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Our clinical studies

We are committed to make our Clinical trials Information and Results accessible and transparent while maintaining participants privacy.

 

Clinical studies

This site provides information on both ongoing and completed clinical trials sponsored by Pierre Fabre since 2004. Real-world evidence studies which began after 01 January 2020 are also accessible.

 

Total studies

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Current studies

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Oncology

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Dermatology

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Rare diseases

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Title Therapeutic area Phase Status Start date Planned End date

Phase 2, open-label, single arm, multicenter study of Encorafenib, Binimetinib plus Cetuximab in subjects with previously untreated BRAFV600E -mutant metastatic colorectal cancer

Oncology Phase II Active not recruiting 14 January 2019 March 2023

A prospective, open-label, genotype-match controlled, multicenter clinical trial to investigate the efficacy and safety of intra-amniotic ER004 as a prenatal treatment for male subjects with X-linked hypohidrotic ectodermal dysplasia (XLHED)

Dermatology Phase II Recruiting 26 April 2022 January 2029

Multicenter, Open-label, Phase II Study with a Safety Lead-in part Investigating the Efficacy, Safety and Pharmacokinetics of Encorafenib and Binimetinib Combination in BRAFV600E mutated Chinese Patients with Metastatic Non-Small Cell Lung Cancer who are BRAF- and MEK inhibitor treatment-naïve

Oncology Phase II Recruiting 02 June 2022 February 2025

A multicenter, randomized, open-label, 2-arm, Phase II trial with a safety lead-in phase evaluating the combination of encorafenib and cetuximab versus irinotecan/cetuximab or infusional 5-fluorouracil (5-FU)/folinic acid (FA)/irinotecan (FOLFIRI)/cetuximab in Chinese patients with BRAFV600E mutant metastatic colorectal cancer.

Oncology Phase II Recruiting 02 September 2021 September 2024

Phase I dose escalation and dose expansion, international, multicenter study of W0180 as single agent and in combination with pembrolizumab (anti-PD-1) in adult participants with locally advanced or metastatic solid tumors.

Oncology Phase I Recruiting 08 September 2020 May 2024

A randomized, single-center, open-label, single dose, two-period, crossover pivotal bioequivalence study comparing binimetinib 3 x 15 mg and 45 mg tablets in healthy participants

Oncology Phase I Completed 31 August 2022 December 2022

An open label, multicentre, phase I study to evaluate the impact of moderate and severe hepatic impairments on the pharmacokinetics and safety of encorafenib in combination with binimetinib in adult patients with unresectable or metastatic BRAF V600-mutant solid tumors.

Oncology Phase I Completed 30 May 2022 December 2023

A multicenter, open-label, phase 1 study investigating the safety and tolerability of encorafenib monotherapy in BRAFV600E-mutated Chinese patients with advanced metastatic solid tumors

Oncology Phase I Completed 15 September 2021 06 May 2022

Frequency and Intensity of local reactions in patients treated with 4% 5-FU vs 4% 5-FU associated with an emollient cream: a randomised, controlled clinical trial

Dermatology Phase IV Completed 16 February 2021 31 January 2022

An observational study describing diagnosis and treatment patterns in adults with metastatic non-small cell lung cancer with BRAF V600E mutation in clinical practice, to assess treatment effectiveness and quality of life.

Oncology RWE Recruiting 23 June 2022 June 2025

Advanced breast cancer patients treated with oral vinorelbine: a prospective and retrospective, observational study – VINOREAL

Oncology RWE Active 03 May 2023 30 June 2028

Encorafenib in combination with Cetuximab in BRAFV600E–Mutated Metastatic Colorectal Cancer: A European pooled analysis of observational studies

Oncology RWE Completed 01 January 2020 31 October 2024

Multicentre, multi-country, prospective, observational, post-authorisation safety study to describe the incidence of discontinuation due to diarrhoea within the first 3 months of treatment with neratinib, in adult breast cancer patients treated in extended adjuvant in a real-world setting: the NERLYFE study..

Oncology RWE Recruiting 09 May 2022 January 2026

A 6-months prospective, observational study to evaluate the quality of life of patients treated with phytotherapy or alpha-blockers for benign prostatic hyperplasia.

Urology RWE Active June 2022 February 2024

Retrospective observational study of adult patients with early-stage HER-2 positive breast cancer, treated with neratinib as extended adjuvant therapy in the context of the European Early Access Program.

Oncology RWE Completed July 2022 July 2023

A prospective non interventional study on targeted therapy for patients with unresectable or metastatic BRAFV600E mutant melanoma (TAVIE-Skin)

Oncology RWE Recruiting February 2021 December 2024

Phase I/II open label dose escalation and dose expansion study of intravenous infusion of W0101, an antibody-drug conjugate, in patients with advanced or metastatic solid tumors. International, multicenter, open label study.

Oncology Phase I / II Completed 24 November 2017 04 October 2021

Adjuvant encorafenib & binimetinib vs. placebo in resected stage II BRAF V600E/K mutated melanoma: a randomized triple-blind Phase III Study in collaboration with the EORTC Melanoma Group.

Oncology Phase III Active not recruiting 18 May 2022 May 2035

Get access to Partner's pivotal studies supporting our authorized drugs in Europe

Results from pivotal studies conducted by our partners and supporting a marketing approval for whom Pierre Fabre is the holder in Europe are shared below:

 

Melanoma

SPONSOR: PFIZER

Breast cancer 

SPONSOR: PUMA BIOTECHNOLOGY

Colorectal cancer

SPONSOR: PFIZER

Post-transplantation lymphoproliferative disease EBV+

SPONSOR: ATARA