Tests LY5830966 in adults with myelofibrosis after a prior JAK2 inhibitor
Tests a new pill, LY5830966, in adults with myelofibrosis, a bone marrow disease.
Plain-language title generated from the registry record
Registry title: A Phase 1 Study of LY5830966 in Participants With Primary Myelofibrosis (PMF), Post-Polycythemia Vera Myelofibrosis (PPV-MF), or Post-Essential Thrombocythemia Myelofibrosis (PET-MF) Who Have Been Failed by a Type I JAK2 Inhibitor (JAK2i)
Key facts
- Where
- Paris, FranceSee the site
- Phase
- Phase 1
Where in France
- Hopital Saint LouisParis, FranceTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Ajax Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company
- Trial code
- NCT06343805EU 2025-522033-64-00
- Record updated
- 9 October 2026
- Original description
J8G-MC-JDIA (AJX-101) is a first-in-human (FIH), phase 1, non-randomized, multi-center, open-label clinical trial designed to investigate the safety, tolerability, pharmacokinetics (PK), clinical activity and changes in biomarkers of an orally administered type II Janus Kinase 2 (JAK2) inhibitor, LY5830966, in participants with primary or secondary myelofibrosis previously treated with at least one type I JAK2 inhibitor.Read full original descriptionShow less
A Phase 1, Open-Label Study of LY5830966, a Type II JAK2 Inhibitor, in Patients With Myelofibrosis Previously Treated With a Type I JAK2 Inhibitor, JAK2 Inhibitor-Naïve Myelofibrosis, or High-risk Relapsed/Refractory Polycythemia Vera
J8G-MC-JDIA (AJX-101) is a first-in-human (FIH), phase 1, non-randomized, multi-center, open-label clinical trial designed to investigate the safety, tolerability, pharmacokinetics (PK), clinical activity and changes in biomarkers of an orally administered type II Janus Kinase 2 (JAK2) inhibitor, LY5830966, in participants with primary or secondary myelofibrosis previously treated with at least one type I JAK2 inhibitor.
Inclusion: Diagnosis of PMF, post-PV MF, or post-ET MF; Dynamic International Prognostic Scoring System (DIPSS) Intermediate-1, Intermediate-2 or High-risk MF with less than or equal to (≤)10% blasts, regardless of JAK2 mutation status; Estimated spleen volume greater than or equal to (≥)450 cubic centimeter (cm ³); Myelofibrosis Symptom Assessment Form, version 4.0 (MFSAF v.4.0) TSS ≥10, or at least 2 of 7 MFSAF-assessed symptoms with scores ≥3; Eastern Cooperative Oncology Group performance score (ECOG PS) of 0, 1, 2, or 3; Prior therapy with at least 1 type I JAK2 inhibitor, and either failed to achieve a response or relapsed after achieving a response; Absolute neutrophil count greater than or equal to 1,000 per microliter of blood (ANC ≥1.0×10\^9/L); Platelet count ≥75×10\^9/L; Estimated glomerular filtration rate greater than or equal to 45 milliliters per minute per 1.73 square meters (eGFR ≥45 mL/min/1.73m²); Serum total bilirubin ≤2.0 × upper limit of normal (ULN); Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3.0 × upper limit normal (ULN); QTcF ≤470 msec; Polycythemia vera (PV) Only; Confirmed diagnosis of PV; Participants must have high-risk disease as defined by 60 years of age or older and/or have prior history of thrombotic event; R/R or intolerant to at least one line of prior therapy including but not limited to interferon-based therapies, ruxolitinib, or hydroxyurea (HU) as defined by European LeukemiaNet (ELN) criteria.
Exclusion: Prior splenectomy or splenic irradiation within 3 months; Ongoing use of systemic corticosteroids at dose equivalent to greater than (>) 20 milligrams per day (mg/day) of prednisone; Chemotherapy in the previous 4 weeks or prior JAK2 inhibitor not discontinued per required washout prior to first dose; Requirement for therapy with a medication that is a strong Cytochrome P450 3A4 CYP3A4 inhibitor as a concomitant medication; Currently on an interventional therapeutic trial in the treatment phase; Prior treatment with JAK2 inhibitors; High-risk R/R PV only:; Prior PV-directed therapy without required washout; Active or chronic bleeding within 2 months prior to enrollment; Clinically significant thrombosis (e.g., pulmonary embolism, deep vein thrombosis, or splenic vein thrombosis) within 2 months prior to enrollment; Active, uncontrolled systemic infection or active Hepatitis B or C; Significant cardiovascular disease; Active second primary malignancy (or diagnosed within 2 years) at high risk of progression, with standard exceptions (treated skin cancer, in situ cervical cancer, curatively treated localized breast/prostate cancer); Individual with a history of (noninfectious) pneumonitis/interstitial lung disease; First line (1L) MF only:; Peripheral neuropathy ≥ Grade 2 (NCI CTCAE v 5.0); Pregnant or breastfeeding: males planning to father a child during treatment and for 3 months after last dose; Prolongation of the corrected QTcF ≥470 millisecond during screening; Requires phlebotomy at hematocrit levels <45%.