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A Study to Evaluate Efficacy and Safety of MK-7240 in Participants With Moderately to Severely Active Ulcerative Colitis (MK-7240-001)

Primary Purpose

Ulcerative Colitis

Status

Not yet recruiting

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

IV MK-7240

IV Placebo

SC MK-7240

SC Placebo

About this trial

This is an interventional treatment trial for Ulcerative Colitis focused on measuring Inflammatory Bowel Disease

Eligibility Criteria

16 Years - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Has had ulcerative colitis (UC) (from onset of symptoms) for at least 3 months before randomization Has moderately to severely active UC Weight ≥40 kg Satisfies at least 1 of the following criteria: Has had an inadequate response or loss of response to 1 or more protocol-specified UC treatments Protocol specified corticosteroid dependence Has been intolerant to 1 or more protocol-specified UC treatments Is on treatment with any protocol-specified drugs during the study and meets drug stabilization requirements, as applicable Adolescent participants ≥16 and <18 years of age can participate if approved by the country or regulatory/health authority Participant assigned male sex at birth, if capable of producing sperm, agrees to abstain from penile-vaginal intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) and agrees to remain abstinent; or uses prescribed contraception unless azoospermic A participant assigned female sex at birth is eligible to participate if not pregnant or breastfeeding and Is not a participant of childbearing potential (POCBP); or is a POCBP and uses an acceptable contraceptive method, or is abstinent from penile-vaginal intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis), has a negative highly sensitive pregnancy test (urine or serum) as required by local regulations within 24 hours (for a urine test) or 72 hours (for a serum test) before the first dose of study intervention, medical history, menstrual history, and recent sexual activity has been reviewed by the investigator to decrease the risk for inclusion of a POCBP with an early undetected pregnancy Exclusion Criteria: Has a diagnosis of Crohn's Disease (CD) or indeterminate colitis (inflammatory bowel disease (IBD)-undefined) or other types of colitis or enteritis that may confound efficacy assessment. Has a current diagnosis of fulminant colitis and/or toxic megacolon Has UC limited to the rectum (i.e, must have evidence of UC extending beyond the rectosigmoid junction, which is ~10 cm from the anal margin) Has a current or impending need for colostomy or ileostomy Has had a total proctocolectomy or partial colectomy Has received fecal microbial transplantation within 4 weeks before randomization Has been hospitalized for the treatment of UC within 2 weeks before screening Has prior or current evidence of definite low-grade or high-grade colonic dysplasia including dysplasia identified during the Screening colonoscopy that has not been completely removed Has any active or serious infections without resolution after adequate treatment Has had a herpes zoster reactivation or cytomegalovirus that resolved less than 8 weeks before screening Has a transplanted organ which requires continued immunosuppression Has a history of cancer (except fully treated non-melanoma skin cell cancers or cervical carcinoma in situ after complete surgical removal) within the last 5 years Is known to be infected with hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV) Has evidence of active tuberculosis (TB), latent TB not successfully treated (per local guidelines), or inadequately treated TB (for participants with history of TB) Has confirmed or suspected COVID-19 infection Has a history of drug or alcohol abuse within 6 months prior to screening Has had major surgery within 3 months before screening or has a major surgery (i.e, requiring general anesthesia) planned during the study Is currently receiving or is planning to receive total parenteral nutrition at any time during study treatment Has received UC-related antibiotics and has not been on stable doses for at least 14 days before randomization or has discontinued these medications within 14 days of randomization Requires treatment with a therapy that does not adhere to the protocol-specified guidance parameters Has received protocol-specified prohibited medications Has had prior exposure to MK-7240 or another anti-tumor necrosis factor-like cytokine 1A (TL1A) antibody

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Experimental

Arm Label

Study 1: High Dose Induction, High Dose Maintenance

Study 1: High Dose Induction, Low Dose Maintenance

Study 1: Low Dose Induction, Low Dose Maintenance

Study 1: Placebo

Study 1: High Dose Extension

Study 1: Low Dose Extension

Study 2: High Dose Induction

Study 2: Low Dose Induction

Study 2: Placebo

Study 2: High Dose Extension

Study 2: Low Dose Extension

Arm Description

Participants receive high dose intravenous (IV) MK-7240, followed by a high dose subcutaneous (SC) MK-7240 regimen.

Participants receive high dose IV MK-7240, followed by a low dose SC MK-7240 regimen.

Participants receive low dose IV MK-7240, followed by a low dose SC MK-7240 regimen.

Participants receive IV placebo, followed by an SC placebo regimen.

Participants receive a high dose SC MK-7240 regimen. Participants may be enrolled in this arm after completing participation in their original arm, if they meet protocol-specific prerequisites.

Participants receive a low dose SC MK-7240 and placebo regimen. Participants may be enrolled in this arm after completing participation in their original arm, if they meet protocol-specific prerequisites.

Participants receive high dose IV MK-7240.

Participants receive low dose IV MK-7240.

Participants receive IV placebo. Participants who meet protocol-specified conditions may later enter either the Study 2: High Dose Extension arm or Study 2: Low Dose Extension arm.

Participants receive a high dose SC MK-7240 regimen. Participants may be enrolled in this arm only after completing participation in their original arm, if they meet protocol-specific prerequisites.

Participants receive a low dose SC MK-7240 regimen. Participants may be enrolled in this arm only after completing participation in their original arm, if they meet protocol-specific prerequisites.

Outcomes

Primary Outcome Measures

Study 1: Percentage of Participants Achieving Clinical Remission Per Modified Mayo Score (MMS) at Week 12

The Modified Mayo Score (MMS) is a composite score of ulcerative colitis (UC) disease activity on a scale of increasing severity from 0-9, calculated by summing three subscores: Endoscopic subscore (ES), scored on a scale of increasing severity from 0 (normal or inactive disease) to 3 (severe disease, such as spontaneous bleeding or ulceration); Stool frequency subscore (SFS), scored on a scale of increasing frequency from 0 (normal number of stools) to 3 (≥5 stools more than normal per day for the participant); and rectal bleeding subscore (RBS), scored on a scale of increasing severity from 0 (no blood seen) to 3 (blood alone passed). Clinical Remission is defined as an ES of 0 or 1, RBS of 0, and SFS of 0 or 1 and not greater than the baseline SFS.

Study 1: Percentage of Participants Achieving Clinical Remission Per MMS at Week 52

The MMS is a composite score of UC disease activity on a scale of increasing severity from 0-9, calculated by summing three subscores: ES, scored on a scale of increasing severity from 0 (normal or inactive disease) to 3 (severe disease, such as spontaneous bleeding or ulceration); SFS, scored on a scale of increasing frequency from 0 (normal number of stools) to 3 (≥5 stools more than normal per day for the participant); and RBS, scored on a scale of increasing severity from 0 (no blood seen) to 3 (blood alone passed). Clinical Remission is defined as an ES of 0 or 1, RBS of 0, and SFS of 0 or 1 and not greater than the baseline SFS.

Study 1: Percentage of Participants With One or More Adverse Events (AEs)

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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants who experience an AE will be reported.

Study 1: Percentage of Participants Who Discontinued Study Intervention 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 the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who discontinue study treatment due to an AE will be reported.

Study 2: Percentage of Participants Achieving Clinical Remission Per MMS at Week 12

Study 2: Percentage of Participants With One or More AEs

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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who experience an AE will be reported.

Study 2: Percentage of Participants Who Discontinued Study Intervention 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 the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who discontinue study treatment due to an AE will be reported.

Secondary Outcome Measures

Study 1: Percentage of Participants Achieving Clinical Response Per Partial Modified Mayo Score (pMMS) at Week 2

The partial Modified Mayo Score (pMMS) is a composite score of UC disease activity on a scale of increasing severity from 0-6, calculated by summing two subscores: SFS, scored from 0 (normal number of stools) to 3 (≥5 stools more than normal per day for the participant); RBS, scored from 0 (no blood seen) to 3 (blood alone passed). Clinical response is defined as pMMS reduction of 1 or more points and 30% or more, plus a reduction of 1 or more points in RBS or an absolute RBS of 0 or 1.

Study 1: Percentage of Participants With Endoscopic Improvement at Week 12

Endoscopic improvement is defined as Mayo endoscopic subscore (ES) of 0 or 1. The ES measures UC severity based on endoscopy on a 0-3 scale of increasing severity.

Study 1: Percentage of Participants Achieving a Clinical Response Per MMS at Week 12

The MMS is a composite score of UC disease activity on a scale of increasing severity from 0-9, calculated by summing three subscores: ES, scored on a scale of increasing severity from 0 (normal or inactive disease) to 3 (severe disease, such as spontaneous bleeding or ulceration); SFS, scored on a scale of increasing frequency from 0 (normal number of stools) to 3 (≥5 stools more than normal per day for the participant); and RBS, scored on a scale of increasing severity from 0 (no blood seen) to 3 (blood alone passed). Clinical response is defined as an MMS reduction of 2 or more points and 30% or more, plus a reduction of more than 1 point in RBS or an absolute RBS of 0 or 1.

Study 1: Percentage of Participants Achieving Histologic-Endoscopic Mucosal Improvement (HEMI) at Week 12

HEMI is defined as a Geboes score of 3.1 or less and ES of 0 or 1. The Geboes score is a histologic grading system for inflammation in UC with scores ranging from 0 to 5.4, with higher scores indicating more severe inflammation. ES measures UC severity based on endoscopy, scored from 0 (normal or inactive disease) to 3 (severe disease, such as spontaneous bleeding or ulceration).

Study 1: Percentage of Participants Achieving Clinical Remission Per pMMS at Week 12

pMMS is a composite score of UC disease activity on a scale of increasing severity from 0-6, calculated by summing two subscores: SFS, scored from 0 (normal number of stools) to 3 (≥5 stools more than normal per day for the participant); RBS, scored from 0 (no blood seen) to 3 (blood alone passed). Clinical remission per pMMS is defined as an RBS of 0 and SFS of ≤1.

Study 1: Percentage of Participants With Endoscopic Remission at Week 12

ES measures UC severity based on endoscopy, scored from 0 (normal or inactive disease) to 3 (severe disease, such as spontaneous bleeding or ulceration). Endoscopic remission is defined as an ES of 0.

Study 1: Percentage of Participants Reporting No Bowel Urgency at Week 12

Bowel urgency is measured using an NRS, which rates bowel urgency on a 0-11 scale of increasing severity. Resolution is defined as a score of 0 or 1 in participants who had a baseline score of 3 or more.

Study 1: Percentage of Participants Reporting No Abdominal Pain at Week 12

Abdominal pain is measured on a 0-4 NRS of increasing pain severity. Absence of abdominal pain is defined as a rating of 0.

Study 1: Percentage of Participants Achieving Inflammatory Bowel Disease Questionnaire (IBDQ) Remission at Week 12

The IBDQ measures health related quality of life in subjects with inflammatory bowel disease. It consists of 32 questions each with a graded response of 1 (worst) to 7 (best). The score ranges from 32 to 224. IBDQ remission is defined as a score of at least 170.

Study 1: Change from Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Score at Week 12

The FACIT-Fatigue is a 13-item measure that assesses self-reported fatigue and its impact upon daily activities and function, scored on a 0-52 point scale, with greater scores indicating a better fatigue-related quality of life. The change from baseline in FACIT-Fatigue score will be presented.

Percentage of Diagnostic Assay Positive (Dx+) Participants Achieving Clinical Remission Per MMS at Week 12

Dx+ participants are those who meet protocol-specific diagnostic assay criteria during screening. The MMS is a composite score of UC disease activity on a scale of increasing severity from 0-9, calculated by summing three subscores: ES, scored on a scale of increasing severity from 0 (normal or inactive disease) to 3 (severe disease, such as spontaneous bleeding or ulceration); SFS, scored on a scale of increasing frequency from 0 (normal number of stools) to 3 (≥5 stools more than normal per day for the participant); and RBS, scored on a scale of increasing severity from 0 (no blood seen) to 3 (blood alone passed). Clinical Remission is defined as an ES of 0 or 1, RBS of 0, and SFS of 0 or 1 and not greater than the baseline SFS.

Percentage of Dx+ Participants With Endoscopic Improvement at Week 12

Dx+ participants are those who meet protocol-specific diagnostic assay criteria during screening. Endoscopic improvement is defined as ES of 0 or 1. The ES measures UC severity based on endoscopy on a 0-3 scale of increasing severity.

Study 1: Percentage of Participants Achieving Histologic-Endoscopic Remission (HER) at Week 12

HER is defined as a Geboes score of less than 2 and ES of 0 or 1. The Geboes score is a histologic grading system for inflammation in UC with scores ranging from 0 to 5.4, with higher scores indicating more severe inflammation. ES measures UC severity based on endoscopy, scored from 0 (normal or inactive disease) to 3 (severe disease, such as spontaneous bleeding or ulceration).

Study 1: Percentage of Participants with Endoscopic Improvement at Week 52

Endoscopic improvement is defined as ES of 0 or 1. The ES measures UC severity based on endoscopy on a 0-3 scale of increasing severity.

Study 1: Percentage of Participants Achieving Corticosteroid-Free Clinical Remission Per MMS at Week 52

The Modified Mayo Score (MMS) is a composite score of ulcerative colitis (UC) disease activity on a scale of increasing severity from 0-9, calculated by summing three subscores: Endoscopic subscore (ES), scored on a scale of increasing severity from 0 (normal or inactive disease) to 3 (severe disease, such as spontaneous bleeding or ulceration); Stool frequency subscore (SFS), scored on a scale of increasing frequency from 0 (normal number of stools) to 3 (≥5 stools more than normal per day for the participant); and rectal bleeding subscore (RBS), scored on a scale of increasing severity from 0 (no blood seen) to 3 (blood alone passed). Corticosteroid-free clinical remission is defined as an ES of 0 or 1, RBS of 0, and SFS of 0 or 1 and not greater than the baseline SFS, and no corticosteroid use for ≥90 days before Week 52.

Study 1: Percentage of Participants Achieving HEMI at Week 52

Study 1: Percentage of Participants Achieving Clinical Remission Per pMMS at Week 52

Study 1: Percentage of Participants Achieving Sustained Clinical Remission Per MMS at Both Week 12 and Week 52

The MMS is a composite score of UC disease activity on a scale of increasing severity from 0-9, calculated by summing three subscores: ES, scored on a scale of increasing severity from 0 (normal or inactive disease) to 3 (severe disease, such as spontaneous bleeding or ulceration); SFS, scored on a scale of increasing frequency from 0 (normal number of stools) to 3 (≥5 stools more than normal per day for the participant); and RBS, scored on a scale of increasing severity from 0 (no blood seen) to 3 (blood alone passed). Sustained clinical remission is defined as an ES of 0 or 1, RBS of 0, and SFS of 0 or 1 and not greater than the baseline SFS, at both Week 12 and Week 52.

Study 1: Percentage of Participants Reporting No Bowel Urgency at Week 52

Study 1: Percentage of Participants Reporting No Abdominal Pain at Week 52

Abdominal pain is measured on a 0-4 NRS of increasing pain severity. Absence of abdominal pain is defined as a rating of 0.

Study 1: Percentage of Participants With Endoscopic Remission at Week 52

Study 1: Percentage of Participants with Sustained Clinical Response Per MMS at Both Week 12 and Week 52

The MMS is a composite score of UC disease activity on a scale of increasing severity from 0-9, calculated by summing three subscores: ES, scored on a scale of increasing severity from 0 (normal or inactive disease) to 3 (severe disease, such as spontaneous bleeding or ulceration); SFS, scored on a scale of increasing frequency from 0 (normal number of stools) to 3 (≥5 stools more than normal per day for the participant); and RBS, scored on a scale of increasing severity from 0 (no blood seen) to 3 (blood alone passed). Sustained clinical response is defined as an MMS reduction of 2 or more points and 30% or more, plus a reduction of more than 1 point in RBS or an absolute RBS of 0 or 1, at both Week 12 and Week 52.

Study 1: Percentage of Participants with Sustained Endoscopic Improvement at Both Week 12 and Week 52

Sustained endoscopic improvement is defined as an ES of 0 or 1 at both Week 12 and Week 52. The ES measures UC severity based on endoscopy on a 0-3 scale of increasing severity.

Study 1: Percentage of Participants Achieving HER at Week 52

Study 1: Percentage of Participants Achieving IBDQ Remission at Week 52

Study 1: Change from Baseline in FACIT-Fatigue Score at Week 52

Percentage of Dx+ Participants Achieving Clinical Remission Per MMS at Week 52

Percentage of Dx+ Participants With Endoscopic Improvement at Week 52

Study 2: Percentage of Participants with Clinical Response Per pMMS at Week 2

pMMS is a composite score of UC disease activity on a scale of increasing severity from 0-6, calculated by summing two subscores: SFS, scored from 0 (normal number of stools) to 3 (≥5 stools more than normal per day for the participant); RBS, scored from 0 (no blood seen) to 3 (blood alone passed). Clinical response is defined as pMMS reduction of 1 or more points and 30% or more, plus a reduction of 1 or more points in RBS or an absolute RBS of 0 or 1.

Study 2: Percentage of Participants With Endoscopic Improvement at Week 12

Endoscopic improvement is defined as Mayo endoscopic subscore (ES) of 0 or 1. The ES measures UC severity based on endoscopy on a 0-3 scale of increasing severity.

Study 2: Percentage of Participants Achieving a Clinical Response Per MMS at Week 12

The MMS is a composite score of UC disease activity on a scale of increasing severity from 0-9, calculated by summing three subscores: ES, scored on a scale of increasing severity from 0 (normal or inactive disease) to 3 (severe disease, such as spontaneous bleeding or ulceration); SFS, scored on a scale of increasing frequency from 0 (normal number of stools) to 3 (≥5 stools more than normal per day for the participant); and RBS, scored on a scale of increasing severity from 0 (no blood seen) to 3 (blood alone passed). Clinical response is defined as an MMS reduction of 2 or more points and 30% or more, plus a reduction of more than 1 point in RBS or an absolute RBS of 0 or 1.

Study 2: Percentage of Participants Achieving HEMI at Week 12

Study 2: Percentage of Participants Achieving Clinical Remission Per pMMS at Week 12

Study 2: Percentage of Participants With Endoscopic Remission at Week 12

Study 2: Percentage of Participants Reporting No Bowel Urgency at Week 12

Bowel urgency is measured using a numeric rating scale (NRS), which rates bowel urgency on a 0-11 scale of increasing severity.

Study 2: Percentage of Participants Reporting No Abdominal Pain at Week 12

Abdominal pain is measured on a 0-4 NRS of increasing pain severity. Absence of abdominal pain is defined as a rating of 0.

Study 2: Percentage of Participants Achieving IBDQ Remission at Week 12

Study 2: Change from Baseline in FACIT-Fatigue Score at Week 12

Study 2: Percentage of Participants Achieving HER at Week 12

Full Information

NCT ID

NCT06052059

First Posted

September 18, 2023

Last Updated

October 9, 2023

Sponsor

Merck Sharp & Dohme LLC

Collaborators

PPD, Part of Thermo Fisher Scientific

1. Study Identification

Unique Protocol Identification Number

NCT06052059

Brief Title

A Study to Evaluate Efficacy and Safety of MK-7240 in Participants With Moderately to Severely Active Ulcerative Colitis (MK-7240-001)

Official Title

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Induction and Maintenance Study to Evaluate the Efficacy and Safety of PRA023 in Subjects With Moderately to Severely Active Ulcerative Colitis

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Not yet recruiting

Study Start Date

October 23, 2023 (Anticipated)

Primary Completion Date

November 21, 2026 (Anticipated)

Study Completion Date

December 17, 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Merck Sharp & Dohme LLC

Collaborators

PPD, Part of Thermo Fisher Scientific

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this protocol is to evaluate the efficacy and safety of MK-7240 in participants with moderately to severely active ulcerative colitis. Study 1's primary hypotheses are that at least 1 MK-7240 dose level is superior to Placebo in the proportion of participants achieving clinical remission per Modified Mayo Score at Week 12, and that at least 1 MK-7240 dose level is superior to Placebo in the proportion of participants achieving clinical remission per Modified Mayo Score at week 52. Study 2's primary hypothesis is that at least 1 MK-7240 dose level is superior to Placebo in the proportion of participants achieving clinical remission per Modified Mayo Score at Week 12.

Detailed Description

The protocol consists of 2 studies. Study 1 includes induction and maintenance treatment, and Study 2 includes only induction treatment. Each study has its own hypotheses and outcome measures that will be assessed independently.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ulcerative Colitis

Keywords

Inflammatory Bowel Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Masking Description

Induction and maintenance treatments will be blinded. Reinduction will not be blinded.

Allocation

Randomized

Enrollment

1020 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Study 1: High Dose Induction, High Dose Maintenance

Arm Type

Experimental

Arm Description

Participants receive high dose intravenous (IV) MK-7240, followed by a high dose subcutaneous (SC) MK-7240 regimen.

Arm Title

Study 1: High Dose Induction, Low Dose Maintenance

Arm Type

Experimental

Arm Description

Participants receive high dose IV MK-7240, followed by a low dose SC MK-7240 regimen.

Arm Title

Study 1: Low Dose Induction, Low Dose Maintenance

Arm Type

Experimental

Arm Description

Participants receive low dose IV MK-7240, followed by a low dose SC MK-7240 regimen.

Arm Title

Study 1: Placebo

Arm Type

Placebo Comparator

Arm Description

Participants receive IV placebo, followed by an SC placebo regimen.

Arm Title

Study 1: High Dose Extension

Arm Type

Experimental

Arm Description

Participants receive a high dose SC MK-7240 regimen. Participants may be enrolled in this arm after completing participation in their original arm, if they meet protocol-specific prerequisites.

Arm Title

Study 1: Low Dose Extension

Arm Type

Experimental

Arm Description

Arm Title

Study 2: High Dose Induction

Arm Type

Experimental

Arm Description

Participants receive high dose IV MK-7240.

Arm Title

Study 2: Low Dose Induction

Arm Type

Experimental

Arm Description

Participants receive low dose IV MK-7240.

Arm Title

Study 2: Placebo

Arm Type

Placebo Comparator

Arm Description

Participants receive IV placebo. Participants who meet protocol-specified conditions may later enter either the Study 2: High Dose Extension arm or Study 2: Low Dose Extension arm.

Arm Title

Study 2: High Dose Extension

Arm Type

Experimental

Arm Description

Participants receive a high dose SC MK-7240 regimen. Participants may be enrolled in this arm only after completing participation in their original arm, if they meet protocol-specific prerequisites.

Arm Title

Study 2: Low Dose Extension

Arm Type

Experimental

Arm Description

Participants receive a low dose SC MK-7240 regimen. Participants may be enrolled in this arm only after completing participation in their original arm, if they meet protocol-specific prerequisites.

Intervention Type

Drug

Intervention Name(s)

IV MK-7240

Other Intervention Name(s)

PRA023

Intervention Description

Humanized monoclonal antibody that binds human tumor necrosis factor-like cytokine 1A (TL1A), administered intravenously

Intervention Type

Drug

Intervention Name(s)

IV Placebo

Intervention Description

Placebo matching IV MK-7240

Intervention Type

Drug

Intervention Name(s)

SC MK-7240

Other Intervention Name(s)

PRA023

Intervention Description

Humanized monoclonal antibody that binds human tumor necrosis factor-like cytokine 1A (TL1A), administered subcutaneously

Intervention Type

Drug

Intervention Name(s)

SC Placebo

Intervention Description

Placebo matching SC MK-7240

Primary Outcome Measure Information:

Title

Study 1: Percentage of Participants Achieving Clinical Remission Per Modified Mayo Score (MMS) at Week 12

Description

Time Frame

Week 12

Title

Study 1: Percentage of Participants Achieving Clinical Remission Per MMS at Week 52

Description

Time Frame

Week 52

Title

Study 1: Percentage of Participants With One or More Adverse Events (AEs)

Description

Time Frame

Up to approximately 52 weeks

Title

Study 1: Percentage of Participants Who Discontinued Study Intervention Due to an AE

Description

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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who discontinue study treatment due to an AE will be reported.

Time Frame

Up to approximately 52 weeks

Title

Study 2: Percentage of Participants Achieving Clinical Remission Per MMS at Week 12

Description

Time Frame

Week 12

Title

Study 2: Percentage of Participants With One or More AEs

Description

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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who experience an AE will be reported.

Time Frame

Up to approximately 12 weeks

Title

Study 2: Percentage of Participants Who Discontinued Study Intervention Due to an AE

Description

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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who discontinue study treatment due to an AE will be reported.

Time Frame

Up to approximately 12 weeks

Secondary Outcome Measure Information:

Title

Study 1: Percentage of Participants Achieving Clinical Response Per Partial Modified Mayo Score (pMMS) at Week 2

Description

Time Frame

Week 2

Title

Study 1: Percentage of Participants With Endoscopic Improvement at Week 12

Description

Endoscopic improvement is defined as Mayo endoscopic subscore (ES) of 0 or 1. The ES measures UC severity based on endoscopy on a 0-3 scale of increasing severity.

Time Frame

Week 12

Title

Study 1: Percentage of Participants Achieving a Clinical Response Per MMS at Week 12

Description

The MMS is a composite score of UC disease activity on a scale of increasing severity from 0-9, calculated by summing three subscores: ES, scored on a scale of increasing severity from 0 (normal or inactive disease) to 3 (severe disease, such as spontaneous bleeding or ulceration); SFS, scored on a scale of increasing frequency from 0 (normal number of stools) to 3 (≥5 stools more than normal per day for the participant); and RBS, scored on a scale of increasing severity from 0 (no blood seen) to 3 (blood alone passed). Clinical response is defined as an MMS reduction of 2 or more points and 30% or more, plus a reduction of more than 1 point in RBS or an absolute RBS of 0 or 1.

Time Frame

Week 12

Title

Study 1: Percentage of Participants Achieving Histologic-Endoscopic Mucosal Improvement (HEMI) at Week 12

Description

Time Frame

Week 12

Title

Study 1: Percentage of Participants Achieving Clinical Remission Per pMMS at Week 12

Description

Time Frame

Week 12

Title

Study 1: Percentage of Participants With Endoscopic Remission at Week 12

Description

Time Frame

Week 12

Title

Study 1: Percentage of Participants Reporting No Bowel Urgency at Week 12

Description

Time Frame

Week 12

Title

Study 1: Percentage of Participants Reporting No Abdominal Pain at Week 12

Description

Abdominal pain is measured on a 0-4 NRS of increasing pain severity. Absence of abdominal pain is defined as a rating of 0.

Time Frame

Week 12

Title

Study 1: Percentage of Participants Achieving Inflammatory Bowel Disease Questionnaire (IBDQ) Remission at Week 12

Description

Time Frame

Week 12

Title

Study 1: Change from Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Score at Week 12

Description

Time Frame

Baseline and Week 12

Title

Percentage of Diagnostic Assay Positive (Dx+) Participants Achieving Clinical Remission Per MMS at Week 12

Description

Time Frame

Week 12

Title

Percentage of Dx+ Participants With Endoscopic Improvement at Week 12

Description

Time Frame

Week 12

Title

Study 1: Percentage of Participants Achieving Histologic-Endoscopic Remission (HER) at Week 12

Description

Time Frame

Week 12

Title

Study 1: Percentage of Participants with Endoscopic Improvement at Week 52

Description

Endoscopic improvement is defined as ES of 0 or 1. The ES measures UC severity based on endoscopy on a 0-3 scale of increasing severity.

Time Frame

Week 52

Title

Study 1: Percentage of Participants Achieving Corticosteroid-Free Clinical Remission Per MMS at Week 52

Description

The Modified Mayo Score (MMS) is a composite score of ulcerative colitis (UC) disease activity on a scale of increasing severity from 0-9, calculated by summing three subscores: Endoscopic subscore (ES), scored on a scale of increasing severity from 0 (normal or inactive disease) to 3 (severe disease, such as spontaneous bleeding or ulceration); Stool frequency subscore (SFS), scored on a scale of increasing frequency from 0 (normal number of stools) to 3 (≥5 stools more than normal per day for the participant); and rectal bleeding subscore (RBS), scored on a scale of increasing severity from 0 (no blood seen) to 3 (blood alone passed). Corticosteroid-free clinical remission is defined as an ES of 0 or 1, RBS of 0, and SFS of 0 or 1 and not greater than the baseline SFS, and no corticosteroid use for ≥90 days before Week 52.

Time Frame

Week 52

Title

Study 1: Percentage of Participants Achieving HEMI at Week 52

Description

Time Frame

Week 52

Title

Study 1: Percentage of Participants Achieving Clinical Remission Per pMMS at Week 52

Description

Time Frame

Week 52

Title

Study 1: Percentage of Participants Achieving Sustained Clinical Remission Per MMS at Both Week 12 and Week 52

Description

The MMS is a composite score of UC disease activity on a scale of increasing severity from 0-9, calculated by summing three subscores: ES, scored on a scale of increasing severity from 0 (normal or inactive disease) to 3 (severe disease, such as spontaneous bleeding or ulceration); SFS, scored on a scale of increasing frequency from 0 (normal number of stools) to 3 (≥5 stools more than normal per day for the participant); and RBS, scored on a scale of increasing severity from 0 (no blood seen) to 3 (blood alone passed). Sustained clinical remission is defined as an ES of 0 or 1, RBS of 0, and SFS of 0 or 1 and not greater than the baseline SFS, at both Week 12 and Week 52.

Time Frame

Week 12 and Week 52

Title

Study 1: Percentage of Participants Reporting No Bowel Urgency at Week 52

Description

Time Frame

Week 52

Title

Study 1: Percentage of Participants Reporting No Abdominal Pain at Week 52

Description

Abdominal pain is measured on a 0-4 NRS of increasing pain severity. Absence of abdominal pain is defined as a rating of 0.

Time Frame

Week 52

Title

Study 1: Percentage of Participants With Endoscopic Remission at Week 52

Description

Time Frame

Week 52

Title

Study 1: Percentage of Participants with Sustained Clinical Response Per MMS at Both Week 12 and Week 52

Description

The MMS is a composite score of UC disease activity on a scale of increasing severity from 0-9, calculated by summing three subscores: ES, scored on a scale of increasing severity from 0 (normal or inactive disease) to 3 (severe disease, such as spontaneous bleeding or ulceration); SFS, scored on a scale of increasing frequency from 0 (normal number of stools) to 3 (≥5 stools more than normal per day for the participant); and RBS, scored on a scale of increasing severity from 0 (no blood seen) to 3 (blood alone passed). Sustained clinical response is defined as an MMS reduction of 2 or more points and 30% or more, plus a reduction of more than 1 point in RBS or an absolute RBS of 0 or 1, at both Week 12 and Week 52.

Time Frame

Week 12, and Week 52

Title

Study 1: Percentage of Participants with Sustained Endoscopic Improvement at Both Week 12 and Week 52

Description

Sustained endoscopic improvement is defined as an ES of 0 or 1 at both Week 12 and Week 52. The ES measures UC severity based on endoscopy on a 0-3 scale of increasing severity.

Time Frame

Week 12 and Week 52

Title

Study 1: Percentage of Participants Achieving HER at Week 52

Description

Time Frame

Week 52

Title

Study 1: Percentage of Participants Achieving IBDQ Remission at Week 52

Description

Time Frame

Week 52

Title

Study 1: Change from Baseline in FACIT-Fatigue Score at Week 52

Description

Time Frame

Baseline and Week 52

Title

Percentage of Dx+ Participants Achieving Clinical Remission Per MMS at Week 52

Description

Time Frame

Week 52

Title

Percentage of Dx+ Participants With Endoscopic Improvement at Week 52

Description

Time Frame

Week 52

Title

Study 2: Percentage of Participants with Clinical Response Per pMMS at Week 2

Description

pMMS is a composite score of UC disease activity on a scale of increasing severity from 0-6, calculated by summing two subscores: SFS, scored from 0 (normal number of stools) to 3 (≥5 stools more than normal per day for the participant); RBS, scored from 0 (no blood seen) to 3 (blood alone passed). Clinical response is defined as pMMS reduction of 1 or more points and 30% or more, plus a reduction of 1 or more points in RBS or an absolute RBS of 0 or 1.

Time Frame

Week 2

Title

Study 2: Percentage of Participants With Endoscopic Improvement at Week 12

Description

Endoscopic improvement is defined as Mayo endoscopic subscore (ES) of 0 or 1. The ES measures UC severity based on endoscopy on a 0-3 scale of increasing severity.

Time Frame

Week 12

Title

Study 2: Percentage of Participants Achieving a Clinical Response Per MMS at Week 12

Description

The MMS is a composite score of UC disease activity on a scale of increasing severity from 0-9, calculated by summing three subscores: ES, scored on a scale of increasing severity from 0 (normal or inactive disease) to 3 (severe disease, such as spontaneous bleeding or ulceration); SFS, scored on a scale of increasing frequency from 0 (normal number of stools) to 3 (≥5 stools more than normal per day for the participant); and RBS, scored on a scale of increasing severity from 0 (no blood seen) to 3 (blood alone passed). Clinical response is defined as an MMS reduction of 2 or more points and 30% or more, plus a reduction of more than 1 point in RBS or an absolute RBS of 0 or 1.

Time Frame

Week 12

Title

Study 2: Percentage of Participants Achieving HEMI at Week 12

Description

Time Frame

Week 12

Title

Study 2: Percentage of Participants Achieving Clinical Remission Per pMMS at Week 12

Description

Time Frame

Week 12

Title

Study 2: Percentage of Participants With Endoscopic Remission at Week 12

Description

Time Frame

Week 12

Title

Study 2: Percentage of Participants Reporting No Bowel Urgency at Week 12

Description

Bowel urgency is measured using a numeric rating scale (NRS), which rates bowel urgency on a 0-11 scale of increasing severity.

Time Frame

Week 12

Title

Study 2: Percentage of Participants Reporting No Abdominal Pain at Week 12

Description

Abdominal pain is measured on a 0-4 NRS of increasing pain severity. Absence of abdominal pain is defined as a rating of 0.

Time Frame

Week 12

Title

Study 2: Percentage of Participants Achieving IBDQ Remission at Week 12

Description

Time Frame

Week 12

Title

Study 2: Change from Baseline in FACIT-Fatigue Score at Week 12

Description

Time Frame

Baseline and Week 12

Title

Study 2: Percentage of Participants Achieving HER at Week 12

Description

Time Frame

Week 12

10. Eligibility

Sex

All

Minimum Age & Unit of Time

16 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Medical Director

Organizational Affiliation

Merck Sharp & Dohme LLC

Official's Role

Study Director

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

IPD Sharing URL

http://engagezone.msd.com/ds_documentation.php

Links:

URL

https://www.merckclinicaltrials.com

Description

Merck Clinical Trials Information

URL

https://trialstransparency.merckclinicaltrials.com/Study.aspx?id=7240-001&kw=7240-001

Description

Plain Language Summary

Learn more about this trial

A Study to Evaluate Efficacy and Safety of MK-7240 in Participants With Moderately to Severely Active Ulcerative Colitis (MK-7240-001)

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