Trial · NCT03775109

IL-1 Signal Inhibition in Alcoholic Hepatitis

NCT03775109, Phase 2, Completed, Imperial College London; results first posted 2025-03-11

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. IL-1 Signal Inhibition in Alcoholic Hepatitis. Trials, record NCT03775109. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03775109

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: IL-1 Signal Inhibition in Alcoholic Hepatitis
NCT number: NCT03775109
Status: Completed
Phases: Phase 2
Enrollment: 55 participants, actual
Lead sponsor: Imperial College London
Conditions: Alcoholic Hepatitis
Interventions: Canakinumab 150mg/ml solution for injection, Placebo
First posted: 2018-12-13
Last updated: 2025-03-11
Results first posted: 2025-03-11

Source ClinicalTrials.gov

Registered outcomes31

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Number of Patients Presenting Histological Improvement of Alcoholic Hepatitis on Liver Biopsy After 28 Days of Treatment Compared to Baseline.	Baseline and 28 days	Histological improvement is defined as a reduction in lobular inflammation (regardless of cell type).
Secondary	Difference in Proportions of Participants With Improvement of Polymorphonuclear Cell Infiltrate From Baseline to Day 28.	Baseline and 28 days	Improvement will be recorded as a binary Yes/No outcome. The outcome will be analysed as the proportion of patients, within each treatment group, with improvement on each individual component (polymorphonuclear cell infiltrate, ballooned hepatocytes and steatosis).
Secondary	Number of Patients Presenting Changes in Degree of Fibrosis (AHHS) From Baseline to Day 28	Baseline and 28 days	Where presence of bridging fibrosis or Cirrhosis at day 28 is the outcome. Firth logistic regression model was used. An intercept term and treatment indicator are the only predictor variables.
Secondary	Number of Participants Presenting Changes in Steatosis Grade (NAS) From Baseline to Day 28	28 days	Number of patients in whom the histological degree of liver steatosis improved between baseline and day 28. Steatosis is assessed using an ordinal scale (1,2,3,4). There are four categories of steatosis grade: (1) \<5%, (2) 5% to 33%, (3) \>33% to 66%, and (4) \>66% Ordinal logistic regression was used for statistical analysis
Secondary	Number of Participants Presenting Changes in Hepatic Venous Pressure Gradient (HVPG) Between Baseline and Day 28	28 days	This outcome measure was included in the protocol as a secondary objective. However, no data was generated as HVPG is difficult to obtain and the outcome measure was therefore abandoned
Secondary	Number of Participants Presenting Changes in Serum CK18-M30/M65 From Baseline to Day 7, 14, 21, 28, 42 and 90	Baseline and 7, 14, 21, 28, 42, 90 days	Samples were not available. It was reported as a SAP deviation in the final statistical report.
Secondary	Change in Serum Bilirubin Concentration From Baseline to Day 28	28 days
Secondary	Change in MELD (Model For End-Stage Liver Disease) Score at From Baseline to Day 28	Day 0 to day 28	MELD score is based on the following formula: MELD Score = (9.57 \* ln(Creatinine)) + (3.78 \* ln(Bilirubin)) + (11.2 \* ln(INR)) + 6.43. Higher score is a worse outcome. Minimum value is around 9 and maximum value is around 40.
Secondary	Change in Glasgow Alcoholic Hepatitis Score (GAHS) From Day 28	Day 0 to day 28	Predicts mortality in patients with alcoholic hepatitis by laboratory results and age. GAHS score is calculated after Forrest et al., 2007 where a score of 5 to 12 is assigned based on age, WCC, Urea, PT ratio or INR and bilirubin. Higher score means a worse outcome and a score greater than or equal to 9 is associated with a poor prognosis. Outcome measure is the score at day 28 - score at day 0
Secondary	Change in Maddrey's Discriminant Function (mDF) Score From Baseline to Day 28	28 days	mDF is calculated using the following formula: mDF = 4.6 x (Prothrombin time - control time) + Serum Bilirubin (μmol/l) / 17. A higher score is associated with poorer prognosis. A value more than 32 implies poor outcome.

1 to 10 of 31Source ClinicalTrials.gov

See all 31 registered outcomes

Outcomes31

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Patients Presenting Histological Improvement of Alcoholic Hepatitis on Liver Biopsy After 28 Days of Treatment Compared to Baseline.	Baseline and 28 days		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Difference in Proportions of Participants With Improvement of Polymorphonuclear Cell Infiltrate From Baseline to Day 28.	Baseline and 28 days		Proportion of participants	NUMBER
SECONDARY	Number of Patients Presenting Changes in Degree of Fibrosis (AHHS) From Baseline to Day 28	Baseline and 28 days		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants Presenting Changes in Steatosis Grade (NAS) From Baseline to Day 28	28 days		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants Presenting Changes in Hepatic Venous Pressure Gradient (HVPG) Between Baseline and Day 28	28 days	No data collected There was no measurement taken
SECONDARY	Number of Participants Presenting Changes in Serum CK18-M30/M65 From Baseline to Day 7, 14, 21, 28, 42 and 90	Baseline and 7, 14, 21, 28, 42, 90 days	No data collected Data was not available as samples were not available.
SECONDARY	Change in Serum Bilirubin Concentration From Baseline to Day 28	28 days	Bilirubin levels at day 28 only.	micromole/litre	MEAN
SECONDARY	Change in MELD (Model For End-Stage Liver Disease) Score at From Baseline to Day 28	Day 0 to day 28	Patients with available day 28 MELD score only.	MELD difference (Units on a scale)	MEAN
SECONDARY	Change in Glasgow Alcoholic Hepatitis Score (GAHS) From Day 28	Day 0 to day 28	Patients on whom the Glasgow Alcoholic Hepatitis Score was available at day 28	score on a scale	NUMBER
SECONDARY	Change in Maddrey's Discriminant Function (mDF) Score From Baseline to Day 28	28 days	Day 28 results.	score on a scale	MEAN

1 to 10 of 31Source ClinicalTrials.gov

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Results by group70

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Number of Patients Presenting Histological Improvement of Alcoholic Hepatitis on Liver Biopsy After 28 Days of Treatment Compared to Baseline.	Canakinumab	14		Participants
Number of Patients Presenting Histological Improvement of Alcoholic Hepatitis on Liver Biopsy After 28 Days of Treatment Compared to Baseline.	Placebo	10		Participants
Difference in Proportions of Participants With Improvement of Polymorphonuclear Cell Infiltrate From Baseline to Day 28.	Canakinumab	0.652	95% Confidence Interval 0.458 to 0.847	Proportion of participants
Difference in Proportions of Participants With Improvement of Polymorphonuclear Cell Infiltrate From Baseline to Day 28.	Placebo	0.609	95% Confidence Interval 0.409 to 0.808	Proportion of participants
Number of Patients Presenting Changes in Degree of Fibrosis (AHHS) From Baseline to Day 28	Canakinumab	23		Participants
Number of Patients Presenting Changes in Degree of Fibrosis (AHHS) From Baseline to Day 28	Placebo	22		Participants
Number of Participants Presenting Changes in Steatosis Grade (NAS) From Baseline to Day 28	Canakinumab	15		Participants
Number of Participants Presenting Changes in Steatosis Grade (NAS) From Baseline to Day 28	Placebo	18		Participants
Change in Serum Bilirubin Concentration From Baseline to Day 28	Canakinumab	126	Standard Deviation 63.1	micromole/litre
Change in Serum Bilirubin Concentration From Baseline to Day 28	Placebo	102	Standard Deviation 41.5	micromole/litre

1 to 10 of 70Source ClinicalTrials.gov

See all 70 results by group

Participant flow8

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Canakinumab	28
Overall Study	STARTED	Placebo	27
Overall Study	Received First Dose	Canakinumab	27
Overall Study	Received First Dose	Placebo	27
Overall Study	COMPLETED	Canakinumab	23
Overall Study	COMPLETED	Placebo	23
Overall Study	NOT COMPLETED	Canakinumab	5
Overall Study	NOT COMPLETED	Placebo	4

Source ClinicalTrials.gov

Adverse events70

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	General AE	General disorders	Canakinumab	26	28	114
other	General AE	General disorders	Placebo	24	27	102
serious	Anaemia	Blood and lymphatic system disorders	Canakinumab	1	28	1
serious	Anaemia	Blood and lymphatic system disorders	Placebo	0	27	0
serious	Cardiac arrest	Cardiac disorders	Canakinumab	1	28	1
serious	Cardiac arrest	Cardiac disorders	Placebo	0	27	0
serious	Palpitations	Cardiac disorders	Canakinumab	1	28	1
serious	Palpitations	Cardiac disorders	Placebo	0	27	0
serious	Abdominal distension	Gastrointestinal disorders	Canakinumab	1	28	1
serious	Abdominal distension	Gastrointestinal disorders	Placebo	0	27	0

1 to 10 of 70Source ClinicalTrials.gov

See all 70 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Canakinumab	2	28
Total, all-cause mortality	Placebo	2	27
Total, other adverse events	Canakinumab	26	28
Total, other adverse events	Placebo	24	27
Total, serious adverse events	Canakinumab	10	28
Total, serious adverse events	Placebo	10	27

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
34763711	RESULT	PubMed
39181422	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons17

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Canakinumab vs Placebo: Number of Participants Presenting Changes in Steatosis Grade (NAS) From Baseline to Day 28	Trial comparisons
Canakinumab vs Placebo: Number of Patients Presenting Histological Improvement of Alcoholic Hepatitis on Liver Biopsy After 28 Days of Treatment Compared to Baseline.	Trial comparisons
Canakinumab vs Placebo: Number of Deaths at Day 90	Trial comparisons
Canakinumab vs Placebo: Number of Patients With Variceal Haemorrhage Over 90 Days	Trial comparisons
Canakinumab vs Placebo: Number of Patients Presenting Changes in Presence of Megamitochondria (AHHS) From Baseline to Day 28	Trial comparisons
Canakinumab vs Placebo: Number of Patients With Incidence of Systemic Inflammatory Response Syndrome (SIRS) at Day 28 in Patients Without SIRS at Baseline	Trial comparisons
Canakinumab vs Placebo: Number of Patients Presenting Changes in Degree of Neutrophil Infiltration (AHHS) From Baseline to Day 28	Trial comparisons
Canakinumab vs Placebo: Number of Patients With Encephalopathy Over 90 Days	Trial comparisons
Canakinumab vs Placebo: Number of Patients With Infection Over 90 Days	Trial comparisons
Canakinumab vs Placebo: Number of Patients With Sepsis Over 90 Days	Trial comparisons

1 to 10 of 17

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Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT03775109

GET https://conductscience.org/api/trials/v1/NCT03775109/registered?page=2

API reference For AI assistants