MK-2225 for Systemic Sclerosis

Recruiting at 22 trial locations

Overseen By Toll Free Number

Age: 18+

Sex: Any

Trial Phase: Phase 1

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

Must be taking: Immunosuppressive therapy

Must not be taking: Anticoagulants, Antiplatelets, Cyclophosphamide, Nintedanib

Disqualifiers: Pulmonary hypertension, Lung disease, Infection, others

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

5 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it requires that any non-excluded immunosuppressive therapy be stable for more than 2 months before screening. Some medications like cyclophosphamide, nintedanib, pirfenidone, and tocilizumab have specific time restrictions before joining the trial.

How is the drug MK-2225 unique for treating systemic sclerosis?

MK-2225, also known as ACE-1334, is unique because it may target the inflammatory activation in systemic sclerosis by potentially neutralizing Angiopoietin-2, which is involved in monocyte activation and elevated in patients with this condition. This approach could offer a novel way to manage the disease compared to existing treatments that focus on other mechanisms. ^{1 2 3 4 5}

Research Team

Medical Director

Principal Investigator

Merck Sharp & Dohme LLC

Eligibility Criteria

Inclusion Criteria

You have a specific condition called systemic sclerosis (SSc) according to the guidelines set by the American College of Rheumatology and European League Against Rheumatism in 2013.

Women of childbearing potential must:

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

Exclusion Criteria

You have a significant lung condition, like asthma or obstructive lung disease, as determined by the doctor.

You currently have a serious infection or were hospitalized for an infection within the past 4 weeks.

You have a history of bleeding in your stomach or digestive system.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive MK-2225 or placebo plus standard of care for 12 weeks

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

8 weeks

Treatment Details

Interventions

• ACE-1334
• MK-2225
• Placebo

Participant Groups

Group I: Cohort 6: MK-2225 Experimental Treatment 1 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-2225 Experimental Treatment 1 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-2225 Experimental Treatment 1 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-2225 Experimental Treatment 1 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-2225 Experimental Treatment 1 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-2225 Experimental Treatment 1 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: Placebo Placebo Group 1 Intervention

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

Group VIII: Cohort 6: Placebo Placebo Group 1 Intervention

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

Group IX: Cohort 4: Placebo Placebo Group 1 Intervention

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

Group X: Cohort 5: Placebo Placebo Group 1 Intervention

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

Group XI: Cohort 1: Placebo Placebo Group 1 Intervention

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

Group XII: Cohort 2: Placebo Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

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

Lead Sponsor

Trials

33

Recruited

4,300+

Acceleron Pharma Inc.

Lead Sponsor

Trials

27

Recruited

3,100+

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

Lead Sponsor

Trials

33

Recruited

4,300+

References

1. Canada pubmed.ncbi.nlm.nih.gov

Angiotensin-converting enzyme gene does not contribute to genetic susceptibility to systemic sclerosis in European Caucasians. [2022]

2. France pubmed.ncbi.nlm.nih.gov

[Treatment of scleroderma]. [2013]

3. Japan pubmed.ncbi.nlm.nih.gov

Successful treatment of the crisis of scleroderma with enalapril maleate (MK-421). [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Prevention of vascular damage in scleroderma and autoimmune Raynaud's phenomenon: a multicenter, randomized, double-blind, placebo-controlled trial of the angiotensin-converting enzyme inhibitor quinapril. [2022]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Angiopoietin-2 Promotes Inflammatory Activation in Monocytes of Systemic Sclerosis Patients. [2021]