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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

Summary

This trial is testing a new drug called MK-2225 (ACE-1334) along with standard treatments in patients with Systemic Sclerosis. The goal is to see if the new drug is safe and can be tolerated without causing serious side effects.

Eligible Conditions
  • Scleroderma

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of Participants Discontinuing from Study Therapy Due to AE
Number of Participants with ≥1 Adverse Event (AE)
Secondary study objectives
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.

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
John Butler, MDStudy DirectorAcceleron Pharma Inc.
1 Previous Clinical Trials
444 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,900 Previous Clinical Trials
8,090,429 Total Patients Enrolled
1 Trials studying Scleroderma
12 Patients Enrolled for Scleroderma

Media Library

Scleroderma Research Study Groups: Cohort 6: MK-2225, Cohort 3: MK-2225, Cohort 4: 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
~2 spots leftby Dec 2025
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