Trial Of IW001 in Patients With Idiopathic Pulmonary Fibrosis

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01199887
• Date of registration: 09/09/2010
• Prospective Registration: No
• Primary sponsor: ImmuneWorks
• Public title: Trial Of IW001 in Patients With Idiopathic Pulmonary Fibrosis
• Scientific 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)
• Date of first enrolment: September 2010
• Target sample size: 30
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01199887
• Study type: Interventional
• Study design: Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 1

Countries of recruitment

United States

Contacts

• Name: Terrence Chew, MD
• Affiliation: ImmuneWorks, Medical Consultant

Key inclusion & exclusion criteria

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:

- 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.



Age minimum: 35 Years
Age maximum: 75 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Idiopathic Pulmonary Fibrosis

Intervention(s)

Drug: IW001

Primary Outcome(s)

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 Outcome(s)

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.]

Secondary ID(s)

IW001-01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors