A Study of MK-6194 (PT101) in Participants With Active Ul... | NCT04924114 | Trialant
NCT04924114
Sponsor
Merck Sharp & Dohme LLC
Status
Completed
Last Update Posted
Aug 29, 2025Actual
Enrollment
57Actual
Phase
Phase 1
Conditions
Ulcerative Colitis
Interventions
MK-6194
MK-6194-matching placebo
Countries
United States
Georgia
Germany
Hungary
Moldova
Poland
Ukraine
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT04924114
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
6194-002
Secondary IDs
ID
Type
Description
Link
PT101-201
Other Identifier
Pandion
2021-000093-28
EudraCT Number
Brief Title
A Study of MK-6194 (PT101) in Participants With Active Ulcerative Colitis (UC) (MK-6194-002)
Official Title
A Phase 1b, Randomized, Adaptive, Double-Blind, Placebo-Controlled, Multicenter Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Doses of PT101 in Subjects With Active Ulcerative Colitis
Acronym
Not provided
Organization
Merck Sharp & Dohme LLCINDUSTRY
Status Module
Record Verification Date
Aug 2025
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Oct 14, 2021Actual
Primary Completion Date
Jan 8, 2024Actual
Completion Date
Jul 15, 2024Actual
First Submitted Date
Feb 26, 2021
First Submission Date that Met QC Criteria
Jun 9, 2021
First Posted Date
Jun 11, 2021Actual
Results Waived
Not provided
Results First Submitted Date
Jan 2, 2025
Results First Submitted that Met QC Criteria
Mar 10, 2025
Results First Posted Date
Mar 24, 2025Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Aug 12, 2025
Last Update Posted Date
Aug 29, 2025Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Merck Sharp & Dohme LLCINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of MK-6194 in participants with active UC.
Detailed Description
Not provided
Conditions Module
Conditions
Ulcerative Colitis
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
57Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
MK-6194 Low Dose - Interval 1 (Less Frequent)
Experimental
Participants received low dose of MK-6194 at specified less frequent intervals
Drug: MK-6194
MK-6194 Medium Dose- Interval 2 (More Frequent)
Experimental
Participants received medium dose of MK-6194 at specified more frequent intervals
Drug: MK-6194
MK-6194 High Dose- Interval 2 (More Frequent)
Experimental
Participants received high dose of MK-6194 at specified more frequent intervals
Drug: MK-6194
MK-6194 High Dose- Interval 1 (Less Frequent)
Experimental
Participants received high dose MK-6194 at specified less frequent intervals
Drug: MK-6194
Placebo
Placebo Comparator
Participants received MK- 6194-matching placebo via subcutaneous injection, administered either at interval 1 or interval 2
Drug: MK-6194-matching placebo
Interventions
Name
Type
Description
Arm Group Labels
Other Names
MK-6194
Drug
Subcutaneous injection
MK-6194 High Dose- Interval 1 (Less Frequent)
MK-6194 High Dose- Interval 2 (More Frequent)
MK-6194 Low Dose - Interval 1 (Less Frequent)
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants Who Experienced an Adverse Event (AE)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Up to approximately 85 days
Number of Participants Who Interrupted or Discontinued Study Treatment Due to an AE
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to thestudy intervention
Up to approximately 72 days
Secondary Outcomes
Measure
Description
Time Frame
Maximum Concentration (Cmax) of MK-6194
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.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Diagnosis of UC at least 3 months prior to screening.
Mildly to severely active UC.
Inadequate response, loss of response, or intolerance to at least 1 prior conventional therapy, and no more than 2 prior advanced therapies.
Participants at risk for colorectal cancer must have a colonoscopy prior to or at screening as follows:
Participants > 50 years of age must have documentation of a colonoscopy within 3 years of the screening visit to exclude adenomatous polyps. Participants whose adenomas have been completely excised at screening are eligible.
Participants with extensive colitis for ≥ 8 years, or disease limited to the left side of the colon for ≥ 10 years, must either have had a full colonoscopy to assess for the presence of dysplasia within 1 year before first administration of study drug or a full colonoscopy to assess for the presence of malignancy at the screening visit.
No evidence of active tuberculosis (TB), latent TB, or inadequately treated TB.
Women of childbearing potential (WOCBP) and males with female partners of childbearing potential must utilize highly effective contraceptive methods beginning 4 weeks prior to first dose of study drug and continue for 30 days after the last dose of study drug.
Body mass index (BMI) 18 to 35 kg/m^2 inclusive and weight ≥ 50 kg.
Exclusion Criteria:
Prior treatment with recombinant IL-2 or modified IL-2 therapy, including MK-6194 (PT101).
Known sensitivity to MK-6194 (PT101) or its excipients.
Known history of hypersensitivity to interleukin-2 (IL-2).
Disease limited to the rectum (i.e., within 15 cm of the anal verge).
Diagnosis of toxic megacolon.
Suspected or known colon stricture or stenosis.
Diagnosis of Crohn's disease, or indeterminant colitis.
Has severe colitis as evidenced by:
Current hospitalization for the treatment of UC
Likely to require a colectomy within 12 weeks of baseline in the opinion of the Investigator
At least 4 symptoms of severe colitis as identified at screening or baseline visits.
Previously had surgery for UC, or likely to require surgery for UC during the study period in the opinion of the Investigator.
History of abnormal thallium stress test or functional cardiac function test.
History of significant cardiac, pulmonary, renal, hepatic, or central nervous system (CNS) impairment.
Active clinically significant infection, or any infection requiring hospitalization or treatment with intravenous anti-infectives within 8 weeks of randomization, or any infection requiring oral anti-infective therapy within 6 weeks of randomization.
History of opportunistic infection.
History of symptomatic herpes zoster within 16 weeks of randomization, or any history of disseminated herpes simplex, disseminated herpes zoster, ophthalmic zoster, or central nervous system (CNS) zoster.
Currently on any chronic systemic (oral or IV) anti-infective therapy for chronic infection (such as pneumocystis, cytomegalovirus, herpes zoster, or atypical mycobacteria).
Currently receiving lymphocyte depleting therapy.
History of abnormal pulmonary function tests.
Participants with organ or tissue allograft.
Malignancy within 5 years of screening, with the exception of adequately treated or excised non-metastatic basal cell or squamous cell cancer of the skin.
Exposure to advanced therapy within 5 half-lives of the Day 1 visit, or documentation of detectable drug during screening.
Received a live attenuated vaccine < 1 month prior to screening or is planning to receive a live attenuated vaccine during the study period or within 12 weeks of the end of participation in the study.
Is pregnant or nursing or is planning to become pregnant during the study.
Any uncontrolled or clinically significant concurrent systemic disease other than UC.
Upon concluding the Initial Blinded Treatment (IBT) phase, participants could either complete the study or enter one of the next 2 phases. Participants who achieved clinical response could enter the continued blinded treatment (CBT) phase and continue receiving the same treatment as the IBT phase. Participants who did not achieve clinical response could enter an open label (OL) phase and receive MK-6194 at the same dose/regimen of their IBT cohort for active MK-6194 treatment.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
MK-6194 Low Dose - Interval 1 (Less Frequent)
Participants received low dose of MK-6194 at specified less frequent intervals
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.
Time to Cmax (Tmax) of MK-6194
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.
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
Minimum Concentration (Cmin) of MK-6194
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.
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
Apparent Half-life (t1/2) of MK-6194
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.
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
Apparent Clearance (CL/F) of MK-6194
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.
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
Apparent Volume of Distribution (Vd/F) of MK-6194
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.
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
Area Under the Concentration Time-curve From Time 0 to the Last Quantifiable Concentration (AUC0-t)
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.
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
Area Under the Curve From Time 0 to Infinity (AUC0-inf) of MK-6194
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.
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
Change in Number of Peripheral Regulatory T-cells (Tregs) in Whole Blood
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.
Change in Number of Natural Killer (NK) Cells in Whole Blood
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.
Change in Number of Conventional T Cells (Tcons) in Whole Blood
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.
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
Pre dose (week 0) and Weeks 4, 8, 12
Kissimmee
Florida
34741
United States
Carolina's GI Research, LLC ( Site 0105)
Raleigh
North Carolina
27607
United States
Pinnacle Clinical Research ( Site 0103)
San Antonio
Texas
78229
United States
Southern Star Research Institute ( Site 0101)
San Antonio
Texas
78229
United States
ARENSIA Exploratory Medicine Georgia ( Site 0801)
Tbilisi
0112
Georgia
Charite Research Organisation GmbH ( Site 0201)
Berlin
10117
Germany
PRA Magyarorszag Kutatasi es Fejlesztesi Kft. ( Site 0302)
Budapest
1007
Hungary
ARENSIA Exploratory Medicine ( Site 0401)
Chisinau
2025
Moldova
Allmedica Badania Kliniczne Sp z o. o. Sp. K. ( Site 0502)
Nowy Targ
Lesser Poland Voivodeship
34-400
Poland
WIP Warsaw IBD Point Professor Kierkus ( Site 0501)
Warsaw
Masovian Voivodeship
00-728
Poland
Arensia Exploratory Medicine GmbH Ukraine ( Site 0701)
Kyiv
Kyivska Oblast
01135
Ukraine
MAC Clinical Research Prescot ( Site 0604)
Prescot
Knowsley
L34 1BH
United Kingdom
Memory Assessment Clinics Ltd ( Site 0601)
Blackpool
Lancashire
FY2 0JH
United Kingdom
MAC Clinical Research ( Site 0602)
Barnsley
S75 3DL
United Kingdom
MAC Clinical Research Centre Leeds ( Site 0603)
Leeds
LS10 1DU
United Kingdom
MAC Clinical Research Ltd. ( Site 0605)
Manchester
M13 9NQ
United Kingdom
Participants received medium dose of MK-6194 at specified more frequent intervals
FG002
MK-6194 High Dose - Interval 2 (More Frequent)
Participants received high dose of MK-6194 at specified more frequent intervals
FG003
MK-6194 High Dose - Interval 1 (Less Frequent)
Participants received high dose MK-6194 at specified less frequent intervals
FG004
Placebo
Participants received MK-6194-matching placebo via subcutaneous injection, administered either at interval 1 or interval 2
FG0007 subjects
FG00111 subjects
FG00218 subjects
FG00310 subjects
FG00411 subjects
Continued in CBT Phase
Participants who achieved clinical response after IBT phase could enter the continued blinded treatment (CBT) phase and continue receiving the same treatment as the IBT phase.
FG0002 subjects
FG0011 subjects
FG0022 subjects
FG0033 subjects
FG0043 subjects
Treated in CBT Phase
FG0002 subjects
FG0011 subjects
FG0022 subjects
FG0033 subjects
FG0043 subjects
Continued in OL Phase
Participants who did not achieve clinical response after IBT phase could enter an open label (OL) phase and receive MK-6194 at the same dose/regimen of their IBT cohort for active MK-6194 treatment.
FG0002 subjects
FG0013 subjects
FG0024 subjects
FG0030 subjects
FG0042 subjects
Treated in OL Phase
2 participants who received placebo in IBT phase received MK-6194 at the same dose/regimen of their IBT cohort for active MK-6194 treatment
FG0003 subjects1 participant who received placebo in IBT phase received MK-6194 1mg Q4W in the OL phase
FG0014 subjects1 participant who received placebo in IBT phase received MK-6194 2.5mg Q2W in the OL phase
FG0024 subjects
FG0030 subjects
FG0040 subjects
COMPLETED
FG0007 subjects
FG0019 subjects
FG00216 subjects
FG00310 subjects
FG0049 subjects
NOT COMPLETED
FG0000 subjects
FG0012 subjects
FG0022 subjects
FG0030 subjects
FG0042 subjects
Type
Comment
Reasons
Withdrawal by Subject
FG0000 subjects
FG0012 subjects
FG0022 subjects
FG0030 subjects
FG0042 subjects
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
MK-6194 Low Dose - Interval 1 (Less Frequent)
Participants received low dose of MK-6194 at specified less frequent intervals
BG001
MK-6194 Medium Dose- Interval 2 (More Frequent)
Participants received medium dose of MK-6194 at specified more frequent intervals
BG002
MK-6194 High Dose - Interval 2 (More Frequent)
Participants received high dose of MK-6194 at specified more frequent intervals
BG003
MK-6194 High Dose - Interval 1 (Less Frequent)
Participants received high dose MK-6194 at specified less frequent intervals
BG004
Placebo
Participants received MK-6194-matching placebo via subcutaneous injection, administered either at interval 1 or interval 2
BG005
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0007
BG00111
BG00218
BG00310
BG00411
BG00557
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
Years
Title
Denominators
Categories
Title
Measurements
BG00043.4± 11.59
BG00143.4± 14.64
BG00247.7± 11.43
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0004
BG0015
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0002
BG0010
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Secondary
Maximum Concentration (Cmax) of MK-6194
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.
All randomized participants who received at least 1 dose of study intervention and who had least 1 valid analytical result at baseline, at least 1 post-dose analytical result and had no major relevant protocol or dosing deviations that could potentially affect the pharmacokinetic (PK) profile. Per protocol, samples from participants who received placebo were not analyzed for PK values.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
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.
ID
Title
Description
OG000
MK-6194 Low Dose - Interval 1 (Less Frequent)
Participants received low dose of MK-6194 at specified less frequent intervals test
OG001
MK-6194 Medium Dose- Interval 2 (More Frequent)
Participants received medium dose of MK-6194 at specified more frequent intervals
OG002
MK-6194 High Dose - Interval 2 (More Frequent)
Participants received high dose of MK-6194 at specified more frequent intervals
OG003
MK-6194 High Dose - Interval 1 (Less Frequent)
Participants received high dose MK-6194 at specified less frequent intervals
OG004
Placebo
Participants received MK-6194-matching placebo via subcutaneous injection, administered either at interval 1 or interval 2
Units
Counts
Participants
OG0007
OG0019
OG00218
OG003
Title
Denominators
Categories
Title
Measurements
OG0009.55± 67.80
OG00130.02± 95.85
OG00251.80± 71.97
OG003
Secondary
Time to Cmax (Tmax) of MK-6194
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.
All randomized participants who received at least 1 dose of study intervention and who had least 1 valid analytical result at baseline, at least 1 post-dose analytical result and had no major relevant protocol or dosing deviations that could potentially affect he pharmacokinetic (PK) profile. Per protocol, samples from participants receiving placebo were not analyzed for PK values.
Posted
Median
Full Range
hours
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
ID
Title
Description
OG000
MK-6194 Low Dose - Interval 1 (Less Frequent)
Participants received low dose of MK-6194 at specified less frequent intervals
OG001
MK-6194 Medium Dose- Interval 2 (More Frequent)
Participants received medium dose of MK-6194 at specified more frequent intervals
OG002
MK-6194 High Dose - Interval 2 (More Frequent)
Secondary
Minimum Concentration (Cmin) of MK-6194
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.
All randomized participants who received at least 1 dose of study intervention and who had least 1 valid analytical result at baseline, at least 1 post-dose analytical result and had no major relevant protocol or dosing deviations that could potentially affect the PK profile. Per protocol, samples participants receiving placebo were not analyzed for PK values.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
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
ID
Title
Description
OG000
MK-6194 Low Dose - Interval 1 (Less Frequent)
Participants received low dose of MK-6194 at specified less frequent intervals
OG001
MK-6194 Medium Dose- Interval 2 (More Frequent)
Participants received medium dose of MK-6194 at specified more frequent intervals
Secondary
Apparent Half-life (t1/2) of MK-6194
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.
All randomized participants who received at least 1 dose of study intervention and who had least 1 valid analytical result at baseline, at least 1 post-dose analytical result and had no major relevant protocol or dosing deviations that could potentially affect the PK profile. Per protocol, samples from participants receiving placebo were not analyzed for PK values.
Posted
Geometric Mean
Geometric Coefficient of Variation
hours
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
ID
Title
Description
OG000
MK-6194 Low Dose - Interval 1 (Less Frequent)
Participants received low dose of MK-6194 at specified less frequent intervals
OG001
MK-6194 Medium Dose- Interval 2 (More Frequent)
Participants received medium dose of MK-6194 at specified more frequent intervals
OG002
MK-6194 High Dose - Interval 2 (More Frequent)
Secondary
Apparent Clearance (CL/F) of MK-6194
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.
All randomized participants who received at least 1 dose of study intervention and who had least 1 valid analytical result at baseline, at least 1 post-dose analytical result and had no major relevant protocol or dosing deviations that could potentially affect the PK profile. Per protocol, samples from participants receiving placebo were not analyzed for PK values.
Posted
Geometric Mean
Geometric Coefficient of Variation
L/hours
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
ID
Title
Description
OG000
MK-6194 Low Dose - Interval 1 (Less Frequent)
Participants received low dose of MK-6194 at specified less frequent intervals
OG001
MK-6194 Medium Dose- Interval 2 (More Frequent)
Participants received medium dose of MK-6194 at specified more frequent intervals
OG002
MK-6194 High Dose - Interval 2 (More Frequent)
Secondary
Apparent Volume of Distribution (Vd/F) of MK-6194
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.
All randomized participants who received at least 1 dose of study intervention and who had least 1 valid analytical result at baseline, at least 1 post-dose analytical result and had no major relevant protocol or dosing deviations that could potentially affect the PK profile. Per protocol, samples from participants who received placebo were not analyzed for PK values.
Posted
Geometric Mean
Geometric Coefficient of Variation
Liters
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
ID
Title
Description
OG000
MK-6194 Low Dose - Interval 1 (Less Frequent)
Participants received low dose of MK-6194 at specified less frequent intervals
OG001
MK-6194 Medium Dose- Interval 2 (More Frequent)
Participants received medium dose of MK-6194 at specified more frequent intervals
OG002
Secondary
Area Under the Concentration Time-curve From Time 0 to the Last Quantifiable Concentration (AUC0-t)
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.
All randomized participants who received at least 1 dose of study intervention and who had least 1 valid analytical result at baseline, at least 1 post-dose analytical result and had no major relevant protocol or dosing deviations that could potentially affect the PK profile. Per protocol, samples from participants who received placebo were not analyzed for PK values.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng*hour/mL
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
ID
Title
Description
OG000
MK-6194 Low Dose - Interval 1 (Less Frequent)
Participants received low dose of MK-6194 at specified less frequent intervals
OG001
MK-6194 Medium Dose- Interval 2 (More Frequent)
Participants received medium dose of MK-6194 at specified more frequent intervals
Secondary
Area Under the Curve From Time 0 to Infinity (AUC0-inf) of MK-6194
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.
All randomized participants who received at least 1 dose of study intervention and who had least 1 valid analytical result at baseline, at least 1 post-dose analytical result and had no major relevant protocol or dosing deviations that could potentially affect the PK profile. Per protocol, samples from participants who received placebo were not analyzed for PK values.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng*hour/mL
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
ID
Title
Description
OG000
MK-6194 Low Dose - Interval 1 (Less Frequent)
Participants received low dose of MK-6194 at specified less frequent intervals
OG001
MK-6194 Medium Dose- Interval 2 (More Frequent)
Participants received medium dose of MK-6194 at specified more frequent intervals
Secondary
Change in Number of Peripheral Regulatory T-cells (Tregs) in Whole Blood
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.
All randomized participants who received at least 1 dose of study intervention and who had least 1 valid analytical result at baseline, at least 1 post-dose analytical result and had no major relevant protocol or dosing deviations that could potentially affect the pharmacodynamic profile.
Participants received low dose of MK-6194 at specified less frequent intervals
OG001
MK-6194 Medium Dose- Interval 2 (More Frequent)
Participants received medium dose of MK-6194 at specified more frequent intervals
OG002
MK-6194 High Dose - Interval 2 (More Frequent)
Participants received high dose of MK-6194 at specified more frequent intervals
Secondary
Change in Number of Natural Killer (NK) Cells in Whole Blood
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.
All randomized participants who received at least 1 dose of study intervention and who had least 1 valid analytical result at baseline, at least 1 post-dose analytical result and had no major relevant protocol or dosing deviations that could potentially affect the pharmacodynamic profile
Participants received low dose of MK-6194 at specified less frequent intervals
OG001
MK-6194 Medium Dose- Interval 2 (More Frequent)
Participants received medium dose of MK-6194 at specified more frequent intervals
OG002
MK-6194 High Dose - Interval 2 (More Frequent)
Participants received high dose of MK-6194 at specified more frequent intervals
OG003
Secondary
Change in Number of Conventional T Cells (Tcons) in Whole Blood
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.
All randomized participants who received at least 1 dose of study intervention and who had least 1 valid analytical result at baseline, at least 1 post-dose analytical result and had no major relevant protocol or dosing deviations that could potentially affect the pharmacodynamic profile
Participants received low dose of MK-6194 at specified less frequent intervals
OG001
MK-6194 Medium Dose- Interval 2 (More Frequent)
Participants received medium dose of MK-6194 at specified more frequent intervals
OG002
MK-6194 High Dose - Interval 2 (More Frequent)
Participants received high dose of MK-6194 at specified more frequent intervals
OG003
Secondary
Titer of Anti-drug Antibody (ADA) to MK-6194
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
All randomized participants who received at least 1 dose of study intervention and who had least 1 valid analytical result at baseline, at least 1 post-dose analytical result and had no major relevant protocol or dosing deviations that could potentially affect the pharmacodynamic profile. ADA titer was assessed only in participants who were ADA positive.
Posted
Median
Full Range
Titer
Pre dose (week 0) and Weeks 4, 8, 12
ID
Title
Description
OG000
MK-6194 Low Dose - Interval 1 (Less Frequent)
Participants received low dose of MK-6194 at specified less frequent intervals
OG001
MK-6194 Medium Dose- Interval 2 (More Frequent)
Participants received medium dose of MK-6194 at specified more frequent intervals
OG002
MK-6194 High Dose - Interval 2 (More Frequent)
Participants received high dose of MK-6194 at specified more frequent intervals
Primary
Number of Participants Who Experienced an Adverse Event (AE)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
All participants who received at least one dose of study drug.
Posted
Count of Participants
Participants
Up to approximately 85 days
ID
Title
Description
OG000
MK-6194 Low Dose - Interval 1 (Less Frequent)
Participants received low dose of MK-6194 at specified less frequent intervals
OG001
MK-6194 Medium Dose- Interval 2 (More Frequent)
Participants received medium dose of MK-6194 at specified more frequent intervals
OG002
MK-6194 High Dose - Interval 2 (More Frequent)
Participants received high dose of MK-6194 at specified more frequent intervals
OG003
MK-6194 High Dose - Interval 1 (Less Frequent)
Participants received high dose MK-6194 at specified less frequent intervals
Primary
Number of Participants Who Interrupted or Discontinued Study Treatment Due to an AE
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to thestudy intervention
All participants who received at least one dose of study drug
Posted
Count of Participants
Participants
Up to approximately 72 days
ID
Title
Description
OG000
MK-6194 Low Dose - Interval 1 (Less Frequent)
Participants received low dose of MK-6194 at specified less frequent intervals test
OG001
MK-6194 Medium Dose- Interval 2 (More Frequent)
Participants received medium dose of MK-6194 at specified more frequent intervals
OG002
MK-6194 High Dose - Interval 2 (More Frequent)
Participants received high dose of MK-6194 at specified more frequent intervals
OG003
MK-6194 High Dose - Interval 1 (Less Frequent)
Participants received high dose MK-6194 at specified less frequent intervals
Time Frame
Up to approximately 52 weeks
Description
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
IBT: MK-6194 Low Dose Interval 1 (Less Frequent)
Participants received low dose MK-6194 at specified less frequent intervals for up to 12 weeks
0
7
1
7
7
7
EG001
IBT-MK-6194 Medium Dose- Interval 2 (More Frequent)
Participants received medium dose of MK-6194 at specified more frequent intervals for up to 12 weeks
0
11
0
11
10
11
EG002
IBT: MK-6194 High Dose-Interval 2 (More Frequent)
Participants received high dose of MK-6194 at specified more frequent intervals for up to 12 weeks
0
18
1
18
18
18
EG003
IBT:MK-6194 High Dose-Interval 1 (Less Frequent)
Participants received high dose MK-6194 at specified less frequent intervals for up to 12 weeks
0
10
0
10
10
10
EG004
IBT: Placebo
Participants received MK-6194-matching placebo via subcutaneous injection, administered either at interval 1 or interval 2 for up to 12 weeks
0
11
0
11
7
11
EG005
CBT: MK-6194 Low Dose- Interval 1 (Less Frequent)
Participants who achieved clinical response at week 12 of the IBT continued to receive low dose MK-6194 at specified less frequent intervals for up to 9 months
0
2
0
2
2
2
EG006
CBT: MK-6194 Medium Dose- Interval 2 (More Frequent)
Participants who achieved clinical response at week 12 of the IBT continued to receive medium dose MK-6194 at specified more frequent intervals for up to 9 months
0
1
0
1
1
1
EG007
CBT: MK-6194 High Dose- Interval 2 (More Frequent)
Participants who achieved clinical response at week 12 of the IBT continued to receive high dose MK-6194 at specified more frequent intervals for up to 9 months
0
2
0
2
2
2
EG008
CBT: MK-6194 High Dose - Interval 1 (Less Frequent)
Participants who achieved clinical response at week 12 of the IBT continued to receive high dose MK-6194 at specified less frequent intervals for up to 9 months
0
3
0
3
2
3
EG009
CBT: Placebo
Participants who achieved clinical response at week 12 of the IBT continued to receive placebo at interval 1 or 2 for up to 9 months
0
3
0
3
1
3
EG010
OL: MK-6194 Low Dose -Interval 1 (Less Frequent)
Participants who did not achieve clinical response at week 12 received low dose MK-6194 at specified less frequent intervals for up to 9 months
0
3
0
3
1
3
EG011
OL: MK-6194 Medium Dose- Interval 2 (More Frequent)
Participants who did not achieve clinical response at week 12 received medium dose MK-6194 at specified more frequent intervals for up to 9 months
0
4
0
4
3
4
EG012
OL: MK-6194 High Dose- Interval 2 (More Frequent)
Participants who did not achieve clinical response at week 12 received high dose MK-6194 at specified more frequent intervals for up to 9 months
0
4
0
4
3
4
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Colitis ulcerative
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected11 at risk
EG0021 events1 affected18 at risk
EG0030 events0 affected10 at risk
EG0040 events0 affected11 at risk
EG0050 events0 affected2 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected2 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected3 at risk
EG0110 events0 affected4 at risk
EG0120 events0 affected4 at risk
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 26.0
Systematic Assessment
EG0002 events2 affected7 at risk
EG0010 events0 affected11 at risk
EG0021 events1 affected18 at risk
EG0032 events1 affected10 at risk
EG0040 events0 affected11 at risk
EG0050 events0 affected2 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected2 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected3 at risk
EG0110 events0 affected4 at risk
EG0121 events1 affected4 at risk
Eosinophilia
Blood and lymphatic system disorders
MedDRA 26.0
Systematic Assessment
EG0004 events3 affected7 at risk
EG00126 events7 affected11 at risk
EG00250 events17 affected18 at risk
EG003
Iron deficiency anaemia
Blood and lymphatic system disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0011 events1 affected11 at risk
EG0020 events0 affected18 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected11 at risk
EG0021 events1 affected18 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected11 at risk
EG0021 events1 affected18 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected18 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected11 at risk
EG0023 events2 affected18 at risk
EG003
Colitis ulcerative
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected11 at risk
EG0021 events1 affected18 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected18 at risk
EG003
Loose tooth
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected11 at risk
EG0021 events1 affected18 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected11 at risk
EG0021 events1 affected18 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected18 at risk
EG003
Influenza like illness
General disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected11 at risk
EG0021 events1 affected18 at risk
EG003
Injection site discolouration
General disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected18 at risk
EG003
Injection site erythema
General disorders
MedDRA 26.0
Systematic Assessment
EG00013 events5 affected7 at risk
EG00119 events7 affected11 at risk
EG00239 events12 affected18 at risk
EG003
Injection site induration
General disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected11 at risk
EG0023 events3 affected18 at risk
EG003
Injection site oedema
General disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected11 at risk
EG0023 events3 affected18 at risk
EG003
Injection site pain
General disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected18 at risk
EG003
Injection site pruritus
General disorders
MedDRA 26.0
Systematic Assessment
EG0004 events2 affected7 at risk
EG0014 events4 affected11 at risk
EG0022 events2 affected18 at risk
EG003
Injection site rash
General disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected11 at risk
EG0021 events1 affected18 at risk
EG003
Injection site swelling
General disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected18 at risk
EG003
Bacteriuria
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected18 at risk
EG003
COVID-19
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0011 events1 affected11 at risk
EG0020 events0 affected18 at risk
EG003
Clostridium difficile infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected18 at risk
EG003
Enterocolitis infectious
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0011 events1 affected11 at risk
EG0020 events0 affected18 at risk
EG003
Gastrointestinal infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected11 at risk
EG0021 events1 affected18 at risk
EG003
Gastrointestinal viral infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected18 at risk
EG003
Hepatitis E
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected18 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected11 at risk
EG0022 events2 affected18 at risk
EG003
Norovirus infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected18 at risk
EG003
Oral herpes
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected18 at risk
EG003
Ankle fracture
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected11 at risk
EG0021 events1 affected18 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected18 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected18 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected18 at risk
EG003
Hepatic enzyme increased
Investigations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected18 at risk
EG003
Lipase increased
Investigations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0011 events1 affected11 at risk
EG0020 events0 affected18 at risk
EG003
Weight decreased
Investigations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected18 at risk
EG003
Weight increased
Investigations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected18 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0011 events1 affected11 at risk
EG0020 events0 affected18 at risk
EG003
Vitamin D deficiency
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected11 at risk
EG0021 events1 affected18 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected11 at risk
EG0021 events1 affected18 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected11 at risk
EG0021 events1 affected18 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected11 at risk
EG0021 events1 affected18 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected11 at risk
EG0021 events1 affected18 at risk
EG003
Headache
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected11 at risk
EG0022 events2 affected18 at risk
EG003
Intercostal neuralgia
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected18 at risk
EG003
Somnolence
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected18 at risk
EG003
Dermatillomania
Psychiatric disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected11 at risk
EG0021 events1 affected18 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected11 at risk
EG0021 events1 affected18 at risk
EG003
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected11 at risk
EG0021 events1 affected18 at risk
EG003
Rhinitis allergic
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected18 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected18 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected18 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected18 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected11 at risk
EG0021 events1 affected18 at risk
EG003
Hypertension
Vascular disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected18 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
The investigator will submit the proposed publication to the sponsor at least 30 days prior to the date of submission for publication. The sponsor can request to remove any confidential information other than study data from a proposed publication during the review period. The sponsor may also suggest changes to the presentation of study data and timing of the proposed publication.
Point of Contact
Title
Organization
Phone
Extension
Email
Senior Vice President, Global Clinical Development