Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
MSC2364447C · 1 trial · 1 indication
TEAEs will be defined as the adverse events (AEs) that occur between first dose of study drug administration up to 4 weeks after the last dose of study drug administration that were absent before treatment or that worsened relative to pretreatment state.
The severity of TEAEs will be graded using National cancer institute-Common Terminology Criteria for Adverse Events version 4.03 (NCI-CTCAE v 4.03) definitions of Grade 1 through Grade 5 following his/her best medical judgment. The severity of the AEs will be classified as follows: Grade 1 or mild, Grade 2 or moderate, Grade 3 or severe, Grade 4 or life-threatening and Grade 5 or death.
Clinical laboratory parameters being monitored for safety will be summarized using descriptive statistics, by postdose shifts relative to Baseline for relevant parameters using relevant cut-offs. Clinical significance will be determined by investigator.
Observed values and changes from Baseline in vital signs will be summarized for each treatment group using descriptive statistics. Clinically noteworthy changes in vital signs will be listed and summarized as appropriate. A semi-automated blood pressure and pulse rate recording device with an appropriate cuff size will be utilized. Blood pressure and pulse rate will be measured after 10 minutes' rest in the semi-supine position with the subject's arm unconstrained by clothing or other material. The blood pressure should be assessed on the same arm for each subject throughout the trial. Clinical significance will be determined by investigator.
Observed values and changes from Baseline in ECG will be summarized for each treatment group using descriptive statistics. Clinically noteworthy changes in ECG will be listed and summarized as appropriate. Clinical significance will be determined by investigator.
| Arm | Type | Description |
|---|---|---|
| MSC2364447C 25 mg | EXPERIMENTAL | - |
| MSC2364447C 75 mg | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| MSC2364447C | DRUG | Subjects will be administered with MSC2364447C 25 milligrams orally once daily for 4 weeks. |
| Placebo | DRUG | Subjects will be administered with placebo matching to MSC2364447C orally once daily for 4 weeks. |
Inclusion Criteria: * Male or female of 18 to 65 years of age * Diagnosis of systemic lupus erythematosus (SLE) (at least 4 of the 11 American College of Rheumatology \[ACR\] classification criteria for SLE) of at least 6 months duration at the Screening visit * Positive test results for anti-nucle...
MSC2364447C is an investigational small molecule being studied for the treatment of systemic lupus erythematosus. It is in Phase 1 clinical development, meaning it is not yet approved and remains under investigation for safety and efficacy in this autoimmune condition.
MSC2364447C is being developed by Merck & Company, Inc., which trades on the New York Stock Exchange under the ticker MRK. The company is conducting clinical research on this small molecule candidate for systemic lupus erythematosus.
MSC2364447C is in Phase 1 clinical development. A Phase 1b trial has been completed, and the drug remains investigational. It has not been approved by regulatory authorities and is still in the early stages of clinical testing.
MSC2364447C has been studied in one completed Phase 1b trial, identified as NCT02537028, which enrolled 24 participants with systemic lupus erythematosus. The trial was conducted in the United States and Bulgaria, was randomized, double-blind, and placebo-controlled, and required participants to be at least 18 years old.
MSC2364447C is the name used for this investigational small molecule in clinical trials. No alternative names have been reported for this drug candidate, and it is distinct from other compounds in Merck's pipeline.