Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
MSB11022 · 1 trial · 3 indications
PASI correlates to the physician's assessment of psoriasis symptoms including redness of lesions, thickness of lesions, scaliness of lesions and extent of disease. Each parameter is graded from 0-4, 0 refers to no disease and 4 to severe involvement. The body is divided into 4 areas for scoring (head, arms, trunk to groin, legs to top of buttocks), and the final score ranges from 0-72 with higher scores reflecting more disease severity. The PASI-75 response is defined as the percentage of participants who achieved at least a 75% improvement in PASI score from Baseline.
| Arm | Type | Description |
|---|---|---|
| MSB11022 (Core Treatment Period) | EXPERIMENTAL | Participants received MSB11022 subcutaneously at an initial dose of 80 milligram (mg) on Day 1 of Week 1 followed by 40 mg every other week starting at Week 2 up to and including Week 14 in Core Treatment Period. |
| EU-Humira | ACTIVE_COMPARATOR | Participants received EU-Humira subcutaneously at an initial dose of 80 mg on Day 1 of Week 1 followed by 40 mg every other week starting at Week 2 up to and including Week 14 in Core Treatment Period. |
| MSB11022 (Extended Treatment Period) | EXPERIMENTAL | Participants who had achieved PASI 50 and received MSB11022 during Core Treatment Period continued to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period. |
| EU-Humira/EU-Humira | ACTIVE_COMPARATOR | Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period and continued to receive EU-Humira subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 after re-randomization in extended treatment period. |
| EU-Humira/MSB11022 | EXPERIMENTAL | Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period were re-randomized to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period. |
| Name | Type | Description |
|---|---|---|
| MSB11022 | DRUG | Participants received MSB11022 drug subcutaneously MSB11022 (Core Treatment Period), MSB11022 (Extended Treatment Period) and EU-Humira/MSB11022 arm. |
| Humira® | DRUG | Participants received EU-Humira subcutaneously in EU-Humira, EU-Humira/EU-Humira and EU-Humira/MSB11022 arm. |
Inclusion Criteria: * Male or female participants greater than or equal to (\>=) 18 years old with a clinical diagnosis of stable moderate to severe plaque psoriasis (defined by Psoriasis Area and Severity Index \[PASI\] score \>=12, Physician Global Assessment \[PGA\] score \>=3, and \>=10% of bod...
MSB11022 is an investigational small molecule being developed for the treatment of moderate to severe chronic plaque psoriasis, a form of psoriasis. It is currently in Phase 3 clinical development and is not yet approved by regulatory authorities.
MSB11022 is being developed by Merck KGaA, a German multinational pharmaceutical company. The company's stock is traded over-the-counter under the ticker symbol MKGAF.
MSB11022 is in Phase 3 clinical development for the treatment of moderate to severe chronic plaque psoriasis. It is an investigational drug, meaning it has not yet received regulatory approval and is still undergoing clinical trials to evaluate its safety and efficacy.
MSB11022 has one completed Phase 3 clinical trial, identified as NCT02660580, titled "MSB11022 in Moderate to Severe Chronic Plaque Psoriasis." This randomized, double-blind, active-controlled study enrolled 443 participants across multiple countries, including the United States, Canada, and several European nations.
No alternative names for MSB11022 have been disclosed. It is identified solely by its developmental code name, MSB11022, in clinical trial registries and scientific literature.