Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New drug may reduce blood transfusions for anemia patients

NCT ID NCT06847867

Disease control Sponsor: GlaxoSmithKline Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a drug called momelotinib in 80 adults with low-risk myelodysplastic syndromes who have anemia. The goal is to see if it can help them need fewer red blood cell transfusions. Participants will receive different doses to find the safest and most effective one.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 80 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2025

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion criteria * Age ≥18 years or of legal age of consent in the jurisdiction in which the study is taking place, at the time of signing the informed consent form (ICF). * Documented diagnosis of MDS according to the World Health Organization classifications with an Revised International Prognostic Scoring System (IPSS-R) classification of very low, low, or intermediate risk disease, with an overall risk score ≤3.5 and bone marrow blasts \< 5%. * Received only one prior line of treatment with either Erythropoiesis-stimulating agent (ESA) or luspatercept for LR-MDS-related anemia that is relapsed/refractory to therapy. Participants intolerant OR ineligible to prior ESA or luspatercept will fulfill this inclusion criterion provided the definition below is met. * Refractory to prior treatment: documentation of loss of erythroid (E) response or never achieved HI-E response as defined by the IWG 2018 criteria. * Intolerant to prior treatment: documentation of reasons for discontinuation of prior ESA containing regimen, either as single agent or combination (e.g., G-CSF) or luspatercept due to intolerance or adverse event. * ESA ineligible: low chance of response to ESA based on endogenous serum erythropoietin level \> 200 U/L for participants not previously treated with ESAs. * Red blood cell transfusion dependence, defined as requiring ≥3 units of Packed red blood cells (pRBC) transfused over 16-week period in at least 2 transfusions episodes during the 16 weeks preceding randomization. Documentation of a participant's transfusion policy during this 16-week period is required. * A female participant is eligible to participate if she is not pregnant or breastfeeding and one of the following conditions applies: * Is a woman of non-childbearing potential (WONCBP). OR * Is a woman of childbearing potential (WOCBP) and using a contraceptive method. * Is capable of giving signed informed consent. * Eastern Cooperative Oncology Group performance status ≤2. * Adequate organ function. Exclusion criteria * Prior treatment with the following with noted time periods: 1. Janus kinase (JAK)1/2 inhibitors; 2. ACVR1 inhibitors, 3. ACTRII receptor ligand trap other than luspatercept 4. Hypomethylating agents or other disease modifying agents (i.e., IMiDs) and immunosuppressive therapy for MDS 5. ESA within 4 weeks, or 8 weeks for long-acting ESA. 6. Growth factors (i.e., G-CSF, GM-CSF) within 4 weeks. 7. Luspatercept within 8 weeks. 8. Investigational agents within 4 weeks or 5 half-lives, whichever is longer. 9. Corticosteroids for treatment of the underlying disease within 28 days. Supportive care use of steroids for non-MDS indications may be used provided participant is on a stable dose equivalent to ≤10 mg prednisone per day. 10. Other active anti-MDS therapy not otherwise listed within 28 days or 5 half-lives whichever is longer. 11. Potent cytochrome P450 3A4 (CYP3A4) inducers, except for rifampin and rifampicin, within 14 days prior to the first dose of momelotinib. 12. Has received a live vaccine within 30 days. * Prior allogeneic or autologous stem cell transplant. * Has had any major surgery within 28 days prior to randomization. * Ongoing adverse reaction(s) from prior therapy that have not recovered to ≤Grade 1 or to the baseline status preceding prior therapy, except if the investigator, with the agreement of the sponsor, considers to be not clinically relevant for the tolerability of study intervention in the current clinical study. * MDS associated with del 5q cytogenetic abnormality. * MDS/ Myeloproliferative neoplasm (MPN) overlap disorders (e.g., Chronic Myelomonocytic Leukemia \[CMML\]). * Secondary MDS (i.e., MDS that is known to have arisen as the result of chemical injury, treatment with chemotherapy, and/or radiation for other diseases). * Known history of diagnosis of acute myeloid leukemia. * Known clinically significant anemia due to iron, vitamin B12, or folate deficiencies, or autoimmune or hereditary hemolytic anemia, gastrointestinal bleeding, or thalassemia. * Diagnosis of invasive malignancy or history of invasive malignancy other than the disease under study within the last 5 years, except as noted below: 1. History of an invasive malignancy for which the participant was definitively treated, and in which the participant has been disease free for at least 2 years, and which, in the opinion of the principal investigator and medical monitor, is not expected to affect the evaluation of the effects of the study intervention on the currently targeted disease under study. 2. Curatively treated basal cell carcinoma of the skin, superficial bladder cancer, squamous cell carcinoma of the skin, in situ cervical cancer, and/or in situ breast cancer may be enrolled. 3. Incidental histologic finding of prostate cancer (T1a or T1b using the Tumor, nodes, metastasis \[TNM\] clinical staging system). * Uncontrolled intercurrent illness including, but not limited to: 1. Active uncontrolled infection (participants receiving outpatient antibacterial and/or antiviral treatments for infection that is under control or as infection prophylaxis may be included in the trial); or 2. Significant active or chronic bleeding event ≥Grade 2 per Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0) within 4 weeks prior randomization. 3. Uncontrolled acute and chronic liver disease (e.g., Child-Pugh score ≥10) OR has current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice, or cirrhosis. * Any of the following conditions within 6 months prior to randomization: 1. Unstable angina pectoris. 2. Symptomatic congestive heart failure. 3. Uncontrolled cardiac arrhythmia. * QTc interval \>480 milliseconds (msec) (corrected using Fridericia formula). * Psychiatric illness, social situation, or any other condition that would limit compliance with trial requirements or may interfere with the interpretation of study results, as judged by investigator or sponsor. * Presence of peripheral neuropathy ≥Grade 2 per CTCAE v5.0. * Known positive status for human immunodeficiency virus (HIV). * Hepatitis B or C status as defined below: 1. Active Hepatitis B infection indicated by the presence of hepatitis B surface antigen (HBsAg) at screening or within 3 months prior to the first dose of study intervention. 2. Positive hepatitis C antibody test result at screening or within 3 months before the first dose of study intervention. Has any clinically significant gastrointestinal conditions or abnormalities that may alter absorption, e.g., uncontrolled nausea, vomiting, malabsorption syndrome or major resection of the stomach and/or bowels. * Is unable to swallow and/or retain oral medications. * Known contraindication or hypersensitivity to momelotinib and its metabolites, or any of their excipients.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Myelodysplastic syndromes are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

myelodysplastic syndrome Myelodysplastic Syndromes

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Myelodysplastic syndromes

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    39 sites in 9 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • GSK Investigational Site

    RECRUITING

    Goodyear, Arizona, 85338, United States

  • GSK Investigational Site

    RECRUITING

    Duarte, California, 91010-3012, United States

  • GSK Investigational Site

    RECRUITING

    Irvine, California, 92618, United States

  • GSK Investigational Site

    RECRUITING

    New Haven, Connecticut, 06519-1110, United States

  • GSK Investigational Site

    RECRUITING

    Canton, Ohio, 44718, United States

  • GSK Investigational Site

    RECRUITING

    Houston, Texas, 77030, United States

  • GSK Investigational Site

    RECRUITING

    Calgary, Alberta, T2N 5G2, Canada

  • GSK Investigational Site

    RECRUITING

    Toronto, Ontario, M5G 2M9, Canada

  • GSK Investigational Site

    RECRUITING

    Le Mans, 72015, France

  • GSK Investigational Site

    RECRUITING

    Nice, 06202, France

  • GSK Investigational Site

    RECRUITING

    Paris, 75010, France

  • GSK Investigational Site

    RECRUITING

    Poitiers, 86021, France

  • GSK Investigational Site

    RECRUITING

    Toulouse, 31059, France

  • GSK Investigational Site

    RECRUITING

    Münster, North Rhine-Westphalia, 48149, Germany

  • GSK Investigational Site

    RECRUITING

    Dresden, 01307, Germany

  • GSK Investigational Site

    RECRUITING

    Leipzig, 04103, Germany

  • GSK Investigational Site

    RECRUITING

    Udine, Friuli Venezia Giulia, 33100, Italy

  • GSK Investigational Site

    RECRUITING

    Catania, 95123, Italy

  • GSK Investigational Site

    RECRUITING

    Florence, 50134, Italy

  • GSK Investigational Site

    RECRUITING

    Milan, 20122, Italy

  • GSK Investigational Site

    RECRUITING

    Orbassano to, 10043, Italy

  • GSK Investigational Site

    RECRUITING

    Rozzano MI, 20089, Italy

  • GSK Investigational Site

    RECRUITING

    Chorzów, Silesian Voivodeship, 40-523, Poland

  • GSK Investigational Site

    RECRUITING

    Warsaw, 02-172, Poland

  • GSK Investigational Site

    RECRUITING

    Seongnam-si Gyeonggi-do, 13620, South Korea

  • GSK Investigational Site

    RECRUITING

    Seoul, 03080, South Korea

  • GSK Investigational Site

    RECRUITING

    Seoul, 05505, South Korea

  • GSK Investigational Site

    RECRUITING

    Seoul, 06591, South Korea

  • GSK Investigational Site

    RECRUITING

    Barcelona, 8035, Spain

  • GSK Investigational Site

    RECRUITING

    Barcelona, 8907, Spain

  • GSK Investigational Site

    RECRUITING

    Madrid, 28027, Spain

  • GSK Investigational Site

    RECRUITING

    Málaga, 29010, Spain

  • GSK Investigational Site

    RECRUITING

    Ourense, 32005, Spain

  • GSK Investigational Site

    RECRUITING

    PamplonaNavarra, 31008, Spain

  • GSK Investigational Site

    RECRUITING

    Salamanca, 37007, Spain

  • GSK Investigational Site

    RECRUITING

    Valencia, 46010, Spain

  • GSK Investigational Site

    RECRUITING

    Boston, PE21 9QS, United Kingdom

  • GSK Investigational Site

    RECRUITING

    London, SE5 9RS, United Kingdom

  • GSK Investigational Site

    RECRUITING

    Manchester, M20 4BX, United Kingdom

More trials for these conditions

Other studies related to the condition(s) this trial covers.