NCT06196203 · Akeso
A Study of AK117 in Combination With Azacitidine in Patients With Myelodysplastic Syndromes
What this study is about
This is a Phase 2 randomly assigned, where neither patients nor doctors know which treatment is given, compared against an inactive treatment, conducted at multiple hospitals study evaluating the effectiveness and safety of AK117 or placebo, combined with azacitidine in patients with newly diagnosed higher-risk myelodysplastic syndromes (HR-MDS).
View original scientific description
This is a Phase 2 randomized, double-blind, placebo-controlled, multicenter study evaluating the efficacy and safety of AK117 or placebo, combined with azacitidine in patients with newly diagnosed higher-risk myelodysplastic syndromes (HR-MDS).
Interventions
DRUG
AK117
AK117 IV injection
DRUG
Placebo
Placebo IV injection
DRUG
Azacitidine
Azacitidine SC injection
Primary outcome measures
Complete remission rate (CRR)
Time frame: Up to approximately 2 years
CRR is defined as the proportion of subjects with complete remission (CR) per International Working Group (IWG) 2023 criteria
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Age ≥ 18 years old at the time of enrolment.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2.
- Expected life expectancy ≥ 3 months.
- Newly diagnosed HR-MDS, according to the 2016 World Health Organization (WHO) classification with the presence of \< 20% blasts in bone marrow or peripheral blood; Overall IPSS-R score ≥ 3.5.
- Ability to undergo the study-required bone marrow sample collection procedures.
- Suitable venous access for the study-required blood sampling (i.e., including PK and immunogenicity).
- Female patients of childbearing age must have negative serum pregnancy test results before randomization or per region-specific guidance documented in the informed consent and a negative urine pregnancy test on the day of first dose prior to dosing.
- Female patients of childbearing potential having sex with an unsterilized male partner must agree to use a highly effective method of contraception from the beginning of screening
Where
- Los Angeles, California
- Aurora, Colorado
- New Haven, Connecticut
- Orange City, Florida
- Bethesda, Maryland
- Columbia, Maryland
- St Louis, Missouri
- The Bronx, New York
- Chapel Hill, North Carolina
- Canton, Ohio
- Columbus, Ohio
- Eugene, Oregon
And 2 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 11, 2025 · Source of record for eligibility and locations