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

Who is this study for? Patients with Systemic Sclerosis, Interstitial Lung Disease
What treatments are being studied? ACE-1334
Status: Terminated
Location: See all (16) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
California
UCSD Altman Clinical and Translational Research Institute (Site 1013)
La Jolla
Keck Medical Center ( Site 1001)
Los Angeles
Washington, D.c.
Georgetown University Medical Center ( Site 1010)
Washington D.c.
Florida
University of Florida ( Site 1002)
Gainesville
Central Florida Pulmonary Group ( Site 1005)
Orlando
Georgia
Medster Research, LLC ( Site 1017)
Valdosta
Kansas
University of Kansas Medical Center ( Site 1007)
Kansas City
Ohio
The Cleveland Clinic Foundation ( Site 1003)
Cleveland
Pennsylvania
Penn State Milton S Hershey Medical Center ( Site 1004)
Hershey
Tennessee
West Tennessee Research Institute ( Site 1012)
Jackson
Texas
Metroplex Clinical Research Center ( Site 1018)
Dallas
Other Locations
Canada
Mount Sinai Hospital ( Site 1101)
Toronto
Italy
Azienda Ospedaliero Universitaria Careggi (Site 1401)
Florence
Azienda Ospedaliera Universitaria Integrata Di Verona ( Site 1402)
Verona
Switzerland
Hôpital Neuchatelois ( Site 1304)
Neuchâtel
Kantonsspital St. Gallen (Site 1301)
Sankt Gallen
Time Frame
Start Date: 2023-03-10
Completion Date: 2023-10-18
Participants
Target number of participants: 5
Treatments
Experimental: Cohort 1: MK-2225
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.
Placebo_comparator: Cohort 1: Placebo
Participants in Cohort 1 will receive placebo Q2W plus SOC for 12 weeks.
Experimental: Cohort 2: MK-2225
Participants in Cohort 2 will receive MK-2225 at 0.5 mg/kg (or lower) Q2W plus SOC for 12 weeks.
Placebo_comparator: Cohort 2: Placebo
Participants in Cohort 2 will receive placebo Q2W plus SOC for 12 weeks.
Experimental: Cohort 3: MK-2225
Participants in Cohort 3 will receive MK-2225 at 1.0 mg/kg (or lower) Q2W plus SOC for 12 weeks.
Placebo_comparator: Cohort 3: Placebo
Participants in Cohort 3 will receive placebo Q2W plus SOC for 12 weeks.
Experimental: Cohort 4: MK-2225
Participants in Cohort 4 will receive MK-2225 at ≤2.0 mg/kg Q2W if needed plus SOC for 12 weeks.
Placebo_comparator: Cohort 4: Placebo
Participants in Cohort 4 will receive placebo Q2W plus SOC for 12 weeks.
Experimental: Cohort 5: MK-2225
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.
Placebo_comparator: Cohort 5: Placebo
Participants in Cohort 5 will receive (no more frequent than Q2W) placebo plus SOC for 12 weeks.
Experimental: Cohort 6: MK-2225
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.
Placebo_comparator: Cohort 6: Placebo
Participants in Cohort 6 will receive (no more frequent than Q2W) placebo plus SOC for 12 weeks.
Related Therapeutic Areas
Sponsors
Leads: Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA

This content was sourced from clinicaltrials.gov