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RecruitingNCT04176198Updated Oct 2, 2026

A Study of Oral Nuvisertib (TP-3654) in Patients With Myelofibrosis

A Phase 1/2 interventional study of Nusivertib and Ruxolitinib in Myelofibrosis, sponsored by Sumitomo Pharma America, Inc.. Recruiting at 91 sites in 10 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-02.

Sponsored by Sumitomo Pharma America, Inc. (part of Sumitomo Pharma Co., Ltd.) · Phase 1/2, Interventional, and Treatment

From the registry’s dates

  • Started Dec 2019; still recruiting 6 years 10 months later.
Updated Oct 2, 2026Site recruiting status changedGo to Updates ↓
Phase
Phase 1/2
Study type
Interventional
Enrollment
240
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

This study is a Phase 1/2, multicenter, dose-escalation, open-label trial to assess safety, tolerability, pharmacokinetics and pharmacodynamics of nuvisertib (TP-3654) in patients with intermediate or high-risk primary or secondary MF.

Read the detailed description

Arm 1 will enroll patients who have been previously treated and failed on a JAK inhibitor or ineligible to receive treatment with a JAK inhibitor.

Arm 2 will enroll patients who are on a stable dose of ruxolitinib, but who have either lost response or had a suboptimal or plateau in response.

Arm 3 will enroll patients who have been previously treated with a JAK inhibitor (except momelotinib)

02

Conditions studied

  • Myelofibrosis

Browse trials for

03

In context

Primary Myelofibrosis

625 studies on the registry are indexed under Primary Myelofibrosis; 124 are open to participants now.

This study's planned enrollment of 240 is above the median of 43 across 489 interventional studies indexed under Primary Myelofibrosis.

Browse Primary Myelofibrosis studies →

Lead sponsor

Sumitomo Pharma America, Inc. is the lead sponsor of 181 studies on the registry; 5 are open to participants now.

Of its 33 completed or terminated interventional studies of FDA-regulated products, 21 (64%) have results posted.

First submitted after Sumitomo Pharma America, Inc. became part of Sumitomo Pharma Co., Ltd..

Browse Sumitomo Pharma America, Inc. studies →All Sumitomo Pharma Co., Ltd. studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Patients must meet all of the following inclusion criteria to be eligible:

Nuvisertib (TP-3654) Monotherapy Arm:

  • Confirmed pathological diagnosis of primary myelofibrosis (PMF) or post-PV-MF/post-ET- MF and intermediate or high-risk primary or secondary MF
  • Previously treated with JAK inhibitor(s) and is intolerant, resistant, or has lost response to the JAK inhibitor(s) or is ineligible to be treated with JAK inhibitor
  • Fulfill the following clinical laboratory parameters:
  • count ≥ 25 x 10\^9 /L, without assistance of growth factors or platelet transfusions
  • ≥ 1 x 10\^9/L without assistance of granulocyte growth factors
  • Peripheral blood blast count \< 5%
  • performance status ≤ 1
  • ≥ 6 months
  • Adequate renal function
  • Adequate hepatic function
  • Adequate coagulation function
  • Splenomegaly (spleen volume of ≥ 450 cm3 by MRI or CT scan) within 2 weeks prior to Cycle 1 Day 1.
  • Dose escalation: At least 2 symptoms measurable (score ≥ 1) using the MF-SAF
  • Dose expansion: At least 2 symptoms measurable with each score of ≥ 3 or a total average score of ≥ 10 per MFSAF

Nuvisertib (TP-3654) + Ruxolitinib Arm:

  • Confirmed pathological diagnosis of PMF or post-PV-MF/post ET- MF and intermediate or high-risk primary or secondary MF
  • On ruxolitinib treatment for ≥ 6 months, and on a stable dose of ruxolitinib (5 to 25 mg BID) for ≥ 8 weeks prior to the first dose of nuvisertib, but has either lost response or had a suboptimal or plateau in response
  • Fulfills the following clinical laboratory parameters:
  • Platelet count ≥ 50 × 10\^9/L (without assistance of growth factors or platelet transfusions)
  • ANC ≥ 1 × 109/L without assistance of granulocyte growth factors
  • Peripheral blood blast count \< 5% at screening
  • Adequate renal function
  • Adequate hepatic function
  • Adequate coagulation function
  • Splenomegaly (spleen volume of ≥ 450 cm3 by MRI/CT scan) within 2 weeks prior to Cycle 1 Day 1
  • At least 2 symptoms measurable with each score ≥ 3 or a total average score of ≥ 10 per MFSAF v4.0
  • ECOG performance status ≤ 1
  • Life expectancy ≥ 6 months

Nuvisertib (TP-3654) + Momelotinib Arm

  • Confirmed pathological diagnosis of PMF or post-PV-MF/post ET-MF and intermediate or high-risk primary or secondary MF
  • Previously treated with an approved JAK inhibitor (except momelotinib) for PMF or Post-PV/ET MF for ≥ 12 weeks, or ≥ 4 weeks if JAK inhibitor therapy was complicated by a transfusion requirement of ≥ 4 units of red blood cells in 8 weeks, or Grade 3/4 AEs of thrombocytopenia, anemia, or hematoma
  • Fulfills the following clinical laboratory parameters:
  • Anemic, defined as \<10 g/dL or requiring RBC transfusion at baseline
  • Platelet count ≥ 50 × 109/L (without assistance of growth factors or platelet transfusions)
  • ANC ≥ 1 × 109/L without assistance of granulocyte growth factors
  • Peripheral blood blast count \< 5% at screening
  • Adequate renal function
  • Adequate hepatic function
  • Adequate coagulation function
  • Splenomegaly (spleen volume of ≥ 450 cm3 by MRI/CT scan) within 2 weeks prior to Cycle 1 Day 1
  • At least 2 symptoms measurable with each score of ≥ 3 or a total average score of ≥ 10 per MFSAF v4.0
  • ECOG performance status ≤ 1
  • Life expectancy ≥ 6 months

Patients meeting any one of these exclusion criteria will be prohibited from participating in this study:

Nuvisertib (TP-3654) Monotherapy Arm:

  • Received previous systemic antineoplastic therapy or any experimental therapy within 2 weeks or 5 half-lives, whichever is longer, prior to Cycle 1 Day 1. Hydroxyurea or anagrelide are allowed up to 24 hours prior to Cycle 1 Day 1).
  • Major surgery within 4 weeks prior to Cycle 1 Day 1 and/or not recovered adequately from from surgery prior to first dose.
  • Splenic irradiation within 6 months prior to Screening or prior splenectomy.
  • Prior stem cell transplant within the last 6 months.
  • Eligible for allogeneic bone marrow or stem cell transplantation.
  • Unresolved Grade ≥ 2 non-hematological toxicity related to prior treatment
  • History of symptomatic congestive heart failure, or myocardial infarction, or uncontrolled arrhythmia within 6 months prior to Cycle 1 Day 1; (LVEF) \< 45% by echocardiogram within 4 weeks prior to Cycle 1 Day 1.
  • interval > 480msec.
  • Prior or concurrent that could interfere with the regime.
  • Known history of chronic liver disease, e.g. portal hypertension or any of its complications, cirrhosis, C, auto-immune hepatitis, alpha-1 anti-trypsin deficiency, Wilson's disease, etc.
  • Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic antimicrobial within 1 week prior to Cycle 1 Day 1.
  • Chronic active or acute viral hepatitis A, B, or C infection (testing for and C are required)
  • Exhibited allergic reactions or sensitivity to nuvisertib, or similar compound.
  • Medical condition or GI tract surgery that could impair absorption or result in short bowel syndrome with diarrhea.
  • Systemic therapy (>10 mg daily prednisone or equivalent) within 1 week prior to the first dose of study treatment (note: topical, inhaled, nasal, and ophthalmic steroids are not prohibited).
  • Known anemia due to iron, vitamin B12, or folate deficiencies, or or hereditary hemolytic anemia, or thalassemia, or severe GI bleeding.
  • Pregnant or breastfeeding
  • Currently receiving any other investigational agent.

Nuvisertib (TP-3654) + Ruxolitinib Arm:

  • Received previous systemic antineoplastic therapy (other than ruxolitinib) or any other experimental therapy within 2 weeks or 5 half-lives, whichever is longer, prior to Cycle 1 Day 1 (Note: Prior treatment with nuvisertib is not allowed. Hydroxyurea or anagrelide are allowed up to 24 hours prior to Cycle 1 Day 1).
  • Received systemic steroid therapy (>10 mg daily prednisone or equivalent) within 1 week prior to Cycle 1 Day 1 (Note: Topical, inhaled, nasal, and ophthalmic steroids are not prohibited)
  • Known allergic reactions or sensitivity to nuvisertib, or similar compound.
  • Splenic irradiation within 6 months prior to Screening or prior splenectomy
  • Prior allogeneic stem cell transplant within the last 6 months (Note: Patients who have relapsed after 6 months post-transplant and do not have active are eligible).
  • Eligible for allogeneic bone marrow or stem cell transplantation (Note: Patients who are not willing to undergo transplantation or for whom a suitable donor is not available are considered as transplant ineligible.)
  • Major surgery within 4 weeks prior to Cycle 1 Day 1 and/or have not recovered adequately prior to first dose.
  • Active, uncontrolled bacterial, viral, or fungal infections, requiring parenteral antimicrobial within 1 week prior to Cycle 1 Day 1
  • Chronic active or acute viral hepatitis A, B, or C infection (testing for hepatitis B and C are required)
  • Known history of chronic liver disease (eg, portal hypertension or any of its complications, cirrhosis, Child-Pugh C, auto-immune hepatitis, alpha-1 anti-trypsin deficiency, Wilson's disease, etc) (Note: Abnormal liver morphology at baseline imaging may require additional testing, as needed).
  • Unresolved Grade ≥ 2 non-hematological adverse events related to prior treatment (stable Grade 2 conditions may be permitted in consultation with the Sponsor)
  • History of myocardial infarction or symptomatic congestive heart failure or uncontrolled arrhythmia within 6 months prior to Cycle 1 Day 1; LVEF \<45% by echocardiogram within 4 weeks prior to Cycle 1 Day 1
  • Corrected QTcF of > 480 msec
  • Prior or concurrent malignancy that could interfere with the safety or efficacy assessment of the study intervention
  • History of a medical condition or GI tract surgery that could impair absorption or could result in short bowel syndrome with diarrhea
  • Known clinically significant anemia due to iron, vitamin B12, or folate deficiencies, or autoimmune or hereditary hemolytic anemia, or thalassemia, or severe GI bleeding
  • Pregnant or breastfeeding

Nuvisertib (TP-3654) + Momelotinib Arm:

  • Received previous systemic antineoplastic therapy or any experimental therapy within 2 weeks or 5 half-lives, whichever is longer, prior to Cycle 1 Day 1 (Notes: Prior treatment with momelotinib or nuvisertib is not allowed; in patients with ongoing JAK inhibitor therapy, ie, ruxolitinib, at screening, JAK inhibitor therapy must be tapered over a period of at least 1 week. Patients on a low dose of ruxolitinib (eg, 5 mg QD) may have a reduced taper period or no taper; hydroxyurea or anagrelide are allowed up to 24 hours prior to Cycle 1 Day 1).
  • Received systemic steroid therapy (>10 mg daily prednisone or equivalent) within 1 week prior to Cycle 1 Day 1 (Note: Topical, inhaled, nasal, and ophthalmic steroids are not prohibited).
  • Known allergic reactions or sensitivity to nuvisertib, momelotinib, or any structurally similar drug, or to any component of the formulations of either study intervention
  • Splenic irradiation within 6 months prior to screening or prior splenectomy
  • Prior allogenic stem cell transplant within the last 6 months (Note: Patients who have relapsed after 6 months post-transplant and do not have active GVHD are eligible).
  • Eligible for allogeneic bone marrow or stem cell transplantation (Note: Patients who are not willing to undergo transplantation or for whom a suitable donor is not available are considered as transplant ineligible).
  • Major surgery within 4 weeks prior to Cycle 1 Day 1 and/or have not recovered adequately from surgery prior to first dose.
  • Active, uncontrolled bacterial, viral, or fungal infections, requiring parenteral antimicrobial within 1 week prior to Cycle 1 Day 1
  • Chronic active or acute viral hepatitis A, B, or C infection (testing for hepatitis B and C are required)
  • Known history of chronic liver disease (eg, portal hypertension or any of its complications, cirrhosis, Child-Pugh C, auto-immune hepatitis, alpha-1 anti-trypsin deficiency, Wilson's disease, etc) (Note: Abnormal liver morphology at baseline imaging may require additional testing, as needed)
  • Unresolved Grade ≥ 2 non-hematological adverse events related to prior treatment (stable Grade 2 conditions may be permitted in consultation with the Sponsor)
  • Presence of Grade ≥ 2 peripheral neuropathy
  • History of myocardial infarction or symptomatic congestive heart failure or uncontrolled arrhythmia within 6 months prior to Cycle 1 Day 1; LVEF \< 45% by echocardiogram within 4 weeks prior to Cycle 1 Day 1
  • Corrected QTcF of > 480 msec
  • Prior or concurrent malignancy that could interfere with the safety or efficacy assessment of the study intervention
  • History of a medical condition or GI tract surgery that could impair absorption or could result in short bowel syndrome with diarrhea
  • Known clinically significant anemia due to iron, vitamin B12, or folate deficiencies, or autoimmune or hereditary hemolytic anemia, or thalassemia, or severe GI bleeding
  • Pregnant or breastfeeding
Terms in these criteria, in plain language(17)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Relapsed and refractory

Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Absolute neutrophil count (ANC)

The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.

It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

Allogeneic and autologous transplant

Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

QT and QTc

On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.

The study may name a correction formula and a limit in milliseconds, often around 450–480.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Child-Pugh class

A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

GVHD (graft-versus-host disease)

After a transplant from a donor, the donor’s immune cells attack the recipient’s body, often the skin, gut or liver.

05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
240 participants (estimated)

Study arms

  • Experimental
    Arm 1: nuvisertib (TP-3654)

    Drug: Nusivertib

  • Experimental
    Arm 2: nuvisertib (TP-3654) added on to ruxolitinib

    Drug: Nusivertib · Drug: Ruxolitinib

  • Experimental
    Arm 3: nuvisertib (TP-3654) in combination with momelotinib

    Drug: Nusivertib · Drug: Momelotinib

Interventions

  • DrugNusivertib

    Oral PIM Inhibitor

    Also known as: TP-3654

  • DrugRuxolitinib

    Oral JAK inhibitor

    Also known as: Jakafi

  • DrugMomelotinib

    Oral JAK inhibitor

    Also known as: Ojjaara

06

What researchers measure

Primary outcomes

  1. Determine the incidence of dose-limiting toxicities (DLTs)

    Number of participants with DLTs

    Time frame: 28 days

  2. Determine the incidence of treatment emergent adverse events

    Number of participants with Treatment Emergent Adverse Events and Serious Adverse Events

    Time frame: From start of treatment to end of study

  3. Assess patients for any evidence of preliminary activity by determining the number of patients with ≥ 35% spleen volume reduction (SVR35)

    Number of participants with ≥ 35% spleen volume reduction (SVR35)

    Time frame: From start of treatment to end of study

Secondary outcomes

  1. Number of participants achieving objective response by IWG-MRT response criteria

    Number of participants achieving complete remission, partial remission, clinical improvement, progressive disease and stable disease.

    Time frame: From start of treatment to end of study

  2. Number of participants who have ≥ 25% spleen volume reduction

    Number of participants who have ≥ 25% spleen volume reduction compared to baseline

    Time frame: Every 12 weeks from cycle 1 day 1 through cycle 19 day 1, and then every 24 weeks therafter during treatment.

  3. Number of participants with ≥ 50% improvement in total symptom score (TSS50) at week 24

    Number of participants who have ≥ 50% total symptom score reduction by MFSAF compared to baseline after 24 weeks of treatment.

    Time frame: 24 weeks

  4. Determine the change in Patient Global Impression of Change (PGIC) at week 24 through end of study.

    Change in PGIC score

    Time frame: After 24 weeks of treatment to end of study

  5. Determine the incidence of QT interval changes

    Changes in QT interval and heart rhythm

    Time frame: 25 hours

  6. Establish the half-life (t½) of nuvisertib monotherapy, in combination with ruxolitinib, and in combination with momelotinib

    The estimate of time for the nuvisertib concentration or amount to be reduced by half

    Time frame: 24 hours

  7. Establish the Area under the plasma concentration versus time curve (AUC) of nuvisertib monotherapy, in combination with ruxolitinib, and in combination with momelotinib

    The amount of drug exposure over 24 hours period after administration

    Time frame: 24 hours

  8. Establish the Peak Plasma Concentration (Cmax) of nuvisertib monotherapy, in combination with ruxolitinib, and in combination with momelotinib

    The maximum nuvisertib concentration after administration

    Time frame: 24 hours

  9. Establish the Time of Maximum concentration observed (tmax) of nuvisertib monotherapy, in combination with ruxolitinib, and in combination with momelotinib

    The time to reach maximum nuvisertib concentration

    Time frame: 24 hours

Other outcomes

  1. Number of patients with reduction in bone marrow fibrosis

    Time frame: Every 24 weeks to end of study

  2. Study potential pharmacodynamic (PD) markers of nuvisertib

    Evaluate exploratory biomarkers, including change in protein phosphorylation and inflammatory cytokines, in peripheral blood samples and bone marrow biopsy samples.

    Time frame: 12 months

  3. Nuvisertib monotherapy: Changes in platelet count over time in patients with baseline platelet count < 100 x 10^9/L

    Time frame: From start of treatment to end of study

  4. Nuvisertib combination arms: Assess the increase in hemoglobin ≥1.5 or ≥ 2 g/dL from baseline

    Time frame: From start of treatment to end of study

  5. Nuvisertib combination arms: Assess red blood cell transfusion independence status or any requirement change

    Time frame: From start of treatment to end of study

  6. Establish overall survival

    The time interval from treatment start date to date of death from any cause

    Time frame: From start of treatment to end of study

07

Study locations

87 of 91 sites recruiting
08

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Dec 2019 (actual). Primary completion is estimated for Apr 2027, 88 months after the start.

Of 26 phase 1/2 interventional studies under Primary Myelofibrosis, half reached primary completion within 69 months of starting (the median), counting those still running; a quarter within 52 and three quarters within 125. This study's planned 88 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 8, 2019
First posted
Nov 25, 2019
StartActual
Dec 16, 2019
Primary completionEst.
Apr 30, 2027
CompletionEst.
Apr 30, 2030
Last update
Oct 2, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Sites
Juravinski Cancer Center is now Recruiting
Oct 2, 2026
Site contacts
Changed at 1 site. See the sites
Show the site
  • Nerima Hikarigaoka Hospital · Tokyo, JapanContact none listed→•••3611
Oct 2, 2026
Show all 1 update
  1. Oct 2, 2026
    Juravinski Cancer Center is now Recruiting
    Site contacts Changed at 1 site. See the sites
    Show the site
    • Nerima Hikarigaoka Hospital · Tokyo, JapanContact none listed→•••3611

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT04176198
Lead sponsor
Sumitomo Pharma America, Inc.
Responsible party
Sponsor
First posted
Nov 25, 2019
Start date
Dec 16, 2019
Primary completion
Apr 30, 2027 (estimated)
Completion
Apr 30, 2030 (estimated)
Last update
Oct 2, 2026

Study contacts

Reyna Bishop
Contact
reyna.bishop@us.sumitomo-pharma.com
617-674-6800
Jordan Simpson
Contact
jordan.simpson@us.sumitomo-pharma.com

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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