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Idiopathic Pulmonary FibrosisPhase 1NCT01199887

Trial Of IW001 in Patients With Idiopathic Pulmonary Fibrosis

A Phase 1 study testing IW001 in people with Idiopathic Pulmonary Fibrosis, run by ImmuneWorks at 11 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 more about this study

Who is it for?
Ages 35 to 75 years
Conditions the study is for
Idiopathic Pulmonary Fibrosis
What is being tested?
IW001
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
11 sitesUnited States
Study dates
Sep 2010to Oct 2012
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 35 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients must meet all of the following to be included in the study:
  • Diagnosis of IPF (ATS criteria) prior to the Baseline visit.
  • Forced Vital Capacity (FVC) ≥ 50% of predicted.
  • Lung Diffusion Capacity (DLCO) ≥ 35% of predicted.
  • Ages 35-75 years inclusive.
  • Positive for anti-Col (V) antibodies.
Show all 14Show fewer
  • White blood cell count (WBC) ≥ 2500 mm3.
  • Hematocrit ≥ 25% and ≤ 59%.
  • Platelets ≥ 100,000 mm3.
  • Creatinine ≤ 1.5x Upper Limits of Normal (ULN).
  • Bilirubin ≤ 1.5x ULN.
  • Aspartate aminotransferase (AST, SGOT) ≤ 1.5x ULN.
  • 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.
  • Willing and able to provide adequate written informed consent.

Who cannot join

  • Patients will be excluded from the study for any of the following:
  • Concurrent use of systemic corticosteroids or immunosuppressives within 30 days of the Baseline visit.
  • 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).
  • N-acetyl cysteine (NAC) use within 14 days of the Baseline visit.
  • Any disease, condition or surgery (e.g. inflammatory bowel disease, surgical resection) that may cause malabsorption of IW001.
  • Known or suspected allergy to bovine products.
Show all 18Show fewer
  • Concurrent or prior use of any experimental medication within 30 days of the Baseline visit.
  • History of smoking within three months prior to the Baseline visit.
  • Known Hepatitis C or Human Immunodeficiency Virus (HIV) infections.
  • Evidence of active infection at the Baseline visit.
  • History of unstable or deteriorating cardiac disease.
  • Myocardial infarction, coronary artery bypass, or angioplasty within 6 months of the Baseline visit.
  • Unstable angina pectoris or congestive heart failure requiring hospitalization within 6 months of the Baseline visit.
  • Uncontrolled arrhythmia.
  • 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.
  • Patient has positive findings on urine drug screen.
  • 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.
  • Females who are pregnant and/or lactating.

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

United States11 sites

  • University of Michigan

    Ann Arbor, Michigan, 48109

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294

  • University of Vermont

    Burlington, Vermont, 05401

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • University of Chicago

    Chicago, Illinois, 60637

  • Ohio State University

    Columbus, Ohio, 43221

  • IUPUI

    Indianapolis, Indiana, 46202

  • University of Louisville

    Louisville, Kentucky, 40202

  • University of Miami

    Miami, Florida, 33136

  • Vanderbilt University

    Nashville, Tennessee, 37232

  • Newark Beth Israel Hospital

    Newark, New Jersey, 07112

Other trials in United States

About this study

Official title: A Phase One, Open Label, Multi-Dose Study to Evaluate the Safety, Tolerability, and Biologic Effects of Three Doses of IW001 in Patients With Idiopathic Pulmonary Fibrosis (IPF)

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).

Being tested
IW001
Keywords
safety, biologic effects, IPF, autoimmune
Medical subject headings
Idiopathic Pulmonary Fibrosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IW001Drug

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

Study groups in NCT01199887
Study groupRoleWhat they receive
IW001ExperimentalThree dose cohorts, 0.1 mg, 0.5 mg, 1.0 mg
Receives: Drug: IW001

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Monthly during the 24 week treatment period.

Secondary outcomes (1)

  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.

    Measured: Monthly during the 24 week treatment period.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Sep 2010 (estimated)
  2. Study startSep 2010
  3. Primary completionOct 2012
  4. Study completionOct 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01199887
Sponsor's protocol ID
IW001-01
Status last verified
Jul 2013
First submitted
9 Sep 2010
Last updated
29 Jul 2013
Results posted
No
Data monitoring committee
No

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

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing IW001 in people with Idiopathic Pulmonary Fibrosis, run by ImmuneWorks at 11 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01199887, which also lists 21 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2013.

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