ESK-001 for Plaque Psoriasis

Recruiting at 39 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Alumis Inc

Must not be taking: Prohibited medications

Disqualifiers: Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

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

Compensation: Varies

Number of Visits: Unknown

165 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial involves patients with plaque psoriasis who have already participated in a previous study of ESK-001. They will continue to receive ESK-001 to see if it helps reduce their symptoms. The study will last for an extended period.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop your current medications, but it mentions that certain medications are prohibited. It's best to check with the trial team to see if your current medications are allowed.

How is the drug ESK-001 different from other treatments for plaque psoriasis?

ESK-001 may target the mitogen- and stress-activated protein kinase 1 (MSK1) pathway, which is involved in the production of pro-inflammatory cytokines in psoriatic skin, potentially offering a novel approach compared to existing treatments that do not specifically target this pathway. ^{1 2 3 4 5}

Eligibility Criteria

This trial is for men and women with plaque psoriasis who have finished a previous study involving ESK-001. Participants must commit to using effective contraception throughout the study. Pregnant individuals or those on certain other medications cannot join.

Inclusion Criteria

I will use effective birth control during the study.

Must have completed a prior ESK-001 study

Exclusion Criteria

I have not taken any medication that is not allowed in the study.

Pregnancy

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Open-label extension

Participants receive ESK-001 at one of two open-label dose levels until the drug is commercially available

Approximately 3 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• ESK-001

Trial Overview The trial is testing the long-term safety and effectiveness of a medication called ESK-001 in treating plaque psoriasis. It's an open-label extension, meaning everyone knows they're getting ESK-001, and it involves multiple centers.

Participant Groups

Group I: ESK-001 Dose Level 2 Experimental Treatment 1 Intervention

ESK-001 administered as an oral tablet

Group II: ESK-001 Dose Level 1 Experimental Treatment 1 Intervention

ESK-001 administered as an oral tablet

Who Is Running the Clinical Trial?

Alumis Inc

Lead Sponsor

Trials

9

Recruited

4,200+

Findings from Research

This study found that MSK1 is significantly activated in lesional psoriatic skin, indicating its potential role in the inflammatory processes associated with psoriasis.

In cultured human keratinocytes, reducing MSK1 expression led to a notable decrease in the production of key pro-inflammatory cytokines (IL-6, IL-8, and TNF-alpha), suggesting that MSK1 could be a target for therapeutic intervention in psoriasis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mitogen- and stress-activated protein kinase 1 is activated in lesional psoriatic epidermis and regulates the expression of pro-inflammatory cytokines. Funding, AT., Johansen, C., Kragballe, K., et al.[2022]

This study found increased activation of MSK2 and CREB in lesional psoriatic skin, suggesting that these proteins may contribute to the development of psoriasis, as evidenced by phospho blotting and immunofluorescence staining.

The research indicates that the p38-MAPK/MSK1/MSK2 and CREB signaling pathway is involved in psoriasis, as activation of this pathway in keratinocytes was inhibited by a p38 inhibitor, highlighting a potential target for therapeutic intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mitogen- and stress-activated protein kinase 2 and cyclic AMP response element binding protein are activated in lesional psoriatic epidermis. Funding, AT., Johansen, C., Kragballe, K., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Mitogen- and stress-activated protein kinase 1 is activated in lesional psoriatic epidermis and regulates the expression of pro-inflammatory cytokines. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Effectiveness of risankizumab in plaque psoriasis with involvement of difficult-to-treat areas: a real-world experience from two referral centers. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Long-term safety of risankizumab from 17 clinical trials in patients with moderate-to-severe plaque psoriasis. [2022]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Changes in the Expression Pattern of DUSP1-7 and miRNA Regulating their Expression in the Keratinocytes Treated with LPS and Adalimumab. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Mitogen- and stress-activated protein kinase 2 and cyclic AMP response element binding protein are activated in lesional psoriatic epidermis. [2022]