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
Side effects of steroids on sarcoidosis patients – take this international survey
The “Side Effects of Steroid” survey is an IRB (Institutional Review Board) approved international online survey designed to bring to light the burden of steroidal medication on sarcoidosis patients. The survey has been designed by Sarcoidosis physician experts in collaboration with sarcoidosis patients. The survey is being distributed with the support of an international group of pulmonary and sarcoidosis advocacy groups. The survey is “unidentified” meaning that we are collecting no information that could be used to identify you.
Who can take the “Side Effects of Steroids” survey?
Any person who has been told they have sarcoidosis by a medical professional can take this survey. We welcome responses from patients who have and have not taken steroids for sarcoidosis.
What is the purpose of the “Side Effects of Steroids” survey?
The goals of the “Side Effects of Steroids” survey is to understand what side effects sarcoidosis patients experience from steroids to encourage…
- Future processes to identify and prevent harmful effects of steroids.
- Future research to develop treatment pathways that minimize side effects for sarcoidosis patients
- Future research to identify new drugs for sarcoidosis
If you want to learn more about the survey, please click on the links to be taken to the survey. You may leave the survey at any time without saving your answers if you choose not to participate in the survey.
Side Effects of Steroids survey in English
Clinical Trials
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)
Contact
Anagha Malur
252-744-1116
malura@ecu.edu
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: Open for Enrollment.
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
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)
- Sub I: Anagha Malur PhD
- Funded by Novartis
- IRB Number: 21-001718
- Closed for enrollment
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)
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
- Open for enrollment
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)
Contact
Anagha Malur
252-744-1116
malura@ecu.edu
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