Scleroderma Lung Study III - Combining Pirfenidone With Mycophenolate

Study Purpose

A Phase II multi-center, double-blind, parallel group, randomized and placebo-controlled clinical trial addressing the treatment of patients with active and symptomatic Scleroderma-related interstitial lung disease (SSc-ILD).

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Age ≥18 yrs 2. Scleroderma as determined by the 2013 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification criteria. 3. Grade ≥2 on the Magnitude of Task component of the Mahler Modified Dyspnea Index 4. FVC-% of ≤85% at screening 5. Onset of the first non-Raynaud manifestation of SSc within the prior 84 months. 6. Presence of any ground-glass opacification (GGO) on thoracic HRCT 7. Repeat FVC-% at the baseline visit within 10% of the FVC-% value measured at screening. If these criteria are not met, a repeat FVC-% may be obtained within 7 days and the subject may qualify for randomization if the repeat FVC-% agrees within 10% of the FVC-% obtained at screening.

Exclusion Criteria:

1. Disease features supporting the primary diagnosis of another connective tissue disease such as rheumatoid arthritis, systemic lupus erythematosus or mixed connective tissue disease (Features consistent with a secondary Sjogren syndrome or scleroderma-associated myopathy will be allowed). 2. FVC-% of <45% at either screening or baseline. 3. Forced Expiratory Volume in the first second (FEV1)/Forced Vital Capacity (FVC) ratio <0.65 at either screening or baseline. 4. DLCOHb-% of <30% at screening or <25% at baseline. a) All participants with a DLCOHb-% between 30 to 40% must have pulmonary artery pressures documented by either echocardiogram, right heart catheterization or magnetic resonance imaging in order to be considered for inclusion. 5. Diagnosis of clinically significant resting pulmonary hypertension requiring treatment or mild pulmonary hypertension requiring treatment with more than one oral medication as ascertained prior to study evaluation or as part of a standard of care clinical assessment performed outside of the study protocol. 6. Evidence of uncontrolled congestive heart failure, unstable ischemic heart disease, history of complicated pulmonary embolism impacting on heart or lung function, or unstable cardiac arrhythmia requiring chronic anticoagulation. 7. Clinically significant abnormalities on HRCT not attributable to SSc 8. Hematologic abnormality at screening including: 1. Leukopenia (white blood cells [WBC] <4.0x10^3/µl). 2. Thrombocytopenia (platelet count <120.0x10^3/µl). 3. Clinically significant anemia [Hemoglobin (Hgb) <10.0 g/dl]. Participants with an identified and correctable etiology may be eligible if repeat testing within the maximal 90-day screening period meets all criteria. 9. A diagnosis of chronic liver disease or abnormal baseline liver function test (LFTs) or total bilirubin that are >2.0 x upper normal limit 10. Serum creatinine >2.0mg/dl 11. History of recurrent aspiration, uncontrolled heartburn, or gastroesophageal reflux disease (GERD) with a reflux scale score of >1.00 as determined by a UCLA Scleroderma Clinical Trial Consortium Gastrointestinal Scale (UCLA SCTC GIT), Version 2.0. Participants with uncontrolled heartburn or GERD that is amenable to medical management may be eligible if repeat testing within the maximal 90-day screening period meets this criteria. 12. Known achalasia, esophageal stricture or esophageal dysfunction sufficient to limit the ability to swallow medication. 13. Pregnancy (as documented by blood test) and/or breast feeding 14. If of child bearing potential (a female participant < 55 years of age who has not been postmenopausal for ≥ 5 years or who has not had a hysterectomy and/or oophorectomy), failure to employ two reliable means of contraception which may include surgical sterilization, barrier methods, spermicidals, intrauterine devices, and/or hormonal contraception, unless the participant chooses abstinence (to avoid heterosexual intercourse completely). If a subject chooses abstinence, then a second reliable means of contraception is not needed. 15. Prior use of potential disease modifying antirheumatic drugs (DMARDs) according to the following exposure rules: 1. Use of oral cyclophosphamide (CYC), MMF, azathioprine or other oral or short half-life DMARDs (as detailed in Protocol Section 7.5.1a) for more than 6 months in the past year as determined at the time of the initial screening visit. 2. Treatment with more than three intravenous doses of CYC, one treatment course of Rituximab or other intravenous or injectable DMARDs (as detailed in Protocol Section 7.5.1b) in the past year. 3. More distant history of treatment with a DMARD is allowed as long as the patient has a new diagnosis/new episode of active SSc-ILD since stopping that treatment and meets the criteria noted in 15a or 15b. . 16. Use of CYC, MMF, azathioprine, Rituximab or other DMARD (as defined in Protocol Section 7.5.1a&b) in the 30 days prior to their baseline visit unless the patient is on MMF and the responsible physician indicates that continued use is in the best clinical interest of the patient. 17. Active infection (lung, ulcers or elsewhere) whose management would be compromised by immunosuppression. 18. Other serious concomitant medical illness (e.g., active malignancy within the past 5 years other than surgically-removed local skin cancer such as a basal cell carcinoma), chronic debilitating illness (other than SSc), unreliability or drug abuse that might compromise the patient's participation in the trial. 19. Current use, or use within the 30 days prior to their baseline visit, of prednisone (or equivalent) in doses >10 mg/day. 20. Smoking of cigars, pipes, or cigarettes during the past 6 months. 21. Use of contraindicated medications, including medications with putative disease-modifying properties that do not meet the exposure limits described in Exclusion Criteria #15 and #16, moderate or strong inhibitors of cytochrome P450 (CYP) isozyme 1A2 (CYP1A2) (note ciprofloxacin allowed up to a dose of 500 mg twice daily), and moderate inducers of CYP1A2 (such as tobacco smoke or phenytoin). See Protocol Section 7.5 for complete list.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03221257
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Michael Roth
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Michael D Roth, MD
Principal Investigator Affiliation Pulmonary & Critical Care Medicine, Geffen School of Medicine at UCLA
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

OtherOtherIndustryOther
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Scleroderma, Systemic, Interstitial Lung Disease
Additional Details

A Phase II multi-center, double-blind, parallel group, randomized and placebo-controlled clinical trial addressing the treatment of patients with active and symptomatic Scleroderma-related interstitial lung disease (SSc-ILD). Patients who are either treatment naive or only recently started treatment (

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of Washington Medical Center, Seattle, Washington

Status

Recruiting

Address

University of Washington Medical Center

Seattle, Washington, 98195

Site Contact

Chessa Goss

cagoss@uw.edu

206-616-8459

University of Utah, Salt Lake City, Utah

Status

Recruiting

Address

University of Utah

Salt Lake City, Utah, 84108

Site Contact

Cassie Larsen

cassie.larsen@hsc.utah.edu

801-581-5811

Houston, Texas

Status

Recruiting

Address

University of Texas Medical School at Houston

Houston, Texas, 77030

Site Contact

Pat Gonzalez, LVN, CCRP

Patricia.Gonzales@uth.tmc.edu

713-500-7118

Medical University of South Carolina, Charleston, South Carolina

Status

Recruiting

Address

Medical University of South Carolina

Charleston, South Carolina, 29425

Site Contact

Nathan Wilson, MPH

wilsonn@musc.edu

843-792-8272

University of Pittsburgh, Pittsburgh, Pennsylvania

Status

Recruiting

Address

University of Pittsburgh

Pittsburgh, Pennsylvania, 15261

Site Contact

Maureen Laffoon

laffoonm@pitt.edu

412-648-7871

Hospital for Special Surgery, New York, New York

Status

Recruiting

Address

Hospital for Special Surgery

New York, New York, 10021

Site Contact

Taz Kabir

kabirm@hss.edu

212-774-7194

Rutgers University, New Brunswick, New Jersey

Status

Recruiting

Address

Rutgers University

New Brunswick, New Jersey, 08901

Site Contact

Deborah McCloskey, RN

mcclosda@rwjms.rutgers.edu

732-235-5965

University of Michigan, Ann Arbor, Michigan

Status

Recruiting

Address

University of Michigan

Ann Arbor, Michigan, 48109

Site Contact

Monica Sanborn

monsan@med.umich.edu

734-232-2090

Boston University, School of Medicine, Boston, Massachusetts

Status

Recruiting

Address

Boston University, School of Medicine

Boston, Massachusetts, 02118

Site Contact

Eric Stratton, MTS, MPH

eas@bu.edu

617-358-6777

Boston, Massachusetts

Status

Recruiting

Address

Harvard Medical School, Brigham & Women's Hospital

Boston, Massachusetts, 02115

Site Contact

Maura Alvarez Baumgartner

malvarezbaumgartner@bwh.harvard.edu

617-525-8686

Johns Hopkins University, Baltimore, Maryland

Status

Recruiting

Address

Johns Hopkins University

Baltimore, Maryland, 21224

Site Contact

Margaret Sampedro

msamped2@jhmi.edu

410-550-6270

Northwestern University, Chicago, Illinois

Status

Recruiting

Address

Northwestern University

Chicago, Illinois, 60611

Site Contact

Adeeb Ansari

Adeeb.ansari@northwestern.edu

312-695-6021

Georgetown University, Washington, District of Columbia

Status

Recruiting

Address

Georgetown University

Washington, District of Columbia, 20007

Site Contact

Sabrina Elliott

sabrina.elliott@georgetown.edu

202-444-6210

University of Colorado, Aurora, Colorado

Status

Active, not recruiting

Address

University of Colorado

Aurora, Colorado, 80045

University of California San Francisco, San Francisco, California

Status

Recruiting

Address

University of California San Francisco

San Francisco, California, 94143

Site Contact

Fizaa Ahmed

Fizaa.ahmed@ucsf.edu

415-502-1958

University of California Los Angeles, Los Angeles, California

Status

Recruiting

Address

University of California Los Angeles

Los Angeles, California, 90095

Site Contact

Eileen Callahan

ecallahan@mednet.ucla.edu

310-794-2466

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