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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 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 November 2017 October 2021

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 Completed June 2020 April 2023

Neratinib in patients with HER2+ breast cancer: a multi-centric, multi-national, prospective, longitudinal, non-interventional study in Switzerland, Germany and Austria. rEal-LifE pAN-HER-blOckade with neRatinib: ELEANOR

Oncology Real world study Completed July 2020 September 2024

A retrospective non interventional study on first line treatment for patients with BRAF V600E mutant metastatic colorectal cancer (mCRC) (CAPSTAN CRC)

Oncology Real world study Completed August 2020 March 2021

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 Completed September 2020 October 2023

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

Oncology Real world study Completed February 2021 March 2024

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 February 2021 January 2022

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 Active September 2021 September 2024

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 September 2021 May 2022

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 April 2022 January 2029

A Nerlyfe ancillary study to describe recurrence in breast cancer patients treated with neratinib in a real-world setting

Oncology Real world study Active not recruiting May 2022

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 Completed May 2022 November 2024

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 May 2022 January 2023

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 Real world study Active not recruiting May 2022 January 2026

An observational study to evaluate the quality of life of patients treated with phytotherapy or alpha-blockers for benign prostatic hyperplasia (PERQOL).

Urology Real world study Completed June 2022 July 2024

An observational study to describe treatment patterns of patients with BRAFV600E mutant metastatic non-small cell lung cancer - OCTOPUS.

Oncology Real world study Completed June 2022 January 2025

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 - NEAR.

Oncology Real world study Completed July 2022 July 2022

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 August 2022 December 2022

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

Oncology Real world study Recruiting May 2023 June 2028

A Prospective Non-Interventional Study on STRUctum® in Adult Patients with oSTeoarthritis – TRUST

Rhumatology Real world study Completed July 2023 October 2024

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