Safety, Tolerability, and Efficacy Study of Idiopathic Pulmonary Fibrosis

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01262001
• Date of registration: 15/12/2010
• Prospective Registration: Yes
• Primary sponsor: FibroGen
• Public title: Safety, Tolerability, and Efficacy Study of Idiopathic Pulmonary Fibrosis FGCL-3019-049
• Scientific title: A Phase 2, Open-Label, Dose-Escalation Study to Evaluate the Safety, Tolerability, and Efficacy of FG-3019 in Subjects With Idiopathic Pulmonary Fibrosis
• Date of first enrolment: March 2011
• Target sample size: 90
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01262001
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

United States

Key inclusion & exclusion criteria

Main Inclusion Criteria:

1. Age 35 to 80 years, inclusive.

2. Clinical diagnosis of IPF by high resolution computed tomography (HRCT) scan (and in
some cases by surgical lung biopsy) and reduced lung function (forced vital capacity).

3. History of IPF of 5 years duration or less.

4. Evidence of progression of IPF within the last 3-12 months for Cohort 1, or within the
last 18 months for Cohort 2 before screening.

5. Women of childbearing potential, and men, must be willing to use a medically
acceptable method of contraception during the trial and 3 months after the last dose
of study drug.

Main Exclusion Criteria:

1. Women who are pregnant or nursing.

2. History of any other types of lung or heart disease and any other medical conditions
that, in the opinion of the investigator, would preclude the subject's participation
in the study.

3. Clinically important abnormal laboratory tests.

4. Upper or lower respiratory tract infection of any type within 4 weeks of the first
screening visit.

5. Acute exacerbation of IPF within 3 months of the first screening visit.

6. Use of certain medications within 4 weeks of the first screening visit.

7. Receipt of an investigational drug within 6 weeks of the first screening visit.

8. History of cancer of any type in the 5 years preceding the first screening visit,
excluding non-melanomatous skin cancer, localized bladder cancer, or in situ cervical
cancer.

9. Trauma or surgical procedures requiring hospitalization within 4 weeks of the first
screening visit.

10. Planned elective surgery during the study including 4 weeks following the final dose
of study drug.

11. History of allergic or anaphylactic reaction to human, humanized, chimeric or murine
monoclonal antibodies.

12. Inability to cooperate with study personnel or history of non-compliance to a medical
regimen.

13. Previous treatment with FG-3019.



Age minimum: 35 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Idiopathic Pulmonary Fibrosis

Intervention(s)

Drug: FG-3019

Primary Outcome(s)

To determine the safety and tolerability of FG-3019 administered at doses of 15 mg/kg (Cohort 1 and Cohort 1-EX) and 30 mg/kg (Cohort 2 and Cohort 2-EX) every 3 wks for 45 weeks, and every 3 weeks thereafter for three additional treatment years. [Time Frame: Cohort 1: Up to 60 weeks, Cohort 1-EX (original subjects): up to 109 weeks, Cohort 1-EX (subjects who complete Week 48-EX and continue in the trial): up to 151 weeks, Cohort 2: up to 58 weeks, Cohort 2-EX: up to 202 weeks]

Secondary Outcome(s)

To evaluate the effect of FG-3019 on dyspnea in subjects with IPF. [Time Frame: Cohort 1: Up to 60 weeks, Cohort 1-EX (original subjects): up to 109 weeks, Cohort 1-EX (subjects who complete Week 48-EX and continue in the trial): up to 151 weeks, Cohort 2: up to 58 weeks, Cohort 2-EX: up to 202 weeks]

To evaluate the effect of FG-3019 on pulmonary function in subjects with IPF. [Time Frame: Cohort 1: Up to 60 weeks, Cohort 1-EX (original subjects): up to 109 weeks, Cohort 1-EX (subjects who complete Week 48-EX and continue in the trial): up to 151 weeks, Cohort 2: up to 58 weeks, Cohort 2-EX: up to 202 weeks]

To evaluate the effect of FG-3019 on the extent of pulmonary fibrosis in subjects with IPF. [Time Frame: Cohort 1: Up to 60 weeks, Cohort 1-EX (original subjects): up to 109 weeks, Cohort 1-EX (subjects who complete Week 48-EX and continue in the trial): up to 151 weeks, Cohort 2: up to 58 weeks, Cohort 2-EX: up to 202 weeks]

Secondary ID(s)

FGCL-3019-049

Source(s) of Monetary Support

Please refer to primary and secondary sponsors