A Study of MK-2225 / ACE-1334 in Participants With Systemic Sclerosis With and Without Interstitial Lung Disease (MK-2225-002)

November 2, 2023 updated by: Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA

A Phase 1b Randomized, Double-Blind, Placebo-Controlled, Multiple-Ascending Dose Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of ACE-1334 Plus Standard of Care in Participants With Systemic Sclerosis

The purpose of the MK-2225-002 (A1334-02) study is to evaluate the safety and tolerability of MK-2225 (ACE-1334) plus standard of care (SOC) in participants with Systemic Sclerosis (SSc) following multiple doses.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
48

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5T 3L9
        • Mount Sinai Hospital ( Site 1101)
  • Italy
    • Tuscany
      • Florence, Tuscany, Italy, 50134
        • Azienda Ospedaliero Universitaria Careggi (Site 1401)
    • Veneto
      • Verona, Veneto, Italy, 37134
        • Azienda Ospedaliera Universitaria Integrata Di Verona ( Site 1402)
  • Switzerland
    • Neuchâtel (fr)
      • Neuchâtel, Neuchâtel (fr), Switzerland, 2000
        • Hôpital Neuchatelois ( Site 1304)
    • Sankt Gallen
      • St Gallen, Sankt Gallen, Switzerland, 9000
        • Kantonsspital St. Gallen (Site 1301)
  • United States
    • California
      • La Jolla, California, United States, 92037-0943
        • UCSD Altman Clinical and Translational Research Institute (Site 1013)
      • Los Angeles, California, United States, 90033
        • Keck Medical Center ( Site 1001)
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • Georgetown University Medical Center ( Site 1010)
    • Florida
      • Gainesville, Florida, United States, 32610
        • University of Florida ( Site 1002)
      • Orlando, Florida, United States, 32803
        • Central Florida Pulmonary Group ( Site 1005)
    • Georgia
      • Valdosta, Georgia, United States, 31605-1096
        • Medster Research, LLC ( Site 1017)
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Medical Center ( Site 1007)
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • The Cleveland Clinic Foundation ( Site 1003)
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Penn State Milton S Hershey Medical Center ( Site 1004)
    • Tennessee
      • Jackson, Tennessee, United States, 38305
        • West Tennessee Research Institute ( Site 1012)
    • Texas
      • Dallas, Texas, United States, 75231-4446
        • Metroplex Clinical Research Center ( Site 1018)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

The main inclusion and exclusion criteria include but are not limited to the following:

Inclusion Criteria:

  • Participants must have SSc, as defined using the 2013 American College of Rheumatology/European League Against Rheumatism criteria
  • If participant is on a non-excluded immunosuppressive therapy (e.g. mycophenolate, methotrexate, azathioprine, etc.) the dose should be stable for > 2 months at the time of screening

  • Women of childbearing potential must:

    • If sexually active, have used, and agree to use, highly effective contraception without interruption, for at least 28 days prior to starting investigational product, during the study (including dose interruptions), and for 17 weeks (119 days) after discontinuation of study treatment
    • Refrain from breastfeeding a child or donating blood, eggs, or ovum for the duration of the study and for at least 17 weeks (119 days) after the last dose of study treatment

  • Male participants must:

    • Agree to use a condom, defined as a male latex condom or nonlatex condom NOT made out of natural (animal) membrane (e.g., polyurethane), during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions, and for at least 17 weeks (119 days) following investigational product discontinuation, even if he has undergone a successful vasectomy
    • Refrain from donating blood or sperm for the duration of the study and for 17 weeks (119 days) after the last dose of study treatment
  • Must agree to not participate in any other study of investigational drugs/devices while enrolled in this study

Exclusion Criteria:

  • Participant with SSc-pulmonary arterial hypertension (PAH) (except those participants with mild PAH on up to 2 oral drugs and mean pulmonary arterial pressure < 30 mmHg or low risk by risk calculator)
  • In the opinion of the investigator, other clinically significant pulmonary abnormalities (such as obstructive lung disease, asthma, etc.)
  • Other investigational therapy received within 1 month or 6 half-lives (whichever is greater) prior to the Screening Visit
  • Prior exposure to MK-2225 or other TGF-β antibodies or any TGF-β family targeted biologic or hypersensitivity to the components of MK-2225
  • Hypersensitivity to placebo or any of its components
  • Previous hematopoietic stem cell transplantation (HSCT) or HSCT planned within the next year
  • Major surgical procedures planned during the study period
  • Oral prednisone or equivalent > 10 mg/day
  • Participant with history of gastric antral vascular ectasia or gastrointestinal bleed
  • On anticoagulation therapy (such as prophylaxis anticoagulation, warfarin, direct thrombin inhibitors or other including low molecular weight subcutaneous or intravenous therapeutic heparin), or antiplatelet therapy including aspirin. Use of fish oil supplements within 2 weeks prior to randomization and throughout study is not permitted.
  • History of any other medical condition that might interfere with a participant's ability to participate in the study
  • Active clinically significant viral, bacterial, or fungal infection, or any episode of infection requiring hospitalization within 4 weeks prior to screening
  • Use of cyclophosphamide ≤ 6 months from screening
  • Use of nintedanib or pirfenidone ≤ 28 days from screening
  • Recent scleroderma renal crisis < 6 months before screening
  • Use of tocilizumab ≤ 2 months from screening
  • Has received any nonlive vaccine starting from 14 days prior to study intervention or is scheduled to receive any nonlive vaccine through 30 days following study intervention. Exception: COVID-19 vaccine may be administered.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Cohort 1: MK-2225
Participants in Cohort 1 will receive MK-2225 at 0.25 mg/kg once every two weeks (Q2W) plus standard of care (SOC) for 12 weeks.
Biological: MK-2225
Administered Subcutaneously (SC)
Other Names:
  • ACE-1334
Placebo Comparator: Cohort 1: Placebo
Participants in Cohort 1 will receive placebo Q2W plus SOC for 12 weeks.
Biological: Placebo
Administered SC
Experimental: Cohort 2: MK-2225
Participants in Cohort 2 will receive MK-2225 at 0.5 mg/kg (or lower) Q2W plus SOC for 12 weeks.
Biological: MK-2225
Administered Subcutaneously (SC)
Other Names:
  • ACE-1334
Placebo Comparator: Cohort 2: Placebo
Participants in Cohort 2 will receive placebo Q2W plus SOC for 12 weeks.
Biological: Placebo
Administered SC
Experimental: Cohort 3: MK-2225
Participants in Cohort 3 will receive MK-2225 at 1.0 mg/kg (or lower) Q2W plus SOC for 12 weeks.
Biological: MK-2225
Administered Subcutaneously (SC)
Other Names:
  • ACE-1334
Placebo Comparator: Cohort 3: Placebo
Participants in Cohort 3 will receive placebo Q2W plus SOC for 12 weeks.
Biological: Placebo
Administered SC
Experimental: Cohort 4: MK-2225
Participants in Cohort 4 will receive MK-2225 at ≤2.0 mg/kg Q2W if needed plus SOC for 12 weeks.
Biological: MK-2225
Administered Subcutaneously (SC)
Other Names:
  • ACE-1334
Placebo Comparator: Cohort 4: Placebo
Participants in Cohort 4 will receive placebo Q2W plus SOC for 12 weeks.
Biological: Placebo
Administered SC
Experimental: Cohort 5: MK-2225
Participants in Cohort 5 will receive MK-2225 (no more frequent than Q2W) ≤2.25 mg/kg Q2W or ≤4.5 mg/kg Q4W if needed plus SOC for 12 weeks.
Biological: MK-2225
Administered Subcutaneously (SC)
Other Names:
  • ACE-1334
Placebo Comparator: Cohort 5: Placebo
Participants in Cohort 5 will receive (no more frequent than Q2W) placebo plus SOC for 12 weeks.
Biological: Placebo
Administered SC
Experimental: Cohort 6: MK-2225
Participants in Cohort 6 will receive MK-2225 (no more frequent than Q2W) ≤2.25 mg/kg Q2W or ≤4.5 mg/kg Q4W if needed plus SOC for 12 weeks.
Biological: MK-2225
Administered Subcutaneously (SC)
Other Names:
  • ACE-1334
Placebo Comparator: Cohort 6: Placebo
Participants in Cohort 6 will receive (no more frequent than Q2W) placebo plus SOC for 12 weeks.
Biological: Placebo
Administered SC

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants with ≥1 Adverse Event (AE)
Time Frame: Up to 20 Weeks
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 experienced an AE will be reported.
Up to 20 Weeks
Number of Participants Discontinuing from Study Therapy Due to AE
Time Frame: Up to 12 Weeks
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 discontinued study treatment due to an AE will be reported.
Up to 12 Weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Area Under the Concentration-Time Curve (AUC0-tau) of MK-2225
Time Frame: Up to 12 Weeks
AUC0-tau is the area under the concentration-time curve. Blood samples will be collected at designated timepoints to determine AUC0-tau of MK-2225.
Up to 12 Weeks
Serum Maximum Concentration (Cmax) of MK-2225
Time Frame: Up to 12 Weeks
Cmax is the maximum concentration of the drug observed in plasma. Blood samples will be collected at designated timepoints to determine Cmax of MK-2225.
Up to 12 Weeks
Time to peak Serum Concentration (Tmax) of MK-2225
Time Frame: Up to 12 Weeks
Tmax is the amount of time required to reach Cmax. Blood samples will be collected at designated timepoints to determine Tmax of MK-2225.
Up to 12 Weeks
Serum Apparent Terminal Half-Life (t1/2) of MK-2225
Time Frame: Up to 12 Weeks
t1/2 is the time required for 50% of drug to be cleared from serum. Blood samples will be collected at designated timepoints to determine t1/2 of MK-2225.
Up to 12 Weeks
Accumulation ratio of AUCtau (RAUC)
Time Frame: Up to 12 Weeks
RAUC is the accumulation ratio of AUCtau after multiple doses relative to after a single dose. Blood samples will be collected at designated timepoints to determine RAUC of MK-2225.
Up to 12 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 10, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 17, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 17, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 4, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 24, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 2, 2021

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 3, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 2, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2225-002
  • A1334-02 (Other Identifier: Acceleronpharma)
  • MK-2225-002 (Other Identifier: Merck)
  • 2021-001004-15 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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