Alcoholic Liver DiseasePhase 1NCT04736966
Guselkumab (Anti-IL 23 Monoclonal Antibody) for Alcohol Associated Liver Disease
A Phase 1 study testing Guselkumab 30mg, Guselkumab 70mg and Guselkumab 100mg in people with Alcoholic Liver Disease, run by University of California, San Diego at 1 site in United States.
Trial summary
A Phase I clinical trial to determine the safety and tolerability of an anti-IL23 antibody for the treatment of patients with alcoholic liver disease Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Alcoholic Liver Disease
- What is being tested?
- Guselkumab 30mg, Guselkumab 70mg and Guselkumab 100mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Mar 2021to 31 Mar 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to provide written informed consent (either from patient or patient's legally acceptable representative)
- Male or female patients 21 years of age or older with BMI ≥ 20 to ≤ 45 kg/m2
- Patients with moderate alcohol use disorder (AUD) as defined by the AASLD Practice Guidance to have ≥ 4 symptoms out of 11:
- Alcohol is often taken in larger amounts and/or over a longer period than the patient intended.
- Persistent attempts or one or more unsuccessful efforts made to cut down or control alcohol use.
- A great deal of time is spent in activities necessary to obtain alcohol, use alcohol, or recover from effects.
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- Craving or strong desire or urge to use alcohol
- Recurrent alcohol use resulting in a failure to fulfill major role obligations at work, school, or home.
- Continued alcohol use despite having persistent or recurrent social or interpersonal problem caused or exacerbated by the effects of the alcohol.
- Important social, occupational or recreational activities given up or reduced because of alcohol use.
- Recurrent alcohol use in situations in which it is physically hazardous.
- Alcohol use is continued despite knowledge of having a persistent or recurrent physical or psychological problem that is likely to have been caused or exacerbated by the alcohol.
- Tolerance, as defined by either of the following:
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- Markedly increased amounts of the alcohol in order to achieve intoxication or desired effect
- Markedly diminished effect with continued use of the same amount
- Withdrawal, as manifested by either of the following:
- The characteristic alcohol withdrawal syndrome or
- Alcohol (or a closely related substance) is taken to relieve or avoid withdrawal symptoms
- Evidence of end-organ damage to the liver as defined by
- MRI-PDFF ≥ 8% suggestive of significant hepatic accumulation of triglyceride within 3 months of screening; if patients cannot get an MRI, CAP ≥ 300dB/m
- Consumed alcohol within 12 weeks of entry into the study, AND
- AST and ALT less than 200 U/L AND
- No evidence of active infection as determined by the investigator.
- Women of child-bearing potential (defined as females who are not surgically sterile or who are not over the age of 52 and amenorrheic for at least 12 months) must utilize appropriate birth control throughout the study duration. Acceptable methods that may be used are abstinence, birth control pills ("The Pill") or patch, diaphragm, intrauterine device (IUD/ coil), vaginal ring, condom, surgical sterilization or progestin implant or injection, or sexual activity limited to a sterile (e.g., vasectomized) male partner.
- Male patients must agree to use a medically acceptable method of contraception/birth control throughout the study duration.
Who cannot join
- History or evidence of other or concomitant cause(s) of liver disease as a result of:
- Autoimmune liver disease
- Wilson disease (ceruloplasmin levels < 10 mcg/L)
- Vascular liver disease
- Drug induced liver disease
- Surface antigen positive hepatitis B (HBsAg+). Note: patients with isolated core antibody (HBcAb) are not excluded.
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- Acute hepatitis A
- Acute HCV or chronic hepatitis C with a history of decompensated cirrhosis. (Note: patients with stable chronic Hep C Virus (HCV) or successfully treated HCV are not excluded. Anti-HBc antibody positive patients will be given a prophylaxis with entecavir 0.5mg PO once daily, starting one week prior to start of guselkumab to 6 months after the last dose of guselkumab)
- Noninvasive criteria to exclude cirrhosis:
- MRE ≥ 3.63 kPa; if MRE not available, VCTE ≥ 16 kPa
- FIB-4 ≥ 2.67
- Imaging evidence of varices, splenomegaly, ascites, or shrunken cirrhotic liver
- Co-infection with human immunodeficiency virus (HIV)
- History or evidence of positive Urine Drug Screen (amphetamines, barbiturates, benzodiazepines, cocaine and opiates) except THC and legal prescription medications.
- Any active malignancies other than curatively treated skin cancer (basal cell or squamous cell carcinomas) or any other malignancy diagnosed within the last five years
- History or evidence of active tuberculosis
- Positive Quantiferon test
- Significant systemic or major illness other than liver disease, including coronary artery disease, cerebrovascular disease, pulmonary disease, renal failure, serious psychiatric disease, that, in the opinion of the Investigator would preclude the patient from participating in and completing the study
- Patients requiring the use of vasopressors or inotropic support.
- Any patient that has received any investigational drug within 30 days of dosing or who is scheduled to receive another investigational drug at any time during the study
- Patients who are taking drug products that are primarily the substrates of CYP2C8, such as chloroquine, paclitaxel, rosiglitazone, repaglinide
- If female, known pregnancy, or has a positive serum pregnancy test, or is lactating/breastfeeding
- Serum creatinine > 1.5 mg/dL
- Patients who have had organ transplantation (such as liver, kidney, lung, heart, bone marrow, or stem cell etc.), other than cornea transplant
- Presence of cirrhosis on imaging or any of following lab parameters:
- Albumin < 3.7 g/dL
- Direct bilirubin > 0.5 mg/dl unless due to Gilbert's syndrome
- Platelets < 140K
- INR > 1.3
- Presence of any features of portal hypertension such as ascites, history of ascites or varices, or encephalopathy
- Previous use of guselkumab ( or another IL-23 inhibitors) or hypersentivity to guselkumab
- Previous history of skin cancers in the last one year
- Previous history of breast or prostate cancer or any cancer within the last 5 years
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Diego
La Jolla, California, 92093
About this study
Official title: A Phase I Clinical Trial to Determine the Safety and Tolerability of Anti-IL23 Monoclonal Antibody, for the Treatment of Patients With Alcohol Associated Liver Disease
A Phase I clinical trial to determine the safety and tolerability of an anti-IL23 antibody for the treatment of patients with alcoholic liver disease
Read the detailed description
This is a phase I study of guselkumab, a humanized anti-IL23 monoclonal antibody, for patients with alcoholic liver disease. This drug is approved for the use in psoriatic arthritis but not for alcoholic liver disease. The investigators will be using a standard 3+3 phase I dose escalation trial design, the dose levels will start from 30 mg, 70 mg and to 100 mg, a maximum total of 24 patients will be evaluable. In this study the investigators propose to establish safety of the product in those with alcoholic liver disease and efficacy (secondary endpoint) will be determined by biomarkers for liver inflammation and fibrosis surrogate biomarkers.
- Conditions
- Alcoholic Liver Disease
- Being tested
- Guselkumab 30mg, Guselkumab 70mg, Guselkumab 100mg
- Medical subject headings
- Liver Diseases, Alcoholic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guselkumab 30mgDrug
Also called Tremfya
30mg of Guselkumab administered by subcutaneous injection
Guselkumab 70mgDrug
Also called Tremfya
70mg of Guselkumab administered by subcutaneous injection
Guselkumab 100mgDrug
Also called Tremfya
100mg of Guselkumab administered by subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| Guselkumab 30mg | Experimental | Guselkumab administered by subcutaneous injection at Day 1 and Day 29 Receives: Drug: Guselkumab 30mg |
| Guselkumab 70 mg | Experimental | Guselkumab administered by subcutaneous injection at Day 1 and Day 29 Receives: Drug: Guselkumab 70mg |
| Guselkumab 100mg | Experimental | Guselkumab administered by subcutaneous injection at Day 1 and Day 29 Receives: Drug: Guselkumab 100mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the safety and tolerability of Guselkumab
Incidence of treatment-emergent adverse events: Outcome measures will include incidence of treatment-emergent adverse events and the proportion of subjects prematurely withdrawn from the study due to adverse events.
Measured: 48 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2021
- Study start3 Mar 2021
- Primary completion31 Mar 2024
- Study completion31 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcoholic Liver DiseaseStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rohit Loomba, University of California, San Diego
- Investigators
- Rohit Loomba, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04736966
- Sponsor's protocol ID
- Anti-IL23 Trial Phase 1
- Status last verified
- Aug 2024
- First submitted
- 19 Jan 2021
- Last updated
- 6 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Trial to Determine the Safety and Tolerability of Anti-IL23 Monoclonal Antibody, for the Treatment of Patients With Alcohol Associated Liver Disease
- ClinicalTrials.gov ID
- NCT04736966
- Acronym / sponsor ID
- Anti-IL23 Trial Phase 1
- Conditions
- Alcoholic Liver Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- 3 Mar 2021 (actual)
- Primary completion
- 31 Mar 2024 (actual)
- Study completion
- 31 Mar 2024 (actual)
- First posted
- 3 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Phase I clinical trial to determine the safety and tolerability of an anti-IL23 antibody for the treatment of patients with alcoholic liver disease
Detailed description
This is a phase I study of guselkumab, a humanized anti-IL23 monoclonal antibody, for patients with alcoholic liver disease. This drug is approved for the use in psoriatic arthritis but not for alcoholic liver disease. The investigators will be using a standard 3+3 phase I dose escalation trial design, the dose levels will start from 30 mg, 70 mg and to 100 mg, a maximum total of 24 patients will be evaluable. In this study the investigators propose to establish safety of the product in those with alcoholic liver disease and efficacy (secondary endpoint) will be determined by biomarkers for liver inflammation and fibrosis surrogate biomarkers.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Guselkumab 30mg | Experimental | Drug: Guselkumab 30mgGuselkumab administered by subcutaneous injection at Day 1 and Day 29 |
| Guselkumab 70 mg | Experimental | Drug: Guselkumab 70mgGuselkumab administered by subcutaneous injection at Day 1 and Day 29 |
| Guselkumab 100mg | Experimental | Drug: Guselkumab 100mgGuselkumab administered by subcutaneous injection at Day 1 and Day 29 |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (26 listed)
- Able to provide written informed consent (either from patient or patient's legally acceptable representative)
- Male or female patients 21 years of age or older with BMI ≥ 20 to ≤ 45 kg/m2
- Patients with moderate alcohol use disorder (AUD) as defined by the AASLD Practice Guidance to have ≥ 4 symptoms out of 11:
- <!-- -->
- Evidence of end-organ damage to the liver as defined by
Key exclusion criteria (33 listed)
- History or evidence of other or concomitant cause(s) of liver disease as a result of:
- Noninvasive criteria to exclude cirrhosis:
- Co-infection with human immunodeficiency virus (HIV)
- History or evidence of positive Urine Drug Screen (amphetamines, barbiturates, benzodiazepines, cocaine and opiates) except THC and legal prescription medications.
- Any active malignancies other than curatively treated skin cancer (basal cell or squamous cell carcinomas) or any other malignancy diagnosed within the last five years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Guselkumab 30mgAlso: Tremfya30mg of Guselkumab administered by subcutaneous injection | Drug | Guselkumab 30mg |
| Guselkumab 70mgAlso: Tremfya70mg of Guselkumab administered by subcutaneous injection | Drug | Guselkumab 70 mg |
| Guselkumab 100mgAlso: Tremfya100mg of Guselkumab administered by subcutaneous injection | Drug | Guselkumab 100mg |
Primary outcome
Assess the safety and tolerability of Guselkumab
Time frame: 48 Weeks
Incidence of treatment-emergent adverse events: Outcome measures will include incidence of treatment-emergent adverse events and the proportion of subjects prematurely withdrawn from the study due to adverse events.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rohit Loomba principal investigator
University of California, San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Guselkumab 30mg, Guselkumab 70mg and Guselkumab 100mg in people with Alcoholic Liver Disease, run by University of California, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 26 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess the safety and tolerability of Guselkumab (time frame: 48 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2024.