Clinical Research

The Clinical Research Division in the Department of Dermatology conducts ongoing studies of novel therapeutic agents. Established to explore new drugs, devices and therapies, the Clinical Research Division is dedicated to pioneering innovative breakthroughs in the field of dermatology. Housed within the Department of Dermatology, the Clinical Research Division has ample office space and a fully equipped lab dedicated to tissue acquisition and analysis, laser scanning confocal microscopy, and more.

Current Studies

Atopic Dermatitis / Eczema

Expand all

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 [email protected] or 612-624-6718.

 

________________________________________________________________________________

 

Study Title: A Phase ll, Multicenter, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of RO7790121 in Patients with Moderate to Severe 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 RO7790121 versus a placebo.

 

Study Length: Participation is expected to last up to 44 weeks. This study will require 16 study visits. Participation involves a physical exam, completion of questionnaires, vital signs, medical history, Atopic Dermatitis assessment, 12-lead electrocardiogram (ECG), optional skin punch biopsy, chest x-ray, collection of blood, stool, and urine, and administration of either placebo or test drug through sub-cutaneous (SQ) route.

 

Participant Requirements:

 

 

  • 18-years and older
  • Overtly healthy

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

  • Body weight > 88 pounds

 

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 [email protected] or 612-625-2624.

Expand all

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 here.

Alternatively, contact the study coordinator: 612-625-2624 or [email protected]

 

 

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 here

Alternatively, contact the study coordinator: 612-625-2624 or [email protected]

Hair Diseases / Alopecia

Expand all

We are looking for participants in a new study for Alopecia Areata. More information is available at the link.

________________________________________________________________________________________________

Study Title: 

A Phase 3, External and Synthetic Placebo-Controlled Randomized Study with Dose-Up for Non-Responders to Investigate Safety and Efficacy of Ritlecitinib 50 MG and 100 MG Once Daily in Adult and Adolescent Participants 12 Years of Age and Older with Alopecia Areata

We are conducting Pfizer's ALLEGRO 100 clinical trial, a phase 3, randomized study to investigate the safety and efficacy of ritlecitinib (LITFULO) 100 mg once daily in alopecia areata. Participants must be 12 years of age or older (no upper age limit). Ritlecitinib 50 mg once daily is currently approved by the United States Food and Drug Administration (FDA) to treat severe alopecia areata in individuals 12 years of age or older. However, research has indicated that this dose may not achieve the maximum potential efficacy of ritlecitinib, and greater efficacy is anticipated with higher doses.

Our site is now enrolling eligible participants to this study. There is no placebo arm and all participants will receive medication.

Participant requirements:

  • 12 years of age and older (no upper age limit)
  • Generally healthy with no major changes in recent medical history
  • Diagnosed with scalp Alopecia Areata and does not have hair loss associated with any other conditions
  • Greater than 50% scalp hair loss
  • In a current hair loss episode that has lasted 10 years or less
  • FOR AGES 12-17: Have previously received 2 doses of the varicella (chickenpox) vaccine or have had previous exposure to varicella (chickenpox) as verified with serological (blood) testing
  • Have not previously received a JAK inhibitor (eg, ritlecitinib, baricitnib)
  • Must be willing to stop using other types of medications to treat AA throughout the study

This study is being conducted by Dr. Maria Hordinsky and John Meisenheimer in the Clinical Research Division at the University of Minnesota Department of Dermatology. For additional information, please call the study coordinator: 612-625-2624 or email: [email protected]

________________________________________________________________________________________________

Study Title: 

A Phase 3, Double-Blind, Randomized, Placebo-Controlled Trial to Evaluate the Efficacy, Safety, and Pharmacokinetics of Baricitinib in Children from 6 Years to Less than 18 Years of Age with Alopecia Areata

We are conducting a research study for children ages 6-17 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 Baricitinib. This study will compare the investigational drug to a placebo (inactive substance) to see how well the investigational drug works for 136 weeks to areas affected by Alopecia Areata, including the scalp and eyelashes and eyebrows.

Participant requirements:

  • Children ages 6-17 who are in good health
  • Diagnosed with patchy Alopecia Areata for at least one year
  • A greater than 50% 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 at the University of Minnesota Department of Dermatology. For additional information, please call the study coordinator: 612-625-2624 or email: [email protected]

________________________________________________________________________________________________

Study Title: 

Evaluation of Microbiota Transplant Therapy in Patients with Alopecia Areata

We are conducting a research study on individuals with moderate to severe Alopecia Areata. The purpose of this study is to determine if microbiota transplant therapy (MTT) versus a placebo is an effective treatment for patients with Alopecia Areata.

Participant requirements:

  • Men and women, adults 18- 75 years of age who are in good health
  • 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 9 visits over 24 weeks
  • Other requirements, which the study team will review with you

This study is being conducted by Dr. Maria Hordinsky at the University of Minnesota Department of Dermatology. For additional information, please contact the study coordinator: 612-625-2624 or email: [email protected]

Expand all

Study Title: Capsule Microbiota Transplant Therapy for Hidradenitis Suppurativa

We are conducting a research study on individuals with a diagnosis of Hidradenitis Suppurativa. The purpose of this research study is to learn more about the safety and effectiveness of an oral investigational drug called Capsule Microbiota Transplant Therapy. 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
  • Diagnosis of Hidradenitis Suppurativa by a dermatologist
  • Stable doses of all medications 30 days prior to baseline
  • Attend 6 in-person visits over 90 days
  • Comply to phone call follow-ups throughout the study
  • Other requirements, which the study team will review with you

This study is being conducted by Dr. Noah Goldfarb at the University of Minnesota Department of Dermatology. For additional information, please contact the study coordinator: 612-626-0249 or [email protected]