NCT05003089

A Trial to Learn How BAY1834845 and BAY1830839 Affect Inflammation When Taken by Mouth Twice a Day for 7 Days in a Row in Healthy Male Participants

Completed Phase 1 Last updated 16 December 2022

What this trial tests

Phase 1 trial testing BAY1834845 in Immune Mediated Inflammatory Diseases in 51 participants. Completed in 20 January 2022.

Timeline

28 June 2021

Primary endpoint
16 December 2021

20 January 2022

Quick facts

Lead sponsor	Bayer
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	basic science
Enrollment	51
Start date	28 June 2021
Primary completion	16 December 2021
Estimated completion	20 January 2022
Sites	1 location across Netherlands

Drugs / interventions tested

• BAY1834845 — full drug profile →
• BAY1830839 — full drug profile →
• Prednisolone — full drug profile →
• Placebo

Conditions studied

• Immune Mediated Inflammatory Diseases — all drugs for Immune Mediated Inflammatory Diseases →

Sponsor

Bayer — full company profile →

Who can join

Adults 18 to 55, male only, with Immune Mediated Inflammatory Diseases. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The immune system helps protect the body from diseases. But, sometimes the immune system can be too sensitive and overreact to very small allergens, like dust and pet dander. This can cause skin conditions like dermatitis and eczema. People with these skin conditions have inflammation that can cause dry, red, and itchy skin. These symptoms often "flare up", meaning that the symptoms come back after being gone for some time.

Researchers are looking for a different way to treat people who have skin conditions caused by an overreaction of the immune system. Before a treatment is available to all patients, researchers study it in trials to better understand its safety and how well it works.

In this trial, the researchers will learn more about how BAY1834845 and BAY1830839 work and how safe they are in healthy male participants.

The trial will include about 72 healthy male participants who are between the ages of 18 and 55.

The researchers will use a computer program to randomly choose the treatment each participant will take. This will help make sure the treatments are chosen fairly. Researchers do this so that comparing the results of the treatments is accurate as possible. The participants will be randomly put into 1 of 4 groups. The participants will take their trial treatment 2 times a day for 7 days in a row.

* Group 1: BAY1834845 as tablets by mouth
* Group 2: BAY1830839 as tablets by mouth
* Group 3: A placebo as tablets by mouth
* Group 4: Prednisolone as tablets by mouth A placebo looks like a treatment but does not have any medicine in it. Prednisolone is a steroid treatment that is already available for doctors to prescribe to people with skin conditions caused by an overreaction of the immune system.

All the participants will also receive imiquimod applied as a cream to their back. All participants will also receive lipopolysaccharide as an intravenous infusion. Imiquimod and lipopolysaccharide will be used to cause irritation and inflammation of the skin and in the blood. The researchers want to see if treatment with BAY1834845 and BAY1830939 can then help reduce these symptoms of irritation and inflammation.

In this trial, the researchers will look at:

* the change in the amount of blood flow in the participants after imiquimod
* the change in how red the participants' skin is after imiquimod
* the change in the amount of inflammation applying the participants have after receiving lipopolysaccharide infusion

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Protein kinases: drug targets for immunological disorders.
   Castelo-Soccio L, Kim H, Gadina M, Schwartzberg PL, et al · · 2023 · cited 67× · PMID 37188939 · DOI 10.1038/s41577-023-00877-7
2. Targeting TLR Signaling Cascades in Systemic Lupus Erythematosus and Rheumatoid Arthritis: An Update.
   Kalliolias GD, Basdra EK, Papavassiliou AG. · · 2024 · cited 13× · PMID 38255243 · DOI 10.3390/biomedicines12010138
3. Emerging interleukin-1 receptor-associated kinase 4 (IRAK4) inhibitors or degraders as therapeutic agents for autoimmune diseases and cancer.
   Feng Y, Chen C, Shao A, Wu L, et al · · 2024 · cited 11× · PMID 39807338 · DOI 10.1016/j.apsb.2024.09.008
4. The oral IRAK4 inhibitors zabedosertib and BAY1830839 suppress local and systemic immune responses in a randomized trial in healthy male volunteers.
   Jodl SJ, Ten Voorde W, Klein S, Wagenfeld A, et al · · 2024 · cited 11× · PMID 38511583 · DOI 10.1111/cts.13771