149 Participants NeededMy employer runs this trial

SYX-5219 for Eczema

Recruiting at 13 trial locations
ST
Overseen BySitryx Therapeutics
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment, SYX-5219, to evaluate its safety and effects on the body. Initially, the study will involve healthy individuals, then shift focus to those with atopic dermatitis (commonly known as eczema). In the eczema phase, participants will take the treatment for 42 days to help researchers assess its impact. Eligible participants must have a confirmed diagnosis of active eczema for at least six months, with symptoms covering a significant portion of their body. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

Will I have to stop taking my current medications?

The trial information does not specify if participants with eczema must stop their current medications. However, healthy volunteers in Parts 1 and 2 cannot use any prescription or non-prescription drugs, including supplements, within 35 days before starting the trial.

Is there any evidence suggesting that SYX-5219 is likely to be safe for humans?

Research has shown that SYX-5219 has been tested on healthy individuals and found to be safe and well-tolerated. Early trials reported no significant side effects among participants. The drug also benefited the immune system, showing promise for treating eczema. Specifically, it positively affected the body's defense system without causing major issues. While these early results are encouraging, ongoing studies will offer more detailed safety information.12345

Why do researchers think this study treatment might be promising for eczema?

Unlike the standard treatments for eczema, which typically involve topical steroids or immunosuppressants, SYX-5219 introduces a novel approach. Researchers are excited about SYX-5219 because it employs a unique mechanism that targets specific pathways involved in the inflammatory process of eczema, potentially offering more precise control over symptoms. Additionally, SYX-5219 is administered either as a single dose or multiple doses, which may provide flexibility and convenience for patients compared to current treatment regimens. This innovation could lead to more effective management of eczema with fewer side effects.

What evidence suggests that SYX-5219 might be an effective treatment for eczema?

Research has shown that SYX-5219 targets an enzyme called PKM2, which plays a role in cellular energy use. By affecting this enzyme, SYX-5219 may help control inflammation and reduce itching in atopic dermatitis, a type of eczema. Early studies found that SYX-5219 can lower substances in the body that signal inflammation. These findings suggest that SYX-5219 could be a safe and effective oral treatment for atopic dermatitis. It aims to relieve symptoms and might even lead to long-term improvement of the condition. Participants in this trial will receive SYX-5219 in different dosing regimens to evaluate its effectiveness and safety.678910

Who Is on the Research Team?

ST

Sitryx Therapeutics

Principal Investigator

Study Sponsor

Are You a Good Fit for This Trial?

This trial is for adults aged 18-65. Healthy volunteers can join Parts 1 and 2, while Part 3 is for people with moderate to severe eczema (atopic dermatitis) affecting at least 10% of their body for over six months. Participants must have stable health and meet certain lab and heart test requirements.

Inclusion Criteria

Part 3
I am 18-65 years old with active atopic dermatitis and my BMI is 40 or less.
I am a woman who cannot become pregnant or I am not having sex.
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Single Ascending Dose (SAD) and Food Effect

Participants receive single doses of SYX-5219 with a food effect evaluation including a second dosing period following washout

6 days
Multiple visits for dosing and monitoring

Multiple Ascending Dose (MAD)

Participants receive multiple doses of SYX-5219 over a defined treatment period

19 days
Multiple visits for dosing and monitoring

Multiple Dose in Participants with AD

Participants with AD receive SYX-5219 or placebo for up to 42 days

42 days
Regular visits for dosing and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

14 days
Follow-up visits for safety assessments

What Are the Treatments Tested in This Trial?

Interventions

  • SYX-5219

Trial Overview

The study tests an oral capsule called SYX-5219 in three parts: single or multiple doses in healthy volunteers, then multiple doses versus placebo in people with eczema over about six weeks. The main goals are to check safety, tolerability, and how the drug moves through the body.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Group I: Part 3 AD Participants Multiple DosesExperimental Treatment1 Intervention
Group II: Part 2 Multiple Ascending Dose (MAD)Experimental Treatment1 Intervention
Group III: Part 1 Single Ascending Dose (SAD)Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Sitryx Therapeutics Ltd

Lead Sponsor

Citations

Sitryx presents new preclinical data highlighting PKM2 as a ...

Preclinical data highlight that PKM2 modulation inhibits several important mechanisms underlying atopic dermatitis pathology; SYX-5219 is ...

Sitryx advances development of PKM2 modulator SYX ...

Phase 1a study align with pre-clinical data on SYX-5219 showing reduction of inflammatory markers and drivers of itch, and enhancement of repair ...

107 PKM2 is a promising novel target in atopic dermatitis

SYX-5219 could address the major unmet needs of AD as a safe oral, convenient and effective therapy for AD. 108. Guselkumab Pharmacokinetics and Immunogenicity ...

Long‐Term, Site‐Specific Effectiveness of Tralokinumab in ...

Tralokinumab, an anti‐IL‐13 antibody, is effective for atopic dermatitis (AD); however, its long‐term (> 1 year) effectiveness specific to each anatomical site ...

Sitryx initiates Phase 1 clinical trial of potential disease ...

SYX-5219 is a first-in-class oral PKM2 modulator designed to drive sustained disease remission; Novel mechanism of action suggests SYX-5219 ...

Sitryx advances development of PKM2 modulator SYX ...

The safety and pharmacology data, as well as the observed TARC reduction, provide biological evidence supporting SYX-5219's proposed mechanism ...

SYX-5219 shows safety and immune benefits in Ph...

The trial in healthy volunteers showed the drug was safe, well tolerated, and demonstrated immune system modulation by reducing a key ...

107 PKM2 is a promising novel target in atopic dermatitis

The PKM2 modulator, SYX-5219, has recently entered clinical trials in healthy volunteers and patients with moderate to severe AD. SYX-5219 could address the ...

A 3-part Study of SYX-5219 in Healthy Volunteers and ...

The objectives of this study are to determine the safety, tolerability and levels of SYX-5219 in the blood and urine when SYX-5219 is given in ...

First-in-Class Oral PKM2 Modulator SYX-5219 Phase 1a Trial

First-in-human healthy volunteers trial showed SYX-5219 was safe and well toleratedSystemic immunomodulation of type 2 inflammation ...