Evidence map›Paper›PMID 35058236›Full record

ArticleBMJ open respiratory research2022

CC-90001, a c-Jun N-terminal kinase (JNK) inhibitor, in patients with pulmonary fibrosis: design of a phase 2, randomised, placebo-controlled trial.

Zoran Popmihajlov, Donna J Sutherland, Gerald S Horan, Atalanta Ghosh, David A Lynch, Paul W Noble, Luca Richeldi, Theodore F Reiss, Steven Greenberg

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in BMJ open respiratory research, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03142191 (A Phase 2, 24-Week, Randomized, Double-blind, Placebo-controlled, Multicenter Study, With an 80-Week Active Treatment Extension, to Evaluate the Efficacy and Safety of CC-90001 in Subjects With Idiopathic Pulmonary Fibrosis), which is not on this map. Cited by 18 papers.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed
5.8field-weighted citation impact, top 3% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03142191 phase2terminatednot on this map

A Phase 2, 24-Week, Randomized, Double-blind, Placebo-controlled, Multicenter Study, With an 80-Week Active Treatment Extension, to Evaluate the Efficacy and Safety of CC-90001 in Subjects With Idiopathic Pulmonary Fibrosis

TypeinterventionalSponsorCelgeneRan2017 to 2021Enrolled138ConditionsIdiopathic Pulmonary Fibrosis, Fibrosis, Idiopathic Interstitial Pneumonias, Pathologic ProcessesArmsCC-90001, Placebo
3 · Its place in the literature

Who cites it

18 citing papers in PubMed, 38 citations in OpenAlex.

  1. Article
  2. Article
  3. Review
  4. Review
  5. Review
  6. Mechanisms and Therapeutic Potential of Myofibroblast Transformation in Pulmonary Fibrosis.Journal of respiratory biology and translational medicine · 2025
    Article
  7. Article
  8. Review
  9. Review
  10. Article
  11. c-Jun N-terminal kinase signaling in aging.Frontiers in aging neuroscience · 2024
    Review
  12. Article
  13. Article
  14. Article
  15. A Phase Ib Trial of AVID200, a TGFβ 1/3 Trap, in Patients with Myelofibrosis.Clinical cancer research : an official journal of the American Association for Cancer Research · 2023
    Article
  16. Article
  17. Article
  18. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 5 institutions in 3 countries.

Zoran PopmihajlovBristol Myers Squibb, Princeton, New Jersey, USA zoran.popmihajlov@bms.com.
Donna J SutherlandBristol Myers Squibb, Princeton, New Jersey, USA.
Gerald S HoranBristol Myers Squibb, Princeton, New Jersey, USA.
Atalanta GhoshBristol Myers Squibb, Princeton, New Jersey, USA.
David A LynchDepartment of Radiology, National Jewish Health, Denver, Colorado, USA.
Paul W NobleDepartment of Medicine, Cedars-Sinai Medical Center, Los Angeles, California, USA.
Luca RicheldiUniversità Cattolica del Sacro Cuore, Fondazione Policlinico A. Gemelli IRCSS, Rome, Italy.
Theodore F ReissBristol Myers Squibb, Princeton, New Jersey, USA.
Steven GreenbergBristol Myers Squibb, Princeton, New Jersey, USA.
Bristol-Myers Squibb (Germany) · DEBristol-Myers Squibb (United States) · USCedars-Sinai Medical Center · USNational Jewish Health · USUniversità Cattolica del Sacro Cuore · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionIdiopathic pulmonary fibrosis (IPF) is a progressive and often fatal interstitial lung disease (ILD); other ILDs have a progressive, fibrotic phenotype (PF-ILD). Antifibrotic agents can slow but not stop disease progression in patients with IPF or PF-ILD. c-Jun N-terminal kinases (JNKs) are stress-activated protein kinases implicated in the underlying mechanisms of fibrosis, including epithelial cell death, inflammation and polarisation of profibrotic macrophages, fibroblast activation and collagen production. CC-90001, an orally administered (PO), one time per day, JNK inhibitor, is being evaluated in IPF and PF-ILD. METHODS AND ANALYSIS: This is a phase 2, randomised, double-blind, placebo-controlled study evaluating efficacy and safety of CC-90001 in patients with IPF (main study) and patients with PF-ILD (substudy). Both include an 8-week screening period, a 24-week treatment period, up to an 80-week active-treatment extension and a 4-week post-treatment follow-up. Patients with IPF (n=165) will be randomised 1:1:1 to receive 200 mg or 400 mg CC-90001 or placebo administered PO one time per day; up to 25 patients/arm will be permitted concomitant pirfenidone use. Forty-five patients in the PF-ILD substudy will be randomised 2:1 to receive 400 mg CC-90001 or placebo. The primary endpoint is change in per cent predicted forced vital capacity from baseline to Week 24 in patients with IPF. ETHICS AND DISSEMINATION: This study will be conducted in accordance with Good Clinical Practice guidelines, Declaration of Helsinki principles and local ethical and legal requirements. Results will be reported in a peer-reviewed publication. TRIAL REGISTRATION NUMBER: NCT03142191.

Indexed as

Idiopathic Pulmonary FibrosisLung Diseases, InterstitialProtein Kinase InhibitorsClinical Trials, Phase II as TopicFibrosisHumansJNK Mitogen-Activated Protein KinasesPyrimidinesRandomized Controlled Trials as TopicVital CapacityJNK Mitogen-Activated Protein KinasesProtein Kinase InhibitorsPyrimidinesinterstitial fibrosis

Identifiers

PMID35058236
PMCPMC8783810
OpenAlexW4205586110

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.