A Phase 2 interventional study of LY3972406 and Placebo in Plaque Psoriasis, sponsored by Eli Lilly and Company. Completed at 12 sites in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-10-15.
Sponsored by Eli Lilly and Company · Phase 2, Interventional, and Treatment
The main purpose of this study is to determine the efficacy and safety of LY3972406 in adult participants with moderate-to-severe plaque psoriasis.
Eli Lilly and Company is the lead sponsor of 2,048 studies on the registry; 140 are open to participants now.
Of its 521 completed or terminated interventional studies of FDA-regulated products, 341 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants received an oral dose of LY3972406 for 12 weeks.
Drug: LY3972406
Participants received an oral dose of placebo for 12 weeks.
Drug: Placebo
Administered orally
Administered orally
Percentage of Participants Achieving ≥75% Reduction From Baseline in Psoriasis Area and Severity Index (PASI-75)
* The PASI is an investigator-administered, multi-item scale used to measure the severity of psoriasis based on lesion severity and the percent of body surface area (BSA) affected. * Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomical regions: head, trunk, upper limbs, lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). * The sum of severity scores for erythema, thickness, and scaling is multiplied by the degree of involvement for each anatomic region, and then multiplied by a constant corresponding to the region's percent BSA (0.1, 0.3, 0.2, and 0.4 for the above 4 regions, respectively). The resultant score for each anatomic region is then summed to yield the final PASI score. It ranges from 0 to 72, with higher scores reflecting greater disease severity. * The nonresponder imputation (NRI) method was used to handle missing data.
Time frame: Week 12
Change From Baseline in Percent Body Surface Area (BSA)
The percent BSA is the total percentage of psoriasis involvement on the participant's body surface, ranging from 0% (no involvement) to 100% (full involvement). It is measured using the handprint method, where 1% corresponds to the size of the participant's hand (including the palm, fingers, and thumb). The number of handprints fitting into the affected areas across the body is summed to estimate the total percentage of involvement.
Time frame: Baseline, Week 12
Change From Baseline in Dermatology Life Quality Index (DLQI)
The DLQI is a validated, dermatology-specific, patient-reported outcomes 10-item questionnaire that evaluates participants health-related quality of life over the past week. The 10 questions are grouped into 6 domains, including symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. Response categories and corresponding scores are: * Very much = 3 * A lot = 2 * A little = 1 * Not at all = 0 * Not relevant = 0. The total score is calculated by summing all 10 question responses and has a range of 0 (no impact of skin disease on quality of life) to 30 (maximum impact on quality of life).
Time frame: Baseline, Week 12
Pharmacokinetics (PK): Observed Trough Plasma Concentration of LY3972406
Observed trough plasma concentration (Ctrough) of LY3972406.
Time frame: Predose at Week 12
| Milestone | LY3972406 | Placebo |
|---|---|---|
| Started | 16 | 17 |
| Received at least 1 dose of the study drug | 16 | 17 |
| Completed | 3 | 4 |
| Not completed | 13 | 13 |
| Withdrew: Adverse event | 1 | 0 |
| Withdrew: Assigned treatment by mistake | 1 | 0 |
| Withdrew: Lost to follow-up | 0 | 3 |
| Withdrew: Physician decision | 1 | 0 |
| Withdrew: Protocol deviation | 3 | 1 |
| Withdrew: Other | 1 | 0 |
| Withdrew: Withdrawal by subject | 6 | 9 |
* The PASI is an investigator-administered, multi-item scale used to measure the severity of psoriasis based on lesion severity and the percent of body surface area (BSA) affected. * Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomical regions: head, trunk, upper limbs, lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). * The sum of severity scores for erythema, thickness, and scaling is multiplied by the degree of involvement for each anatomic region, and then multiplied by a constant corresponding to the region's percent BSA (0.1, 0.3, 0.2, and 0.4 for the above 4 regions, respectively). The resultant score for each anatomic region is then summed to yield the final PASI score. It ranges from 0 to 72, with higher scores reflecting greater disease severity. * The nonresponder imputation (NRI) method was used to handle missing data.
| percentage of participants | LY3972406 | Placebo |
|---|---|---|
| Percentage of Participants Achieving ≥75% Reduction From Baseline in Psoriasis Area and Severity Index (PASI-75) | 18.8 (0 to 37.9) | 5.9 (0 to 17.1) |
The percent BSA is the total percentage of psoriasis involvement on the participant's body surface, ranging from 0% (no involvement) to 100% (full involvement). It is measured using the handprint method, where 1% corresponds to the size of the participant's hand (including the palm, fingers, and thumb). The number of handprints fitting into the affected areas across the body is summed to estimate the total percentage of involvement.
| percent BSA | LY3972406 | Placebo |
|---|---|---|
| Change From Baseline in Percent Body Surface Area (BSA) | -7.26 ± 3.35 | -0.48 ± 3.19 |
The DLQI is a validated, dermatology-specific, patient-reported outcomes 10-item questionnaire that evaluates participants health-related quality of life over the past week. The 10 questions are grouped into 6 domains, including symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. Response categories and corresponding scores are: * Very much = 3 * A lot = 2 * A little = 1 * Not at all = 0 * Not relevant = 0. The total score is calculated by summing all 10 question responses and has a range of 0 (no impact of skin disease on quality of life) to 30 (maximum impact on quality of life).
| score on a scale | LY3972406 | Placebo |
|---|---|---|
| Change From Baseline in Dermatology Life Quality Index (DLQI) | -6.71 ± 1.64 | -4.35 ± 1.54 |
Observed trough plasma concentration (Ctrough) of LY3972406.
| Nanogram per milliliter (ng/mL) | LY3972406 |
|---|---|
| Pharmacokinetics (PK): Observed Trough Plasma Concentration of LY3972406 | 158 ± 155 |
Collected over From baseline to the end of follow-up (up to Week 24). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| LY3972406 | 0/16 (0%) | 0/16 (0%) | 9/16 (56.3%) |
| Placebo | 0/17 (0%) | 1/17 (5.9%) | 6/17 (35.3%) |
| Event | LY3972406 | Placebo |
|---|---|---|
| Metastases to boneNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/16 | 1/17 |
| Event | LY3972406 | Placebo |
|---|---|---|
| FallInjury, poisoning and procedural complications | 2/16 | 0/17 |
| HeadacheNervous system disorders | 2/16 | 0/17 |
| UrticariaSkin and subcutaneous tissue disorders | 2/16 | 0/17 |
| Conjunctival haemorrhageEye disorders | 1/16 | 0/17 |
| Gastrooesophageal reflux diseaseGastrointestinal disorders | 1/16 | 0/17 |
| FatigueGeneral disorders | 1/16 | 0/17 |
| GastroenteritisInfections and infestations | 1/16 | 0/17 |
| ContusionInjury, poisoning and procedural complications | 1/16 | 0/17 |
| HypoglycaemiaMetabolism and nutrition disorders | 1/16 | 0/17 |
| Psoriatic arthropathyMusculoskeletal and connective tissue disorders | 1/16 | 0/17 |
All randomized participants.
| Age, Continuous(years) | LY3972406 | Placebo | Total |
|---|---|---|---|
| Mean | 50.4 ± 13.3 | 50.2 ± 13.5 | 50.3 ± 13.2 |
| Sex: Female, Male(Participants) | LY3972406 | Placebo | Total |
|---|---|---|---|
| Female | 1 | 3 | 4 |
| Male | 15 | 14 | 29 |
| Ethnicity (NIH/OMB)(Participants) | LY3972406 | Placebo | Total |
|---|---|---|---|
| Hispanic or Latino | 13 | 10 | 23 |
| Not Hispanic or Latino | 3 | 7 | 10 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | LY3972406 | Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 1 | 0 | 1 |
| Asian | 1 | 1 | 2 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 1 | 4 | 5 |
| White | 12 | 11 | 23 |
| More than one race | 0 | 1 | 1 |
| Unknown or Not Reported | 1 | 0 | 1 |
| Region of Enrollment(Participants) | LY3972406 | Placebo | Total |
|---|---|---|---|
| United States | 16 | 17 | 33 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Supporting information: Study protocol, Sap, Csr
This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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