding screening.

Key Dates

Start date
Jul 30, 2025
Status verified
May 2026
Primary completion
Dec 31, 2026
Completion
Feb 28, 2027

Study Design

Enrollment
58 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Pirtobrutinib Phase 1
    Pirtobrutinib administered orally
  • Experimental: Pirtobrutinib Phase 2
    Pirtobrutinib administered orally
  • Placebo Comparator: Placebo Phase 2
    Placebo administered orally

Primary Outcome Measure

Phase 1-Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration [ Time Frame: Baseline Up to Week 4 ]

Central Contacts

  • Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
    1-317-615-4559
    [email protected]
  • Physicians interested in becoming principal investigators please contact
    [email protected]

Locations (11)

FacilityCityStateZIPSite coordinators
USC Norris Comprehensive Cancer CenterLos AngelesCalifornia90033-
Stanford UniversityStanfordCalifornia94305-5406-
MedStar Georgetown University HospitalWashington D.C.District of Columbia20007-
University of Miami Hospital and Clinics Sylvester Comprehensive Cancer CenterMiamiFlorida33136-
Bleeding and Clotting Disorders InstitutePeoriaIllinois61614-
Ochsner Clinic FoundationNew OrleansLouisiana70121-
Mayo ClinicRochesterMinnesota55905-
Clinical Research AllianceWestburyNew York11590-
Texas Oncology - Central SouthAustinTexas78758-
MD Anderson Cancer CenterHoustonTexas77030-
Texas Oncology Gulf CoastThe WoodlandsTexas77380-

Find similar trials in Los Angeles, CA

By research site
USC Norris Comprehensive Cancer Center· Los Angeles, CAStanford University· Stanford, CAMedStar Georgetown University Hospital· Washington D.C., DCUniversity of Miami Hospital and Clinics Sylvester Comprehensive Cancer Center· Miami, FLBleeding and Clotting Disorders Institute· Peoria, ILOchsner Clinic Foundation· New Orleans, LA

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