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A phase III, randomized, open label, multicenter, controlled trial of niraparib versus physician*s choice in previously-treated, HER2 negative, germline BRCA mutation-positive breast cancer;patients

Primary objective: To compare progression-free survival (PFS) as assessed by blinded, central review between patients randomized to niraparib versus physician*s choice. Key secondary objective: To compare overall survival between patients randomized…

A RANDOMIZED COMPARISON OF DEGRADABLE ESOPHAGEAL STENT VS DILATION THERAPY: *DESTINY TRIAL* FOR PATIENTS WITH RECURRENT BENIGN ESOPHAGEAL STRICTURES

To compare the efficacy and safety of dilation of recurrent benign esophageal strictures by using a degradable self-expanding stent or standard dilation therapy.

A two-part phase I study with the antibody-drug conjugate SYD985 in combination with niraparib to evaluate safety, pharmacokinetics and efficacy in patients with HER2-expressing locally advanced or metastatic solid tumours.

Objectives: The primary objectives of this study are: • Part 1 (dose-escalation): To evaluate the safety of SYD985 in combination with niraparib to determine the maximum tolerated dose (MTD) and recommended combination dose regimen for expansion (…

An open-label, randomized study to assess the relative bioavailability (BA) and bioequivalence (BE) of fixed-dose combination (FDC) formulations of niraparib plus abiraterone acetate (AA) compared to niraparib and AA co-administered as single agents in men with prostate cancer

This study has been transitioned to CTIS with ID 2023-508150-26-00 check the CTIS register for the current data. Primary Objectives:- To determine the BE of a RS FDC tablet formulation of niraparib and Abiraterone Acetate with respect to niraparib…

A Randomized Phase 3 Double-Blinded Study Comparing the Efficacy and Safety of Niraparib to Placebo in Participants with Either HER2-Negative BRCA-Mutated or Triple-Negative Breast Cancer with Molecular Disease Based on Presence of Circulating Tumor DNA After Definitive Therapy (ZEST)

This study has been transitioned to CTIS with ID 2023-504454-35-00 check the CTIS register for the current data. Primary objective:Evaulation of safety and tolerability of niraparibExploratory:Evaluation of the efficacy of niraparib relative to…

Randomized, double-blind, placebo-controlled, study of spesolimab in patients with moderate or severe hidradenitis suppurativa.

The primary objective is to estimate the effect of spesolimab compared to placebo for the mean percent change from baseline in total abscessand inflammatory nodule count at Week 12. Secondary objectives are the evaluation of efficacy of spesolimab…

Multi-center, double-blind, randomized, placebo-controlled, phase IIa trial to evaluate spesolimab (BI 655130) efficacy in patients with fibrostenotic Crohn*s Disease

To demonstrate that spesolimab is effective in maintaining Symptomatic Stenosis Responseand / or inducing Radiographic Stenosis Response (defined in Table 2.3: 1) in patients withsymptomatic CD-related small bowel stenosis, who have achieved…

A feasibility study of niraparib for advanced, BRCA1-like, HER2-negative breast cancer patients: the ABC study

To establish whether niraparib single agent treatment in advanced BRCA1-like, HER2 negative breast cancer patients deserves to be further studied

A Phase 2 Efficacy and Safety Study of Niraparib in Men with Metastatic Castration-
Resistant Prostate Cancer and DNA-Repair Anomalies

Primary objective:- To assess the efficacy of niraparib in subjects with measurable mCRPC and who have either biallelic DNA-repair anomalies in BRCA (BRCA 1 and BRCA 2 or germline BRCA. Secondary objectives:- To assess the efficacy of niraparib in…

A Phase II/III Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of BI 655130 Induction Therapy in patients with moderate-to-severely active ulcerative colitis who have failed previous biologics therapy

Protocol section 2.1 and 2.2

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Comparing Niraparib Plus Pembrolizumab Versus Placebo Plus Pembrolizumab as Maintenance Therapy in Participants Whose Disease has Remained Stable or Responded to First-Line Platinum-Based Chemotherapy with Pembrolizumab for Stage IIIB/IIIC or IV Non-Small Cell Lung Cancer (ZEAL-1L)

This study has been transitioned to CTIS with ID 2023-508443-40-00 check the CTIS register for the current data. Dual Primary Objectives:• To compare progression-free survival (PFS) as assessed by Blinded Independent Central Review (BICR) using…

A RANDOMIZED, DOUBLE-BLIND, PHASE 3 COMPARISON OF PLATINUM-BASED THERAPY WITH TSR 042 AND NIRAPARIB VERSUS STANDARD OF CARE PLATINUM-BASED THERAPY AS FIRST LINE TREATMENT OF STAGE III OR IV NONMUCINOUS EPITHELIAL OVARIAN CANCER

This study has been transitioned to CTIS with ID 2024-510605-28-00 check the CTIS register for the current data. Primary Objective• To compare the progression free survival (PFS) of programmed death-ligand 1 (PD-L1) positive patients with Stage III…

Effisayil* 2: Multi-center, randomized, parallel group, double blind, placebo controlled, Phase IIb dose-finding study to evaluate efficacy and safety of BI 655130 (Spesolimab) compared to placebo in preventing generalized pustular psoriasis (GPP) flares in patients with history of GPP

The primary objective of the trial is to demonstrate a non-flat curve and evaluate the doseresponse relationship for 3 subcutaneous dosing regimens of BI 655130 (spesolimab) (with each regimen consisting of a single loading dose and a separate…

A Phase 3 Randomized, Placebo-controlled, Double-blind Study of Niraparib in Combination with Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for Treatment of Subjects with Metastatic Prostate Cancer

The purpose of this study is to understand if a new treatment for prostate cancer (niraparib) added to a standard treatment (abiraterone acetate plus prednisone) will work better than the standard treatment alone.Cohort 3: the purpose is to evaluate…

Exploratory study of neo-adjuvant treatment with carboplatin, paclitaxel and pembrolizumab in primary stage IV serous ovarian cancer

The primary objective of this study is to determine the immune-activating capacity of treatment with pembrolizumab and carboplatin/paclitaxel in the neo-adjuvant setting of primary stage IV ovarian cancer as measured by the alteration in magnitude…

A Phase 3 Randomized, Placebo-controlled, Double-blind Study of Niraparib in Combination with Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for the Treatment of Participants with Deleterious Germline or Somatic Homologous Recombination Repair (HRR) Gene-Mutated Metastatic Castration-Sensitive Prostate Cancer (mCSPC)

This study has been transitioned to CTIS with ID 2023-506365-64-00 check the CTIS register for the current data. The purpose of this study is to investigate if niraparib added to a standard treatment (consisting of abiraterone acetate plus…

An open-label, long-term extension trial of spesolimab treatment in adult patients with Hidradenitis Suppurativa (HS)

The primary objective of this trial is to assess the long-term safety of spesolimab in patients with HS who have completed the 1368-0052 PoCC trial and are qualified for entry into this trial. The secondary objectives are to evaluate efficacy at a…