SAR444656 for Eczema

(ADVANTA Trial)

Not currently recruiting at 60 trial locations

Overseen By Trial Transparency email recommended (Toll free number for US & Canada)

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Sanofi

Disqualifiers: Psoriasis, Lupus, Immunosuppression, Malignancy, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 16 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called SAR444656 for individuals with eczema, a skin condition causing itchy and inflamed patches. The goal is to evaluate the effectiveness of different doses of SAR444656 compared to a placebo, a non-active lookalike pill. It targets those whose eczema isn't controlled by creams or who can't use them and might need a systemic treatment. Individuals who have had eczema for at least a year and find creams ineffective might be suitable candidates. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, it mentions that certain therapies are prohibited within a specific timeframe before the baseline visit, so it's best to discuss your current medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that SAR444656, also known as KT-474, has undergone safety testing in people. In a previous study, researchers examined how well participants tolerated the treatment by testing different doses. The primary goal was to identify any side effects or adverse reactions.

The results indicated that SAR444656 was generally well-tolerated. Most side effects were mild to moderate, such as headaches or stomach discomfort, while serious side effects were rare. This suggests that SAR444656 is relatively safe at the doses tested. However, ongoing safety monitoring remains crucial as more people participate in trials. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard eczema treatments, which often include topical steroids and immunosuppressants, SAR444656 is taken orally and offers a fresh approach. Researchers are excited because SAR444656 might target the underlying inflammation with a novel mechanism that could enhance efficacy and safety compared to existing options. With its distinct oral delivery, SAR444656 could provide a more convenient alternative for those who struggle with topical treatments.

What evidence suggests that this trial's treatments could be effective for eczema?

Research has shown that SAR444656 is a promising new treatment for immune-inflammatory diseases. It breaks down a protein called IRAK4, which causes inflammation. Early studies have demonstrated that SAR444656 reduces inflammation by blocking a pathway that activates the immune system. This could help conditions like eczema, where the immune system overreacts. Although detailed information on its effectiveness for eczema is limited, its mechanism suggests potential benefits. Early trials focused on safety and understanding how the drug works in the body, paving the way for the current study, which will evaluate the effectiveness of different doses of SAR444656. ^{1 2 4 5 6}

Are You a Good Fit for This Trial?

Adults with moderate to severe atopic dermatitis (AD), who haven't responded well to topical treatments or can't use them, are eligible for this trial. They must have had AD for at least a year, an EASI score of 12 or more, and AD covering 10% of their body. Participants need to commit to using daily moisturizers and completing an electronic diary throughout the study.

Inclusion Criteria

Topical medications haven't worked for me or are not advised.

My skin condition affects more than 10% of my body.

I have used a daily moisturizer for at least the last 7 days and will continue to do so.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 to 4 weeks

Treatment

Participants receive SAR444656 dose 1, dose 2, dose 3, or matching placebo for 16 weeks

16 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• SAR444656

Trial Overview The trial is testing two different doses of SAR444656 against a placebo in adults with AD. It's designed as a double-blind study where neither participants nor researchers know who gets the actual drug versus placebo. The treatment lasts 16 weeks followed by a follow-up period, with patients grouped based on their severity of AD.

How Is the Trial Designed?

Group I: SAR444656 dose 3 Experimental Treatment 1 Intervention

Participants will receive SAR444656 dose 3 orally

Group II: SAR444656 dose 2 Experimental Treatment 1 Intervention

Participants will receive SAR444656 dose 2 orally

Group III: SAR444656 dose 1 Experimental Treatment 1 Intervention

Participants will receive SAR444656 dose 1 orally

Group IV: Placebo Placebo Group 1 Intervention

Participants will receive placebo orally

Who Is Running the Clinical Trial?

Sanofi

Lead Sponsor

Trials

2,246

Recruited

4,085,000+

Paul Hudson

Sanofi

Chief Executive Officer since 2019

Degree in Economics from Manchester Metropolitan University

Christopher Corsico

Sanofi

Chief Medical Officer

MD from Cornell University, MPH in Chronic Disease Epidemiology from Yale University

Kymera Therapeutics, Inc.

Industry Sponsor

Trials

8

Recruited

850+

Citations

1. investors.kymeratx.com investors.kymeratx.com/news-releases/news-release-details/kymera-announces-expansion-kt-474-sar444656-hs-and-ad-phase-2

Kymera Announces Expansion of KT-474 (SAR444656) ... KT-474 (SAR444656) is a first-in-class IRAK4 degrader in development for the treatment of immune-inflammatory diseases with significant patient ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06058156

NCT06058156 | Phase 2 Study of SAR444656 in Adult ... This is a multinational, multicenter, double-blind, placebo-controlled, parallel-group Phase 2, 4-arm study in adult participants with moderate to severe AD

3. nature.com nature.com/articles/s41591-023-02635-7

IRAK4 degrader in hidradenitis suppurativa and atopic ... KT-474 (SAR444656), an IRAK4 degrader, was studied in a randomized, double-blind, placebo-controlled phase 1 trial where the primary objective was safety and ...

4. kymeratx.com kymeratx.com/wp-content/uploads/2022/10/Kymera-TPD-Plenary_Jared_Gollob_-20221026_.pdf

Phase 1 Single and Multiple Ascending Dose Trial of KT- ... IRAK4 degradation leads to inhibition of TLR9/. CpG-B induced IL-6. • Pathway engagement results in downstream NF-κB activation which only a degrader can block.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT04772885?term=NCT04772885&rank=1

A Single and Multiple Ascending Dose Trial of KT-474 in ... This first-in-human (FIH) study will characterize the safety, tolerability and the pharmacokinetics/pharmacodynamics (PK/PD) of a single ascending dose and ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37957373/

IRAK4 degrader in hidradenitis suppurativa and atopic ... KT-474 (SAR444656), an IRAK4 degrader, was studied in a randomized, double-blind, placebo-controlled phase 1 trial where the primary objective was safety and ...