Trial · NCT03573323
A Study of Ixekizumab (LY2439821) Compared to Guselkumab in Participants With Moderate-to-Severe Plaque Psoriasis
NCT03573323, Phase 4, Completed, Eli Lilly and Company; results first posted 2020-07-28
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Ixekizumab (LY2439821) Compared to Guselkumab in Participants With Moderate-to-Severe Plaque Psoriasis. Trials, record NCT03573323. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03573323
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Ixekizumab (LY2439821) Compared to Guselkumab in Participants With Moderate-to-Severe Plaque Psoriasis
- NCT number
- NCT03573323
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 1,027 participants, actual
- Lead sponsor
- Eli Lilly and Company
- Conditions
- Plaque Psoriasis
- Interventions
- Ixekizumab, Guselkumab, Placebo
- First posted
- 2018-06-29
- Last updated
- 2020-07-28
- Results first posted
- 2020-07-28
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Achieving 100% Improvement From Baseline in Psoriasis Area and Severity Index (PASI 100) | Week 12 | The PASI combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation (scaling), erythema, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis to 72 for the most severe disease. Participants achieving PASI 100 were defined as having an improvement of at least 100% in the PASI scores compared to baseline. |
| Secondary | Percentage of Participants Achieving PASI 75 | Week 2 | The PASI combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation (scaling), erythema, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis to 72 for the most severe disease. Participants achieving PASI 75 were defined as having an improvement of at least 75% in the PASI scores compared to baseline. |
| Secondary | Percentage of Participants Achieving PASI 90 | Week 4 | The PASI combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation (scaling), erythema, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis to 72 for the most severe disease. Participants achieving PASI 90 were defined as having an improvement of at least 90% in the PASI scores compared to baseline. |
| Secondary | Percentage of Participants Achieving PASI 100 | Week 4 | The PASI combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation (scaling), erythema, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis to 72 for the most severe disease. Participants achieving PASI 100 were defined as having an improvement of at least 100% in the PASI scores compared to baseline. |
| Secondary | Percentage of Participants Achieving PASI 90 | Week 8 | The PASI combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation (scaling), erythema, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis to 72 for the most severe disease. Participants achieving PASI 90 were defined as having an improvement of at least 90% in the PASI scores compared to baseline. |
| Secondary | Percentage of Participants Achieving Static Physician Global Assessment (sPGA) (0) | Week 12 | The sPGA is a physician's determination of the participant's psoriasis lesions overall at a given time point categorized by descriptions for induration, erythema, and scaling. For the analysis of responses, the participant's psoriasis is assessed as clear (0), minimal (1), mild (2), moderate (3), severe (4), or very severe (5). An sPGA (0) response was defined as a post-baseline sPGA score of 0. |
| Secondary | Percentage of Participants Achieving PASI 50 | Week 1 | The PASI combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation (scaling), erythema, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis to 72 for the most severe disease. Participants achieving PASI 50 were defined as having an improvement of at least 50% in the PASI scores compared to baseline. |
| Secondary | Percentage of Participants Achieving PASI 100 | Week 8 | The PASI combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation (scaling), erythema, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis to 72 for the most severe disease. Participants achieving PASI 100 were defined as having an improvement of at least 100% in the PASI scores compared to baseline. |
| Secondary | Percentage of Participants Achieving PASI 100 | Week 24 | The PASI combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation (scaling), erythema, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis to 72 for the most severe disease. Participants achieving PASI 100 were defined as having an improvement of at least 100% in the PASI scores compared to baseline. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Achieving 100% Improvement From Baseline in Psoriasis Area and Severity Index (PASI 100) | Week 12 | All randomized participants. Participants who did not meet clinical response criteria or have missing data at Week 12 were considered as non-responders for the Non-Responder Imputation (NRI) analysis. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving PASI 75 | Week 2 | All randomized participants. Participants who did not meet clinical response criteria or have missing data at Week 12 were considered as non-responders for the Non-Responder Imputation (NRI) analysis. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving PASI 90 | Week 4 | All randomized participants. Participants who did not meet clinical response criteria or have missing data at Week 12 were considered as non-responders for the Non-Responder Imputation (NRI) analysis. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving PASI 100 | Week 4 | All randomized participants. Participants who did not meet clinical response criteria or have missing data at Week 12 were considered as non-responders for the Non-Responder Imputation (NRI) analysis. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving PASI 90 | Week 8 | All randomized participants. Participants who did not meet clinical response criteria or have missing data at Week 12 were considered as non-responders for the Non-Responder Imputation (NRI) analysis. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving Static Physician Global Assessment (sPGA) (0) | Week 12 | All randomized participants. Participants who did not meet clinical response criteria or have missing data at Week 12 were considered as non-responders for the Non-Responder Imputation (NRI) analysis. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving PASI 50 | Week 1 | All randomized participants. Participants who did not meet clinical response criteria or have missing data at Week 12 were considered as non-responders for the Non-Responder Imputation (NRI) analysis. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving PASI 100 | Week 8 | All randomized participants. Participants who did not meet clinical response criteria or have missing data at Week 12 were considered as non-responders for the Non-Responder Imputation (NRI) analysis. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving PASI 100 | Week 24 | All randomized participants. Participants who did not meet clinical response criteria or have missing data at Week 12 were considered as non-responders for the Non-Responder Imputation (NRI) analysis. | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants Achieving 100% Improvement From Baseline in Psoriasis Area and Severity Index (PASI 100) | Ixekizumab | 41.3 | 95% Confidence Interval 37.1 to 45.6 | percentage of participants | |
| Percentage of Participants Achieving 100% Improvement From Baseline in Psoriasis Area and Severity Index (PASI 100) | Guselkumab | 24.9 | 95% Confidence Interval 21.1 to 28.6 | percentage of participants | |
| Percentage of Participants Achieving PASI 75 | Ixekizumab | 22.9 | 95% Confidence Interval 19.3 to 26.5 | percentage of participants | |
| Percentage of Participants Achieving PASI 75 | Guselkumab | 5.1 | 95% Confidence Interval 3.2 to 7.0 | percentage of participants | |
| Percentage of Participants Achieving PASI 90 | Ixekizumab | 21.0 | 95% Confidence Interval 17.5 to 24.5 | percentage of participants | |
| Percentage of Participants Achieving PASI 90 | Guselkumab | 7.9 | 95% Confidence Interval 5.5 to 10.2 | percentage of participants | |
| Percentage of Participants Achieving PASI 100 | Ixekizumab | 6.7 | 95% Confidence Interval 4.6 to 8.9 | percentage of participants | |
| Percentage of Participants Achieving PASI 100 | Guselkumab | 1.4 | 95% Confidence Interval 0.4 to 2.4 | percentage of participants | |
| Percentage of Participants Achieving PASI 90 | Ixekizumab | 58.5 | 95% Confidence Interval 54.2 to 62.7 | percentage of participants | |
| Percentage of Participants Achieving PASI 90 | Guselkumab | 35.9 | 95% Confidence Interval 31.7 to 40.1 | percentage of participants |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow14
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Blinded Treatment Period (Weeks 0-24) | STARTED | Ixekizumab | 520 | |
| Blinded Treatment Period (Weeks 0-24) | STARTED | Guselkumab | 507 | |
| Blinded Treatment Period (Weeks 0-24) | Received at Least One Dose of Study Drug | Ixekizumab | 519 | |
| Blinded Treatment Period (Weeks 0-24) | Received at Least One Dose of Study Drug | Guselkumab | 506 | |
| Blinded Treatment Period (Weeks 0-24) | COMPLETED | Ixekizumab | 465 | |
| Blinded Treatment Period (Weeks 0-24) | COMPLETED | Guselkumab | 459 | |
| Blinded Treatment Period (Weeks 0-24) | NOT COMPLETED | Ixekizumab | 55 | |
| Blinded Treatment Period (Weeks 0-24) | NOT COMPLETED | Guselkumab | 48 | |
| Post-Treatment Follow Up (Weeks 25-36) | STARTED | Ixekizumab | 465 | |
| Post-Treatment Follow Up (Weeks 25-36) | STARTED | Guselkumab | 456 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 participant flowAdverse events188
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Injection site reaction | General disorders | Ixekizumab | 49 | 519 | 80 |
| other | Injection site reaction | General disorders | Guselkumab | 6 | 506 | 9 |
| other | Injection site reaction | General disorders | Ixekizumab Post-Treatment Follow Up | 0 | 465 | 0 |
| other | Injection site reaction | General disorders | Guselkumab Post-Treatment Follow Up | 1 | 456 | 2 |
| other | Nasopharyngitis | Infections and infestations | Ixekizumab | 34 | 519 | 41 |
| other | Nasopharyngitis | Infections and infestations | Guselkumab | 27 | 506 | 29 |
| other | Nasopharyngitis | Infections and infestations | Ixekizumab Post-Treatment Follow Up | 5 | 465 | 5 |
| other | Nasopharyngitis | Infections and infestations | Guselkumab Post-Treatment Follow Up | 2 | 456 | 2 |
| other | Upper respiratory tract infection | Infections and infestations | Ixekizumab | 40 | 519 | 44 |
| other | Upper respiratory tract infection | Infections and infestations | Guselkumab | 41 | 506 | 50 |
1 to 10 of 188Source ClinicalTrials.gov
See all 188 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ixekizumab | 0 | 519 |
| Total, all-cause mortality | Guselkumab | 0 | 506 |
| Total, all-cause mortality | Ixekizumab Post-Treatment Follow Up | 0 | 465 |
| Total, all-cause mortality | Guselkumab Post-Treatment Follow Up | 0 | 456 |
| Total, other adverse events | Ixekizumab | 113 | 519 |
| Total, other adverse events | Guselkumab | 73 | 506 |
| Total, other adverse events | Ixekizumab Post-Treatment Follow Up | 11 | 465 |
| Total, other adverse events | Guselkumab Post-Treatment Follow Up | 9 | 456 |
| Total, serious adverse events | Ixekizumab | 18 | 519 |
| Total, serious adverse events | Guselkumab | 16 | 506 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers4
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03573323
GET https://conductscience.org/api/trials/v1/NCT03573323/events?page=2