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MK-2225 for Systemic Sclerosis

Phase 1

Waitlist Available

Research Sponsored by Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 20 weeks

Awards & highlights

Study Summary

This trial will test whether a new drug is safe and tolerated by people with scleroderma when taken with standard care.

Eligible Conditions

Systemic Sclerosis (Scleroderma) With and Without Interstitial Lung Disease

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 20 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 20 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 20 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of Participants Discontinuing from Study Therapy Due to AE

Number of Participants with ≥1 Adverse Event (AE)

Secondary outcome measures

Accumulation ratio of AUCtau (RAUC)

Area Under the Concentration-Time Curve (AUC0-tau) of MK-2225

Serum Apparent Terminal Half-Life (t1/2) of MK-2225

+2 more

Trial Design

12Treatment groups

Experimental Treatment

Placebo Group

Group I: Cohort 6: MK-2225Experimental Treatment1 Intervention

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.

Group II: Cohort 5: MK-2225Experimental Treatment1 Intervention

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.

Group III: Cohort 4: MK-2225Experimental Treatment1 Intervention

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

Group IV: Cohort 3: MK-2225Experimental Treatment1 Intervention

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

Group V: Cohort 2: MK-2225Experimental Treatment1 Intervention

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

Group VI: Cohort 1: MK-2225Experimental Treatment1 Intervention

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.

Group VII: Cohort 3: PlaceboPlacebo Group1 Intervention

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

Group VIII: Cohort 6: PlaceboPlacebo Group1 Intervention

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

Group IX: Cohort 4: PlaceboPlacebo Group1 Intervention

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

Group X: Cohort 5: PlaceboPlacebo Group1 Intervention

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

Group XI: Cohort 1: PlaceboPlacebo Group1 Intervention

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

Group XII: Cohort 2: PlaceboPlacebo Group1 Intervention

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USALead Sponsor

32 Previous Clinical Trials

4,262 Total Patients Enrolled

Acceleron Pharma Inc.Lead Sponsor

26 Previous Clinical Trials

3,040 Total Patients Enrolled

Acceleron Pharma Inc. (a wholly owned subsidiary of Merck Sharp and Dohme, a subsidiary of Merck & Co., Inc.)Lead Sponsor

32 Previous Clinical Trials

4,262 Total Patients Enrolled

Media Library

Systemic Sclerosis Research Study Groups: Cohort 4: MK-2225, Cohort 6: MK-2225, Cohort 3: MK-2225, Cohort 3: Placebo, Cohort 6: Placebo, Cohort 4: Placebo, Cohort 5: MK-2225, Cohort 5: Placebo, Cohort 1: MK-2225, Cohort 1: Placebo, Cohort 2: MK-2225, Cohort 2: Placebo

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this clinical trial still seek participants?

"As indicated on clinicaltrials.gov, this medical research is not presently seeking participants. Although the trial first posted on November 18th 2022 and was last updated nine months ago, there are 805 other trials searching for volunteers at present."

Answered by AI

To what extent is MK-2225 hazardous to individuals' health?

"Our evaluation of MK-2225's safety is a 1 since this study is in its initial Phase 1, which entails limited information regarding efficacy and security."

Answered by AI

Is the trial being conducted in multiple medical institutions across North America?

"The trial is currently running in 5 distinct locations, three of which are Jackson, Orlando and Los Angeles. To reduce travel demands if you decide to participate, selecting the closest site would be beneficial. There are also 2 other sites available for recruitment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "A Study of MK-2225 / ACE-1334 in Participants With Systemic Sclerosis With and Without Interstitial Lung Disease (MK-2225-002)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04948554.