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A Phase 2b Study of the Efficacy, Safety, and Tolerability of M1095 in Subjects With Moderate to Severe Psoriasis
This is a multi-center phase 2b study in subjects with moderate to severe chronic plaque-type psoriasis. Approximately 300 subjects will be enrolled at approximately 60 investigator sites in North America and Europe.
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
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|Eligible Ages||18 Years - 75 Years|
Inclusion Criteria:1. Male and female subjects between 18 and 75 years of age. 2. Moderate to severe plaque-type psoriasis for at least 6 months. 3. Subject is a candidate for systemic biologic therapy. 4. Subject has IGA ≥3, involved body surface area (BSA) ≥10%, and PASI ≥12 at screening and at baseline. 5. Subject is able to comply with the study procedures. 6. Subject must provide informed consent. Exclusion Criteria (Main): 1. Non-plaque type psoriasis, drug-induced psoriasis, or other skin conditions (e.g., eczema). (Psoriatic arthritis is allowed). 2. Other medical conditions, including planned surgery or active infection / history of infection, as defined in the study protocol. Subjects will be screened for tuberculosis and hepatitis B / hepatitis C. 3. Laboratory abnormalities at screening, as defined in the study protocol. 4. Prior use of systemic or topical treatments for psoriasis, as defined in the study protocol. 5. Prior use of any compound targeting IL-17, more than two biologic therapies, ustekinumab within 6 months, or TNF targeting therapies within 12 weeks. 6. History of suicidal thoughts within 12 months.
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|Bond Avillion 2 Development LP|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Dr. Kim Papp|
|Principal Investigator Affiliation||Probity Medical Research Inc|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
|Countries||Bulgaria, Canada, Czechia, Germany, Hungary, Poland, United States|
The disease, disorder, syndrome, illness, or injury that is being studied.
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