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A Phase 2b Study of the Efficacy, Safety, and Tolerability of M1095 in Subjects With Moderate to Severe Psoriasis

Study Purpose

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.

Recruitment Criteria

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Accepts Healthy Volunteers
No

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.


Searching Both is inclusive of interventional and observational studies.

Study Type
Interventional
Eligible Ages 18 Years - 75 Years
Gender All
More Inclusion & Exclusion Criteria

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.

Trial Details

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.

Trial ID:
NCT03384745

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.

Phase
Phase 2

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Lead Sponsor
Bond Avillion 2 Development LP

The person who is responsible for the scientific and technical direction of the entire clinical study.

Principal Investigator
Dr. Kim Papp
Principal Investigator Affiliation Probity Medical Research Inc

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Agency Class
IndustryIndustry
Overall Status Recruiting
Countries Bulgaria, Canada, Czechia, Germany, Hungary, Poland, United States

The disease, disorder, syndrome, illness, or injury that is being studied.

Conditions
Psoriasis

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Investigative Site, San Antonio, Texas

Status

Recruiting

Address

Investigative Site

San Antonio, Texas, 78229

Investigative Site, Houston, Texas

Status

Recruiting

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Investigative Site

Houston, Texas, 77004

Investigative Site, Dallas, Texas

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Not yet recruiting

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Investigative Site

Dallas, Texas, 75246

Investigative Site, Bexley, Ohio

Status

Recruiting

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Investigative Site

Bexley, Ohio, 43209

Investigative Site, New York, New York

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Not yet recruiting

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Investigative Site

New York, New York, 10029

Investigative Site, Albuquerque, New Mexico

Status

Recruiting

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Investigative Site

Albuquerque, New Mexico, 87102

Investigative Site, Saint Louis, Missouri

Status

Recruiting

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Investigative Site

Saint Louis, Missouri, 63117

Investigative Site, Sandy Springs, Georgia

Status

Recruiting

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Investigative Site

Sandy Springs, Georgia, 30328

Investigative Site, DeLand, Florida

Status

Recruiting

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Investigative Site

DeLand, Florida, 32720

Investigative Site, San Diego, California

Status

Recruiting

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Investigative Site

San Diego, California, 92123

Investigative Site, Birmingham, Alabama

Status

Recruiting

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Investigative Site

Birmingham, Alabama, 35205

International Sites

Investigative Site, Warszawa, Poland

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Not yet recruiting

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Investigative Site

Warszawa, , 04-141

Investigative Site, Warszawa, Poland

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Not yet recruiting

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Investigative Site

Warszawa, , 02-777

Investigative Site, Warszawa, Poland

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Not yet recruiting

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Investigative Site

Warszawa, , 02-507

Investigative Site, Skierniewice, Poland

Status

Not yet recruiting

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Investigative Site

Skierniewice, , 96-100

Investigative Site, Siedlce, Poland

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Not yet recruiting

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Investigative Site

Siedlce, , 08-110

Investigative Site, Poznań, Poland

Status

Not yet recruiting

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Investigative Site

Poznań, , 60-848

Investigative Site, Lublin, Poland

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Not yet recruiting

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Investigative Site

Lublin, , 20-314

Investigative Site, Katowice, Poland

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Not yet recruiting

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Investigative Site

Katowice, , 40-060

Investigative Site, Szolnok, Hungary

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Not yet recruiting

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Investigative Site

Szolnok, , 5000

Investigative Site, Szeged, Hungary

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Not yet recruiting

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Investigative Site

Szeged, , 6720

Investigative Site, Orosháza, Hungary

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Not yet recruiting

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Investigative Site

Orosháza, , 5900

Investigative Site, Kecskemét, Hungary

Status

Not yet recruiting

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Investigative Site

Kecskemét, , 6000

Investigative Site, Budapest, Hungary

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Not yet recruiting

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Investigative Site

Budapest, , 1135

Investigative Site, Budapest, Hungary

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Not yet recruiting

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Investigative Site

Budapest, , 1085

Investigative Site, Schwerin, Germany

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Not yet recruiting

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Investigative Site

Schwerin, , 19055

Investigative Site, Quedlinburg, Germany

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Not yet recruiting

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Investigative Site

Quedlinburg, , 06484

Investigative Site, Osnabrück, Germany

Status

Not yet recruiting

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Investigative Site

Osnabrück, , 49074

Investigative Site, Mainz, Germany

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Not yet recruiting

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Investigative Site

Mainz, , 55131

Investigative Site, Mahlow, Germany

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Not yet recruiting

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Investigative Site

Mahlow, , 15831

Investigative Site, Kiel, Germany

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Not yet recruiting

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Investigative Site

Kiel, , 24105

Investigative Site, Hamburg, Germany

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Not yet recruiting

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Investigative Site

Hamburg, , 20354

Investigative Site, Friedrichshafen, Germany

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Not yet recruiting

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Investigative Site

Friedrichshafen, , 88045

Investigative Site, Frankfurt/Main, Germany

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Not yet recruiting

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Investigative Site

Frankfurt/Main, , 60590

Investigative Site, Darmstadt, Germany

Status

Not yet recruiting

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Investigative Site

Darmstadt, , 64297

Investigative Site, Bochum, Germany

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Not yet recruiting

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Investigative Site

Bochum, , 44793

Investigative Site, Berlin, Germany

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Not yet recruiting

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Investigative Site

Berlin, , 10789

Investigative Site, Augsburg, Germany

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Not yet recruiting

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Investigative Site

Augsburg, , 86179

Investigative Site, Uherské Hradiště, Czechia

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Not yet recruiting

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Investigative Site

Uherské Hradiště, , 686 01

Investigative Site, Praha, Czechia

Status

Recruiting

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Investigative Site

Praha, , 130 00

Investigative Site, Pardubice, Czechia

Status

Recruiting

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Investigative Site

Pardubice, , 530 02

Investigative Site, Ostrava, Czechia

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Not yet recruiting

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Investigative Site

Ostrava, , 708 52

Investigative Site, Ostrava, Czechia

Status

Not yet recruiting

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Investigative Site

Ostrava, , 702 00

Investigative Site, Náchod, Czechia

Status

Recruiting

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Investigative Site

Náchod, , 547 01

Investigative Site, Nový Jičín, Czechia

Status

Not yet recruiting

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Investigative Site

Nový Jičín, , 741 01

Investigative Site, Brno, Czechia

Status

Recruiting

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Investigative Site

Brno, , 602 00

Investigative Site, Quebec City, Quebec, Canada

Status

Not yet recruiting

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Investigative Site

Quebec City, Quebec, G1V 4X7

Investigative Site, Windsor, Ontario, Canada

Status

Recruiting

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Investigative Site

Windsor, Ontario, N8W 1E6

Investigative Site, Waterloo, Ontario, Canada

Status

Recruiting

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Investigative Site

Waterloo, Ontario, N2J 1C4

Investigative Site, Richmond Hill, Ontario, Canada

Status

Recruiting

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Investigative Site

Richmond Hill, Ontario, L4B 1A5

Investigative Site, Ottawa, Ontario, Canada

Status

Recruiting

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Investigative Site

Ottawa, Ontario, K2G 6E2

Investigative Site, Oakville, Ontario, Canada

Status

Recruiting

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Investigative Site

Oakville, Ontario, L6J 7W5

Investigative Site, North Bay, Ontario, Canada

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Not yet recruiting

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Investigative Site

North Bay, Ontario, P1B 3Z7

Investigative Site, Markham, Ontario, Canada

Status

Recruiting

Address

Investigative Site

Markham, Ontario, L3P 1X2

Investigative Site, Surrey, British Columbia, Canada

Status

Recruiting

Address

Investigative Site

Surrey, British Columbia, V3V 0C6

Investigative Site, Surrey, British Columbia, Canada

Status

Recruiting

Address

Investigative Site

Surrey, British Columbia, V3R 6A7

Investigative Site, Edmonton, Alberta, Canada

Status

Not yet recruiting

Address

Investigative Site

Edmonton, Alberta, T5K 1X3

Investigative Site, Varna, Bulgaria

Status

Recruiting

Address

Investigative Site

Varna, , 9010

Investigative Site, Sofia, Bulgaria

Status

Recruiting

Address

Investigative Site

Sofia, , 1431

Investigative Site, Dupnitsa, Bulgaria

Status

Recruiting

Address

Investigative Site

Dupnitsa, , 2600

The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation.

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