Center of Excellence

Howard University

Through community engagement, education, and equitable trial access, the COE is dedicated to improving representation in clinical research and advancing health outcomes for the communities we serve.

About the center

The Howard University Clinical Trials Center of Excellence (COE) was established in 2021 through the Novartis US Foundation’s Beacon of Hope Initiative to address health disparities through community‑based clinical research.

The COE focuses on conducting Good Clinical Practice–compliant clinical trials, publishing high‑quality research findings, and building sustainable research capacity through workforce training and infrastructure development.

Howard’s mission has been, and continues to be, to increase participation of Black/African American individuals and other communities of color in clinical trials. The COE serves underrepresented and underserved populations across the Washington, DC, Maryland, and Virginia (DMV) region, while also supporting faculty, investigators, and trainees at Howard University.

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Clinical Trials & Research

A Randomized, Double-blind, Double-dummy, Placebo-controlled, Multicenter, Phase 3 Study Assessing the Efficacy, Safety, and Tolerability of 2 Doses of Remibrutinib Over a 68-week Treatment Period in Adult and Adolescent Patients With Moderate to Severe Hidradenitis Suppurativa. (RECHARGE-1)

The purpose of this study is to establish the efficacy, safety, and tolerability of remibrutinib (LOU064) Dose A and Dose B compared to placebo in participants with moderate to severe hidradenitis suppurativa (HS).

A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase II Platform Study to Assess the Efficacy and Safety of Investigational Compound(s) in Patients With Moderate to Severe Atopic Dermatitis

This trial is designed to evaluate multiple compounds in participants with moderate to severe atopic dermatitis (AD).

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

This is a US, multi-center, randomized, double-blind, double-dummy, Phase 3b study to evaluate efficacy of remibrutinib (25 mg twice daily [b.i.d.] by mouth [p.o.]) compared to dupilumab (600 mg loading dose administered subcutaneously (s.c.) followed by 300 mg every 2 weeks s.c.) at early timepoints (4 weeks and earlier), when administered as an add-on treatment to second generation H1-antihistamines (sgH1-AH) (standard label dose as background therapy) in adult US participants with moderate to severe chronic spontaneous urticaria (CSU) inadequately controlled by sgH1-AHs.

Randomized, Phase 2, Double-blind, Placebo-controlled, Parallel-group, 2-arm Study to Investigate the Efficacy, Safety, and Tolerability of Subcutaneous Lunsekimig (SAR443765) in Adult Participants With High-risk Asthma Who Are Not Currently Eligible for Biologic Treatment

The purpose of this study is to assess the efficacy, safety, and tolerability of add-on therapy with subcutaneous (SC) lunsekimig compared with placebo in male and female participants (aged 18 to 80 years, inclusive) with asthma, who are not currently eligible for biologic treatments. This is a parallel-group, Phase 2, randomized, double-blind, placebo-controlled, 2-arm study for the treatment of asthma.

A Phase 2b/Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study, to Investigate the Efficacy and Safety of Lunsekimig in Adult Participants With Inadequately Controlled Chronic Obstructive Pulmonary Disease (COPD) Characterized by an Eosinophilic Phenotype

This is a parallel, Phase 2b/Phase 3, 3-arm study to investigate the efficacy, safety, and tolerability of subcutaneous (SC) treatment with lunsekimig compared with placebo in adult participants (aged 40 to 80 years, inclusive) with inadequately controlled Chronic obstructive pulmonary disease (COPD) characterized by an eosinophilic phenotype.

To contact Howard University regarding clinical trials, contact Eddie Bauer (edward.bauer1@Howard.edu).

Upcoming Events

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Leadership & Fellows

Celia Maxwell, MD, FACP, FIDSA

Celia Maxwell, MD, FACP, FIDSA

Director of Clinical Trials
Thomas Mellman, MD

Thomas Mellman, MD

Co-Director of Clinical Trials
Eddie Bauer

Eddie Bauer

Senior Lead Study Coordinator
Finie Richardson, PhD, MPH

Finie Richardson, PhD, MPH

Senior Lead Study Coordinator
Kevin Boyd, PhD

Kevin Boyd, PhD

Data Manager
Isabella PeBenito

Isabella PeBenito

Research Associate
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