Search Results | Research Studies | School of Medicine


A Phase 3, multicenter, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy, safety, and tolerability of cenerimod in adult subjects with moderate-to-severe systemic lupus erythematosus (SLE) on top of background therapy University of Colorado Hospital The study comprises of screening period that lasts upto 60 days and ends with the participant's randomization, the treatment period starts with the administration of first dose of study drug and lasts 12 months. Participants who complete the treatment period will be offered to enter a 12 m...
Safety, Tolerability, and Impact of Oral TLR8 Agonist Selgantolimod on HBsAg in Participants with both Chronic Hepatitis B and HIV CTRC Inpatient, Outpatient CTRC, University of Colorado Hospital A5394 is a phase II, double-blinded, placebo-controlled trial. Forty-eight study participants will be randomized 3:1 to receive SLGN or its placebo (36 active and 12 placebo), and randomization will be stratified by HBeAg status. One-half of the study participants will be HBeAg positive (n...
Blood Samples for the Study of Peanut, Tree Nut and Other Food Allergies Childrens Hospital Colorado, Outpatient CTRC, University of Colorado Hospital Food allergies are characterized by recurrent symptoms such as wheezing, hives, swelling of the lips, and/or loss of blood pressure (anaphylaxis) upon exposure to a specific food. Food allergies are caused by an abnormal immune response to particular foods (allergens) tolerated by most ind...
A Phase 1, Open-Label, Multicenter Study of KYV-101-001, an Autologous Fully-Human Anti-CD19 Chimeric Antigen Receptor T-Cell (CD19 CAR T) Therapy, in Subjects with Refractory Lupus Nephritis Outpatient CTRC, Renal Research Center, University of Colorado Hospital Apheresis (collection of white blood cells) followed by lymphodepletion (medications to weaken, temporarily, your immune system so that the CAR T cells can grow and work in the body, followed by single infusion of KYV-101 (the CAR T cells made specifically for your body)...
A Phase 1b, Randomized, Placebo-controlled, Multi-center Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Imvotamab in Participants with Moderate to Severe Rheumatoid Arthritis who have Failed Prior Therapies Barbara Davis Center, Cherry Creek Medical Center, CTRC Inpatient, University of Colorado Hospital Screening period (6 weeks): During this period, you will have screening tests and procedures done to see if you meet the requirements to be in this research study. The initial screening tests are planned to be done on a single day and may take a total of approximately 2-4 hours. Study Tr...
Program for Individuals with an Elevated Risk of Spondyloarthritis (PIERS) University of Colorado Hospital The Program for Individuals with an Elevated Risk of Spondyloarthritis (PIERS) is a registry proposed by the affiliate members of the University of Colorado Program to Advance Spondyloarthritis Treatment (U.C.PAST). The purpose of PIERS is to identify individuals at risk for spondyloarthri...
Giving Standardized Estradiol Therapy in Transgender Women to Research Interactions with HIV Therapy: the GET IT RIgHT Study Outpatient CTRC, University of Colorado Hospital Transgender women (TW) are the fastest-growing group of people with HIV (PWH). Historically, TW have had few opportunities to participate in research, and often experience barriers to engaging in care. More research is needed to help providers when it comes to choosing HIV medication in TW...
A Double-Blind, Randomized, Placebo-Controlled Clinical Trial of Combination HIV-Specific Broadly Neutralizing Monoclonal Antibodies Combined with ART Initiation during Acute HIV Infection to Induce HIV Remission Outpatient CTRC, University of Colorado Hospital Scientists are looking for ways to minimize the distribution of HIV-1 in the body, especially where anti-HIV medications (ART) are unable to reach. Starting ART as soon as possible following a diagnosis of Acute HIV Infection (AHI) has been shown to better preserve the immune system. Broad...
Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of BIIB059 in Adult Participants With Active Systemic Lupus Erythematosus Receiving Background Nonbiologic Lupus Standard of Care Barbara Davis Center, University of Colorado Hospital This study will last upto 48 weeks with three drug intervention. One group receiving background nonbiologic lupus SOC therapy will receive high dose of BIIB059 subcutaneously every 4 weeks upto 48 weeks. Second group receiving background nonbiologic lupus SOC therapy will receive low dose ...
PrecISE: Precision Interventions for Severe and/or Exacerbation-Prone Asthma Network (adolescents, age 12-18) Childrens Hospital Colorado PrecISE: A breath of fresh air from the National Institutes of Health (NIH). Severe asthma is different for everyone. That is why we need you for PrecISE. Join a severe asthma study unlike any other. Have the opportunity to try many different therapies not available otherwise. Talk with a...
Classification of Axial Spondyloarthritis Inception Cohort (CLASSIC) study Barbara Davis Center, Rocky Mountain Regional VA Medical Center, University of Colorado Hospital The ASAS group has developed classification criteria for axial spondyloarthritis (axSpA) that allow the inclusion of patients with an early form of disease that is not yet clearly visible on plain radiography. These criteria include both an "imaging arm," that incorporates either radiograp...
A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Activity of Single Ascending Doses of SBT777101 in Subjects with Rheumatoid Arthritis University of Colorado Hospital What happens at the study visits? Screening: You will receive screening health assessments to confirm if you qualify to join the trial. You will answer questions about your medical history, symptoms, and current medications. Joint Biopsy: You will have a biopsy of your joints once durin...
PHACS Health Outcomes around Pregnancy and Exposure to HIV/ARVs (HOPE) Childrens Hospital Colorado, University of Colorado Hospital The study is designed to evaluate the health outcomes of women living with HIV over time. Women who elect to participate in this study complete a combination of online surveys, clinical assessments, and interviews, with a blood draw and other samples collected at the time a person enrolls ...
Study of inflammatory Arthritis and Interstitial Lung Disease in Early Rheumatoid Arthritis: SAIL-RA University of Colorado Hospital In this research study we want to learn more about rheumatoid arthritis (RA). Some people with rheumatoid arthritis develop a related condition called RA-associated interstitial lung disease (RA-ILD). We are doing this study to understand why some people with RA develop RA-ILD and others d...
Gut microbiome effects on intestinal barrier function in metabolic syndrome in HIV positive men who have sex with men Outpatient CTRC, University of Colorado Hospital The aim of this study is to determine whether intestinal barrier dysfunction is higher in HIV+ MSM with MS compared to without MS and related to deficiency in butyrate-production and/or activity of mucolytic bacteria in the gut microbiome....
Study of the Association between Cellular Processes in the Lung & Blood and Patient Health in Individuals with Rheumatoid Arthritis with and without Evidence of Interstitial Lung Disease Barbara Davis Center, University of Colorado Hospital This study involves blood tests, sputum collection, physical exams, and questionnaires; it may also involve pulmonary function tests (PFTs) and a high-resolution computed tomography (HRCT) scan of your lungs. PFTs involve breathing into a tube to determine any lung abnormalities while HRCT...
A Phase 3b/4 Randomized, Double-Blind, Double-Dummy, Active Comparator-Controlled Study, Comparing the Efficacy and Safety of Upadacitinib Versus Adalimumab in Subjects with Moderate to Severe Rheumatoid Arthritis on a Stable Background of MTX and who had an Inadequate Response or Intolerance to a Single TNF Inhibitor (SELECT- SWITCH) Barbara Davis Center, University of Colorado Hospital This is a Phase 3b/4 multicenter study that includes 2 periods. Period 1 is a 12-week randomized, double-blind, double-dummy, active comparator-controlled period designed to compare the efficacy and safety of upadacitinib (15 mg QD) + MTX versus dalimumab (40 mg eow) + MTX in adult subjec...
A Randomized, Blinded, Placebo-Controlled, Phase 2a, Proof-of-Concept Study to Evaluate Efficacy, Safety, and Tolerability of GS-5718 in Participants With Cutaneous Lupus Erythematosus (CLE) Outpatient CTRC This is a Phase 2s multicenter randomized study to evaluate the efficacy, safety and tolerability of GS-5178 in participants with Cutaneous Lupus Erythematosus. Participants who meet eligible criteria will be randomized in a 2:1 ratio to one of the two treatment groups: GS-5178 2 15mg tabl...
Accelerating Medicines Partnership: Autoimmune and Immune-Mediated Disease (AIM) Rheumatoid Arthritis Barbara Davis Center, University of Colorado Hospital If you participate you will be asked to come in for a screening to determine eligibility for a synovial biopsy of your wrist, knee, or ankle. You will also be asked to complete health questionnaires and have your blood drawn. You may be compensated up to $305 for completion of 3 visits ove...
A Phase 4, Randomized, Double-blind, Multicenter Non-inferiority Trial Evaluating the Efficacy and Safety of Intravenous KRYSTEXXA® (pegloticase) Administered Every 4 Weeks Compared with KRYSTEXXA Administered Every 2 Weeks with Co-administration of Weekly Doses of Methotrexate, Followed by an Open-label Extension, in Participants with Uncontrolled Refractory Gout (FORWARD II) Barbara Davis Center, University of Colorado Hospital The study consists of 24-week double-blind trial to evaluate the non-inferiority of the efficacy and safety of pegloticase Q4W with MTX versus pegloticase Q2W with MTX, followed by a 24-week open-label extension of pegloticase Q4W with MTX, in participants with uncontrolled refractory gout...
A Phase 2 Study to Evaluate the Safety, Pharmacodynamics, Pharmacokinetics, and Clinical Activity of ADX-097 Administered Subcutaneously in Male and Female Participants Aged 18 Years or Older With Immunoglobulin A Nephropathy (IgAN), Lupus Nephritis (LN), or Complement Component 3 Glomerulopathy (C3G) Childrens Hospital Colorado, University of Colorado Hospital Phase 2 study to evaluated the ADX-097 in patients with IgAN, LN, or C3G over the period of 6 months....
Phase 3, Open-label Trial to Evaluate Safety, Pharmacokinetics, and Efficacy of Benralizumab in Children With Eosinophilic Diseases (CLIPS) Childrens Hospital Colorado open-label, single treatment arm, multicentre, basket study to evaluate safety, PK, PD, efficacy, and immunogenicity of repeat dosing of benralizumab...
StopRA: National Network to Prospectively Study Individuals At-Risk for Rheumatoid Arthritis Barbara Davis Center This study is designed to help us learn more about the development of rheumatoid arthritis (RA). This study is going to be a national study following people who have an abnormal blood test that is related to rheumatoid arthritis (RA). This test is called ‘anti-CCP’ and can be a marker for...
An Open_label, Randomized Controlled Trial of Pramipexole versus Escitalopram to Treat Major Depressive Disorder (MDD) and Comorbid MDD with Mild Neurocognitive Disorder (MND) in Persons with HIV Outpatient CTRC, University of Colorado Hospital The purpose of this research study is to evaluate the safety and efficacy of pramipexole extended release (ER) versus escitalopram for the treatment of major depressive disorder (MDD) and mild neurocognitive disorder (MND) in people living with HIV (PWH)....

A Phase 3, multicenter, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy, safety, and tolerability of cenerimod in adult subjects with moderate-to-severe systemic lupus erythematosus (SLE) on top of background therapy

University of Colorado Hospital

The study comprises of screening period that lasts upto 60 days and ends with the participant's randomization, the treatment period starts with the administration of first dose of study drug and lasts 12 months. Participants who complete the treatment period will be offered to enter a 12 m...

Safety, Tolerability, and Impact of Oral TLR8 Agonist Selgantolimod on HBsAg in Participants with both Chronic Hepatitis B and HIV

CTRC Inpatient, Outpatient CTRC, University of Colorado Hospital

A5394 is a phase II, double-blinded, placebo-controlled trial. Forty-eight study participants will be randomized 3:1 to receive SLGN or its placebo (36 active and 12 placebo), and randomization will be stratified by HBeAg status. One-half of the study participants will be HBeAg positive (n...

Blood Samples for the Study of Peanut, Tree Nut and Other Food Allergies

Childrens Hospital Colorado, Outpatient CTRC, University of Colorado Hospital

Food allergies are characterized by recurrent symptoms such as wheezing, hives, swelling of the lips, and/or loss of blood pressure (anaphylaxis) upon exposure to a specific food. Food allergies are caused by an abnormal immune response to particular foods (allergens) tolerated by most ind...

A Phase 1, Open-Label, Multicenter Study of KYV-101-001, an Autologous Fully-Human Anti-CD19 Chimeric Antigen Receptor T-Cell (CD19 CAR T) Therapy, in Subjects with Refractory Lupus Nephritis

Outpatient CTRC, Renal Research Center, University of Colorado Hospital

Apheresis (collection of white blood cells) followed by lymphodepletion (medications to weaken, temporarily, your immune system so that the CAR T cells can grow and work in the body, followed by single infusion of KYV-101 (the CAR T cells made specifically for your body)...

A Phase 1b, Randomized, Placebo-controlled, Multi-center Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Imvotamab in Participants with Moderate to Severe Rheumatoid Arthritis who have Failed Prior Therapies

Barbara Davis Center, Cherry Creek Medical Center, CTRC Inpatient, University of Colorado Hospital

Screening period (6 weeks): During this period, you will have screening tests and procedures done to see if you meet the requirements to be in this research study. The initial screening tests are planned to be done on a single day and may take a total of approximately 2-4 hours. Study Tr...

Program for Individuals with an Elevated Risk of Spondyloarthritis (PIERS)

University of Colorado Hospital

The Program for Individuals with an Elevated Risk of Spondyloarthritis (PIERS) is a registry proposed by the affiliate members of the University of Colorado Program to Advance Spondyloarthritis Treatment (U.C.PAST). The purpose of PIERS is to identify individuals at risk for spondyloarthri...

Giving Standardized Estradiol Therapy in Transgender Women to Research Interactions with HIV Therapy: the GET IT RIgHT Study

Outpatient CTRC, University of Colorado Hospital

Transgender women (TW) are the fastest-growing group of people with HIV (PWH). Historically, TW have had few opportunities to participate in research, and often experience barriers to engaging in care. More research is needed to help providers when it comes to choosing HIV medication in TW...

A Double-Blind, Randomized, Placebo-Controlled Clinical Trial of Combination HIV-Specific Broadly Neutralizing Monoclonal Antibodies Combined with ART Initiation during Acute HIV Infection to Induce HIV Remission

Outpatient CTRC, University of Colorado Hospital

Scientists are looking for ways to minimize the distribution of HIV-1 in the body, especially where anti-HIV medications (ART) are unable to reach. Starting ART as soon as possible following a diagnosis of Acute HIV Infection (AHI) has been shown to better preserve the immune system. Broad...

Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of BIIB059 in Adult Participants With Active Systemic Lupus Erythematosus Receiving Background Nonbiologic Lupus Standard of Care

Barbara Davis Center, University of Colorado Hospital

This study will last upto 48 weeks with three drug intervention. One group receiving background nonbiologic lupus SOC therapy will receive high dose of BIIB059 subcutaneously every 4 weeks upto 48 weeks. Second group receiving background nonbiologic lupus SOC therapy will receive low dose ...

PrecISE: Precision Interventions for Severe and/or Exacerbation-Prone Asthma Network (adolescents, age 12-18)

Childrens Hospital Colorado

PrecISE: A breath of fresh air from the National Institutes of Health (NIH). Severe asthma is different for everyone. That is why we need you for PrecISE. Join a severe asthma study unlike any other. Have the opportunity to try many different therapies not available otherwise. Talk with a...

Classification of Axial Spondyloarthritis Inception Cohort (CLASSIC) study

Barbara Davis Center, Rocky Mountain Regional VA Medical Center, University of Colorado Hospital

The ASAS group has developed classification criteria for axial spondyloarthritis (axSpA) that allow the inclusion of patients with an early form of disease that is not yet clearly visible on plain radiography. These criteria include both an "imaging arm," that incorporates either radiograp...

A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Activity of Single Ascending Doses of SBT777101 in Subjects with Rheumatoid Arthritis

University of Colorado Hospital

What happens at the study visits? Screening: You will receive screening health assessments to confirm if you qualify to join the trial. You will answer questions about your medical history, symptoms, and current medications. Joint Biopsy: You will have a biopsy of your joints once durin...

PHACS Health Outcomes around Pregnancy and Exposure to HIV/ARVs (HOPE)

Childrens Hospital Colorado, University of Colorado Hospital

The study is designed to evaluate the health outcomes of women living with HIV over time. Women who elect to participate in this study complete a combination of online surveys, clinical assessments, and interviews, with a blood draw and other samples collected at the time a person enrolls ...

Study of inflammatory Arthritis and Interstitial Lung Disease in Early Rheumatoid Arthritis: SAIL-RA

University of Colorado Hospital

In this research study we want to learn more about rheumatoid arthritis (RA). Some people with rheumatoid arthritis develop a related condition called RA-associated interstitial lung disease (RA-ILD). We are doing this study to understand why some people with RA develop RA-ILD and others d...

Gut microbiome effects on intestinal barrier function in metabolic syndrome in HIV positive men who have sex with men

Outpatient CTRC, University of Colorado Hospital

The aim of this study is to determine whether intestinal barrier dysfunction is higher in HIV+ MSM with MS compared to without MS and related to deficiency in butyrate-production and/or activity of mucolytic bacteria in the gut microbiome....

Study of the Association between Cellular Processes in the Lung & Blood and Patient Health in Individuals with Rheumatoid Arthritis with and without Evidence of Interstitial Lung Disease

Barbara Davis Center, University of Colorado Hospital

This study involves blood tests, sputum collection, physical exams, and questionnaires; it may also involve pulmonary function tests (PFTs) and a high-resolution computed tomography (HRCT) scan of your lungs. PFTs involve breathing into a tube to determine any lung abnormalities while HRCT...

A Phase 3b/4 Randomized, Double-Blind, Double-Dummy, Active Comparator-Controlled Study, Comparing the Efficacy and Safety of Upadacitinib Versus Adalimumab in Subjects with Moderate to Severe Rheumatoid Arthritis on a Stable Background of MTX and who had an Inadequate Response or Intolerance to a Single TNF Inhibitor (SELECT- SWITCH)

Barbara Davis Center, University of Colorado Hospital

This is a Phase 3b/4 multicenter study that includes 2 periods. Period 1 is a 12-week randomized, double-blind, double-dummy, active comparator-controlled period designed to compare the efficacy and safety of upadacitinib (15 mg QD) + MTX versus dalimumab (40 mg eow) + MTX in adult subjec...

A Randomized, Blinded, Placebo-Controlled, Phase 2a, Proof-of-Concept Study to Evaluate Efficacy, Safety, and Tolerability of GS-5718 in Participants With Cutaneous Lupus Erythematosus (CLE)

Outpatient CTRC

This is a Phase 2s multicenter randomized study to evaluate the efficacy, safety and tolerability of GS-5178 in participants with Cutaneous Lupus Erythematosus. Participants who meet eligible criteria will be randomized in a 2:1 ratio to one of the two treatment groups: GS-5178 2 15mg tabl...

Accelerating Medicines Partnership: Autoimmune and Immune-Mediated Disease (AIM) Rheumatoid Arthritis

Barbara Davis Center, University of Colorado Hospital

If you participate you will be asked to come in for a screening to determine eligibility for a synovial biopsy of your wrist, knee, or ankle. You will also be asked to complete health questionnaires and have your blood drawn. You may be compensated up to $305 for completion of 3 visits ove...

A Phase 4, Randomized, Double-blind, Multicenter Non-inferiority Trial Evaluating the Efficacy and Safety of Intravenous KRYSTEXXA® (pegloticase) Administered Every 4 Weeks Compared with KRYSTEXXA Administered Every 2 Weeks with Co-administration of Weekly Doses of Methotrexate, Followed by an Open-label Extension, in Participants with Uncontrolled Refractory Gout (FORWARD II)

Barbara Davis Center, University of Colorado Hospital

The study consists of 24-week double-blind trial to evaluate the non-inferiority of the efficacy and safety of pegloticase Q4W with MTX versus pegloticase Q2W with MTX, followed by a 24-week open-label extension of pegloticase Q4W with MTX, in participants with uncontrolled refractory gout...

A Phase 2 Study to Evaluate the Safety, Pharmacodynamics, Pharmacokinetics, and Clinical Activity of ADX-097 Administered Subcutaneously in Male and Female Participants Aged 18 Years or Older With Immunoglobulin A Nephropathy (IgAN), Lupus Nephritis (LN), or Complement Component 3 Glomerulopathy (C3G)

Childrens Hospital Colorado, University of Colorado Hospital

Phase 2 study to evaluated the ADX-097 in patients with IgAN, LN, or C3G over the period of 6 months....

Phase 3, Open-label Trial to Evaluate Safety, Pharmacokinetics, and Efficacy of Benralizumab in Children With Eosinophilic Diseases (CLIPS)

Childrens Hospital Colorado

open-label, single treatment arm, multicentre, basket study to evaluate safety, PK, PD, efficacy, and immunogenicity of repeat dosing of benralizumab...

StopRA: National Network to Prospectively Study Individuals At-Risk for Rheumatoid Arthritis

Barbara Davis Center

This study is designed to help us learn more about the development of rheumatoid arthritis (RA). This study is going to be a national study following people who have an abnormal blood test that is related to rheumatoid arthritis (RA). This test is called ‘anti-CCP’ and can be a marker for...

An Open_label, Randomized Controlled Trial of Pramipexole versus Escitalopram to Treat Major Depressive Disorder (MDD) and Comorbid MDD with Mild Neurocognitive Disorder (MND) in Persons with HIV

Outpatient CTRC, University of Colorado Hospital

The purpose of this research study is to evaluate the safety and efficacy of pramipexole extended release (ER) versus escitalopram for the treatment of major depressive disorder (MDD) and mild neurocognitive disorder (MND) in people living with HIV (PWH)....

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