NCT01366209

Brief Summary

PIPF-016 (ASCEND) is a Randomized, Double-Blind, Placebo Controlled, Phase 3 Study of the Efficacy and Safety of Pirfenidone in Patients with Idiopathic Pulmonary Fibrosis. The study objectives are to confirm the treatment effect of pirfenidone compared with placebo on change in percent predicted forced vital capacity (%FVC) in patients with idiopathic pulmonary fibrosis (IPF), and to confirm the safety of treatment with pirfenidone compared with placebo in patients with IPF.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
555

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jun 2011

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2011

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

June 2, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 3, 2011

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

March 12, 2015

Completed
Last Updated

April 5, 2017

Status Verified

March 1, 2017

Enrollment Period

2.7 years

First QC Date

June 2, 2011

Results QC Date

February 27, 2015

Last Update Submit

March 8, 2017

Conditions

Idiopathic Pulmonary Fibrosis

Keywords

PirfenidoneASCENDIPFFVC

Outcome Measures

Primary Outcomes (1)

  • Change in Percent Predicted Forced Vital Capacity (%FVC) From Baseline to Week 52

    52 weeks

Study Arms (2)

Active Arm

ACTIVE COMPARATOR
Drug: Pirfenidone

Placebo Arm

PLACEBO COMPARATOR
Drug: Placebo

Interventions

PirfenidoneDRUG

Pirfenidone, total daily dose of 2403 mg/ day, given as 3 divided doses 3 times per day.

Active Arm
PlaceboDRUG

Placebo equivalent given as 3 divided doses 3 times per day.

Placebo Arm

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of idiopathic pulmonary fibrosis (IPF), consistent with the ATS 2011 Guidelines, of 6-48 months' duration
  • Age 40 to 80 at randomization
  • Percent Forced Vital Capacity (%FVC) ≥50% and ≤90% at screening
  • Percent Carbon Monoxide Diffusing Capacity (%DLCO) ≥30% and ≤90% at screening

You may not qualify if:

  • Forced expiratory volume in one second (FEV1)/FVC ratio \<0.8 after administration of bronchodilator at Screening
  • Expected to receive a lung transplant within 1 year from randomization or, for patients at sites in the United States, on a lung transplant waiting list at randomization
  • Known explanation for interstitial lung disease
  • History of asthma or chronic obstructive pulmonary disease
  • Active infection
  • Ongoing IPF treatments including investigational therapy, immunosuppressants, and cytokine modulating agents
  • History of unstable or deteriorating cardiac or pulmonary disease (other than IPF) within the previous 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

InterMune Inc.

Brisbane, California, 94005, United States

Location

Related Publications (17)

  • Kulkarni T, Newton CA, Gupta S, Samara K, Bernstein EJ. The Impact of Autoantibodies on Outcomes in Patients with Idiopathic Pulmonary Fibrosis: Post-Hoc Analyses of the Phase III ASCEND Trial. Pulm Ther. 2024 Sep;10(3):331-346. doi: 10.1007/s41030-024-00267-x. Epub 2024 Jul 29.

    PMID: 39073523DERIVED

  • Behr J, Nathan SD, Costabel U, Albera C, Wuyts WA, Glassberg MK, Haller H Jr, Alvaro G, Gilberg F, Samara K, Lancaster L. Efficacy and Safety of Pirfenidone in Advanced Versus Non-Advanced Idiopathic Pulmonary Fibrosis: Post-Hoc Analysis of Six Clinical Studies. Adv Ther. 2023 Sep;40(9):3937-3955. doi: 10.1007/s12325-023-02565-3. Epub 2023 Jun 30.

    PMID: 37391667DERIVED

  • Allen RJ, Stockwell A, Oldham JM, Guillen-Guio B, Schwartz DA, Maher TM, Flores C, Noth I, Yaspan BL, Jenkins RG, Wain LV; International IPF Genetics Consortium. Genome-wide association study across five cohorts identifies five novel loci associated with idiopathic pulmonary fibrosis. Thorax. 2022 Aug;77(8):829-833. doi: 10.1136/thoraxjnl-2021-218577. Epub 2022 Jun 10.

    PMID: 35688625DERIVED

  • Kreuter M, Lee JS, Tzouvelekis A, Oldham JM, Molyneaux PL, Weycker D, Atwood M, Kirchgaessler KU, Maher TM. Monocyte Count as a Prognostic Biomarker in Patients with Idiopathic Pulmonary Fibrosis. Am J Respir Crit Care Med. 2021 Jul 1;204(1):74-81. doi: 10.1164/rccm.202003-0669OC.

    PMID: 33434107DERIVED

  • Glassberg MK, Nathan SD, Lin CY, Morgenthien EA, Stauffer JL, Chou W, Noble PW. Cardiovascular Risks, Bleeding Risks, and Clinical Events from 3 Phase III Trials of Pirfenidone in Patients with Idiopathic Pulmonary Fibrosis. Adv Ther. 2019 Oct;36(10):2910-2926. doi: 10.1007/s12325-019-01052-y. Epub 2019 Aug 10.

    PMID: 31401786DERIVED

  • Nathan SD, Costabel U, Albera C, Behr J, Wuyts WA, Kirchgaessler KU, Stauffer JL, Morgenthien E, Chou W, Limb SL, Noble PW. Pirfenidone in patients with idiopathic pulmonary fibrosis and more advanced lung function impairment. Respir Med. 2019 Jul;153:44-51. doi: 10.1016/j.rmed.2019.04.016. Epub 2019 Apr 24.

    PMID: 31153107DERIVED

  • Kreuter M, Lederer DJ, Molina-Molina M, Noth I, Valenzuela C, Frankenstein L, Weycker D, Atwood M, Kirchgaessler KU, Cottin V. Association of Angiotensin Modulators With the Course of Idiopathic Pulmonary Fibrosis. Chest. 2019 Oct;156(4):706-714. doi: 10.1016/j.chest.2019.04.015. Epub 2019 Apr 29.

    PMID: 31047956DERIVED

  • Nathan SD, Costabel U, Glaspole I, Glassberg MK, Lancaster LH, Lederer DJ, Pereira CA, Trzaskoma B, Morgenthien EA, Limb SL, Wells AU. Efficacy of Pirfenidone in the Context of Multiple Disease Progression Events in Patients With Idiopathic Pulmonary Fibrosis. Chest. 2019 Apr;155(4):712-719. doi: 10.1016/j.chest.2018.11.008. Epub 2018 Nov 22.

    PMID: 30472023DERIVED

  • Nathan SD, Lancaster LH, Albera C, Glassberg MK, Swigris JJ, Gilberg F, Kirchgaessler KU, Limb SL, Petzinger U, Noble PW. Dose modification and dose intensity during treatment with pirfenidone: analysis of pooled data from three multinational phase III trials. BMJ Open Respir Res. 2018 Aug 2;5(1):e000323. doi: 10.1136/bmjresp-2018-000323. eCollection 2018.

    PMID: 30116539DERIVED

  • Neighbors M, Cabanski CR, Ramalingam TR, Sheng XR, Tew GW, Gu C, Jia G, Peng K, Ray JM, Ley B, Wolters PJ, Collard HR, Arron JR. Prognostic and predictive biomarkers for patients with idiopathic pulmonary fibrosis treated with pirfenidone: post-hoc assessment of the CAPACITY and ASCEND trials. Lancet Respir Med. 2018 Aug;6(8):615-626. doi: 10.1016/S2213-2600(18)30185-1. Epub 2018 Jun 29.

    PMID: 30072107DERIVED

  • Paterniti MO, Bi Y, Rekic D, Wang Y, Karimi-Shah BA, Chowdhury BA. Acute Exacerbation and Decline in Forced Vital Capacity Are Associated with Increased Mortality in Idiopathic Pulmonary Fibrosis. Ann Am Thorac Soc. 2017 Sep;14(9):1395-1402. doi: 10.1513/AnnalsATS.201606-458OC.

    PMID: 28388260DERIVED

  • Kreuter M, Bonella F, Maher TM, Costabel U, Spagnolo P, Weycker D, Kirchgaessler KU, Kolb M. Effect of statins on disease-related outcomes in patients with idiopathic pulmonary fibrosis. Thorax. 2017 Feb;72(2):148-153. doi: 10.1136/thoraxjnl-2016-208819. Epub 2016 Oct 5.

    PMID: 27708114DERIVED

  • Nathan SD, Albera C, Bradford WZ, Costabel U, du Bois RM, Fagan EA, Fishman RS, Glaspole I, Glassberg MK, Glasscock KF, King TE Jr, Lancaster L, Lederer DJ, Lin Z, Pereira CA, Swigris JJ, Valeyre D, Noble PW, Wells AU. Effect of continued treatment with pirfenidone following clinically meaningful declines in forced vital capacity: analysis of data from three phase 3 trials in patients with idiopathic pulmonary fibrosis. Thorax. 2016 May;71(5):429-35. doi: 10.1136/thoraxjnl-2015-207011. Epub 2016 Mar 11.

    PMID: 26968970DERIVED

  • Lancaster L, Albera C, Bradford WZ, Costabel U, du Bois RM, Fagan EA, Fishman RS, Glaspole I, Glassberg MK, King TE Jr, Lederer DJ, Lin Z, Nathan SD, Pereira CA, Swigris JJ, Valeyre D, Noble PW. Safety of pirfenidone in patients with idiopathic pulmonary fibrosis: integrated analysis of cumulative data from 5 clinical trials. BMJ Open Respir Res. 2016 Jan 12;3(1):e000105. doi: 10.1136/bmjresp-2015-000105. eCollection 2016.

    PMID: 26835133DERIVED

  • Wijsenbeek MS, Grutters JC, Wuyts WA. Early Experience of Pirfenidone in Daily Clinical Practice in Belgium and The Netherlands: a Retrospective Cohort Analysis. Adv Ther. 2015 Jul;32(7):691-704. doi: 10.1007/s12325-015-0225-1. Epub 2015 Jul 15.

    PMID: 26173796DERIVED

  • Lederer DJ, Bradford WZ, Fagan EA, Glaspole I, Glassberg MK, Glasscock KF, Kardatzke D, King TE Jr, Lancaster LH, Nathan SD, Pereira CA, Sahn SA, Swigris JJ, Noble PW. Sensitivity Analyses of the Change in FVC in a Phase 3 Trial of Pirfenidone for Idiopathic Pulmonary Fibrosis. Chest. 2015 Jul;148(1):196-201. doi: 10.1378/chest.14-2817.

    PMID: 25856121DERIVED

  • King TE Jr, Bradford WZ, Castro-Bernardini S, Fagan EA, Glaspole I, Glassberg MK, Gorina E, Hopkins PM, Kardatzke D, Lancaster L, Lederer DJ, Nathan SD, Pereira CA, Sahn SA, Sussman R, Swigris JJ, Noble PW; ASCEND Study Group. A phase 3 trial of pirfenidone in patients with idiopathic pulmonary fibrosis. N Engl J Med. 2014 May 29;370(22):2083-92. doi: 10.1056/NEJMoa1402582. Epub 2014 May 18.

    PMID: 24836312DERIVED

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Interventions

pirfenidone

Condition Hierarchy (Ancestors)

Pulmonary FibrosisLung Diseases, InterstitialLung DiseasesRespiratory Tract Diseases

Results Point of Contact

Title
Medical Communications
Organization
Hoffmann-LaRoche
genentech@druginfo.com
800-821-8590

Study Officials

  • For additional information, call InterMune Medical Information Telephone: 1-888-486-6411

    InterMune

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 2, 2011

First Posted

June 3, 2011

Study Start

June 1, 2011

Primary Completion

February 1, 2014

Study Completion

February 1, 2014

Last Updated

April 5, 2017

Results First Posted

March 12, 2015

Record last verified: 2017-03

Locations

US(1)