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CompletedNCT01199887Updated Jul 29, 2013

Trial Of IW001 in Patients With Idiopathic Pulmonary Fibrosis

A Phase 1 interventional study of IW001 in Idiopathic Pulmonary Fibrosis, sponsored by ImmuneWorks. Completed at 11 sites in United States. Open to participants aged 35 Years to 75 Years. Per ClinicalTrials.gov, last updated 2013-07-29.

Sponsored by ImmuneWorks · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
35 Years to 75 Years
Sex
All
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Study summary

This is an open label, Phase One, multicenter study, designed to evaluate the safety, tolerability, to explore the biologic effects, and to explore the clinical effects of the following doses of IW001: 0.1mg/day, 0.5 mg/day, and 1.0 mg/day, when administered once a day orally for 24 weeks in patients with IPF.

Read the detailed description

IW001 is a therapeutic designed to treat anti-Col (V)-mediated autoimmune diseases via oral tolerance. With the identification of the specific antigen involved in the autoimmune disease process in IPF, IW001 induced oral tolerance may be an effective treatment. IW001 is taken orally, introduced into the mucosal immune system at the Peyer's Patches in the distal small intestine, where antigen-presenting cells present the antigen to regulatory T cells (Tregs). These antigen-specific Tregs enter the blood stream and traffic to areas where the specific antigen has generated an autoimmune response. Thus, IW001 may produce selective suppression of immune responses against Col (V).

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Conditions studied

  • Idiopathic Pulmonary Fibrosis

Keywords

  • safety, biologic effects, IPF, autoimmune
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In context

Idiopathic Pulmonary Fibrosis

565 studies on the registry are indexed under Idiopathic Pulmonary Fibrosis; 117 are open to participants now.

This study's enrollment of 30 is below the median of 55 across 388 interventional studies indexed under Idiopathic Pulmonary Fibrosis.

Browse Idiopathic Pulmonary Fibrosis studies →

Lead sponsor

This is the only study on the registry with ImmuneWorks as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
35 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients must meet all of the following to be included in the study:

    1. Diagnosis of IPF (ATS criteria) prior to the Baseline visit.
    2. Forced Vital Capacity (FVC) ≥ 50% of predicted.
    3. Lung Diffusion Capacity (DLCO) ≥ 35% of predicted.
    4. Ages 35-75 years inclusive.
    5. Positive for anti-Col (V) antibodies.
    6. White blood cell count (WBC) ≥ 2500 mm3.
    7. Hematocrit ≥ 25% and ≤ 59%.
    8. Platelets ≥ 100,000 mm3.
    9. Creatinine ≤ 1.5x Upper Limits of Normal (ULN).
    10. Bilirubin ≤ 1.5x ULN.
    11. Aspartate aminotransferase (AST, SGOT) ≤ 1.5x ULN.
    12. Females of child-bearing potential (defined as less than one year post-menopausal or not surgically sterile) must be using an acceptable method of birth control or practicing abstinence from the time consent is signed until 30 days after treatment discontinuation. If sexually active, female patients must use a double barrier method of birth control, such as a condom and spermicidal. Patient must have a negative pregnancy test at the Screening and Baseline visits.
    13. Willing and able to provide adequate written informed consent.

Exclusion criteria

Exclusion Criteria:

  • Patients will be excluded from the study for any of the following:

    1. Concurrent use of systemic corticosteroids or immunosuppressives within 30 days of the Baseline visit.
    2. Chronic NSAID use (limited, i.e., up to 72 hours continuous use of NSAIDs will be permitted during the study), (see Section 9, concomitant medications).
    3. N-acetyl cysteine (NAC) use within 14 days of the Baseline visit.
    4. Any disease, condition or surgery (e.g. inflammatory bowel disease, surgical resection) that may cause malabsorption of IW001.
    5. Known or suspected allergy to bovine products.
    6. Concurrent or prior use of any experimental medication within 30 days of the Baseline visit.
    7. History of smoking within three months prior to the Baseline visit.
    8. Known Hepatitis C or Human Immunodeficiency Virus (HIV) infections.
    9. Evidence of active infection at the Baseline visit.
    10. History of unstable or deteriorating cardiac disease.
    11. Myocardial infarction, coronary artery bypass, or angioplasty within 6 months of the Baseline visit.
    12. Unstable angina pectoris or congestive heart failure requiring hospitalization within 6 months of the Baseline visit.
    13. Uncontrolled arrhythmia.
    14. Patient has a history of illicit drug or alcohol abuse in the past year or current evidence of such abuse or addiction in the opinion of the Investigator.
    15. Patient has positive findings on urine drug screen.
    16. Any other clinically significant illness, that, in the opinion of the Investigator, might put the patient at risk of harm during the study or might adversely affect the interpretation of the study data.
    17. Females who are pregnant and/or lactating.
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Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    IW001

    Three dose cohorts, 0.1 mg, 0.5 mg, 1.0 mg

    Drug: IW001

Interventions

  • DrugIW001

    IW001, 0.1 mg, 0.5 mg, 1.0 mg PO daily for 24 weeks.

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What researchers measure

Primary outcomes

  1. To evaluate the safety and tolerability of three doses of IW001 (0.1 mg/day, 0.5 mg/day, and 1.0 mg/day orally) in patients with IPF patients over a 24 week treatment period.

    Time frame: Monthly during the 24 week treatment period.

Secondary outcomes

  1. To explore the biologic effects of IW001 on T-cell and B-cell reactivity. To explore relationships between Col V reactivity and clinical measures of lung function in patients with IPF.

    Time frame: Monthly during the 24 week treatment period.

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Study locations

11 sites
  • University of Alabama at Birmingham
    Birmingham, Alabama 35294, United States
  • University of Miami
    Miami, Florida 33136, United States
  • University of Chicago
    Chicago, Illinois 60637, United States
  • IUPUI
    Indianapolis, Indiana 46202, United States
  • University of Louisville
    Louisville, Kentucky 40202, United States
  • University of Michigan
    Ann Arbor, Michigan 48109, United States
  • Newark Beth Israel Hospital
    Newark, New Jersey 07112, United States
  • Ohio State University
    Columbus, Ohio 43221, United States
  • Medical University of South Carolina
    Charleston, South Carolina 29425, United States
  • Vanderbilt University
    Nashville, Tennessee 37232, United States
  • University of Vermont
    Burlington, Vermont 05401, United States
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References and documents

Publications

  • American Thoracic Society. Idiopathic pulmonary fibrosis: diagnosis and treatment. International consensus statement. American Thoracic Society (ATS), and the European Respiratory Society (ERS). Am J Respir Crit Care Med. 2000 Feb;161(2 Pt 1):646-64. doi: 10.1164/ajrccm.161.2.ats3-00. No abstract available. PubMed 10673212 ↗
  • Raghu G, Weycker D, Edelsberg J, Bradford WZ, Oster G. Incidence and prevalence of idiopathic pulmonary fibrosis. Am J Respir Crit Care Med. 2006 Oct 1;174(7):810-6. doi: 10.1164/rccm.200602-163OC. Epub 2006 Jun 29. PubMed 16809633 ↗
  • Martinez FJ, Safrin S, Weycker D, Starko KM, Bradford WZ, King TE Jr, Flaherty KR, Schwartz DA, Noble PW, Raghu G, Brown KK; IPF Study Group. The clinical course of patients with idiopathic pulmonary fibrosis. Ann Intern Med. 2005 Jun 21;142(12 Pt 1):963-7. doi: 10.7326/0003-4819-142-12_part_1-200506210-00005. PubMed 15968010 ↗
  • Walter N, Collard HR, King TE Jr. Current perspectives on the treatment of idiopathic pulmonary fibrosis. Proc Am Thorac Soc. 2006 Jun;3(4):330-8. doi: 10.1513/pats.200602-016TK. PubMed 16738197 ↗
  • Trulock EP, Edwards LB, Taylor DO, Boucek MM, Keck BM, Hertz MI. Registry of the International Society for Heart and Lung Transplantation: twenty-second official adult lung and heart-lung transplant report--2005. J Heart Lung Transplant. 2005 Aug;24(8):956-67. doi: 10.1016/j.healun.2005.05.019. No abstract available. PubMed 16102428 ↗
  • Kim DS, Collard HR, King TE Jr. Classification and natural history of the idiopathic interstitial pneumonias. Proc Am Thorac Soc. 2006 Jun;3(4):285-92. doi: 10.1513/pats.200601-005TK. PubMed 16738191 ↗
  • Maher TM, Wells AU, Laurent GJ. Idiopathic pulmonary fibrosis: multiple causes and multiple mechanisms? Eur Respir J. 2007 Nov;30(5):835-9. doi: 10.1183/09031936.00069307. PubMed 17978154 ↗
  • Hunninghake GW, Schwarz MI. Does current knowledge explain the pathogenesis of idiopathic pulmonary fibrosis? A perspective. Proc Am Thorac Soc. 2007 Aug 15;4(5):449-52. doi: 10.1513/pats.200702-036MS. PubMed 17684287 ↗
  • Bobadilla JL, Love RB, Jankowska-Gan E, Xu Q, Haynes LD, Braun RK, Hayney MS, Munoz del Rio A, Meyer K, Greenspan DS, Torrealba J, Heidler KM, Cummings OW, Iwata T, Brand D, Presson R, Burlingham WJ, Wilkes DS. Th-17, monokines, collagen type V, and primary graft dysfunction in lung transplantation. Am J Respir Crit Care Med. 2008 Mar 15;177(6):660-8. doi: 10.1164/rccm.200612-1901OC. Epub 2008 Jan 3. PubMed 18174545 ↗
  • Burlingham WJ, Love RB, Jankowska-Gan E, Haynes LD, Xu Q, Bobadilla JL, Meyer KC, Hayney MS, Braun RK, Greenspan DS, Gopalakrishnan B, Cai J, Brand DD, Yoshida S, Cummings OW, Wilkes DS. IL-17-dependent cellular immunity to collagen type V predisposes to obliterative bronchiolitis in human lung transplants. J Clin Invest. 2007 Nov;117(11):3498-506. doi: 10.1172/JCI28031. PubMed 17965778 ↗
  • Faria AM, Weiner HL. Oral tolerance. Immunol Rev. 2005 Aug;206:232-59. doi: 10.1111/j.0105-2896.2005.00280.x. PubMed 16048553 ↗
  • Whitacre CC, Song F, Wardrop RM 3rd, Campbell K, McClain M, Benson J, Guan Z, Gienapp I. Regulation of autoreactive T cell function by oral tolerance to self-antigens. Ann N Y Acad Sci. 2004 Dec;1029:172-9. doi: 10.1196/annals.1309.033. PubMed 15681756 ↗
  • Nussenblatt R. Orally and nasally induced tolerance studies in ocular inflammatory disease: guidance for future interventions. Ann N Y Acad Sci. 2004 Dec;1029:278-85. doi: 10.1196/annals.1309.058. PubMed 15681765 ↗
  • Artik S, Haarhuis K, Wu X, Begerow J, Gleichmann E. Tolerance to nickel: oral nickel administration induces a high frequency of anergic T cells with persistent suppressor activity. J Immunol. 2001 Dec 15;167(12):6794-803. doi: 10.4049/jimmunol.167.12.6794. PubMed 11739495 ↗
  • Barnett ML, Kremer JM, St Clair EW, Clegg DO, Furst D, Weisman M, Fletcher MJ, Chasan-Taber S, Finger E, Morales A, Le CH, Trentham DE. Treatment of rheumatoid arthritis with oral type II collagen. Results of a multicenter, double-blind, placebo-controlled trial. Arthritis Rheum. 1998 Feb;41(2):290-7. doi: 10.1002/1529-0131(199802)41:23.0.CO;2-R. PubMed 9485087 ↗
  • McKown KM, Carbone LD, Bustillo J, Seyer JM, Kang AH, Postlethwaite AE. Induction of immune tolerance to human type I collagen in patients with systemic sclerosis by oral administration of bovine type I collagen. Arthritis Rheum. 2000 May;43(5):1054-61. doi: 10.1002/1529-0131(200005)43:53.0.CO;2-W. PubMed 10817559 ↗
  • Carbone LD, McKown K, Pugazhenthi M, Barrow KD, Warrington K, Somes G, Postlethwaite AE. Dosage effects of orally administered bovine type I collagen on immune function in patients with systemic sclerosis. Arthritis Rheum. 2004 Aug;50(8):2713-5. doi: 10.1002/art.20361. No abstract available. PubMed 15334493 ↗
  • Postlethwaite AE, Wong WK, Clements P, Chatterjee S, Fessler BJ, Kang AH, Korn J, Mayes M, Merkel PA, Molitor JA, Moreland L, Rothfield N, Simms RW, Smith EA, Spiera R, Steen V, Warrington K, White B, Wigley F, Furst DE. A multicenter, randomized, double-blind, placebo-controlled trial of oral type I collagen treatment in patients with diffuse cutaneous systemic sclerosis: I. oral type I collagen does not improve skin in all patients, but may improve skin in late-phase disease. Arthritis Rheum. 2008 Jun;58(6):1810-22. doi: 10.1002/art.23501. PubMed 18512816 ↗
  • Baccarani U, Adani GL, Montanaro D, Risaliti A, Lorenzin D, Avellini C, Tulissi P, Groppuzzo M, Curro G, Luvisetto F, Beltrami A, Bresadola V, Viale PL, Bresadola F. De novo malignancies after kidney and liver transplantations: experience on 582 consecutive cases. Transplant Proc. 2006 May;38(4):1135-7. doi: 10.1016/j.transproceed.2006.02.016. PubMed 16757287 ↗
  • Yasufuku K, Heidler KM, O'Donnell PW, Smith GN Jr, Cummings OW, Foresman BH, Fujisawa T, Wilkes DS. Oral tolerance induction by type V collagen downregulates lung allograft rejection. Am J Respir Cell Mol Biol. 2001 Jul;25(1):26-34. doi: 10.1165/ajrcmb.25.1.4431. PubMed 11472972 ↗
  • Mizobuchi T, Yasufuku K, Zheng Y, Haque MA, Heidler KM, Woods K, Smith GN Jr, Cummings OW, Fujisawa T, Blum JS, Wilkes DS. Differential expression of Smad7 transcripts identifies the CD4+CD45RChigh regulatory T cells that mediate type V collagen-induced tolerance to lung allografts. J Immunol. 2003 Aug 1;171(3):1140-7. doi: 10.4049/jimmunol.171.3.1140. PubMed 12874199 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 29, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01199887
Lead sponsor
ImmuneWorks
Responsible party
Sponsor
First posted
Sep 13, 2010
Start date
Sep 2010
Primary completion
Oct 2012
Completion
Oct 2012
Last update
Jul 29, 2013

Study contacts

Terrence Chew, MD
study director · ImmuneWorks, Medical Consultant

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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