Prometheus Biosciences, Inc. is recruiting patients for a placebo-controlled trial of an investigational biologic drug, PRA023, in Systemic Sclerosis Associated with Interstitial Lung Disease. 

PRA023 is a humanized monoclonal antibody that is prepared in the laboratory. It binds to a specific human protein called TL1A which promotes inflammation and scarring (fibrosis). PRA023 is designed to block the action of this protein, thereby potentially countering both inflammation and fibrosis. This may improve the treatment of Systemic Sclerosis and Interstitial Lung Disease. 

PRA023 has previously been given to healthy adults and adults with inflammatory bowel disease. However, this is the first study of PRA023 in patients with Systemic Sclerosis and Interstitial Lung Disease. The study seeks to understand whether PRA023 can slow or halt disease in the lungs and improve quality of life. The study will also examine the potential benefit for skin involvement and overall Systemic Sclerosis disease severity. Key study requirements are: • Adult patients 18 years of age or older • Diagnosis of the diffuse form of scleroderma within 5 years • Interstitial lung disease, a common form of lung disease associated with inflammation and scarring • Patients who complete the study are offered access to continued treatment For More Information, This Trial is Posted on the Following Public Website: ClinicalTrials.gov Identifier: NCT05270668 

Prometheus Biosciences Selected Participating Sites: 

Contact: Prometheus Biosciences Call Center at 855-422-4300  

-Los Angeles, California, United States, 90045

-Los Angeles, California, United States, 90048-1804

-Los Angeles, California, United States, 90095

Investigator: Dr. Elizabeth Volkmann

Study Coordinator: Nancy R. Lopez Phone: 310-794-1638 

Email: nancyrlopez@mednet.ucla.edu

-Palo Alto, California, United States, 94304 

Investigator: Dr. Lorinda Chung

Study Coordinator: Kathryn Jee Email: kjee@stanford.edu

Evaluation of Safety, Tolerability and Preliminary Efficacy of EHP-101 in Diffuse Cutaneous Systemic Sclerosis

An interventional, double-blind, randomized, intracohort placebo-controlled design will be used to test safety, tolerability, pharmacokinetics, and preliminary efficacy of EHP-101 in 36 patients ≥ 18 and ≤ 74 years of age with documented dcSSc. There is a screening period of 28 days, 84 days treatment period, and 28 days follow-up.

Contact: Amanda Hughes: 858-832-4887 ahughes@emeraldpharma.com

Participating Sites:

-Care Access Research - Huntington 

Huntington Beach, California, United States, 92648

-Pacific Arthritis Care Center

Los Angeles, California, United States, 90045

-UCLA Division of Rheumatology

Los Angeles, California, United States, 90095

-Inland Rheumatology Clinical

Upland, California, United States, 91786

A Multicenter Trial to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of HZN-825 in Patients With Diffuse Cutaneous Systemic Sclerosis

This is a randomized, double-blind, placebo-controlled, repeat-dose, multicenter trial. Participants will be screened within 4 weeks prior to the Baseline (Day 1) Visit. Approximately 300 participants who meet the trial eligibility criteria will be randomized on Day 1 in a 1:1:1 ratio to receive HZN-825 300 mg QD, HZN-825 300 mg BID or placebo for 52 weeks. 

The trial will include up to a 4-week Screening Period and a 52-week Double-blind Treatment Period. Participants will take their first dose of trial drug at the clinic and will return to the clinic for trial visits at Week 4 and every 6 weeks thereafter until Week 52. All participants who complete the Double-blind Treatment Period (Week 52) will be eligible to enter a 52-week extension trial (HZNP-HZN-825-302, NCT not available yet). Participants not entering the extension will return to the clinic for a Safety Follow-up Visit 4 weeks after the last dose of trial drug.

Contact: HorizonTherapeutics 866-479-6742 clinicaltrials@horizontherapeutics.com
Participating Sites:

-Pacific Arthritis Care Center 

Los Angeles, California, United States, 90045

Contact: Stanique Thomas    310-297-6812    stanique.pa.clinicalresearch@gmail.com 

Principal Investigator: Daniel Furst, MD         

-UCLA Department of Medicine

Los Angeles, California, United States, 90095-1670

Contact: Contact: Nancy R Lopez    310-794-6213    nancyrlopez@mednet.ucla.edu  

Principal Investigator: Elizabeth Volkmann, MD

-Stanford University School of Medicine

Palo Alto, California, 94304-1808

Contact Study Coordinator: Kathryn Jee Email: kjee@stanford.edu

Principal Investigator: Dr. Lorinda Chung

Oral Ifetroban to Treat Diffuse Cutaneous Systemic Sclerosis (SSc) or SSc-associated Pulmonary Arterial Hypertension

This study is a randomized, placebo-controlled, double-blind phase 2 trial of patients with dcSSc or SSc-PAH. Twenty participants with SSc-PAH and 14 participants with dcSSc will be randomized to receive either oral ifetroban daily or matching placebo. Study participants will be treated for 12 months, followed by a 30-day follow-up period. The study will test whether ifetroban is safe and statistically superior to placebo in reducing the effects of their disease at month 12 and explore the ability of ifetroban to prevent or reverse progression in patients with early disease duration and reverse established disease in patients with longer disease duration.

Participating Site:

UCLA Recruiting 

Los Angeles, California, United States, 90095-1670

Contact: Nashla Barroso  310-825-9682      

Principal Investigator: Suzanne Kafaja, MD  

A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of RO7303509 in Participants With Systemic Sclerosis

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of RO7303509 treatment in participants with systemic sclerosis (SSc) during a multiple-ascending-dose (MAD) portion of the trial. In the MAD phase, increasing doses of study drug will be tested sequentially. For each dose tested, the MAD stage will consist of a treatment period of 12 weeks followed by either a safety follow-up period of 13 weeks or continued treatment in an optional open-label safety extension (OSE) stage of 52 weeks to assess the long-term safety. All patients in the OSE stage will receive RO7303509 and no patient will receive placebo.

Contact: Reference Study ID Number: GA43360 https://forpatients.roche.com/

888-662-6728 (U.S. Only 

global-roche-genentech-trials@gene.com

Location: Stanford University

Palo Alto, California, United States, 94304-1808

A Study of MK-2225 / ACE-1334 in Participants With Systemic Sclerosis With and Without Interstitial Lung Disease (MK-2225-002)

The purpose of the MK-2225-002 (A1334-02) study is to evaluate the safety and tolerability of MK-2225 (ACE-1334) plus standard of care (SOC) in participants with Systemic Sclerosis (SSc) following multiple doses.

Participating Sites:

UCSD Altman Clinical and Translational Research Institute (Site 1013) Recruiting

La Jolla, California, United States, 92037-0943

Contact: Study Coordinator    858-246-2387      

Keck Medical Center ( Site 1001) Recruiting

Los Angeles, California, United States, 90033

Contact: Study Coordinator    323-409-5383  

COllaborative National QUality and Efficacy Registry (CONQUER) for Tracking Disease Progression in Systemic Sclerosis (systemic sclerosis with diffuse or limited skin disease) 

This is an observational study (no intervention is given) where select Scleroderma Centers of Excellence in the US enter patient data into a registry to understand how the disease evolves and to discover novel biomarkers that predict organ involvement. Any patient with systemic sclerosis with a disease duration of less than 5 years is eligible to participate. 

Participating Sites:

-UCLA Department of Medicine

Los Angeles, California, United States, 90095-1670

Contact: Contact: Nancy R Lopez    310-794-6213    nancyrlopez@mednet.ucla.edu  

Principal Investigator: Elizabeth Volkmann, MD

-Stanford University

Principal Investigator: Lorinda Chung, MD, MS 

A Phase II, Randomized, Placebo-controlled, Double-blind, Parallel Group, Efficacy and Safety Study of at Least 48 Weeks of Oral BI 685509 Treatment in Adults With Early Progressive Diffuse Cutaneous Systemic Sclerosis
The purpose of this study is to find out whether a medicine called BI 685509 helps people with scleroderma who have symptoms due to lung fibrosis or vascular problems.

This study is open to adults aged 18 and older or above legal age who have early systemic sclerosis. People can participate if they have a specific subtype called diffuse cutaneous systemic sclerosis. Systemic sclerosis is also called scleroderma.

Participants are put into 2 groups by chance. One group takes BI 685509 tablets 3 times a day and the other group takes placebo tablets 3 times a day. Placebo tablets look like BI 685509 tablets but do not contain any medicine. Participants take the tablets for at least 11 months. Afterwards, participants can continue to take the tablets until the last participant has completed the 11-months treatment period. This means that the time in the study and duration of treatment is different for each participant, depending on when they start the study. At the beginning of the study, participants visit the study site every 2 weeks. The time between the visits to the study site gets longer over the course of the study. After the 11-months treatment period, participants visit the study site every 3 months.

During the study, participants regularly do lung function tests. The results are compared between the 2 groups to see whether the treatment works. The participants also regularly fill in questionnaires about their scleroderma symptoms. The doctors regularly check participants' skin condition and general health and take note of any unwanted effects.

Name: Boehringer Ingelheim: 800-243-0127
Email: clintriage.rdg@boehringer-ingelheim.com
Participating sites:

Medvin Clinical Research     Covina, California, United States, 91722
Contact: Boehringer Ingelheim    833-602-2368    unitedstates@bitrialsupport.com  
Medvin Clinical Research     
Whittier, California, United States, 90602
Contact: Boehringer Ingelheim    833-602-2368    unitedstates@bitrialsupport.com

A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of RO7303509 in Participants With Systemic Sclerosis
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of RO7303509 treatment in participants with systemic sclerosis (SSc) during a multiple-ascending-dose (MAD) portion of the trial. In the MAD phase, increasing doses of study drug will be tested sequentially. For each dose tested, the MAD stage will consist of a treatment period of 12 weeks followed by either a safety follow-up period of 13 weeks or continued treatment in an optional open-label safety extension (OSE) stage of 52 weeks to assess the long-term safety. All patients in the OSE stage will receive RO7303509 and no patient will receive placebo.
Name: Roche: 888-662-6728 (U.S. Only)Reference Study ID Number: GA43360 https://forpatients.roche.com/
Email: global-roche-genentech-trials@gene.com
Participating Sites:
Stanford University - Palo Alto, California, United States, 94304-1808

A Phase 1b Randomized, Double-Blind, Placebo-Controlled, Multiple-Ascending Dose Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of ACE-1334 Plus Standard of Care in Participants With Systemic Sclerosis
The purpose of the MK-2225-002 (A1334-02) study is to evaluate the safety and tolerability of MK-2225 (ACE-1334) plus standard of care (SOC) in participants with Systemic Sclerosis (SSc) following multiple doses.
Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA: 
888-577-8839
Email: Trialsites@merck.com
Participating Sites: 
-UCSD Altman Clinical and Translational Research Institute (Site 1013) La Jolla, California, United States, 92037-0943
Contact: Study Coordinator    858-246-2387      
-Keck Medical Center ( Site 1001)   
Los Angeles, California, United States, 90033
Contact: Study Coordinator    323-409-5383   

TBI Using IMRT and Cyclophosphamide Prior to Stem Cell Transplant for the Treatment of Severe Systemic Sclerosis

This early phase I trial studies the side effects and feasibility of total body irradiation using intensity modulation radiation therapy (IMRT) when given in combination with cyclophosphamide prior to stem cell transplant to treat severe systemic sclerosis. IMRT delivers total body radiation therapy more precisely and may reduce radiation exposure to sensitive normal organs. Giving chemotherapy, such as cyclophosphamide, and total body irradiation before a donor stem cell transplant helps kill cancer cells in the body and helps make room in the bone marrow for new blood-forming cells (stem cells) to grow. Giving IMRT and cyclophosphamide prior to stem cell transplant may work better in treating severe systemic sclerosis and reduce radiation doses to lung and kidneys compared to cyclophosphamide alone.

Patients undergo TBI using IMRT twice daily (BID) on days -5 and -4 in the absence of disease progression or disease progression. Patients then receive cyclophosphamide on days -3 and -2 and undergo HSCT on day 0 in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up on days 30 and 100.

Contact: City of Hope Medical Center

Duarte, California, United States, 91010

Contact: Jeffrey Y. Wong    626-218-2247    jwong@coh.org   

Principal Investigator: Jeffrey Y. Wong