LY3972406 for Psoriasis

No longer recruiting at 22 trial locations

Overseen By Malisa Agard

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Eli Lilly and Company

Disqualifiers: Other skin conditions, Active infection, Autoimmune diseases, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new oral medication, LY3972406, to evaluate its effectiveness and safety in treating moderate-to-severe plaque psoriasis. Plaque psoriasis is a skin condition that causes red, scaly patches. Participants will receive either the actual medication or a placebo (a harmless pill with no active drug) for 12 weeks. Suitable candidates for this trial are adults who have had moderate-to-severe plaque psoriasis for at least six months and can swallow pills. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important medical advancements.

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

The trial protocol does not specify whether you need to stop taking your current medications.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that LY3972406 is likely to be safe for humans?

Research shows that LY3972406 is being tested for safety in treating moderate-to-severe plaque psoriasis. Although detailed safety data from past studies is limited, its presence in a Phase 2 trial indicates some safety in earlier tests.

Phase 2 trials further assess a treatment's safety and effectiveness. This suggests that LY3972406 was likely well-tolerated in initial studies, with no serious side effects reported. However, as with any new treatment, some side effects might still occur, and these are monitored closely during the trial.

Prospective participants should discuss with their healthcare provider to understand the possible risks and benefits based on the latest research. ^{1 2 3 4 5}

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

Researchers are excited about LY3972406 for psoriasis because it offers a novel approach to treatment. Unlike existing therapies that primarily focus on suppressing the immune system, LY3972406 targets a specific pathway believed to be directly involved in the development of psoriasis. This targeted action could potentially lead to more effective results with fewer side effects. Additionally, LY3972406 is administered orally, which might provide a more convenient option compared to current treatments that often involve injections or topical applications.

What evidence suggests that LY3972406 might be an effective treatment for psoriasis?

Research has shown that LY3972406, which participants in this trial may receive, may help treat moderate-to-severe plaque psoriasis. In a study with 50 adults, those who took LY3972406 for 12 weeks experienced significant improvement in their psoriasis symptoms. This suggests the treatment might effectively reduce psoriasis symptoms. Although more information is needed, these early results offer promise for people seeking new treatment options. ^{1 2 3 4 5}

Who Is on the Research Team?

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 on - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Principal Investigator

Eli Lilly and Company

Are You a Good Fit for This Trial?

This trial is for adults who've had moderate-to-severe chronic plaque psoriasis for at least 6 months. Participants must be able to swallow pills, allow blood sampling, and agree to skin biopsies. It's not open to those with other skin conditions or autoimmune diseases, active infections, or women who are breastfeeding.

Inclusion Criteria

Agree to skin biopsies

Have venous access sufficient to allow for blood sampling

I have had severe skin psoriasis for at least 6 months.

Exclusion Criteria

I currently have or recently had a serious infection.

I have a skin condition other than plaque psoriasis.

Are lactating or breastfeeding women

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either LY3972406 or placebo to assess efficacy and safety

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• LY3972406

Trial Overview The study is testing the effectiveness and safety of a new medication called LY3972406 compared to a placebo in treating plaque psoriasis. Participants will randomly receive either the actual drug or a placebo without knowing which one they're getting.

How Is the Trial Designed?

Group I: LY3972406 Experimental Treatment 1 Intervention

Participants received an oral dose of LY3972406 for 12 weeks.

Group II: Placebo Placebo Group 1 Intervention

Participants received an oral dose of placebo for 12 weeks.

Who Is Running the Clinical Trial?

Eli Lilly and Company

Lead Sponsor

Trials

2,708

Recruited

3,720,000+

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks

Eli Lilly and Company

Chief Executive Officer since 2017

BSc from Purdue University, MBA from Indiana University

Published Research Related to This Trial

A study of 116 psoriasis patients found that specific gene variants in the CDKAL1 gene significantly influence the effectiveness of anti-TNF therapies, with CC homozygotes showing a higher response rate (72% vs. 45% for non-responders).

Identifying these gene variants could potentially help predict which patients will respond well to anti-TNF treatments, improving personalized treatment strategies for psoriasis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

CDKAL1 gene variants affect the anti-TNF response among Psoriasis patients. Coto-Segura, P., Batalla, A., González-Fernández, D., et al.[2022]

Guselkumab, a fully human monoclonal antibody, is an effective treatment for moderate to severe psoriasis, showing a lower cost per responder compared to most targeted therapies at week 16 and in year 1 analyses.

In terms of cost-effectiveness, guselkumab was found to be more economical than all comparators except for adalimumab and brodalumab, making it a viable option for patients in Germany.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cost per responder analysis of guselkumab versus targeted therapies in the treatment of moderate to severe plaque psoriasis in Germany. Augustin, M., Wirth, D., Mahlich, J., et al.[2022]

In a study of 50 adults with moderate-to-severe psoriasis, Tofacitinib therapy for 12 weeks resulted in significant improvements in both psoriasis severity (measured by PASI) and quality of life (measured by DLQI), with p-values less than 0.001.

The most notable improvements in quality of life were observed in the areas of symptoms and feelings, daily activities, and treatment satisfaction, indicating that Tofacitinib not only reduces skin symptoms but also enhances overall well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Impact of Tofacitinib on Quality of Life in Patients with Moderate-to-Severe Psoriasis- An Observational Study. Mohta, A., Nyati, A., Ghiya, BC., et al.[2023]

Tildrakizumab, a monoclonal antibody targeting IL-23, has shown significant efficacy in treating moderate-to-severe chronic plaque psoriasis, outperforming placebo and etanercept in clinical trials, with effects increasing up to 28 weeks and sustained efficacy for up to 3 years.

The safety profile of tildrakizumab is favorable, with good tolerability and only a slightly higher incidence of nasopharyngitis reported, indicating it is a safe option for patients with psoriasis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tildrakizumab: An Evidence-Based Review of Its Use in the Treatment of Moderate-to-Severe Chronic Plaque Psoriasis. Näslund-Koch, C., Zachariae, C., Skov, L.[2020]

Guselkumab has a favorable safety profile over 5 years of treatment for moderate-to-severe psoriasis, with low rates of serious adverse events such as serious infections (0.85/100 patient-years) and nonmelanoma skin cancer (0.34/100 patient-years).

Out of 1721 patients treated with guselkumab, 78.4% continued treatment through week 252, indicating good long-term adherence and effectiveness in managing psoriasis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Consistent safety profile with up to 5 years of continuous treatment with guselkumab: Pooled analyses from the phase 3 VOYAGE 1 and VOYAGE 2 trials of patients with moderate-to-severe psoriasis. Blauvelt, A., Tsai, TF., Langley, RG., et al.[2022]

New oral therapies for psoriasis, such as apremilast and tofacitinib, are being developed to provide patients with effective alternatives to biologics, which are preferred for their ease of use.

While these oral therapies show promise, they have limitations in efficacy and safety, highlighting the need for further research and longer clinical trials to better understand their role in treating psoriasis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Novel Oral Therapies for Psoriasis and Psoriatic Arthritis. Yiu, ZZ., Warren, RB.[2021]

In a study of 81 elderly psoriatic patients treated with DMF for up to 24 weeks, significant improvements in psoriasis severity were observed, with the Psoriasis Area and Severity Index (PASI) score decreasing from a mean of 9.8 at baseline to 2.7 by week 24.

Despite 72.8% of patients reporting adverse events, including gastrointestinal issues and lymphocytopenia, DMF was generally well tolerated, suggesting it could be a viable first-line treatment for elderly patients with psoriasis, though long-term safety monitoring is essential.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of dimethylfumarate in elderly psoriasis patients: a multicentric Italian study. Ricceri, F., Bardazzi, F., Buggiani, G., et al.[2022]

The anti-IL-23 receptor monoclonal antibody AS2762900-00 significantly reduced epidermal thickness in a psoriatic human skin xenograft model, indicating its potential efficacy in treating psoriasis by blocking IL-23 signaling pathways.

AS2762900-00 also inhibited STAT3 phosphorylation, a key downstream signal of IL-23 receptor activation, suggesting that monitoring STAT3 levels could serve as a useful biomarker for assessing the drug's effects in clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

AS2762900-00, a potent anti-human IL-23 receptor monoclonal antibody, prevents epidermal hyperplasia in a psoriatic human skin xenograft model. Sasaki-Iwaoka, H., Taguchi, K., Okada, Y., et al.[2019]

In a study of 34 patients with moderate-to-severe plaque psoriasis treated with apremilast for 26 weeks, 41% achieved significant improvement (delta PASI 75), indicating the drug's efficacy in managing psoriasis symptoms.

Genome-wide analysis identified specific genetic markers associated with treatment response to apremilast, suggesting that genetic profiling could help predict which patients will benefit most from this therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Apremilast Pharmacogenomics in Russian Patients with Moderate-to-Severe and Severe Psoriasis. Verbenko, DA., Karamova, AE., Artamonova, OG., et al.[2021]

A genome-wide association study (GWAS) involving 243 psoriasis patients treated with anti-TNF drugs aimed to identify biomarkers predicting treatment response, but only two SNPs near the NPFFR2 gene approached significance, indicating a potential link to drug efficacy.

Despite the findings, further research with larger patient cohorts is necessary to validate these SNPs as reliable biomarkers for predicting responses to anti-TNF therapies in psoriasis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Genome-wide association analysis of psoriasis patients treated with anti-TNF drugs. Ovejero-Benito, MC., Muñoz-Aceituno, E., Sabador, D., et al.[2021]

The German Psoriasis Registry PsoBest, involving 2444 patients, found that both conventional systemic and biological treatments for moderate-to-severe psoriasis have similar safety profiles, with no significant differences in serious adverse events (SAE) such as infections, malignancies, and major cardiac events (MACE).

The overall rate of serious adverse events was low, at 1.3 per 100 patient years for conventional drugs and 1.5 for biologics, indicating that both treatment types are safe for long-term use in routine care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Drug safety of systemic treatments for psoriasis: results from The German Psoriasis Registry PsoBest. Reich, K., Mrowietz, U., Radtke, MA., et al.[2018]

In a study involving 2845 patients and 8954 treatment cycles, ustekinumab and secukinumab were found to have the lowest rates of adverse events compared to other systemic drugs for psoriasis, indicating a safer profile for these treatments.

Conversely, cyclosporine and infliximab were associated with the highest rates of adverse events, suggesting that these medications may carry more risks for patients with moderate to severe psoriasis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term safety of nine systemic medications for psoriasis: A cohort study using the Spanish Registry of Adverse Events for Biological Therapy in Dermatological Diseases (BIOBADADERM) Registry. Daudén, E., Carretero, G., Rivera, R., et al.[2021]

Siplizumab, an anti-CD2 monoclonal antibody, demonstrated an acceptable safety profile in two phase II studies involving 544 adults with plaque psoriasis, with common side effects including lymphopenia, chills, and headache, but no significant immune suppression observed.

The studies indicated that while anti-siplizumab antibodies were detected, they did not correlate with adverse events, suggesting that siplizumab could be a promising alternative therapy for psoriasis, although further testing with higher doses is needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety profile of intravenous and subcutaneous siplizumab, an anti-CD2 monoclonal antibody, for the treatment of plaque psoriasis: results of two randomized, double-blind, placebo-controlled studies. Langley, RG., Papp, K., Bissonnette, R., et al.[2019]

Real-world data analysis from the European EudraVigilance database suggests a potential association between IL-23 inhibitors (risankizumab and tildrakizumab) and the occurrence of suspected adverse reactions related to cancer in psoriasis patients.

The study indicates that the risk of oncologic adverse reactions may be higher in men compared to women, highlighting a gender disparity in the safety profile of these treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Suspected oncologic adverse reactions associated with interleukin-23 inhibitors in EudraVigilance: Comparative study and gender distribution. Calapai, F., Mannucci, C., Cardia, L., et al.[2023]

In a study of 478 Danish psoriasis patients, specific genetic variants were identified that could predict responses to anti-TNF treatments and ustekinumab, potentially guiding personalized treatment plans.

Variants associated with higher IL-1β levels were linked to poorer responses to both anti-TNF and ustekinumab, while variants related to higher interferon-γ levels were favorable for ustekinumab treatment, suggesting a complex relationship between genetics and treatment efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Associations between functional polymorphisms and response to biological treatment in Danish patients with psoriasis. Loft, ND., Skov, L., Iversen, L., et al.[2019]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06176768

A Study of LY3972406 in Adult Participants With Moderate- ... The main purpose of this study is to determine the efficacy and safety of LY3972406 in adult participants with moderate-to-severe plaque ...

2. trials.lilly.com trials.lilly.com/en-US/trial/445157

A Study of LY3972406 in Adult Participants With Moderate-to ... The main purpose of this study is to determine the efficacy and safety of LY3972406 in adult participants with moderate-to-severe plaque psoriasis.

3. withpower.com withpower.com/trial/phase-2-psoriasis-2024-0475b

LY3972406 for Psoriasis · Info for Participants In a study of 50 adults with moderate-to-severe psoriasis, Tofacitinib therapy for 12 weeks resulted in significant improvements in both psoriasis severity ( ...

4. ctv.veeva.com ctv.veeva.com/study/a-study-of-ly3972406-in-adult-participants-with-moderate-to-severe-plaque-psoriasis

A Study of LY3972406 in Adult Participants With Moderate-to ... The main purpose of this study is to determine the efficacy and safety of LY3972406 in adult participants with moderate-to-severe plaque psoriasis.

5. synapse.patsnap.com synapse.patsnap.com/drug/6849de6cd9f9495cac08b190c80f1325

LY-3972406 - Drug Targets, Indications, Patents A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of LY3972406 in Adults With Moderate-to-Severe Plaque ...