STX-100 in Patients With Idiopathic Pulmonary Fibrosis (IPF) - Full Text View

Sponsor:	Stromedix, Inc.
Information provided by (Responsible Party):	Stromedix, Inc.
ClinicalTrials.gov Identifier:	NCT01371305

Purpose

This is a multi-center, randomized, double-blind, placebo-controlled, multiple dose, dose-escalation study designed to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, and impact on BAL and peripheral blood biomarkers of STX-100 in patients with IPF. Approximately 32 patients will be enrolled into 4 sequential ascending dose cohorts. Each cohort will include 8 patients randomized to receive either STX-100 (6 patients) or placebo (2 patients). Additional patients may be enrolled if deemed appropriate by the Data Safety Monitoring Board (DSMB).

Condition	Intervention	Phase
Idiopathic Pulmonary Fibrosis (IPF)	Drug: STX-100 Drug: Placebo	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Randomized, Double-Blind, Placebo-Controlled, Multiple Dose, Dose-Escalation Study of STX-100 in Patients With Idiopathic Pulmonary Fibrosis (IPF)

Resource links provided by NLM:

MedlinePlus related topics: Pulmonary Fibrosis

U.S. FDA Resources

Further study details as provided by Stromedix, Inc.:

Primary Outcome Measures:

Incidence and severity of adverse events [ Time Frame: Weekly assessment over 24 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Lab tests (hematology, serum chemistry, and urinalysis) [ Time Frame: Screening; Dosing days 1, 8, 15, 29, 43, and 50; Follow up days 3, 8, 29, 57, and 85 ] [ Designated as safety issue: Yes ]
Percent change in lung function: forced (expiratory) vital capacity (FVC), forced expiratory volume over one second (FEV1), total lung capacity (TLC), and carbon monoxide diffusion capacity (DLCO) [ Time Frame: Baseline, 4 weeks and 8 weeks ] [ Designated as safety issue: Yes ]
Change in radiographic evidence of IPF as measured by high resolution computed tomography (HRCT) [ Time Frame: Baseline, week 8 ] [ Designated as safety issue: Yes ]
Change in biomarkers isolated from bronchoalveolar lavage (BAL) [ Time Frame: Baseline, week 8 ] [ Designated as safety issue: Yes ]
Incidence of antibodies to STX-100 [ Time Frame: Baseline, follow up days 29 and 85 ] [ Designated as safety issue: Yes ]
Serum half-life of STX-100 [ Time Frame: Following the final dose of STX 100 at day 50 through day 85 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	32
Study Start Date:	May 2012
Estimated Study Completion Date:	December 2013
Estimated Primary Completion Date:	December 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: STX-100 Active treatment with study drug	Drug: STX-100 Subcutaneous (SC) delivery of 8 consecutive weekly doses
Placebo Comparator: Placebo	Drug: Placebo Subcutaneous (SC) delivery of 8 consecutive weekly doses

Eligibility

Ages Eligible for Study:	18 Years to 84 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Consenting male or female patients, 50 to 84 years old, inclusive. Patients 18 to 49 years of age are eligible if they have a histopathologic diagnosis of usual interstitial pneumonia (UIP) based upon a surgical lung biopsy in the appropriate clinical setting, and meet all other inclusion/exclusion criteria.
Clinical features consistent with IPF prior to screening (based on the ATS/ERS/JRS/ALAT consensus criteria for the diagnosis of IPF).
FVC ≥ 50% of predicted value.
DLco (corrected for hemoglobin) ≥ 35% predicted value.
Oxygen saturation > 90% by pulse oximetry while breathing ambient air at rest.
Residual volume ≤ 120% predicted value.
Ratio of FEV1 to FVC ≥ 0.65 after the use of a bronchodilator.
Other known causes of interstitial lung disease have been excluded (e.g., drug toxicities, environmental exposures, connective tissue diseases).
HRCT image fulfills the criteria for 'UIP pattern'.
If the HRCT image does not fulfill the criteria for 'UIP pattern' a surgical lung biopsy is necessary for the diagnosis of IPF.
Adequate bone marrow and liver function.
Patient has a life expectancy of at least 12 months.

Exclusion Criteria:

Findings that are diagnostic of a condition other than UIP on surgical lung biopsy, HRCT imaging, transbronchial lung biopsy, or bronchoalveolar lavage (BAL).
Currently receiving high dose corticosteroid, cytotoxic (e.g., chlorambucil, azathioprine, cyclophosphamide, methotrexate), anti-fibrotic (e.g., pirfenidone), vasodilator therapy for pulmonary hypertension (e.g., bosentan), unapproved (e.g., INF-γ, penicillamine, cyclosporine, mycophenolate, Nacetylcysteine), and/or investigational therapy for IPF or administration of such therapeutics within 4 weeks of initial screening. A current dose of ≤ 15 mg/day of prednisone or its equivalent is acceptable if it is anticipated the dose will remain stable during the study.
History of malignancy, including carcinoma during the preceding 5 years.
Significant cardiac disease (e.g., New York Heart Association [NYHA] Class 3 or 4; myocardial infarction within the past 6 months; unstable angina; coronary angioplasty or coronary artery bypass graft [CABG] within the past 6 months; or uncontrolled atrial or ventricular cardiac arrhythmias).
Serious local infection or systemic infection within 3 months prior to screening.
Positive test for HBsAg, HCV antibody, or HIV antibody at screening.
Treatment with another investigational drug, investigational device, or approved therapy for investigational use within 4 weeks of initial screening.
Currently listed and/or anticipated to be listed for lung transplantation within the next 6 months.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01371305

Contacts

Contact: Emily Graham	734-369-3873	emily.graham@covance.com
Contact: Kris Hermanson	608-310-4086	kris.hermanson@covance.com

Locations

United States, Massachusetts
Stromedix	Recruiting
Cambridge, Massachusetts, United States, 02141

Sponsors and Collaborators

Stromedix, Inc.

Investigators

Study Director:

Brad Maroni, MD

Stromedix, Inc.

More Information

No publications provided

Responsible Party:	Stromedix, Inc.
ClinicalTrials.gov Identifier:	NCT01371305 History of Changes
Other Study ID Numbers:	STX-003
Study First Received:	June 3, 2011
Last Updated:	May 9, 2012
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Fibrosis
Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Pathologic Processes

Lung Diseases
Respiratory Tract Diseases
Idiopathic Interstitial Pneumonias
Lung Diseases, Interstitial

ClinicalTrials.gov processed this record on May 23, 2012