A Phase II, Randomised, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging, Proof-of-concept Trial of BI 730357 Given for 12 Weeks in Patients With Active Psoriatic Arthritis

This study is open to adults with active psoriatic arthritis who have tender and swollen joints. The purpose of this study is to find out whether a medicine called BI 730357 helps to reduce symptoms and to prevent damage to joints.
Three different doses of BI 730357 are tested. Participants are put into 4 groups by chance. Participants in 3 of the 4 groups take BI 730357. Participants in the fourth group take placebo. Participants take BI 730357 or placebo as tablets once a day. Placebo tablets look like BI 730357 tablets but do not contain any medicine.
Participants are in the study for about 4.5 months. During this time, they visit the study site about 8 times. At these visits, doctors check whether the swelling of inflamed joints has changed. The results between the BI 730357 and placebo groups are then compared. Doctors also regularly check the general health of the participants.

Start Date02 May 2022

Sponsor / Collaborator

Boehringer Ingelheim GmbH

ACTRN12620001092987 / Not yet recruitingPhase 2

A Phase II, randomised, double-blind, placebo-controlled, parallel-group, dose-ranging, efficacy and safety trial of BI 730357 given for 12 weeks in patients with active psoriatic arthritis

Start Date04 Apr 2022

Sponsor / Collaborator

Boehringer Ingelheim Pty Ltd.

NCT04679948 / CompletedPhase 1

The Effect of Multiple Doses of BI 730357 on the Single Dose Pharmacokinetics of Caffeine, Warfarin, Omeprazole and Midazolam Administered Orally as a Cocktail in Healthy Subjects (an Open-label, Two-period Fixed Sequence Design Trial)

The trial will be performed to assess the influence of BI 730357 on the pharmacokinetics of caffeine, warfarin, omeprazole and midazolam.

Start Date21 Dec 2020

Sponsor / Collaborator

Boehringer Ingelheim GmbH

100 Clinical Results associated with Bevurogant

100 Translational Medicine associated with Bevurogant

100 Patents (Medical) associated with Bevurogant

Literatures (Medical) associated with Bevurogant

01 Feb 2024·Clinical pharmacology in drug development

The Effect of BI 730357 (Retinoic Acid‐Related Orphan Receptor Gamma t Antagonist, Bevurogant) on the Pharmacokinetics of a Transporter Probe Cocktail, Including Digoxin, Furosemide, Metformin, and Rosuvastatin: An Open‐Label, Non‐randomized, 2‐Period Fixed‐Sequence Trial in Healthy Subjects

Article

Author: Huang, Fenglei ; Choi, HeeJae ; Flack, Mary

Abstract:

Evaluating Drug‐Drug Interactions (DDIs) for new investigational compounds requires several trials evaluating different drugs with different transporter specificities. By using a cocktail of drugs with different transporter specificities, a single trial could evaluate the pharmacokinetics (PKs) of each cocktail drug simultaneously, reducing the number of clinical DDI trials required for clinical development. We aimed to investigate the effect of steady‐state Boehringer Ingelheim (BI) 730357 (bevurogant) on the PKs of a validated and optimized 4‐component transporter cocktail. This open‐label, non‐randomized, 2‐period fixed‐sequence phase I trial compared transporter cocktail (0.25 mg digoxin/1 mg furosemide/10 mg metformin hydrochloride/10 mg rosuvastatin) with and without BI 730357 in healthy subjects aged 18‐55 years with body mass index 18.5‐29.9 kg/m2. During reference treatment/period 1, transporter cocktail was administered 90 minutes after breakfast. After a washout period, during test treatment/period 2, BI 730357 was dosed twice daily for 13 days, with transporter cocktail administered on day 1. The primary endpoints were the area under the concentration‐time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0‐∞) and the maximum measured concentration of the analyte in plasma (Cmax), and the secondary endpoint was the area under the concentration‐time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point (AUC0‐tz). Steady‐state BI 730357 increased digoxin (+48% to +94%), minimally affected metformin (−2% to −9%), furosemide (+12% to +18%), and rosuvastatin (+19% to +39%) exposure. Therefore, no clinically relevant inhibition of transporters OCT2/MATE‐1/MATE‐2K, OAT1/OAT3, OATP1B1/OATP1B3 was observed. Potential inhibition of breast cancer resistance protein noted as PK parameters of coproporphyrin I/III (OATP1B1/OATP1B3 biomarkers) remained within bioequivalence boundaries while rosuvastatin PK parameters (AUC0‐∞/Cmax/AUC0‐tz) exceeded the bioequivalence boundary. BI 730357 was safe and well tolerated. This trial confirms the usefulness and tolerability of the transporter cocktail consisting of digoxin, furosemide, metformin, and rosuvastatin in assessing drug‐transporter interactions in vivo.

01 Jun 2023·CPT: pharmacometrics & systems pharmacology

Bounded integer model-based analysis of psoriasis area and severity index in patients with moderate-to-severe plaque psoriasis receiving BI 730357.

Article

Author: Ooi, Qing Xi ; Plan, Elodie ; Kristoffersson, Anders ; Weber, Benjamin ; Korell, Julia ; Flack, Mary

BI 730357 is investigated as an oral treatment of plaque psoriasis. We analyzed the impact of three dosage regimens on the Psoriasis Area and Severity Index (PASI) response with modeling based on phase I and II data from 109 healthy subjects and 274 patients with moderate-to-severe plaque psoriasis. The pharmacokinetics (PK) was characterized by a two-compartment model with dual absorption paths and a first-order elimination. Higher baseline C-reactive protein was associated with lower clearance and patients generally had lower clearance compared with healthy subjects. A bounded integer PK/pharmacodynamic model characterized the effect on the observed PASI. The maximum drug effect was largest for patients with no prior biologic use, smaller for patients with prior use of non-interleukin-17 inhibitors, and smallest for patients with prior interleukin-17 inhibitor use. The models allowed robust simulation of large patient populations, predicting a plateau in PASI outcomes for BI 730357 exposure above 2000 nmol/L.

02 Dec 2021·Expert opinion on drug discoveryQ3 · MEDICINE

Retinoic acid-related orphan receptor gamma t (RORγt) inverse agonists/antagonists for the treatment of inflammatory diseases – where are we presently?

Q3 · MEDICINE

Review

Author: Gege, Christian

Introduction: The transcription factor retinoic acid-related orphan receptor gamma t (RORγt) has been identified as the master regulator of T_H17 cell differentiation and IL-17/22 production and is therefore an attractive target for the treatment of inflammatory diseases. Several orally or topically administered small molecule RORγt inverse agonists (RIAs) have progressed up to the end of clinical Phase 2.Areas covered: Based on publications and patent evaluations this review summarizes the evolution of the chemical matter for all 16 pharmaceutical companies, who develop(ed) a clinical-stage RIAs (until March 2021). Structure proposals for some clinical stage RIAs are presented and the outcome of the clinical trials is discussed.Expert opinion: So far, the clinical trials have been plagued with a high attrition rate. Main reasons were lack of efficacy (topical) or safety signals (oral) as well as, amongst other things, thymic lymphomas as seen with BMS-986251 in a preclinical study and liver enzyme elevations in humans with VTP-43742. Possibilities to mitigate these risks could be the use of RIAs with different chemical structures not interfering with thymocytes maturation and no livertox-inducing properties. With new frontrunners (e.g., ABBV-157 (cedirogant), BI 730357 or IMU-935) this is still an exciting time for this treatment approach.

News (Medical) associated with Bevurogant

18 Jun 2021

·www.globenewswire.com

Axial Spondyloarthritis Pipeline: Drug Pipeline, Regulatory Events and Clinical Trials in the Spotlight| Insights by DelveInsight

Los Angeles, June 17, 2021 (GLOBE NEWSWIRE) -- Axial Spondyloarthritis Pipeline: Drug Pipeline, Regulatory Events and Clinical Trials in the Spotlight| Insights by DelveInsight The report offers the most up-to-date information on Axial Spondyloarthritis pipeline products being developed by notable companies such as Pfizer, Suzhou Zelgen Biopharmaceuticals, Clover Biopharmaceuticals, FunPep Co Ltd., Kinevant Sciences, Izana Bioscience, Mycenax Biotech, and UCB Biopharma, among others. DelveInsight’s ‘Axial Spondyloarthritis (axSpA) Pipeline Insights’ report offers exhaustive coverage of the emerging therapies in different stages of development from pre-clinical till late-stage, along with dormant, inactive, and abandoned therapeutic agents. Some of the important takeaways from the Axial Spondyloarthritis Pipeline report: Request for Sample to know more about the therapies expected to make grab the maximum patient pool @ Axial Spondyloarthritis Emerging Therapies and Forecast The Axial Spondyloarthritis Pipeline reports lay down a thorough coverage of the ongoing clinical trials, collaborations taking place in the domain, recent happenings in the Axial Spondyloarthritis pipeline space, and growth prospects across the Axial Spondyloarthritis domain. Axial Spondyloarthritis: Overview Axial Spondyloarthritis is a chronic, inflammatory rheumatic disease that affects primarily the axial joints leading to severe pain, stiffness, and fatigue. It starts with an early inflammatory phase in which there is no structural damage in the sacroiliac joints (non-radiographic disease) progressing to later stages in which structural damage is visible on X‑ray scans of the sacroiliac joints as erosions, sclerosis, or bony bridges (radiographic disease; also known as Ankylosing Spondylitis). Discover more about the disease, treatments, and pipeline therapies @ axSpA Pipeline Assessment Axial Spondyloarthritis Pipeline Drugs Request for Sample to know more @ Axial Spondyloarthritis Pipeline Analysis, Key Companies, and Futuristic Trends Axial Spondyloarthritis Therapeutics Assessment The Axial Spondyloarthritis Pipeline report presents a kaleidoscopic view of the axSpA emerging novel therapies segmented by Stage, Product Type, Route of Administration (RoA), Molecule Type, Target, and Mechanism of Action. By Product Type By Stage By Molecule Type By Route of Administration By Mechanism of Action By Targets For rich insights into merging therapies and assessment, visit Axial Spondyloarthritis Pipeline: Emerging Novel Therapies Scope of the Axial Spondyloarthritis Pipeline Report Coverage: GlobalKey Players: Izana Bioscience, UCB, Sun Pharma Global, Akeso Biopharma, Kinevant Sciences, Jiangsu Hengrui Medicine Co., Suzhou Zelgen Biopharmaceuticals, Clover Biopharmaceuticals, Mycenax Biotech, Boehringer Ingelheim, and Qyuns Therapeutics among others.Key Axial Spondyloarthritis Pipeline Therapies: Namilumab , Bimekizumab, Tofacitinib, Tildrakizumab, AK-111, NDI 031232, Gimsilumab, QX002N, SHR-0302, Jaktinib, SCB-808, FPP003, KIN-1901, ENIA11, BI 730357, and QX002N among others. Discover more about the report offerings @ axSpA Emerging Therapies, Treatments, and Ongoing Clinical Trials Table of Contents Get in touch with our Business executive for Regulatory Analysis, Licensing Services, and Consulting Solutions Related Reports Axial Spondyloarthritis MarketDelveInsight's "Axial Spondyloarthritis Market Insights, Epidemiology, and Market Forecast-2030" report. Non-Radiographic Axial Spondyloarthritis MarketDelveInsight's "Non-Radiographic Axial Spondyloarthritis (nr-AxSpA) Market Insights, Epidemiology, and Market Forecast-2030" report. Spondylolisthesis Market InsightsDelveInsight's “Spondylolisthesis Market Insights, Epidemiology, and Market Forecast-2030" report. Ankylosing Spondylitis MarketDelveInsight’s ‘Ankylosing Spondylitis Market Insights, Epidemiology, and Market Forecast–2030’ report. Global Kinase Inhibitor In Autoimmune Diseases MarketDelveInsight’s ‘Global Kinase Inhibitor in Autoimmune Diseases Market Insights and Market Forecast – 2030’ report. Adenosine Deaminase Severe Combined Immunodeficiency MarketDelveInsight's "Adenosine Deaminase-Severe Combined Immunodeficiency Market Insights, Epidemiology, and Market Forecast-2030" report. Adult-Onset Still Disease MarketDelveInsight’s “Adult-onset Still’s Disease Market Insights, Epidemiology, and Market Forecast – 2030” report. Browse through our posts ABSSSI Pipeline Analysis Parkinson's Disease Risk FactorsWearable Healthcare Devices Market About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve. For more insights, visit Pharma, Healthcare, and Biotech News

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R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Arthritis, Psoriatic	Phase 2	-	Boehringer Ingelheim GmbH	02 May 2022
Plaque psoriasis	Phase 2	US	Boehringer Ingelheim GmbH	17 Sep 2018
Plaque psoriasis	Phase 2	CA	Boehringer Ingelheim GmbH	17 Sep 2018
Plaque psoriasis	Phase 2	DE	Boehringer Ingelheim GmbH	17 Sep 2018

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03804671 (CTgov)	Phase 1	-	6	[C-14] BI 730357	jkwzxrxxrs(ztdzrpegov) = atnhpwrolg qvlracjqry (teeyvpmhgc, rqeslyrblx - uipacbixsn) View more	-	25 Jul 2023
NCT04147260 (CTgov)	Phase 1	-	85	Placebo (Placebo QD)	hqqezwwnnz(gnvgnnhoeq) = ddsidcsiza skqsisyvnz (fnwaagzwcv, gettaqkvwq - dwmaeevjls) View more	-	17 Jul 2023
				BI 730357 (400 mg QD BI 730357)	hqqezwwnnz(gnvgnnhoeq) = stzgcqnnvr skqsisyvnz (fnwaagzwcv, jrdqcsbigc - uxuvrtdiio) View more
NCT03886272 (CTgov)	Phase 1	-	43	BI 730357 (50 mg BI 730357 iCF (T1))	ecxrdxebwf(yfdnjacscu) = ympvrzbnip gswxsdumes (pmumnpomcj, cuoizlgcjq - jfdndtbebd) View more	-	17 Jul 2023
				TF1 (R1)+BI 730357 (50 mg BI 730357 TF1 (R1))	ecxrdxebwf(yfdnjacscu) = wjdrqknvxd gswxsdumes (pmumnpomcj, iteuhpmfuq - lmpmmcjqsy) View more
NCT03793621 (CTgov)	Phase 1	-	24	Placebo	kibjxkhnye(ezsfiuxzzp) = ovfyygtdef uvazwdxecf (qpiysttoya, smeifvdnka - iwcxfckrox) View more	-	12 Jul 2023
NCT03664011 (CTgov)	Phase 1	-	6	BI 730357 BS (BI 730357)	lnepbhxslm(wkpdbjejan) = uvwyzksnkt ikavjfopoc (uoafbwavst, ttgtjluecc - lanbzbfurl) View more	-	12 Jul 2023
				BI 730357 (14C-BI 730357-EQ and BI 730357)	hisedifrex(nitcjlkpwi) = cenarnlmsv cnbvkoroum (vgbexldbdo, ncbcqixdvn - abzjvtljvz) View more
NCT03782987 (CTgov)	Phase 1	-	14	itraconazole+BI 730357 (BI 730357 + Itraconazole (T))	ytqxczvcgm(dtsczxkvuh) = fgeyeesspg wgmyjjyfaz (ryzqgxvicw, ewxmfunvfp - cjmuvuzvfy) View more	-	12 Jul 2023
				BI 730357 (BI 730357 (R))	ytqxczvcgm(dtsczxkvuh) = gsyppvajpa wgmyjjyfaz (ryzqgxvicw, thwhbekzih - jdtjogxxcp) View more

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