Gut Liver Glasgow
Harmonising Clinical Care and Research in Gastroenterology and Hepatology across the West of Scotland
Explore actively recruiting trials
Education
West of Scotland GI Teaching Day
Save the date for 7th of May 2026 where we will be hosting our inaugural West of Scotland Gastroenterology Teaching Day at the University of Glasgow.
Further details and programme to follow soon.
Research
The Gut Translational Group
The group is focused on understanding the fundamentals of gut biology and disease-specific mechanisms in Inflammatory Bowel Disease by linking basic discovery science to human translation.
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The BINGO Group
The Bacteria, Immunology, Nutrition, Gastroenterology and OMICS (BINGO) group group is an interdisciplinary group exploring the role of gut microbiota and its interaction with the diet and the immune system in health and disease.
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ScotRight
ScotRight (Scottish Trainees' Research in Gastroenterology and Hepatology) is a trainee-led research network across Scotland that aims to foster collaboration and empower members to launch ambitious projects and deliver impactful research across Scotland.
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Current Trials
| Trial | Summary | Key inclusion | Key exclusion | Contact |
|---|---|---|---|---|
| Prospective study tracking mucosal healing markers in active Crohn's disease and ulcerative colitis. | Age 16 years and above with active IBD plus biomarker/endoscopic evidence within 6 weeks; endoscopy suitable for healing assessment. | Acute severe disease (Truelove & Witts), toxic megacolon, significant obstruction, abscess, or fistula. | ibdmusicstudy@ed.ac.uk | |
GI-DAMPs | Biomarker study comparing innate immune activation across IBD, symptomatic controls, and healthy volunteers. | Groups 1 & 2: Age 16-80 years attending for GI assessment; Group 3: healthy volunteers Age 16-80 years without GI symptoms. | Outside 16-80 age range, coagulation risk for biopsies, or language barriers preventing consent. | gidamps_contact@example.com |
ACESO | Upadacitinib Co-therapy with Corticosteroids in Early Acute Severe Ulcerative Colitis. Phase 3 randomised placebo-controlled trial. | Age 18-65 years with suspected/confirmed ASUC (MTWSI ≥11) requiring IV steroids; prior UC therapies incl. biologics/JAKs allowed with appropriate washouts. | Infective colitis, pregnancy, toxic megacolon; strong CYP3A4 inhibitors/inducers; cytopenias or renal/hepatic impairment; VTE without anticoagulation; recent malignancy; other JAK <4 wks; prior upadacitinib; live vaccines; TB/HBV/HCV; CTIMP participation. | ggc.gi.researchteam@nhs.scot |
Abbvie M25-540 | Risankizumab Versus Vedolizumab for Subjects with Ulcerative Colitis Naïve to Targeted Therapies. | Adults 18-80 with active moderate UC (mMS 5-9, endoscopic 2-3), documented ≥3 months, and intolerance/inadequate response to conventional UC therapies. | Prior targeted UC therapies, recent systemic/rectal steroids, significant GI complications or infections, severe uncontrolled comorbidities, or lymphoproliferative disease history. | ggc.gi.researchteam@nhs.scot |
VICTRIVA | Vedolizumab + Upadacitinib combination therapy for the treatment of patients with active Crohn's disease | Adults 18-65 with moderate to severe Crohn's disease (CDAI 220-450, SES-CD >=4/6) who have failed or were intolerant to standard therapies and meet study contraceptive requirements. | Exclude other IBD phenotypes, serious or chronic infections (including TB), high-risk comorbidities, prior vedolizumab/upadacitinib failure, or conflicted recent immunosuppressive/biologic use. | ggc.gi.researchteam@nhs.scot |
Abbvie M24-885 | A Phase 2a Multicenter, Randomized, Platform Study of Targeted Therapies for the Treatment of Adult Subjects with Moderate to Severe Crohn's Disease | Adults 18-75 with Crohn's disease (CDAI >=220, SES-CD >=4/6) weighing >=40 kg, able to consent, and previously intolerant or refractory to steroids, immunomodulators, or targeted biologics/small molecules. | Exclude abnormal safety labs, recent major surgery, significant infections (HBV/HCV/HIV/TB), high-risk comorbidities or CD complications, recent biologic/small-molecule exposure, unstable concomitant therapy, or recent substance abuse. | ggc.gi.researchteam@nhs.scot |
B-SUPREME | A Randomized, Double-Blind, Active-Controlled Multicenter Phase 2 Study Evaluating the Efficacy and Safety of ALG-000184 Compared with Tenofovir Disoproxil Fumarate in Untreated HBeAg-Positive and HBeAg-Negative Adult Subjects with Chronic Hepatitis B Virus Infection | Adults 18-65 with chronic HBV (HBsAg ≥100 IU/mL, HBV DNA ≥20,000 IU/mL, ALT ≤8×ULN) who are treatment-naïve or have completed required washout and meet contraception requirements. | Cirrhosis or significant fibrosis, coinfections (HAV, HCV, HDV, HEV, HIV), clinically significant comorbidities, abnormal labs, recent investigational or prohibited therapies, or other high-risk factors per investigator. | gastrointestinalteam.gcrf@ggc.scot.nhs.uk |
OPERA | Optimising Primary Therapy in Primary Biliary Cholangitis | Adults with recent (<6 months) primary biliary cholangitis, persistent alkaline phosphatase elevation, minimal prior UDCA exposure, and high predicted non-response risk to UDCA alone. | Contraindications to obeticholic acid, cirrhosis or biliary obstruction indicators, prior obeticholic acid use, high alcohol intake, pregnancy/breastfeeding, overlapping liver disease, or prior transplant. | gastrointestinalteam.gcrf@ggc.scot.nhs.uk |
UCAB-CT-05 | A randomised, double-blind, placebo-controlled, two-part study to evaluate the pharmacokinetics, safety and tolerability, and preliminary efficacy of two dose levels of golexanolone in subjects with primary biliary cholangitis, fatigue, and cognitive dysfunction. | Adults ≥18 with PBC meeting ≥2 diagnostic criteria, PBC-40 fatigue ≥29 and cognition ≥16, on stable standard-of-care therapy with appropriate contraception and informed consent. | Exclude advanced liver disease, significant comorbidities or contraindicated therapies, uncontrolled thyroid or immune disorders, pregnancy/nursing, and other factors compromising safety or compliance. | gastrointestinalteam.gcrf@ggc.scot.nhs.uk |
FATE-CD | A prospective cohort observational study investigating the role of fibrosis activity in Crohn's disease | Adults 18-90 with Crohn's disease involving the ileum; cohorts include surgical ileal strictures, non-stricturing ileal CD, age/sex-matched healthy controls, and new-diagnosis ileal CD starting anti-TNF; prior surgery allowed if recurrent ileal stricture on MRE; no stricture length limit. | Unable to consent; claustrophobia or unable to tolerate supine PET/MRI or PET/CT; eGFR <30 mL/min/1.73m²; pregnancy or breastfeeding; contrast allergy; MRI contraindication; significant mental health impairment; colonic-only disease; contraindication/allergy to buscopan. | ggc.gi.researchteam@nhs.scot |
PROMISE | A prospective faecal microbiota tranSplantation trial to improve outcomes in patients with cirrhosis | Age ≥18 with ALD/MASLD/MetALD cirrhosis (clinical/radiologic/histologic), MELD 8-16, alcohol-related cirrhosis ≤20 g/day, able to consent. | Significant food allergy; pregnancy/breastfeeding; recent decompensation (bleeding/infection/HE/SBP/ACLF ≤14 days); alcohol >20 g/day; prior liver transplant; IBD/coeliac or GI surgery altering microbiome; active malignancy; life expectancy <6 months or transplant-listed; HIV/HBV/HCV (unless undetectable); antibiotics/probiotics ≤7 days; swallowing disorder; recent investigational product ≤4 months. | gastrointestinalteam.gcrf@ggc.scot.nhs.uk |
STARLIGHT | A study to investigate the safety and efficacy of GSK4532990 compared with placebo in adult participants aged 18 to 65 years with alcohol-related liver disease. | Adults 18-65 with alcohol-related or metabolic-associated ALD (per investigator), able to consent/comply; women not pregnant/breastfeeding with highly effective contraception; stable dosing (≥3 months) of specified background agents permitted (e.g., GLP‑1/GIP, PPAR, SGLT2, THR‑β, FXR, FASN, FGF21, Vitamin E). | Alcohol abstinence ≥4 months; organ failure or decompensation/high MELD; low fibrosis markers (FibroScan LSM <15 kPa or ELF <9.8); lab/ECG safety thresholds (AST <ULN or AST/ALT ≥250, ALP ≥250, platelets <60×10^9/L, INR >2.3, albumin <2.8 g/dL); renal impairment/eGFR <75; HBV/HCV/HIV or other primary liver diseases; active infection; uncontrolled HTN, BMI >35, HbA1c ≥9.5; significant cardiac/renal disease, malignancy, recent major surgery or investigational therapy; pregnancy/breastfeeding; hypersensitivity to study drug; contraindications to MRE/biopsy; high psychosocial risk. | gastrointestinalteam.gcrf@ggc.scot.nhs.uk |
Asp-PSC | Effect of Aspirin on Reducing Cancer & Improving Outcomes in Primary Sclerosing Cholangitis | Adults ≥18 with established large duct PSC and concomitant colonic IBD; ≥1 year post-PSC; stable UDCA ≤20 mg/kg/day for ≥12 weeks; recent colonoscopy; recent liver imaging per cirrhosis status. | Secondary sclerosing cholangitis/other liver diseases; prior CRC/CCA/gallbladder cancer; liver transplant or listed; prior colonic resection/ostomy; alcohol >14 units/week; current aspirin/NSAIDs/antiplatelet/anticoagulant use or recent CTIMP; history of GI bleed, CHF, or G6PD deficiency; Child-Pugh B/C; untreated thyroid disease; hereditary cancer risk; recent VZV vaccine; aspirin allergy or NSAID-induced asthma; bleeding disorders; peptic ulcer; gout; severe renal impairment; methotrexate >15 mg/week; SSRI use. | gastrointestinalteam.gcrf@ggc.scot.nhs.uk |
React-AVB | Randomised controlled trial of EArly transjugular intrahepatiC porTosystemic stent-shunt in Acute Variceal Bleeding | Adults ≥18 with cirrhosis, acute variceal bleed controlled after initial endoscopic therapy, and Child-Pugh 7-13. | Uncontrolled bleeding, prior portosystemic shunt/TIPSS or occlusive portal vein thrombosis, active cancer affecting 1-year survival, recurrent encephalopathy, pregnancy/lactation, or refractory heart failure/sepsis. | gastrointestinalteam.gcrf@ggc.scot.nhs.uk |
BOOST | β-hydroxy-β-methylbutyrate (HMB) supplementationto improve functional status in people with advanced liver cirrhosis | Adults 18-85 with advanced cirrhosis (Child-Pugh ≥7) and recent portal hypertension, with cirrhosis confirmed clinically/radiologically/histologically or elastography >15 kPa; able to consent or via representative. | Prognosis <6 months, advanced HCC, HMB use within 4 weeks, unable to complete Liver Frailty Index, liver transplant recipient/listed/under assessment, interventional trial in last 4 weeks, or poor engagement per PI. | gastrointestinalteam.gcrf@ggc.scot.nhs.uk |
ICONIC-CD | Efficacy and Safety of Icotrokinra in Participants With Moderately to Severely Active Crohn's Disease | Adults ≥18 with moderately-severely active Crohn's disease: CDAI 220-450 plus central SES-CD ≥6 (≥4 if isolated ileal) with ulceration; diagnosis ≥12 weeks; screening labs within limits; prior inadequate response/intolerance to conventional or advanced CD therapy; on stable or appropriately washed-out background meds; meets consent and contraception requirements. | CD complications likely requiring surgery (symptomatic strictures, short gut), stoma/ostomy, undrained abscess or planned major surgery; history of dysplasia/uncleared polyps or non-CD colitides; active/latent TB or significant/recent infections; uncontrolled systemic comorbidities or recent malignancy/lymphoproliferative disease; prior IL-23p19/IL-23R exposure; recent prohibited biologics/JAKs/immunosuppressants/live vaccines; HIV/HBV/HCV positivity; or other factors compromising safety/compliance. | gastrointestinalteam.gcrf@ggc.scot.nhs.uk |
NASH | Case-control Study Evaluating Biomarkers and Genetic Factors Associated with the Development of Non-alcoholic Steatohepatitis (NASH) and Alcoholic steatohepatitis (ASH). | Patients over 18 years old, have a clinical diagnosis of NAFLD or ALD (or no liver disease for controls), and report alcohol consumption above UK recommended limits for the ALD group. | Patients with other diagnosed liver diseases, suspected other causes of liver injury, hazardous alcohol consumption (except for the ALD group), or inability to provide informed consent are excluded. | gastrointestinalteam.gcrf@ggc.scot.nhs.uk |
VOCAL2 | Using volatile organic markers for monitoring cirrhosis and detecting primary liver tumours. | Adults ≥18 with confirmed HCC, CCA, cirrhosis, PSC, or non-specific GI symptoms with normal liver (healthy controls). | Active infection or immunosuppressive meds in last 8 weeks, history of other cancer in last 5 years, prior liver resection, prior chemo/radiotherapy/surgery for liver cancer, comorbidities preventing breath collection, pregnancy, unable to provide informed consent. | gastrointestinalteam.gcrf@ggc.scot.nhs.uk |
EMERALD | Open-label phase 1/2 multicentre study of RTX001 autologous macrophages in patients with decompensated liver cirrhosis | Adults 18-75 with liver cirrhosis (ALD/MASLD/Met-ALD), recent major hepatic decompensation, MELD 12-20, PEth <200 ng/ml, no contraindications to filgrastim/leukapheresis. | Liver cirrhosis due to viral/autoimmune/cholestatic disorders, acute liver disease, current organ failure, splenomegaly ≥16 cm, thrombocytopenia <50×10^9/L, co-morbidities (transplant, ACLF, active sepsis, HIV/syphilis/HTLV-1, PE, HCC/active malignancy, portal vein thrombosis, hepatic hydrothorax, chronic renal impairment/AKI, heart failure, porto-pulmonary hypertension, severe lung disease, hepatopulmonary syndrome, multiple albumin infusions, untreated psychiatric disease, TIPS), intercurrent illness, immunomodulators/immunosuppressants, prior gene/cell therapy, live attenuated vaccines, investigational product, hypersensitivity to DMSO, unlikely to comply, pregnancy/breastfeeding, alcohol misuse, non-medically supervised drug abuse. | gastrointestinalteam.gcrf@ggc.scot.nhs.uk |
Summary:Prospective study tracking mucosal healing markers in active Crohn's disease and ulcerative colitis.
Key Inclusion:Age 16 years and above with active IBD plus biomarker/endoscopic evidence within 6 weeks; endoscopy suitable for healing assessment.
Key Exclusion:Acute severe disease (Truelove & Witts), toxic megacolon, significant obstruction, abscess, or fistula.
Contact:ibdmusicstudy@ed.ac.uk
GI-DAMPs
Summary:Biomarker study comparing innate immune activation across IBD, symptomatic controls, and healthy volunteers.
Key Inclusion:Groups 1 & 2: Age 16-80 years attending for GI assessment; Group 3: healthy volunteers Age 16-80 years without GI symptoms.
Key Exclusion:Outside 16-80 age range, coagulation risk for biopsies, or language barriers preventing consent.
Contact:gidamps_contact@example.com
ACESO
Summary:Upadacitinib Co-therapy with Corticosteroids in Early Acute Severe Ulcerative Colitis. Phase 3 randomised placebo-controlled trial.
Key Inclusion:Age 18-65 years with suspected/confirmed ASUC (MTWSI ≥11) requiring IV steroids; prior UC therapies incl. biologics/JAKs allowed with appropriate washouts.
Key Exclusion:Infective colitis, pregnancy, toxic megacolon; strong CYP3A4 inhibitors/inducers; cytopenias or renal/hepatic impairment; VTE without anticoagulation; recent malignancy; other JAK <4 wks; prior upadacitinib; live vaccines; TB/HBV/HCV; CTIMP participation.
Contact:ggc.gi.researchteam@nhs.scot
Abbvie M25-540
Summary:Risankizumab Versus Vedolizumab for Subjects with Ulcerative Colitis Naïve to Targeted Therapies.
Key Inclusion:Adults 18-80 with active moderate UC (mMS 5-9, endoscopic 2-3), documented ≥3 months, and intolerance/inadequate response to conventional UC therapies.
Key Exclusion:Prior targeted UC therapies, recent systemic/rectal steroids, significant GI complications or infections, severe uncontrolled comorbidities, or lymphoproliferative disease history.
Contact:ggc.gi.researchteam@nhs.scot
VICTRIVA
Summary:Vedolizumab + Upadacitinib combination therapy for the treatment of patients with active Crohn's disease
Key Inclusion:Adults 18-65 with moderate to severe Crohn's disease (CDAI 220-450, SES-CD >=4/6) who have failed or were intolerant to standard therapies and meet study contraceptive requirements.
Key Exclusion:Exclude other IBD phenotypes, serious or chronic infections (including TB), high-risk comorbidities, prior vedolizumab/upadacitinib failure, or conflicted recent immunosuppressive/biologic use.
Contact:ggc.gi.researchteam@nhs.scot
Abbvie M24-885
Summary:A Phase 2a Multicenter, Randomized, Platform Study of Targeted Therapies for the Treatment of Adult Subjects with Moderate to Severe Crohn's Disease
Key Inclusion:Adults 18-75 with Crohn's disease (CDAI >=220, SES-CD >=4/6) weighing >=40 kg, able to consent, and previously intolerant or refractory to steroids, immunomodulators, or targeted biologics/small molecules.
Key Exclusion:Exclude abnormal safety labs, recent major surgery, significant infections (HBV/HCV/HIV/TB), high-risk comorbidities or CD complications, recent biologic/small-molecule exposure, unstable concomitant therapy, or recent substance abuse.
Contact:ggc.gi.researchteam@nhs.scot
B-SUPREME
Summary:A Randomized, Double-Blind, Active-Controlled Multicenter Phase 2 Study Evaluating the Efficacy and Safety of ALG-000184 Compared with Tenofovir Disoproxil Fumarate in Untreated HBeAg-Positive and HBeAg-Negative Adult Subjects with Chronic Hepatitis B Virus Infection
Key Inclusion:Adults 18-65 with chronic HBV (HBsAg ≥100 IU/mL, HBV DNA ≥20,000 IU/mL, ALT ≤8×ULN) who are treatment-naïve or have completed required washout and meet contraception requirements.
Key Exclusion:Cirrhosis or significant fibrosis, coinfections (HAV, HCV, HDV, HEV, HIV), clinically significant comorbidities, abnormal labs, recent investigational or prohibited therapies, or other high-risk factors per investigator.
OPERA
Summary:Optimising Primary Therapy in Primary Biliary Cholangitis
Key Inclusion:Adults with recent (<6 months) primary biliary cholangitis, persistent alkaline phosphatase elevation, minimal prior UDCA exposure, and high predicted non-response risk to UDCA alone.
Key Exclusion:Contraindications to obeticholic acid, cirrhosis or biliary obstruction indicators, prior obeticholic acid use, high alcohol intake, pregnancy/breastfeeding, overlapping liver disease, or prior transplant.
UCAB-CT-05
Summary:A randomised, double-blind, placebo-controlled, two-part study to evaluate the pharmacokinetics, safety and tolerability, and preliminary efficacy of two dose levels of golexanolone in subjects with primary biliary cholangitis, fatigue, and cognitive dysfunction.
Key Inclusion:Adults ≥18 with PBC meeting ≥2 diagnostic criteria, PBC-40 fatigue ≥29 and cognition ≥16, on stable standard-of-care therapy with appropriate contraception and informed consent.
Key Exclusion:Exclude advanced liver disease, significant comorbidities or contraindicated therapies, uncontrolled thyroid or immune disorders, pregnancy/nursing, and other factors compromising safety or compliance.
FATE-CD
Summary:A prospective cohort observational study investigating the role of fibrosis activity in Crohn's disease
Key Inclusion:Adults 18-90 with Crohn's disease involving the ileum; cohorts include surgical ileal strictures, non-stricturing ileal CD, age/sex-matched healthy controls, and new-diagnosis ileal CD starting anti-TNF; prior surgery allowed if recurrent ileal stricture on MRE; no stricture length limit.
Key Exclusion:Unable to consent; claustrophobia or unable to tolerate supine PET/MRI or PET/CT; eGFR <30 mL/min/1.73m²; pregnancy or breastfeeding; contrast allergy; MRI contraindication; significant mental health impairment; colonic-only disease; contraindication/allergy to buscopan.
Contact:ggc.gi.researchteam@nhs.scot
PROMISE
Summary:A prospective faecal microbiota tranSplantation trial to improve outcomes in patients with cirrhosis
Key Inclusion:Age ≥18 with ALD/MASLD/MetALD cirrhosis (clinical/radiologic/histologic), MELD 8-16, alcohol-related cirrhosis ≤20 g/day, able to consent.
Key Exclusion:Significant food allergy; pregnancy/breastfeeding; recent decompensation (bleeding/infection/HE/SBP/ACLF ≤14 days); alcohol >20 g/day; prior liver transplant; IBD/coeliac or GI surgery altering microbiome; active malignancy; life expectancy <6 months or transplant-listed; HIV/HBV/HCV (unless undetectable); antibiotics/probiotics ≤7 days; swallowing disorder; recent investigational product ≤4 months.
STARLIGHT
Summary:A study to investigate the safety and efficacy of GSK4532990 compared with placebo in adult participants aged 18 to 65 years with alcohol-related liver disease.
Key Inclusion:Adults 18-65 with alcohol-related or metabolic-associated ALD (per investigator), able to consent/comply; women not pregnant/breastfeeding with highly effective contraception; stable dosing (≥3 months) of specified background agents permitted (e.g., GLP‑1/GIP, PPAR, SGLT2, THR‑β, FXR, FASN, FGF21, Vitamin E).
Key Exclusion:Alcohol abstinence ≥4 months; organ failure or decompensation/high MELD; low fibrosis markers (FibroScan LSM <15 kPa or ELF <9.8); lab/ECG safety thresholds (AST <ULN or AST/ALT ≥250, ALP ≥250, platelets <60×10^9/L, INR >2.3, albumin <2.8 g/dL); renal impairment/eGFR <75; HBV/HCV/HIV or other primary liver diseases; active infection; uncontrolled HTN, BMI >35, HbA1c ≥9.5; significant cardiac/renal disease, malignancy, recent major surgery or investigational therapy; pregnancy/breastfeeding; hypersensitivity to study drug; contraindications to MRE/biopsy; high psychosocial risk.
Asp-PSC
Summary:Effect of Aspirin on Reducing Cancer & Improving Outcomes in Primary Sclerosing Cholangitis
Key Inclusion:Adults ≥18 with established large duct PSC and concomitant colonic IBD; ≥1 year post-PSC; stable UDCA ≤20 mg/kg/day for ≥12 weeks; recent colonoscopy; recent liver imaging per cirrhosis status.
Key Exclusion:Secondary sclerosing cholangitis/other liver diseases; prior CRC/CCA/gallbladder cancer; liver transplant or listed; prior colonic resection/ostomy; alcohol >14 units/week; current aspirin/NSAIDs/antiplatelet/anticoagulant use or recent CTIMP; history of GI bleed, CHF, or G6PD deficiency; Child-Pugh B/C; untreated thyroid disease; hereditary cancer risk; recent VZV vaccine; aspirin allergy or NSAID-induced asthma; bleeding disorders; peptic ulcer; gout; severe renal impairment; methotrexate >15 mg/week; SSRI use.
React-AVB
Summary:Randomised controlled trial of EArly transjugular intrahepatiC porTosystemic stent-shunt in Acute Variceal Bleeding
Key Inclusion:Adults ≥18 with cirrhosis, acute variceal bleed controlled after initial endoscopic therapy, and Child-Pugh 7-13.
Key Exclusion:Uncontrolled bleeding, prior portosystemic shunt/TIPSS or occlusive portal vein thrombosis, active cancer affecting 1-year survival, recurrent encephalopathy, pregnancy/lactation, or refractory heart failure/sepsis.
BOOST
Summary:β-hydroxy-β-methylbutyrate (HMB) supplementationto improve functional status in people with advanced liver cirrhosis
Key Inclusion:Adults 18-85 with advanced cirrhosis (Child-Pugh ≥7) and recent portal hypertension, with cirrhosis confirmed clinically/radiologically/histologically or elastography >15 kPa; able to consent or via representative.
Key Exclusion:Prognosis <6 months, advanced HCC, HMB use within 4 weeks, unable to complete Liver Frailty Index, liver transplant recipient/listed/under assessment, interventional trial in last 4 weeks, or poor engagement per PI.
ICONIC-CD
Summary:Efficacy and Safety of Icotrokinra in Participants With Moderately to Severely Active Crohn's Disease
Key Inclusion:Adults ≥18 with moderately-severely active Crohn's disease: CDAI 220-450 plus central SES-CD ≥6 (≥4 if isolated ileal) with ulceration; diagnosis ≥12 weeks; screening labs within limits; prior inadequate response/intolerance to conventional or advanced CD therapy; on stable or appropriately washed-out background meds; meets consent and contraception requirements.
Key Exclusion:CD complications likely requiring surgery (symptomatic strictures, short gut), stoma/ostomy, undrained abscess or planned major surgery; history of dysplasia/uncleared polyps or non-CD colitides; active/latent TB or significant/recent infections; uncontrolled systemic comorbidities or recent malignancy/lymphoproliferative disease; prior IL-23p19/IL-23R exposure; recent prohibited biologics/JAKs/immunosuppressants/live vaccines; HIV/HBV/HCV positivity; or other factors compromising safety/compliance.
NASH
Summary:Case-control Study Evaluating Biomarkers and Genetic Factors Associated with the Development of Non-alcoholic Steatohepatitis (NASH) and Alcoholic steatohepatitis (ASH).
Key Inclusion:Patients over 18 years old, have a clinical diagnosis of NAFLD or ALD (or no liver disease for controls), and report alcohol consumption above UK recommended limits for the ALD group.
Key Exclusion:Patients with other diagnosed liver diseases, suspected other causes of liver injury, hazardous alcohol consumption (except for the ALD group), or inability to provide informed consent are excluded.
VOCAL2
Summary:Using volatile organic markers for monitoring cirrhosis and detecting primary liver tumours.
Key Inclusion:Adults ≥18 with confirmed HCC, CCA, cirrhosis, PSC, or non-specific GI symptoms with normal liver (healthy controls).
Key Exclusion:Active infection or immunosuppressive meds in last 8 weeks, history of other cancer in last 5 years, prior liver resection, prior chemo/radiotherapy/surgery for liver cancer, comorbidities preventing breath collection, pregnancy, unable to provide informed consent.
EMERALD
Summary:Open-label phase 1/2 multicentre study of RTX001 autologous macrophages in patients with decompensated liver cirrhosis
Key Inclusion:Adults 18-75 with liver cirrhosis (ALD/MASLD/Met-ALD), recent major hepatic decompensation, MELD 12-20, PEth <200 ng/ml, no contraindications to filgrastim/leukapheresis.
Key Exclusion:Liver cirrhosis due to viral/autoimmune/cholestatic disorders, acute liver disease, current organ failure, splenomegaly ≥16 cm, thrombocytopenia <50×10^9/L, co-morbidities (transplant, ACLF, active sepsis, HIV/syphilis/HTLV-1, PE, HCC/active malignancy, portal vein thrombosis, hepatic hydrothorax, chronic renal impairment/AKI, heart failure, porto-pulmonary hypertension, severe lung disease, hepatopulmonary syndrome, multiple albumin infusions, untreated psychiatric disease, TIPS), intercurrent illness, immunomodulators/immunosuppressants, prior gene/cell therapy, live attenuated vaccines, investigational product, hypersensitivity to DMSO, unlikely to comply, pregnancy/breastfeeding, alcohol misuse, non-medically supervised drug abuse.