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NCT04924114

A Study of MK-6194 (PT101) in Participants With Active Ulcerative Colitis (UC) (MK-6194-002)

Completed Phase 1 Results posted Last updated 29 August 2025
What this trial tests

Phase 1 trial testing MK-6194 in Ulcerative Colitis in 57 participants. Completed in 15 July 2024.

Timeline
14 October 2021
Primary endpoint
8 January 2024
15 July 2024

Quick facts

Lead sponsorMerck Sharp & Dohme LLC
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designsequential
Maskingquadruple
Primary purposetreatment
Enrollment57
Start date14 October 2021
Primary completion8 January 2024
Estimated completion15 July 2024
Sites17 locations across Georgia, Ukraine, United Kingdom, Germany, Moldova, Hungary, Poland, United States

Drugs / interventions tested

Conditions studied

Sponsor

Merck Sharp & Dohme LLC — full company profile →

Who can join

Adults 18 to 80, any sex, with Ulcerative Colitis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Maximum Concentration (Cmax) of MK-6194 Secondary · Predose on all days of dosing; 12, 24-48, and 120 hours (as available) post dose on the first and last day of dosing; and once each week up to approximately day 85.

Blood samples were collected at pre-specified time points to determine each participant's maximum concentration (Cmax). A participant's Cmax was defined as the maximum concentration of MK-6194 observed in serum over the entire course of the study for that individual and was calculated by taking the maximum over all observed MK-6194 serum concentrations. Geometric mean and geometric coefficient of variation of Cmax were calculated for each dosing group.

GroupValue95% CI
MK-6194 Low Dose - Interval 1 (Less Frequent)9.55± 67.80
MK-6194 Medium Dose- Interval 2 (More Frequent)30.02± 95.85
MK-6194 High Dose - Interval 2 (More Frequent)51.80± 71.97
MK-6194 High Dose - Interval 1 (Less Frequent)52.78± 178.96
Time to Cmax (Tmax) of MK-6194 Secondary · Predose on all days of dosing; 12, 24-48, and 120 hours (as available) post dose on the first and last day of dosing; and once each week up to approximately day 85

Blood samples were collected at pre-specified time points to determine maximum concentration (Cmax) of MK-6194 in each participant's serum and corresponding time of maximum concentration (Tmax). A participant's Tmax was defined as the time post-dose that the maximum concentration of MK-6194 was observed in serum. The median and range of Tmax were calculated for each dosing group.

GroupValue95% CI
MK-6194 Low Dose - Interval 1 (Less Frequent)12.0011.10 – 24.00
MK-6194 Medium Dose- Interval 2 (More Frequent)12.0011.50 – 24.50
MK-6194 High Dose - Interval 2 (More Frequent)12.0511.10 – 25.00
MK-6194 High Dose - Interval 1 (Less Frequent)12.1011.20 – 12.20
Minimum Concentration (Cmin) of MK-6194 Secondary · Predose on all days of dosing; 12, 24-48, and 120 hours (as available) post dose on the first and last day of dosing; and once each week up to approximately day 85

Blood samples were collected at pre-specified time points to determine the minimum concentration (Cmin) of MK-6194 present in each participant's serum. A participant's Cmin was defined as the minimum concentration of MK-6194 observed in serum over the entire course of the study for that individual and was calculated by taking the minimum over all observed MK-6194 serum concentrations. Geometric mean and geometric coefficient of variation of Cmin were calculated for each dosing group.

GroupValue95% CI
MK-6194 Low Dose - Interval 1 (Less Frequent)0.08± 0.00
MK-6194 Medium Dose- Interval 2 (More Frequent)0.08± 0.00
MK-6194 High Dose - Interval 2 (More Frequent)0.09± 97.70
MK-6194 High Dose - Interval 1 (Less Frequent)0.08± 0.00
Apparent Half-life (t1/2) of MK-6194 Secondary · Final day of dosing at 12, 24-48 hours, and 120 hours (as available) post-dose; from the last day of dosing once each week up to approximately day 85

Blood samples were collected at pre-specified time points to determine the apparent half-life (t1/2) of MK-6194. Noncompartmental analysis was used to calculate t1/2 for each participant using the terminal elimination phase after the final dose. Geometric mean and geometric coefficient of variation of t1/2 were calculated for each dosing group.

GroupValue95% CI
MK-6194 Low Dose - Interval 1 (Less Frequent)193.28± 66.51
MK-6194 Medium Dose- Interval 2 (More Frequent)52.84± 23.89
MK-6194 High Dose - Interval 2 (More Frequent)42.06± 80.41
MK-6194 High Dose - Interval 1 (Less Frequent)96.09± 16.51
Apparent Clearance (CL/F) of MK-6194 Secondary · Final day of dosing at 12, 24-48 hours, and 120 hours (as available) post-dose; from the last day of dosing once each week up to approximately day 85

Blood samples were collected at pre-specified time points to determine the apparent clearance (CL/F) of MK-6194 observed in serum. Noncompartmental analysis was used to calculate CL/F for each participant using the terminal elimination phase after the final dose. Geometric mean and geometric coefficient of variation of CL/F were calculated for each dosing group.

GroupValue95% CI
MK-6194 Low Dose - Interval 1 (Less Frequent)0.00± 66.28
MK-6194 Medium Dose- Interval 2 (More Frequent)0.01± 82.72
MK-6194 High Dose - Interval 2 (More Frequent)0.01± 95.07
MK-6194 High Dose - Interval 1 (Less Frequent)0.01± 78.70
Apparent Volume of Distribution (Vd/F) of MK-6194 Secondary · Final day of dosing at 12, 24-48 hours, and 120 hours (as available) post-dose; from the last day of dosing once each week up to approximately day 85

Blood samples were collected at pre-specified time points to determine the apparent volume of distribution (Vd/F) of MK-6194 observed in serum. Noncompartmental analysis was used to calculate Vd/F for each participant using the terminal elimination phase after the final dose. Geometric mean and geometric coefficient of variation of Vd/F were calculated for each dosing group.

GroupValue95% CI
MK-6194 Low Dose - Interval 1 (Less Frequent)1.61± 121.12
MK-6194 Medium Dose- Interval 2 (More Frequent)0.82± 96.99
MK-6194 High Dose - Interval 2 (More Frequent)0.55± 226.96
MK-6194 High Dose - Interval 1 (Less Frequent)0.81± 93.17
Area Under the Concentration Time-curve From Time 0 to the Last Quantifiable Concentration (AUC0-t) Secondary · Predose on all days of dosing; 12, 24-48, and 120 hours (as available) post dose on the first and last day of dosing; and once each week up to approximately day 85

Blood samples were collected at pre-specified timepoints to determine the AUC0-t of MK-6194. AUC0-t is defined as the area under the concentration-time curve from time=0 (Day 1 predose) to the last quantifiable concentration. Noncompartmental analysis was used to calculate AUC0-t for each participant. Geometric mean and geometric coefficient of variation of AUC0-t were calculated for each dosing group.

GroupValue95% CI
MK-6194 Low Dose - Interval 1 (Less Frequent)955.51± 39.92
MK-6194 Medium Dose- Interval 2 (More Frequent)2080.46± 55.64
MK-6194 High Dose - Interval 2 (More Frequent)3546.54± 67.17
MK-6194 High Dose - Interval 1 (Less Frequent)3203.50± 117.92
Area Under the Curve From Time 0 to Infinity (AUC0-inf) of MK-6194 Secondary · Predose on all days of dosing; 12, 24-48, and 120 hours (as available) post dose on the first and last day of dosing; and once each week up to approximately day 85

Blood samples were collected at pre-specified timepoints to determine the AUC0-inf of MK-6194. AUC0-inf is defined as the area under the concentration-time curve from time=0 (Day 1 predose) to time=infinity. Noncompartmental analysis was used to calculate AUC0-inf for each participant; the portion of the AUC following the last observed concentration was assumed to follow an exponential elimination. Geometric mean and geometric coefficient of variation of AUC0-inf were calculated for each dosing group.

GroupValue95% CI
MK-6194 Low Dose - Interval 1 (Less Frequent)899.08± 36.53
MK-6194 Medium Dose- Interval 2 (More Frequent)2036.51± 71.46
MK-6194 High Dose - Interval 2 (More Frequent)3437.33± 65.59
MK-6194 High Dose - Interval 1 (Less Frequent)3169.11± 120.37
Change in Number of Peripheral Regulatory T-cells (Tregs) in Whole Blood Secondary · Pre-dose (baseline) and weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12

Blood samples were collected at pre-specified time points and analyzed by flow cytometry. The absolute change in the number of peripheral Tregs in whole blood was assessed.

Week 1
GroupValue95% CI
MK-6194 Low Dose - Interval 1 (Less Frequent)16.6± 46.10
MK-6194 Medium Dose- Interval 2 (More Frequent)24.0± 130.34
MK-6194 High Dose - Interval 2 (More Frequent)36.5± 76.68
MK-6194 High Dose - Interval 1 (Less Frequent)31.0± 48.95
Placebo0.0± 107.20
Week 2
GroupValue95% CI
MK-6194 Low Dose - Interval 1 (Less Frequent)15.2± 45.43
MK-6194 Medium Dose- Interval 2 (More Frequent)8.4± 78.56
MK-6194 High Dose - Interval 2 (More Frequent)0.0± 84.52
MK-6194 High Dose - Interval 1 (Less Frequent)29.8± 100.53
Placebo6.0± 109.31
Week 3
GroupValue95% CI
MK-6194 Low Dose - Interval 1 (Less Frequent)12.2± 113.83
MK-6194 Medium Dose- Interval 2 (More Frequent)24.5± 95.40
MK-6194 High Dose - Interval 2 (More Frequent)31.7± 92.24
MK-6194 High Dose - Interval 1 (Less Frequent)15.2± 77.36
Placebo4.4± 96.26
Week 4
GroupValue95% CI
MK-6194 Low Dose - Interval 1 (Less Frequent)5.1± 71.20
MK-6194 Medium Dose- Interval 2 (More Frequent)9.5± 78.31
MK-6194 High Dose - Interval 2 (More Frequent)12.8± 82.29
MK-6194 High Dose - Interval 1 (Less Frequent)4.8± 115.02
Placebo0.0± 120.87
Week 5
GroupValue95% CI
MK-6194 Low Dose - Interval 1 (Less Frequent)33.9± 61.55
MK-6194 Medium Dose- Interval 2 (More Frequent)0.0± 66.63
MK-6194 High Dose - Interval 2 (More Frequent)20.9± 78.63
MK-6194 High Dose - Interval 1 (Less Frequent)35.5± 65.56
Placebo0.0± 92.71
Week 6
GroupValue95% CI
MK-6194 Low Dose - Interval 1 (Less Frequent)9.0± 32.73
MK-6194 Medium Dose- Interval 2 (More Frequent)12.9± 73.27
MK-6194 High Dose - Interval 2 (More Frequent)9.8± 100.16
MK-6194 High Dose - Interval 1 (Less Frequent)18.9± 58.45
Placebo0.0± 61.81
Week 7
GroupValue95% CI
MK-6194 Low Dose - Interval 1 (Less Frequent)4.0± 53.29
MK-6194 Medium Dose- Interval 2 (More Frequent)32.3± 44.51
MK-6194 High Dose - Interval 2 (More Frequent)27.1± 69.98
MK-6194 High Dose - Interval 1 (Less Frequent)7.4± 130.11
Placebo0.0± 66.82
Week 8
GroupValue95% CI
MK-6194 Low Dose - Interval 1 (Less Frequent)3.9± 25.00
MK-6194 Medium Dose- Interval 2 (More Frequent)9.4± 101.40
MK-6194 High Dose - Interval 2 (More Frequent)8.8± 62.20
MK-6194 High Dose - Interval 1 (Less Frequent)7.7± 101.49
Placebo0.0± 102.85
Change in Number of Natural Killer (NK) Cells in Whole Blood Secondary · Pre-dose (baseline) and weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12

Blood samples were collected at pre-specified time points and analyzed by flow cytometry. The change in the number of NK cells in whole blood is presented.

Week 1
GroupValue95% CI
MK-6194 Low Dose - Interval 1 (Less Frequent)109.3± 117.56
MK-6194 Medium Dose- Interval 2 (More Frequent)0.0± 149.43
MK-6194 High Dose - Interval 2 (More Frequent)43.2± 86.39
MK-6194 High Dose - Interval 1 (Less Frequent)110.0± 61.90
Placebo34.40± 60.38
Week 2
GroupValue95% CI
MK-6194 Low Dose - Interval 1 (Less Frequent)124.7± 83.32
MK-6194 Medium Dose- Interval 2 (More Frequent)76.1± 62.77
MK-6194 High Dose - Interval 2 (More Frequent)48.6± 81.20
MK-6194 High Dose - Interval 1 (Less Frequent)108.5± 55.48
Placebo19.2± 160.68
Week 3
GroupValue95% CI
MK-6194 Low Dose - Interval 1 (Less Frequent)479.5± 85.51
MK-6194 Medium Dose- Interval 2 (More Frequent)50.3± 73.79
MK-6194 High Dose - Interval 2 (More Frequent)44.2± 110.61
MK-6194 High Dose - Interval 1 (Less Frequent)68.4± 62.20
Placebo64.1± 87.37
Week 4
GroupValue95% CI
MK-6194 Low Dose - Interval 1 (Less Frequent)292.2± 48.38
MK-6194 Medium Dose- Interval 2 (More Frequent)52.8± 67.48
MK-6194 High Dose - Interval 2 (More Frequent)0.0± 102.83
MK-6194 High Dose - Interval 1 (Less Frequent)78.9± 73.40
Placebo42.1± 131.09
Week 5
GroupValue95% CI
MK-6194 Low Dose - Interval 1 (Less Frequent)281.5± 27.43
MK-6194 Medium Dose- Interval 2 (More Frequent)42.1± 76.34
MK-6194 High Dose - Interval 2 (More Frequent)53.8± 61.16
MK-6194 High Dose - Interval 1 (Less Frequent)133.2± 87.96
Placebo65.0± 129.61
Week 6
GroupValue95% CI
MK-6194 Low Dose - Interval 1 (Less Frequent)169.0± 88.11
MK-6194 Medium Dose- Interval 2 (More Frequent)59.3± 72.56
MK-6194 High Dose - Interval 2 (More Frequent)54.7± 80.71
MK-6194 High Dose - Interval 1 (Less Frequent)140.3± 78.10
Placebo55.3± 124.75
Week 7
GroupValue95% CI
MK-6194 Low Dose - Interval 1 (Less Frequent)224.8± 83.09
MK-6194 Medium Dose- Interval 2 (More Frequent)0.0± 112.85
MK-6194 High Dose - Interval 2 (More Frequent)73.2± 66.16
MK-6194 High Dose - Interval 1 (Less Frequent)82.0± 93.62
Placebo44.9± 119.10
Week 8
GroupValue95% CI
MK-6194 Low Dose - Interval 1 (Less Frequent)272.9± 54.62
MK-6194 Medium Dose- Interval 2 (More Frequent)38.4± 113.46
MK-6194 High Dose - Interval 2 (More Frequent)43.7± 148.37
MK-6194 High Dose - Interval 1 (Less Frequent)86.9± 49.10
Placebo30.4± 125.05
Change in Number of Conventional T Cells (Tcons) in Whole Blood Secondary · Pre-dose (baseline) and weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12

Blood samples were collected at pre-specified time points and analyzed by flow cytometry. The change in the number of Tcons in whole blood is presented.

Week 1
GroupValue95% CI
MK-6194 Low Dose - Interval 1 (Less Frequent)216.9± 94.52
MK-6194 Medium Dose- Interval 2 (More Frequent)220.8± 94.37
MK-6194 High Dose - Interval 2 (More Frequent)91.2± 105.12
MK-6194 High Dose - Interval 1 (Less Frequent)189.6± 66.58
Placebo57.6± 79.00
Week 2
GroupValue95% CI
MK-6194 Low Dose - Interval 1 (Less Frequent)106.1± 124.15
MK-6194 Medium Dose- Interval 2 (More Frequent)100.8± 67.50
MK-6194 High Dose - Interval 2 (More Frequent)105.4± 121.23
MK-6194 High Dose - Interval 1 (Less Frequent)184.1± 67.77
Placebo0.0± 71.58
Week 3
GroupValue95% CI
MK-6194 Low Dose - Interval 1 (Less Frequent)347.3± 129.76
MK-6194 Medium Dose- Interval 2 (More Frequent)81.1± 98.95
MK-6194 High Dose - Interval 2 (More Frequent)123.7± 111.06
MK-6194 High Dose - Interval 1 (Less Frequent)192.8± 60.55
Placebo127.7± 52.96
Week 4
GroupValue95% CI
MK-6194 Low Dose - Interval 1 (Less Frequent)280.2± 116.12
MK-6194 Medium Dose- Interval 2 (More Frequent)122.4± 61.71
MK-6194 High Dose - Interval 2 (More Frequent)73.3± 108.47
MK-6194 High Dose - Interval 1 (Less Frequent)163.4± 72.06
Placebo63.3± 105.58
Week 5
GroupValue95% CI
MK-6194 Low Dose - Interval 1 (Less Frequent)456.3± 28.23
MK-6194 Medium Dose- Interval 2 (More Frequent)100.6± 74.36
MK-6194 High Dose - Interval 2 (More Frequent)126.2± 75.69
MK-6194 High Dose - Interval 1 (Less Frequent)166.8± 76.19
Placebo79.3± 66.49
Week 6
GroupValue95% CI
MK-6194 Low Dose - Interval 1 (Less Frequent)114.3± 119.18
MK-6194 Medium Dose- Interval 2 (More Frequent)57.9± 101.25
MK-6194 High Dose - Interval 2 (More Frequent)0.0± 101.48
MK-6194 High Dose - Interval 1 (Less Frequent)193.9± 68.59
Placebo53.8± 90.84
Week 7
GroupValue95% CI
MK-6194 Low Dose - Interval 1 (Less Frequent)137.7± 84.27
MK-6194 Medium Dose- Interval 2 (More Frequent)103.6± 68.22
MK-6194 High Dose - Interval 2 (More Frequent)68.6± 87.88
MK-6194 High Dose - Interval 1 (Less Frequent)154.5± 70.64
Placebo66.1± 87.17
Week 8
GroupValue95% CI
MK-6194 Low Dose - Interval 1 (Less Frequent)381.1± 34.64
MK-6194 Medium Dose- Interval 2 (More Frequent)109.0± 84.28
MK-6194 High Dose - Interval 2 (More Frequent)63.5± 82.18
MK-6194 High Dose - Interval 1 (Less Frequent)159.1± 66.12
Placebo50.6± 93.80
Titer of Anti-drug Antibody (ADA) to MK-6194 Secondary · Pre dose (week 0) and Weeks 4, 8, 12

Blood samples were collected for the determination of ADA to MK-6194 using a screening assay, ADA titer using a confirmatory assay, and neutralizing antibody to MK-6194 in participants with confirmed positive titers

Week 0
GroupValue95% CI
MK-6194 Medium Dose- Interval 2 (More Frequent)20.020.0 – 20.0
MK-6194 High Dose - Interval 1 (Less Frequent)20.020.0 – 20.0
Week 4
GroupValue95% CI
MK-6194 Medium Dose- Interval 2 (More Frequent)20.020.0 – 20.0
MK-6194 High Dose - Interval 2 (More Frequent)20.020.0 – 20.0
MK-6194 High Dose - Interval 1 (Less Frequent)20.020.0 – 160.0
Week 8
GroupValue95% CI
MK-6194 Low Dose - Interval 1 (Less Frequent)160.0160.0 – 160.0
MK-6194 Medium Dose- Interval 2 (More Frequent)20.020.0 – 20.0
MK-6194 High Dose - Interval 2 (More Frequent)20.020.0 – 20.0
MK-6194 High Dose - Interval 1 (Less Frequent)20.020.0 – 40.0
Week 12
GroupValue95% CI
MK-6194 Low Dose - Interval 1 (Less Frequent)640.0640.0 – 640.0
MK-6194 Medium Dose- Interval 2 (More Frequent)40.020.0 – 320.0
MK-6194 High Dose - Interval 2 (More Frequent)20.020.0 – 640.0
MK-6194 High Dose - Interval 1 (Less Frequent)40.020.0 – 160.0

Adverse events — posted to ClinicalTrials.gov

Time frame: Up to approximately 52 weeks. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

IBT: MK-6194 Low Dose Interval 1 (Less Frequent)
Serious: 1/7 (14%)
Deaths: 0/7
IBT-MK-6194 Medium Dose- Interval 2 (More Frequent)
Serious: 0/11 (0%)
Deaths: 0/11
IBT: MK-6194 High Dose-Interval 2 (More Frequent)
Serious: 1/18 (6%)
Deaths: 0/18
IBT:MK-6194 High Dose-Interval 1 (Less Frequent)
Serious: 0/10 (0%)
Deaths: 0/10
IBT: Placebo
Serious: 0/11 (0%)
Deaths: 0/11
CBT: MK-6194 Low Dose- Interval 1 (Less Frequent)
Serious: 0/2 (0%)
Deaths: 0/2
CBT: MK-6194 Medium Dose- Interval 2 (More Frequent)
Serious: 0/1 (0%)
Deaths: 0/1
CBT: MK-6194 High Dose- Interval 2 (More Frequent)
Serious: 0/2 (0%)
Deaths: 0/2
CBT: MK-6194 High Dose - Interval 1 (Less Frequent)
Serious: 0/3 (0%)
Deaths: 0/3
CBT: Placebo
Serious: 0/3 (0%)
Deaths: 0/3
OL: MK-6194 Low Dose -Interval 1 (Less Frequent)
Serious: 0/3 (0%)
Deaths: 0/3
OL: MK-6194 Medium Dose- Interval 2 (More Frequent)
Serious: 0/4 (0%)
Deaths: 0/4
OL: MK-6194 High Dose- Interval 2 (More Frequent)
Serious: 0/4 (0%)
Deaths: 0/4

Serious adverse events (1 terms)

ReactionSystemIBT: MK-6194 Low Dose Inte…IBT-MK-6194 Medium Dose- I…IBT: MK-6194 High Dose-Int…IBT:MK-6194 High Dose-Inte…IBT: PlaceboCBT: MK-6194 Low Dose- Int…CBT: MK-6194 Medium Dose- …CBT: MK-6194 High Dose- In…CBT: MK-6194 High Dose - I…CBT: PlaceboOL: MK-6194 Low Dose -Inte…OL: MK-6194 Medium Dose- I…OL: MK-6194 High Dose- Int…
Colitis ulcerativeGastrointestinal disorders
Other adverse events (57 terms — click to expand)

ReactionSystemIBT: MK-6194 Low Dose Inte…IBT-MK-6194 Medium Dose- I…IBT: MK-6194 High Dose-Int…IBT:MK-6194 High Dose-Inte…IBT: PlaceboCBT: MK-6194 Low Dose- Int…CBT: MK-6194 Medium Dose- …CBT: MK-6194 High Dose- In…CBT: MK-6194 High Dose - I…CBT: PlaceboOL: MK-6194 Low Dose -Inte…OL: MK-6194 Medium Dose- I…OL: MK-6194 High Dose- Int…
EosinophiliaBlood and lymphatic system disorders
Injection site erythemaGeneral disorders
Injection site pruritusGeneral disorders
Injection site indurationGeneral disorders
Injection site oedemaGeneral disorders
AnaemiaBlood and lymphatic system disorders
Abdominal pain upperGastrointestinal disorders
Colitis ulcerativeGastrointestinal disorders
NasopharyngitisInfections and infestations
HeadacheNervous system disorders
Iron deficiency anaemiaBlood and lymphatic system disorders
NeutropeniaBlood and lymphatic system disorders
Abdominal discomfortGastrointestinal disorders
Abdominal painGastrointestinal disorders
DiarrhoeaGastrointestinal disorders
Loose toothGastrointestinal disorders
NauseaGastrointestinal disorders
VomitingGastrointestinal disorders
Influenza like illnessGeneral disorders
Injection site discolourationGeneral disorders
Injection site painGeneral disorders
Injection site rashGeneral disorders
Injection site swellingGeneral disorders
BacteriuriaInfections and infestations
COVID-19Infections and infestations
Clostridium difficile infectionInfections and infestations
Enterocolitis infectiousInfections and infestations
Gastrointestinal infectionInfections and infestations
Gastrointestinal viral infectionInfections and infestations
Hepatitis EInfections and infestations
Norovirus infectionInfections and infestations
Oral herpesInfections and infestations
Ankle fractureInjury, poisoning and procedural complications
Alanine aminotransferase increasedInvestigations
Aspartate aminotransferase increasedInvestigations
Blood bilirubin increasedInvestigations
Hepatic enzyme increasedInvestigations
Lipase increasedInvestigations
Weight decreasedInvestigations
Weight increasedInvestigations

Most-reported serious reactions: Colitis ulcerative.

Data from ClinicalTrials.gov NCT04924114 adverse events section.

Sponsor's own description

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of MK-6194 in participants with active UC.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

  1. A systematic review of interleukin-2-based immunotherapies in clinical trials for cancer and autoimmune diseases.
    Raeber ME, Sahin D, Karakus U, Boyman O. · · 2023 · cited 139× · PMID 37004361 · DOI 10.1016/j.ebiom.2023.104539
  2. Engineering cytokine therapeutics.
    Deckers J, Anbergen T, Hokke AM, de Dreu A, et al · · 2023 · cited 132× · PMID 37064653 · DOI 10.1038/s44222-023-00030-y
  3. "IL-2 immunotherapy for targeting regulatory T cells in autoimmunity".
    Lykhopiy V, Malviya V, Humblet-Baron S, Schlenner SM. · · 2023 · cited 61× · PMID 37741949 · DOI 10.1038/s41435-023-00221-y
  4. Challenges and opportunities in achieving effective regulatory T cell therapy in autoimmune liver disease.
    Richardson N, Wootton GE, Bozward AG, Oo YH. · · 2022 · cited 45× · PMID 35641679 · DOI 10.1007/s00281-022-00940-w
  5. Molecular Engineering of Interleukin-2 for Enhanced Therapeutic Activity in Autoimmune Diseases.
    Tomasovic LM, Liu K, VanDyke D, Fabilane CS, et al · · 2024 · cited 17× · PMID 37999893 · DOI 10.1007/s40259-023-00635-0
  6. Role of FoxP3<sup>+</sup> Regulatory T Cells in Modulating Immune Responses to Adeno-Associated Virus Gene Therapy.
    Muñoz-Melero M, Biswas M. · · 2024 · cited 9× · PMID 38450566 · DOI 10.1089/hum.2023.227
  7. Targeting γc family cytokines with biologics: current status and future prospects.
    Bick F, Blanchetot C, Lambrecht BN, Schuijs MJ. · · 2025 · cited 5× · PMID 39967341 · DOI 10.1080/19420862.2025.2468312

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