CRC Clinical Trials

The CRC runs multiple clinical studies at the same time. The subjects of our studies include pregnancy, women’s health, cancer, and vaccines. Please feel free to browse the studies below and if you have any questions or interest in joining a recruiting study, please call [Name] at [Phone Number]. If there are any terms you do not understand, please refer to our Clinical Glossary to better understand our research and studies.

Current studies – Ongoing clinical trials

Recruiting

Cirrhosis
A randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy and safety of Rifaximin soluble solid dispersion (SSD) tablets for the delay of encephalopathy decompensation in cirrhosis (red-c).

PI: Milton Mutchnik, MD, Paul Naylor, PhD
Sponsor: Salix
Status: Recruiting

Dermatology
An open-label single-arm study of Dupilumab in adolescent and adult skin of color patients with moderate to severe atopic dermatitis.

PI: Geoffrey Potts, MD
Sponsor: Regerneron
Status: Recruiting

Endometriosis
A phase 3 study of the safety and contraceptive efficacy of Relugolix Combination Therapy in women with uterine fibroids or endometriosis who are at risk for pregnancy.

PI: Jay Berman, MD
Sponsor: Myovant
Status: Recruiting

Endometriosis
A phase 3 study to evaluate the safety and efficacy of Elagolix in combination with combined oral contraceptives in premenopausal women with endometriosis and associated moderate to severe pain.

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PI: Jay Berman, MD
Sponsor: Abbvie
Status: Recruiting

Hemodialysis
Trajectory patterns and factors predicting fatigue in individuals on hemodialysis.

PI: Bincy Joshwa, PhD, MSN, RN
Sponsor: BCBSM, Ada Jacox Pain and Symptom Management Internal Research Award, College of Nursing start-up funds
Status: Recruiting

Lupus
A randomized, double-blind, parallel group, placebo-controlled, multicenter phase 3 trial to evaluate the efficacy, safety and tolerability of ianalumab on top of standard-of-care therapy in participants with active lupus nephritis (SIRIUS-LN).

PI: Yahya Osman, MBBS, MD
Sponsor: Novartis
Status: Recruiting

Lupus
A multicenter, open-label extension study to assess the long-term safety and tolerability of Dapirolizumab Pegol treatment in study participants with systemic lupus erythematosus.

PI: Housam Sarakb, MD
Sponsor: UCB Biopharma SRL
Status: Recruiting

Pregnancy
Large scale genome sequencing and integrative analyses to define genomic predictors of recurrent pregnancy loss.

PI: Stephen Krawetz, PhD
Sponsor: NIH
Status: Recruiting

Vaccine
A phase 2, observer-blind, randomized, controlled, study to evaluate immunogenicity and safety of a candidate varicella vaccine compared with Varivax, as a first dose, administered in healthy children in their second year of life.

PI: Paul Kilgore, MD
Sponsor: GlaxosmithKline
Status: Recruiting

Vaccine
A phase 1/2a open-label dose-ranging and observer-blind placebo-controlled, safety and immunogenicity study of mRNA-1647 Cytomegalovirus Vaccine (CMV) in female and male participants 9 to 15 years of age and participants 16 to 25 years of age.

PI: Paul Kilgore, MD
Sponsor: Moderna
Status: Recruiting

Ongoing

A phase 3b study to evaluate the long-term safety and efficacy of Elagolix in combination with estradiol/norethindrone acetate for the management of heavy menstrual bleeding associated with uterine fibroids in premenopausal women (M16-283).

PI: Awoniyi Awonuga, MD
Sponsor: Abbvie
Status: Active follow-up phase

A study to evaluate the safety, tolerability, and immunogenicity of a Modified RNA vaccine against varicella zoster virus.

PI: Paul Kilgore, MD
Sponsor: Pfizer
Status: Active Follow-Up

Chronic renal insufficiency cohort – CRIC 2018 (CRIC IV)CRIC.

PI: James Sondheimer, MD
Sponsor: NIDDK/UoM
Status: Active follow-up phase

A study of the long -term effects of aspirin and other factors on the health of older persons.

PI: Shaun Cardoza, MD
Sponsor: Pfizer
Status: Treatment Complete

Duke CRI and Bodyport Inc – Scale Study

PI: Luis Afonso, MD
Sponsor: Duke
Status: Treatment Complete

Closed

A randomized, placebo-controlled, dose escalation study to evaluate the safety and efficacy of Tildacerfont in adult subjects with Polycystic Ovary Syndrome (PCOS) and elevated adrenal androgens.

PI: Awoniyi Awonuga, MD
Sponsor: SPRUCE
Status: Closed

A multicenter, randomized, double-blind, placebo controlled, parallel-group study to evaluate the efficacy and safety of Dapirolizumab Pegol in study participants with moderately to severely Active Systemic Lupus Erythematosu.

PI: Housam Sarakb, MD
Sponsor: UCB Biopharma SRL
Status: Closed

A phase 3, randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of a respiratory syncytial virus (RSV) prefusion F subunit vaccine in infants born to women vaccinated during pregnancy.

PI: Bernard Gonik, MD
Sponsor: Pfizer
Status: Closed

A phase 3, randomized, double-blind, placebo-controlled multi-country study to demonstrate efficacy of a single dose of unadjuvanted RSV maternal vaccine, administered IM to pregnant women 18 to 49 years of age, for prevention of RSV associated LRTI in their infants up to 6 months of age.

PI: Bernard Gonik, MD
Sponsor: GlaxosmithKline
Status: Closed

A phase 3 study to evaluate the safety and efficacy of Elagolix in combination with estradiol/norethindrone acetate in subjects with moderate to severe endometriosis-associated pain (M14-702).

PI: Awoniyi Awonuga, MD
Sponsor: Abbvie
Status: Closed

Prospective observational cohort study of adults ≥ 16 years of age receiving a Pfizer-BioNTech or Moderna mRNA COVID-19 booster vaccination.

PI: Paul Kilgore, MD
Sponsor: Pfizer
Status: Closed