MK-2225 for Systemic Sclerosis

No longer recruiting at 24 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called MK-2225 (ACE-1334) to determine its safety and tolerability for people with Systemic Sclerosis (SSc), a condition that hardens and tightens the skin and connective tissues. Participants will receive either the new treatment or a placebo, alongside their regular care, to compare outcomes. The trial includes several groups receiving different doses to identify the best dosing schedule. Individuals diagnosed with SSc and on stable doses of certain immune therapies might be suitable for this study. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive it.

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.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research shows that MK-2225, also known as ACE-1334, is under study to determine its safety and tolerability in people with systemic sclerosis. Earlier studies with healthy participants assessed their ability to handle MK-2225, and researchers are closely monitoring for any side effects.

The trials aim to identify the optimal dose where the treatment remains safe and minimizes unwanted reactions. As these are early trials, the primary goal is to understand how the treatment functions in the body and how participants respond. Some side effects may occur, but the focus is on understanding and managing them safely.

If MK-2225 has approval for other conditions, it indicates that it has passed safety checks for those uses, but each new condition can produce different effects. Always consult a doctor if there are concerns or questions about joining a trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for Systemic Sclerosis?

Most treatments for systemic sclerosis, like immunosuppressants and anti-fibrotic drugs, work by reducing inflammation or slowing down the fibrosis process. But MK-2225 works differently, targeting specific pathways involved in the disease's progression. Researchers are excited about MK-2225 because it offers a novel mechanism of action that could potentially halt or even reverse the damage caused by systemic sclerosis. Unlike standard treatments, which often focus on managing symptoms, MK-2225 might directly address the underlying causes, offering hope for more effective disease management.

What evidence suggests that MK-2225 might be an effective treatment for Systemic Sclerosis?

Research has shown that MK-2225, also known as ACE-1334, might benefit people with Systemic Sclerosis. This drug targets the processes that cause fibrosis, where connective tissue becomes thick and scarred. Early studies in Systemic Sclerosis have shown promise, but more detailed information from human studies is still being collected. The FDA has granted MK-2225 an Orphan Drug designation, recognizing its potential as a treatment for rare diseases like Systemic Sclerosis. Initial results suggest effectiveness, but further research is needed to confirm these findings. Participants in this trial will receive MK-2225 in various dosages across different cohorts, while others will receive a placebo for comparison. ^{1 2 3 6 7}

Who Is on the Research Team?

Medical Director

Principal Investigator

Merck Sharp & Dohme LLC

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• ACE-1334
• MK-2225
• Placebo

How Is the Trial Designed?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04948554

A Study of MK-2225 / ACE-1334 in Participants With ... 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 ...

2. trials.arthritis.org trials.arthritis.org/trials/NCT04948554

A Study of MK-2225 / ACE-1334 in Participants With Systemic ... 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 ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06643390

A Study of MK-2225 in Healthy Participants (MK-2225-003) It identifies the role of the intervention that participants receive. Types of arms include experimental arm, active comparator arm, placebo comparator arm, ...

4. withpower.com withpower.com/trial/phase-2-lung-diseases-interstitial-8-2021-dea39

MK-2225 for Systemic Sclerosis · Info for Participants 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 ...

5. biospace.com biospace.com/acceleron-receives-fda-orphan-drug-designation-for-ace-1334-for-the-treatment-of-systemic-sclerosis

Acceleron Receives FDA Orphan Drug Designation for ... The United States Food and Drug Administration (FDA) has granted Orphan Drug designation to ACE-1334 for the treatment of patients with systemic sclerosis.

6. withpower.com withpower.com/trial/phase-1-systemic-sclerosis-progressive-10-2023-04029

MK-2225 Safety Study · Info for Participants The purpose of the study is to learn about the safety of MK-2225, including how well people tolerate it. Researchers also want to learn what happens to ...

7. delta.larvol.com delta.larvol.com/Products/?ProductId=5c7dc33d-7b69-445c-b9c0-5c42d0779ef3

MK-2225 / Merck (MSD) - Systemic Sclerosis Delicious. November 27, 2023. A Study of MK-2225 / ACE-1334 in Participants With Systemic Sclerosis With and Without Interstitial Lung Disease (MK-2225-002) ...