Clinical Research

Study Title: A Phase 1/2B study to investigate the safety and pharmacokinetics and efficacy of UCB1381 in participants with atopic dermatitis 

We are seeking adults diagnosed with Atopic Dermatitis to participate in a clinical trial. The purpose of this study is to investigate the safety and efficacy of an investigational drug called UCB1381 versus a placebo.

Study Length: Participation is expected to last up to 26 weeks. This study will require 16 study visits of which three visits will occur via phone. Participation involves a physical exam, completion of questionnaires, vital signs, medical history, Atopic Dermatitis assessment, 12-lead electrocardiogram (ECG), skin punch biopsy, chest x-ray, collection of blood, stool, and urine, five mandatory and one optional overnight stays, and administration of either placebo or test drug through intravenous (injection through vein, IV) route. 

Participant Requirements:

• 18-65 years old

• Overtly healthy

• Must have diagnosis of Moderate to Severe Atopic Dermatitis that has been present for at least 12 months

• BMI within the range 18 to 35kg/m2

Compensation: Research study participants may be compensated.

This study is being conducted by Dr. Paul Bigliardi at the University of Minnesota, Department of Dermatology. To learn more about this study and to see if you qualify, please contact the study coordinator dermresearch@umn.edu or 612-624-6718.

Study Title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Oral Brepocitinib in Adults with Dermatomyositis

We are conducting a research study on individuals with dermatomyositis. The purpose of this research study is to learn more about the safety and effectiveness of an investigational drug called Brepocitinib. This study will compare the investigational drug to a placebo (inactive substance) to see how well the investigational drug works.

Participant requirements:

• Male and/or Female 18-75 years of age
• Confirmation of dermatomyositis diagnosis
• Attend 13 visits over 56 weeks
• Other requirements, which the study team will review with you

This study is being conducted by Dr. David Pearson in the University Of Minnesota Department Of Dermatology. For additional information, please visit the study page on https://clinicaltrials.gov/ct2/show/NCT05437263

Alternatively, contact the study coordinator: 612-625-2624 or dermresearch@umn.edu

Study Title: A Phase IIa, Randomized, Parallel, Double-Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Enpatoran in Dermatomyositis and Polymyositis Participants receiving Standard of Care

We are conducting a research study on individuals with Dermatomyositis and Polymyositis with active muscle involvement. The purpose of this research study is to learn more about the safety and efficacy of an investigational drug called Enpatoran. This study will compare the investigational drug to a placebo (inactive substance) to see how well the investigational drug works.

Participant requirements:

•  18-75 years of age
•  Diagnosis of Dermatomyositis or Polymyositis
•  Attend 10 visits over 26 weeks
•  Other requirements, which the study team will review with you

This study is being conducted by Dr. David Pearson in the University of Minnesota Department of Dermatology. For additional information, please visit the study page on http://clinicaltrials.gov/ NCT05650567

Alternatively, contact the study coordinator: 612-625-2624 or dermresearch@umn.edu

Study Title:

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Operationally Seamless, Adaptive Phase 2/3 Study to Evaluate the Efficacy and Safety of Baricitinib in Adult Patients with Severe or Very Severe Alopecia Areata 

We are conducting an addendum to a research study on individuals with severe or very severe Alopecia Areata.   In the study that led to the first FDA approved medication for alopecia areata in June, 2022 patients who were Black or African American also showed significantly greater response to baricitinib compared with placebo but the overall response rate was lower in this subgroup compared to other racial subgroups. Therefore, this knowledge gap indicates a need to study more closely the diagnosis and treatment outcomes of Black or African American patients with severe alopecia areata. The present 52-week subpopulation study addendum will allow a closer examination and provide additional descriptive outcomes in response to therapy with 4-mg baricitinib in this subpopulation.

Participant requirements:

• Women ages 18 – 70 years of age 

• Men ages 18 - 60 years of age

• Self-identify as Black or African American race

• Diagnosed with severe or very severe Alopecia Areata and have greater than or equal to 50% scalp hair loss

• Must be willing to stop using other types of medications to treat Alopecia Areata throughout the study

• Attend 11 visits over 52 weeks

• Other requirements, which the study team will review with you

This study is being conducted by Dr. Maria Hordinsky in the University Of Minnesota Department Of Dermatology. For additional information, please visit the study page on ClinicalTrials.gov https://clinicaltrials.gov/ct2/show/NCT03570749

Contact the study coordinator: 612-625-2624 or email: speck007@umn.edu

Study Title: 

Phase 2a Study to Investigate the Efficacy and Safety of Farudodstat Compared with its Placebo in Adult Alopecia Areata Participants

We are conducting a research study on individuals with patchy Alopecia Areata (AA). The purpose of this research study is to learn more about the safety, tolerability and efficacy of an investigational oral drug called Farudodstat. This study will compare the investigational drug to a placebo (inactive substance) to see how well the investigational drug works for 28 weeks to areas affected by Alopecia Areata, including the scalp and eyebrows.

Participant requirements:

• Men and women, ages 18 and older who are in good health

• Diagnosed with Alopecia Areata and have 50% or greater scalp hair loss

• Must be willing to stop using other types of medications to treat AA throughout the study

• Other requirements, which the study team will review with you

This study is being conducted by Dr. Maria Hordinsky in the University Of Minnesota Department Of Dermatology. For additional information, please call the study coordinator: 612-625-2624 or email: dermresearch@umn.edu

Study Title:
A Phase 1b, Randomized, Vehicle-Controlled, Double-Blind, Pharmacokinetics,Pharmacodynamics, and Safety Study of ARQ-255 Topical Suspension in Subjects with Alopecia Areata

We are conducting a research study on individuals with patchy Alopecia Areata (AA). The purpose of this research study is to learn more about the safety, tolerability and efficacy of an investigational drug called ARQ-255-126 a topical solution. This study will compare the investigational drug to a placebo (inactive substance) to see how well the investigational drug works for 12 weeks to areas affected by AA, including the scalp and eyebrows.

Participant requirements:

•  Men and women, ages 18-70 who are in good health
•  Diagnosed with patchy AA and have 30-80% scalp hair loss
•  Must be willing to stop using other types of medications to treat AA throughout the study
•  Other requirements, which the study team will review with you

This study is being conducted by Dr. Maria Hordinsky in the University of Minnesota Department of Dermatology. For additional information, please call the study coordinator: 612-624-0249 or email: dermresearch@umn.edu

Study Title: Capsule Microbiota Transplant Therapy for Hidradenitis Suppurativa

Study Title: A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Efficacy and Safety Study of Povorcitinib (INCB054707) in Participants With Moderate to Severe Hidradenitis Suppurativa

We are conducting a research study on individuals with moderate to severe Hidradenitis Suppurativa for at least 3 months. The purpose of this research study is to learn more about the safety and effectiveness of the investigational drug call Povorcitinib. This study will compare the investigational drug to a placebo (inactive substance) to see how well the investigational drug works.

Participant requirements:

• Men and women 18 years of age and older
• Diagnosed with Hidradenitis Suppurativa for at least 3 months prior to study screening
• Attend 15 visits over 58 weeks
• Other requirements, which the study team will review with you

This study is being conducted by Dr. Noah Goldfarb in the University Of Minnesota Department Of Dermatology. For additional information, please contact the study coordinator: 612-624-0249 or belle116@umn.edu

Study Title: WILLOW study of enpatoran in lupus erythematosus

We are conducting a research study on individuals with systemic and/or cutaneous lupus erythematosus. The purpose of this study is to learn more about the safety and efficacy of an investigational drug called enpatoran. This study will compare the investigational drug to a placebo (inactive substance) to see how well the investigational drug works.

Participant requirements:

• 18-75 years of age
• Confirmation of systemic and/or cutaneous lupus erythematosus
• Attend 10 visits over 26 weeks
• Other requirements, which the study team will review with you

This study is being conducted by Dr. David Pearson in the University of Minnesota Department of Dermatology. For additional information, please visit the study page on ClinicalTrials.gov https://clinicaltrials.gov NCT05162586

Alternatively, contact the study coordinator: 612-626-0249 or belle116@umn.edu