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
Atopic Dermatitis
Atopic Dermatitis
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
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Overtly healthy
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Must have diagnosis of Moderate to Severe Atopic Dermatitis that has been present for at least 12 months
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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.
Dermatomyositis
Dermatomyositis
Study Title: Study of NKX019, a CD19 Chimeric Antigen Receptor-Natural Killer (CAR-NK) Cell Therapy, in Subjects with Immune-Mediated Diseases
We are conducting a research study on individuals with immune-mediated diseases, including dermatomyositis and other idiopathic inflammatory myopathies. The purpose of this study is to learn more about the safety and efficacy of an investigational cell therapy medication called NKX019.
Participant requirements:
- 18 years of age or older
- Confirmation of dermatomyositis or another idiopathic inflammatory myopathy
- Attend 15 visits over 6 months, including 3 overnight hospital stays, and then annually for up to 15 years
- 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 contact the study coordinator: 612-625-2624 or [email protected]
Hair Diseases / Alopecia
Alopecia Areata
We are looking for participants in a new study for Alopecia Areata. More information is available at the link.
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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]
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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]
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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]
Androgenetic Alopecia
Hidradenitis Suppurativa
Hidradenitis Suppurativa
Study Title: A Phase 3, Double-Blind, Randomized, Vehicle Controlled, Efficacy and Safety Study of Ruxolitinib Cream in Participants with Hidradenitis Suppurativa
We are conducting a research study on individuals with mild to moderate Hidradenitis Suppurativa which has lasted at least 6 months. The purpose of this research study is to learn more about the safety and effectiveness of the investigational drug to a vehicle (inactive substance) to see how well the investigational drug works.
Participant requirements:
- Males and females ages 12 and up
- Diagnosed with Hidradenitis Suppurativa at least 6 months ago
- At least 4 abscesses and/or inflammatory nodules (lumps) on at least two parts of your body
- Able to attend 13 visits on site, and 4 phone calls over 60 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 [email protected]
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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]
Urticaria
Urticaria
Study Title: A US Phase 3b, Multi-Center, Randomized, Double-Blind, Double-Dummy Study to Evaluate Efficacy of Remibrutinib Compared to Dupilumab at Early Timepoints in Adults with Chronic Spontaneous Urticaria Inadequately Controlled by Second Generation H1-Antihistamines
We are seeking adults diagnosed with Chronic Spontaneous Urticaria (CSU) to participate in a clinical trial. The purpose of this study is investigate the safety and efficacy of an investigational drug called Remibrutinib versus dupilumab.
Study Length: Participation is expected to last up to 24 weeks. This study will require 10 study visits. Participation involves a physical exam, completion of questionnaires, vital signs, medical history, urticaria assessment, 12-lead electrocardiogram (ECG), collection of blood, urine, and administration of oral remibrutinib or dupilumab.
Participant requirements:
- 18 years of age or older
- Overtly healthy
- Must have had diagnosis of chronic urticaria for at least 6 months
- Must have had hives within the past three months
- No previous use of remibrutinib, dupilumab or other BTK inhibitors
- No serious bleeding, or hematological disorders
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 612-626-0249.