Systemic Sclerosis With and Without Interstitial Lung Disease
Conditions
Keywords
Diffuse Systemic Sclerosis, Scleroderma, Systemic Sclerosis, Systemic Sclerosis-associated Interstitial Lung Disease
Brief 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.
Interventions
BIOLOGICALMK-2225
Administered Subcutaneously (SC)
BIOLOGICALPlacebo
Administered SC
Sponsors
Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
The main inclusion and
Exclusion criteria
include but are not limited to the following: Inclusion Criteria: * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with ≥1 Adverse Event (AE) | Up to 20 Weeks | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who experienced an AE will be reported. |
| Number of Participants Discontinuing from Study Therapy Due to AE | Up to 12 Weeks | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who discontinued study treatment due to an AE will be reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to peak Serum Concentration (Tmax) of MK-2225 | Up to 12 Weeks | Tmax is the amount of time required to reach Cmax. Blood samples will be collected at designated timepoints to determine Tmax of MK-2225. |
| Area Under the Concentration-Time Curve (AUC0-tau) of MK-2225 | Up to 12 Weeks | AUC0-tau is the area under the concentration-time curve. Blood samples will be collected at designated timepoints to determine AUC0-tau of MK-2225. |
| Accumulation ratio of AUCtau (RAUC) | Up to 12 Weeks | RAUC is the accumulation ratio of AUCtau after multiple doses relative to after a single dose. Blood samples will be collected at designated timepoints to determine RAUC of MK-2225. |
| Serum Apparent Terminal Half-Life (t1/2) of MK-2225 | Up to 12 Weeks | t1/2 is the time required for 50% of drug to be cleared from serum. Blood samples will be collected at designated timepoints to determine t1/2 of MK-2225. |
| Serum Maximum Concentration (Cmax) of MK-2225 | Up to 12 Weeks | Cmax is the maximum concentration of the drug observed in plasma. Blood samples will be collected at designated timepoints to determine Cmax of MK-2225. |
Countries
Canada, Italy, Switzerland, United States
Outcome results
None listed