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

Primary Purpose

Systemic Sclerosis With and Without Interstitial Lung Disease

Status
Recruiting
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
MK-2225
Placebo
Sponsored by
Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Systemic Sclerosis With and Without Interstitial Lung Disease focused on measuring Diffuse Systemic Sclerosis, Scleroderma, Systemic Sclerosis, Systemic Sclerosis-associated Interstitial Lung Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • UCSD Altman Clinical and Translational Research Institute (Site 1013)Recruiting
  • Keck Medical Center ( Site 1001)Recruiting
  • Georgetown University Medical Center ( Site 1010)Recruiting
  • University of Florida ( Site 1002)Recruiting
  • Central Florida Pulmonary Group ( Site 1005)Recruiting
  • Medster Research, LLC ( Site 1017)Recruiting
  • University of Kansas Medical Center ( Site 1007)Recruiting
  • The Cleveland Clinic Foundation ( Site 1003)Recruiting
  • Penn State Milton S Hershey Medical Center ( Site 1004)Recruiting
  • West Tennessee Research Institute ( Site 1012)Recruiting
  • Metroplex Clinical Research Center ( Site 1018)
  • Mount Sinai Hospital ( Site 1101)Recruiting
  • Azienda Ospedaliero Universitaria Careggi (Site 1401)Recruiting
  • Azienda Ospedaliera Universitaria Integrata Di Verona ( Site 1402)Recruiting
  • Hôpital Neuchatelois ( Site 1304)Recruiting
  • Kantonsspital St. Gallen (Site 1301)Recruiting

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 12

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

Cohort 1: MK-2225

Cohort 1: Placebo

Cohort 2: MK-2225

Cohort 2: Placebo

Cohort 3: MK-2225

Cohort 3: Placebo

Cohort 4: MK-2225

Cohort 4: Placebo

Cohort 5: MK-2225

Cohort 5: Placebo

Cohort 6: MK-2225

Cohort 6: Placebo

Arm Description

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.

Participants in Cohort 1 will receive placebo Q2W plus SOC for 12 weeks.

Participants in Cohort 2 will receive MK-2225 at 0.5 mg/kg (or lower) Q2W plus SOC for 12 weeks.

Participants in Cohort 2 will receive placebo Q2W plus SOC for 12 weeks.

Participants in Cohort 3 will receive MK-2225 at 1.0 mg/kg (or lower) Q2W plus SOC for 12 weeks.

Participants in Cohort 3 will receive placebo Q2W plus SOC for 12 weeks.

Participants in Cohort 4 will receive MK-2225 at ≤2.0 mg/kg Q2W if needed plus SOC for 12 weeks.

Participants in Cohort 4 will receive placebo Q2W plus SOC for 12 weeks.

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.

Participants in Cohort 5 will receive (no more frequent than Q2W) placebo plus SOC for 12 weeks.

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.

Participants in Cohort 6 will receive (no more frequent than Q2W) placebo plus SOC for 12 weeks.

Outcomes

Primary Outcome Measures

Number of Participants with ≥1 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. 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.
Number of Participants Discontinuing from Study Therapy Due to 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 discontinued study treatment due to an AE will be reported.

Secondary Outcome Measures

Area Under the Concentration-Time Curve (AUC0-tau) of MK-2225
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.
Serum Maximum Concentration (Cmax) of MK-2225
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.
Time to peak Serum Concentration (Tmax) of MK-2225
Tmax is the amount of time required to reach Cmax. Blood samples will be collected at designated timepoints to determine Tmax of MK-2225.
Serum Apparent Terminal Half-Life (t1/2) of MK-2225
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.
Accumulation ratio of AUCtau (RAUC)
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.

Full Information

First Posted
June 4, 2021
Last Updated
October 3, 2023
Sponsor
Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA
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1. Study Identification

Unique Protocol Identification Number
NCT04948554
Brief Title
A Study of MK-2225 / ACE-1334 in Participants With Systemic Sclerosis With and Without Interstitial Lung Disease (MK-2225-002)
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 10, 2023 (Actual)
Primary Completion Date
June 17, 2027 (Anticipated)
Study Completion Date
June 17, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Systemic Sclerosis With and Without Interstitial Lung Disease
Keywords
Diffuse Systemic Sclerosis, Scleroderma, Systemic Sclerosis, Systemic Sclerosis-associated Interstitial Lung Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cohort 1: MK-2225
Arm Type
Experimental
Arm Description
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.
Arm Title
Cohort 1: Placebo
Arm Type
Placebo Comparator
Arm Description
Participants in Cohort 1 will receive placebo Q2W plus SOC for 12 weeks.
Arm Title
Cohort 2: MK-2225
Arm Type
Experimental
Arm Description
Participants in Cohort 2 will receive MK-2225 at 0.5 mg/kg (or lower) Q2W plus SOC for 12 weeks.
Arm Title
Cohort 2: Placebo
Arm Type
Placebo Comparator
Arm Description
Participants in Cohort 2 will receive placebo Q2W plus SOC for 12 weeks.
Arm Title
Cohort 3: MK-2225
Arm Type
Experimental
Arm Description
Participants in Cohort 3 will receive MK-2225 at 1.0 mg/kg (or lower) Q2W plus SOC for 12 weeks.
Arm Title
Cohort 3: Placebo
Arm Type
Placebo Comparator
Arm Description
Participants in Cohort 3 will receive placebo Q2W plus SOC for 12 weeks.
Arm Title
Cohort 4: MK-2225
Arm Type
Experimental
Arm Description
Participants in Cohort 4 will receive MK-2225 at ≤2.0 mg/kg Q2W if needed plus SOC for 12 weeks.
Arm Title
Cohort 4: Placebo
Arm Type
Placebo Comparator
Arm Description
Participants in Cohort 4 will receive placebo Q2W plus SOC for 12 weeks.
Arm Title
Cohort 5: MK-2225
Arm Type
Experimental
Arm Description
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.
Arm Title
Cohort 5: Placebo
Arm Type
Placebo Comparator
Arm Description
Participants in Cohort 5 will receive (no more frequent than Q2W) placebo plus SOC for 12 weeks.
Arm Title
Cohort 6: MK-2225
Arm Type
Experimental
Arm Description
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.
Arm Title
Cohort 6: Placebo
Arm Type
Placebo Comparator
Arm Description
Participants in Cohort 6 will receive (no more frequent than Q2W) placebo plus SOC for 12 weeks.
Intervention Type
Biological
Intervention Name(s)
MK-2225
Other Intervention Name(s)
ACE-1334
Intervention Description
Administered Subcutaneously (SC)
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
Administered SC
Primary Outcome Measure Information:
Title
Number of Participants with ≥1 Adverse Event (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 experienced an AE will be reported.
Time Frame
Up to 20 Weeks
Title
Number of Participants Discontinuing from Study Therapy Due to 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 discontinued study treatment due to an AE will be reported.
Time Frame
Up to 12 Weeks
Secondary Outcome Measure Information:
Title
Area Under the Concentration-Time Curve (AUC0-tau) of MK-2225
Description
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.
Time Frame
Up to 12 Weeks
Title
Serum Maximum Concentration (Cmax) of MK-2225
Description
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.
Time Frame
Up to 12 Weeks
Title
Time to peak Serum Concentration (Tmax) of MK-2225
Description
Tmax is the amount of time required to reach Cmax. Blood samples will be collected at designated timepoints to determine Tmax of MK-2225.
Time Frame
Up to 12 Weeks
Title
Serum Apparent Terminal Half-Life (t1/2) of MK-2225
Description
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.
Time Frame
Up to 12 Weeks
Title
Accumulation ratio of AUCtau (RAUC)
Description
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.
Time Frame
Up to 12 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Toll Free Number
Phone
1-888-577-8839
Email
Trialsites@merck.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
Facility Information:
Facility Name
UCSD Altman Clinical and Translational Research Institute (Site 1013)
City
La Jolla
State/Province
California
ZIP/Postal Code
92037-0943
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
858-246-2387
Facility Name
Keck Medical Center ( Site 1001)
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
323-409-5383
Facility Name
Georgetown University Medical Center ( Site 1010)
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
202-444-6206
Facility Name
University of Florida ( Site 1002)
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
352-273-8948
Facility Name
Central Florida Pulmonary Group ( Site 1005)
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
407-841-1100
Ext
166
Facility Name
Medster Research, LLC ( Site 1017)
City
Valdosta
State/Province
Georgia
ZIP/Postal Code
31605-1096
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
229-491-7991
Facility Name
University of Kansas Medical Center ( Site 1007)
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
913-588-0653
Facility Name
The Cleveland Clinic Foundation ( Site 1003)
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
216-445-0574
Facility Name
Penn State Milton S Hershey Medical Center ( Site 1004)
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
717-531-0003 ext. 284024
Facility Name
West Tennessee Research Institute ( Site 1012)
City
Jackson
State/Province
Tennessee
ZIP/Postal Code
38305
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
731-633-0045
Facility Name
Metroplex Clinical Research Center ( Site 1018)
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231-4446
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Mount Sinai Hospital ( Site 1101)
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 3L9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
416-586-4800 x 5489
Facility Name
Azienda Ospedaliero Universitaria Careggi (Site 1401)
City
Florence
State/Province
Tuscany
ZIP/Postal Code
50134
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+39 3482920658
Facility Name
Azienda Ospedaliera Universitaria Integrata Di Verona ( Site 1402)
City
Verona
State/Province
Veneto
ZIP/Postal Code
37134
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+39 045 8128177
Facility Name
Hôpital Neuchatelois ( Site 1304)
City
Neuchâtel
State/Province
Neuchâtel (fr)
ZIP/Postal Code
2000
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+41 32 7133609
Facility Name
Kantonsspital St. Gallen (Site 1301)
City
St Gallen
State/Province
Sankt Gallen
ZIP/Postal Code
9000
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+4 171-494-2728

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

Learn more about this trial

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

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