Active Clinical Trials, Surveys, and Registries

Registries

East Carolina University Sarcoidosis Registry (ECUSaR): An ongoing longitudinal registry and database of all patients seen in the East Carolina University (ECU) pulmonary clinic with pulmonary and extra pulmonary sarcoidosis.

This is an ongoing longitudinal registry of patients with sarcoidosis seen in the ECU pulmonary and sarcoidosis clinic. The purpose of the registry is to gather demographic, clinical, radiographic and other information that will allow us to learn more about sarcoidosis, available therapies and their effect on quality of life. Data collected will be evaluated for common familial and environmental factors that may be linked to the disease, so that better therapies may be developed for treating or even curing the disease. The patient database will also serve to identify and recruit sarcoidosis patients for future clinical studies and focus group discussions.

Registry Design and maintenance: Ogugua Ndili Obi, MD, MPH, MSc (Epid)
Sponsor: East Carolina University, Investigator initiated
IRB Number: UMCIRB 06-0312
Status: Actively enrolling

ECU Sarcoidosis Patient Registry Information (PDF)

ECU sarcoidosis registry enrollment form

Surveys

Do you have Sarcoidosis and feel tired some or all the time? This Study is for you!!!

The Sarcoidosis Center of Excellence at ECU is partnering with the Cleveland Clinic to conduct the study below.

Many people with sarcoidosis—up to 70%—feel very tired, even when they get enough rest. This tiredness is called fatigue, and there is no medical treatment that works well for it. Some people with sarcoidosis have found that support groups or Mindfulness-Based Therapy help them feel less tired. We want to find out if a Virtual Sarcoidosis Support Group or Mindfulness Based Stress Reduction can help people with fatigue from sarcoidosis.

What will I be asked to do?

We are inviting 100 people with sarcoidosis to join this study. If you qualify after a short screening process, you will be *randomly assigned to one of two groups:

One group will do an 8-week Mindfulness program.
The other group will join a 5-month support group.

“*Randomly assigned” means a computer will choose your group by chance—like flipping a coin. You and your doctor will not be able to pick which group you are in.

Who can participate in this study?

You may be able to take part in this study if you:

Have been diagnosed with sarcoidosis by a doctor
Have significant fatigue (feel very tired often)
Talk with a study team member and sign a consent form to join the study

Why might you consider joining this study?

We don’t know for sure if the study groups will help you. It might improve your symptoms, but it’s also possible that it may not help or that your symptoms could get worse.
Even if the treatment doesn’t help you, your participation will help researchers learn more about how to treat fatigue in people with sarcoidosis.

Who should I contact if I wish to hear more?

If you wish to learn more about this study, please contact either

Tiana Powell – Study coordinator at 216-308-5111or powellt@ccf.org
Logan Harper, MD- Primary Investigator at 216-444-0013

Clinical Trials

A Phase 2 Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Investigate the Safety and Efficacy of Oral Brepocitinib in Adults with Cutaneous Sarcoidosis.

PI: Ogugua Ndili Obi, MD, MPH, MSc (Epid), FCCP
Sponsor: Priovant Therapeutics Inc
IRB Number: 25-0459

Status: Closed to enrollment
For more details on the study, click on the BEACON (Cutaneous Sarcoidosis) (PDF).

Contact
Anagha Malur
252-744-1116
malura@ecu.edu

A seamless, Phase 1b/2 multiple ascending dose/proof of concept study of XTMAB-16 in patients with pulmonary sarcoidosis with or without extrapulmonary manifestations.

The purpose of this study is to learn more about an investigational medicine called XTMAB- 16 that may help to treat Pulmonary Sarcoidosis. This new medicine is part of a group of medications known as tumor necrosis factor alpha (TNF a) inhibitors. Patients on 7.5 mg/day or prednisone or higher may qualify for this study if they are also on methotrexate or other immunosuppressive medication. The study consists of 2 parts, A and B. Part A will run for 26 weeks and include 9 visits. Part B will run for up to 40 weeks and include 14 visits.

PI: Ogugua Ndili Obi, MD, MPH, MSc (Epid), FCCP
Sub-I: Veeranna Maddipati MD; Anagha Malur PhD
Sponsor: Xentria, Inc
IRB Number: 23-001267

Status: Open for Enrollment

For more details on the study go to: A Study of XTMAB-16 in Patients with Pulmonary Sarcoidosis (ClinicalTrials.Gov NCT05890729)

A Long-term Multicenter Open-label Study to Evaluate the Long-term Safety and Durability of Effect of XTMAB-16 in Patients with Pulmonary Sarcoidosis with or without Extra-pulmonary Involvement.

This open-label study is conducted to assess the long-term safety and tolerability as well as to confirm the efficacy (durability/maintenance of effect) of XTMAB-16 in participants with pulmonary sarcoidosis with or without extra-pulmonary involvement by providing participants in the XTMAB-16-201 clinical study access or continued access to XTMAB-16 treatment prior to the product potentially being available commercially.

PI: Ogugua Ndili Obi, MD, MPH, MSc (Epid)
Sub I: Veeranna Maddipati MD, Anagha Malur PhD
Sponsor: Xentria, Inc

Status: Open – subjects enrolled in primary study will have the opportunity to enroll in the open label extension study.

For more details on the study go to: An Open-label Extension Study of XTMAB-16 in Patients with Pulmonary Sarcoidosis (ClinicalTrial.Gov NCT06169397).

Contact
Anagha Malur
252-744-1116
malura@ecu.edu

Completed Clinical Trials

A Phase 3, Randomized, Double-Blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Intravenous Efzofitimod in Patients with Pulmonary Sarcoidosis.

This is a multicenter, randomized, double-blind, placebo-controlled, study comparing the efficacy and safety of intravenous (IV) Efzofitimod (given as 3 mg/Kg or 5 mg/Kg) versus placebo every 4 weeks after 48 weeks of treatment. This study will enroll adults with biopsy confirmed pulmonary sarcoidosis receiving stable treatment with oral steroids (prednisone or other), with or without other immunosuppressant therapy.

PI: Ogugua Ndili Obi, MD, MPH, MSc
Sub-I: Shehabaldin Alqalyoobi, MD, Anagha Malur, PhD, Binita Vadhar, MD
Sponsor: aTyr Pharma Inc
IRB Number: UMCIRB 22-001108

Status: Completed.

For more details on the study go to: Efficacy and Safety of Intravenous Efzofitimod in Patients With Pulmonary Sarcoidosis (ClinicalTrials.Gov NCT05415137)

Contact
Anagha Malur
252-744-1116
malura@ecu.edu

Randomized, Double-blind, Placebo-controlled Phase 2 Study with Open-label Extension to Assess the Efficacy and Safety of Namilumab in Subjects with Chronic Pulmonary Sarcoidosis (Resolve-Lung).

This is a randomized, double-blind, placebo-controlled trial designed to investigate the use of Namilumab in patients with active pulmonary sarcoidosis. Namilumab or placebo will be administered subcutaneously every 4 weeks for a total of 26 weeks. There is also a 28-week open-label extension that participants may be eligible for after the initial 26-week treatment period.

PI: Ogugua Ndili Obi, MD, MPH, MSc (Epid)
Sub I: Anagha Malur PhD
Sponsor: Kinevant Sciences GmbH

Completed

For more details on the study go to: A Study to Assess the Efficacy and Safety of Namilumab in Participants With Chronic Pulmonary Sarcoidosis (ClinicalTrial.Gov NCT05314517)

A subject and investigator blinded, randomized, placebo controlled, repeat-dose, multicenter study to investigate efficacy, safety, and tolerability of CMK389 in patients with chronic pulmonary sarcoidosis

PI: Ogugua Ndili Obi, MD, MPH, MSc (Epid), FCCP
Sub I: Anagha Malur PhD
Funded by Novartis
IRB Number: 21-001718

Completed

For more details on the study go to: Study of Efficacy, Safety and Tolerability of CMK389 in Patients With Chronic Pulmonary Sarcoidosis (ClinicalTrials.Gov NCT04064242)