A Study to Evaluate How Ontamalimab Works and Assess Its Safety and Tolerability in People With N… (NCT07052682) | Clinical Trial Compass
TerminatedPhase 1
A Study to Evaluate How Ontamalimab Works and Assess Its Safety and Tolerability in People With Nonalcoholic Steatohepatitis With Fibrosis Stages 1 to 4
Stopped: Study was terminated early by the sponsor due to a strategic shift and reprioritization of clinical programs within Takeda.
United States11 participantsStarted 2023-01-18
Plain-language summary
The main aim of this study is to evaluate the safety and tolerability of ontamalimab in participants with a liver disease called nonalcoholic steatohepatitis (NASH) or metabolic dysfunction-associated steatohepatitis (MASH) with scarring in the liver (fibrosis stage 1 to 4). The study will also check if there are any important changes in the body's health markers (biomarkers) from the beginning of the study to see if ontamalimab stops liver scarring and reduces inflammation of the liver.
Participants will be in the study for approximately up to 46 weeks.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion criteria
✓. The participant is willing and able to understand and fully comply with study procedures and requirements, in the opinion of the investigator.
✓. The participant and/or the participant's legally acceptable representative has provided informed consent (that is, in writing, documented via a signed and dated informed consent form \[ICF\] or electronic consent \[eConsent\] if applicable) and any required privacy authorization prior to the initiation of any study procedures.
✓. The participant is aged 18 to 70 years, inclusive, at the time of signing the ICF.
✓. The participant has signs of fibrogenic activity (Pro-C3 greater than or equal to \[\>=\] 12.6 nanograms per milliliter \[ng/mL\], ELF score \>=7.7) at the Week -8 (screening visit 1 \[SV1\]) (applies to all participants regardless of whether historical biopsy results are available at screening).
✓. The participant has indication of NASH via biopsy (Nonalcoholic fatty liver disease activity score \[NAS\] \>=3 with at least 1 point in lobular inflammation) and liver fibrosis stage 1 (F1) through fibrosis stage 4 compensated cirrhotic (F4cc) according to NASH Clinical Research Network (CRN).
✓. The participant is a male participant or a nonpregnant, nonlactating female participant who, if sexually active, agrees to comply with the contraceptive requirements of the protocol, or a female participant of nonchildbearing potential. Participants of reproductive potential who are sexually active must agree to use appropriate contraception (that is, highly effective methods for female participants and medically appropriate methods for male participants) for the duration of the study and for at least 12 weeks after the last dose of study drug.
What they're measuring
1
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Timeframe: From first dose of study drug up to Week 36
2
Number of Participants With Clinically Significant Abnormalities in Clinical Laboratory Values
Timeframe: From first dose of study drug up to Week 36
3
Number of Participants With Clinically Significant Abnormalities in 12-lead Electrocardiogram (ECGs) Findings
Timeframe: From first dose of study drug up to Week 24
4
Number of Participants With Clinically Significant Abnormalities in Vital Signs
Timeframe: From first dose of study drug up to 36 weeks
5
Number of Participants With Clinically Significant Abnormalities in Body Weight
Timeframe: From first dose of study drug up to Week 36
✓. The participant, if capable of breastfeeding, agrees to forego breastfeeding for the period from informed consent until 12 weeks after the last dose of study drug.
Exclusion criteria
✕. The following laboratory findings are exclusionary for all participants if found during screening visits (Week -8 \[SV1\], Week -6 \[SV2\] or at Day -4 visit \[Visit 4a2\]):
✕. Aspartate aminotransferase (AST) levels greater than (\>) 5\*the upper limit of normal (ULN).
✕. The following laboratory findings are exclusionary for all participants if found during either screening visit (SV1 or SV2):
✕. Alkaline phosphatase (ALP) \>=2\*ULN.
✕. Serum creatinine \>=1.5\*ULN or has an estimated glomerular filtration rate (eGFR) less than (\<) 45 milliliters per minute per 1.73 square meters (mL/min/1.73 m\^2).
✕. International normalized ratio (INR) \>=1.3 (except for participants who are receiving anticoagulant treatment).
✕. Total bilirubin level (TBL) \>=ULN (except for participants with a documented history of Gilbert's syndrome if direct bilirubin is within normal reference range).