simepdekinra (LY4100511) / Eli Lilly - LARVOL DELTA

Comparing the Extent to Which Three Different Formulations of LY4100511 (DC-853) Are Made Available in the Body, Alone and in the Presence of a Drug That Reduces Stomach Acid (clinicaltrials.gov) - P1 | N=1 | Terminated | Sponsor: Eli Lilly and Company | N=48 ➔ 1 | Active, not recruiting ➔ Terminated; Original scientific question rendered moot by the external scientific community

Enrollment change • Trial termination

Comparing the Extent to Which Three Different Formulations of LY4100511 (DC-853) Are Made Available in the Body, Alone and in the Presence of a Drug That Reduces Stomach Acid (clinicaltrials.gov) - P1 | N=48 | Active, not recruiting | Sponsor: Eli Lilly and Company | Trial completion date: Jan 2026 ➔ Jul 2026 | Trial primary completion date: Jan 2026 ➔ Jul 2026 | Recruiting ➔ Active, not recruiting

Enrollment closed • Trial completion date • Trial primary completion date

Comparing the Extent to Which Three Different Formulations of LY4100511 (DC-853) Are Made Available in the Body, Alone and in the Presence of a Drug That Reduces Stomach Acid (clinicaltrials.gov) - P1 | N=48 | Recruiting | Sponsor: Eli Lilly and Company | Trial completion date: Oct 2025 ➔ Jan 2026 | Trial primary completion date: Oct 2025 ➔ Jan 2026

Trial completion date • Trial primary completion date

A Study of LY4100511 (DC-853) in Adult Participants With Moderate-to-Severe Plaque Psoriasis (clinicaltrials.gov) - P2 | N=222 | Completed | Sponsor: DICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company | Recruiting ➔ Completed

Trial completion • Dermatology • Immunology • Psoriasis

Comparing the Extent to Which Three Different Formulations of LY4100511 (DC-853) Are Made Available in the Body, Alone and in the Presence of a Drug That Reduces Stomach Acid (clinicaltrials.gov) - P1 | N=48 | Recruiting | Sponsor: Eli Lilly and Company | Trial completion date: Jun 2025 ➔ Oct 2025 | Trial primary completion date: Jun 2025 ➔ Oct 2025

Trial completion date • Trial primary completion date

A Study to Assess LY4100511 (DC-853) in Healthy Adult Participants (clinicaltrials.gov) - P1 | N=50 | Completed | Sponsor: DICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company | Active, not recruiting ➔ Completed | Trial completion date: Dec 2024 ➔ Jun 2024

Trial completion • Trial completion date

A Phase I Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of DC-853 in Healthy Participants (clinicaltrials.gov) - P1 | N=88 | Completed | Sponsor: Eli Lilly and Company

New P1 trial

Comparing the Extent to Which Three Different Formulations of LY4100511 (DC-853) Are Made Available in the Body, Alone and in the Presence of a Drug That Reduces Stomach Acid (clinicaltrials.gov) - P1 | N=48 | Recruiting | Sponsor: Eli Lilly and Company | Not yet recruiting ➔ Recruiting

Enrollment open

Comparing the Extent to Which Three Different Formulations of LY4100511 (DC-853) Are Made Available in the Body, Alone and in the Presence of a Drug That Reduces Stomach Acid (clinicaltrials.gov) - P1 | N=48 | Not yet recruiting | Sponsor: Eli Lilly and Company

New P1 trial

A Study to Evaluate Safety, Tolerability of LY4100511 (DC-853) in Healthy Asian and Non-Asian Participants (clinicaltrials.gov) - P1 | N=69 | Completed | Sponsor: DICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company | Recruiting ➔ Completed

Trial completion

Next-Generation Anti-IL-17 Agents for Psoriatic Disease: A Pipeline Review. (PubMed, Am J Clin Dermatol) - "Key agents under investigation include netakimab, vunakizumab, xeligekimab, gumokimab, HB0017, CJM 112, JS005, 608, LZM012, ZL-1102, izokibep, sonelokimab, DC-806, DC-853, and LEO 153339. Both preclinical and clinical trial data for each agent are summarized, with an emphasis on their efficacy, adverse effects, immunogenicity, and future outlooks."

Journal • Dermatology • Immunology • Inflammatory Arthritis • Psoriasis • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies

A Study of LY4100511 (DC-853) Mass Balance and Absolute Bioavailability of LY4100511 in Healthy Male Participants (clinicaltrials.gov) - P1 | N=24 | Completed | Sponsor: DICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company | Recruiting ➔ Completed | N=16 ➔ 24

Enrollment change • Trial completion

A Drug-drug Interaction Study Evaluating the Perpetrator Potential of LY4100511 (DC-853) on Midazolam, Repaglinide, Digoxin, Rosuvastatin in Healthy Participants (clinicaltrials.gov) - P1 | N=49 | Completed | Sponsor: DICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company | Recruiting ➔ Completed

Trial completion

A Study of LY4100511 (DC-853) in Adult Participants With Moderate-to-Severe Plaque Psoriasis (clinicaltrials.gov) - P2 | N=220 | Recruiting | Sponsor: DICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company | Not yet recruiting ➔ Recruiting

Enrollment open • Dermatology • Immunology • Psoriasis

A Drug-drug Interaction Study Evaluating the Perpetrator Potential of LY4100511 (DC-853) on Midazolam, Repaglinide, Digoxin, Rosuvastatin in Healthy Participants (clinicaltrials.gov) - P1 | N=48 | Recruiting | Sponsor: DICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company | N=32 ➔ 48 | Trial completion date: Oct 2024 ➔ Dec 2024 | Trial primary completion date: Oct 2024 ➔ Dec 2024

Enrollment change • Trial completion date • Trial primary completion date

A Study of LY4100511 (DC-853) Mass Balance and Absolute Bioavailability of LY4100511 in Healthy Male Participants (clinicaltrials.gov) - P1 | N=16 | Recruiting | Sponsor: DICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company

New P1 trial

A Drug-drug Interaction Study Evaluating the Perpetrator Potential of LY4100511 (DC-853) on Midazolam, Repaglinide, Digoxin, Rosuvastatin in Healthy Participants (clinicaltrials.gov) - P1 | N=32 | Recruiting | Sponsor: DICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company | Not yet recruiting ➔ Recruiting

Enrollment open

A Study of LY4100511 (Dice 853) in Adult Participants With Moderate-to-Severe Plaque Psoriasis (clinicaltrials.gov) - P2 | N=220 | Not yet recruiting | Sponsor: DICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company

New P2 trial • Dermatology • Immunology • Psoriasis

A Study to Assess LY4100511 (DC-853) in Healthy Adult Participants (clinicaltrials.gov) - P1 | N=50 | Active, not recruiting | Sponsor: DICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company | Recruiting ➔ Active, not recruiting | Trial completion date: Jun 2024 ➔ Dec 2024

Enrollment closed • Trial completion date

A Study to Evaluate Safety, Tolerability of LY4100511 (DC-853) in Healthy Asian and Non-Asian Participants (clinicaltrials.gov) - P1 | N=77 | Recruiting | Sponsor: DICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company | N=59 ➔ 77 | Trial completion date: Jul 2024 ➔ Nov 2024 | Trial primary completion date: Jul 2024 ➔ Nov 2024

Enrollment change • Trial completion date • Trial primary completion date

A Drug-drug Interaction Study Evaluating the Perpetrator Potential of LY4100511 (DC-853) on Cytochrome P450 3A4 and 2C8 Substrates in Healthy Participants (clinicaltrials.gov) - P1 | N=32 | Not yet recruiting | Sponsor: DICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company

New P1 trial

A Study to Evaluate Safety, Tolerability of LY4100511 (DC-853) in Healthy Asian and Non-Asian Participants (clinicaltrials.gov) - P1 | N=59 | Recruiting | Sponsor: DICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company | Not yet recruiting ➔ Recruiting | N=30 ➔ 59

Enrollment change • Enrollment open

A Study to Assess LY4100511 (DC-853) in Healthy Adult Participants (clinicaltrials.gov) - P1 | N=50 | Recruiting | Sponsor: DICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company | Not yet recruiting ➔ Recruiting

Enrollment open

A Study to Assess LY4100511 (DC-853) in Healthy Adult Participants (clinicaltrials.gov) - P1 | N=50 | Not yet recruiting | Sponsor: DICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company

New P1 trial

A Study to Evaluate Safety, Tolerability of LY4100511 (DC-853) in Healthy Asian and Non-Asian Participants (clinicaltrials.gov) - P1 | N=30 | Not yet recruiting | Sponsor: DICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company

New P1 trial