Trial · NCT03556202
A Long-term Study to Evaluate Safety and Maintenance of Treatment Effect of LY3074828 in Participants With Moderate-to-Severe Plaque Psoriasis (OASIS-3)
NCT03556202, Phase 3, Terminated, Eli Lilly and Company; results first posted 2023-03-21
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Long-term Study to Evaluate Safety and Maintenance of Treatment Effect of LY3074828 in Participants With Moderate-to-Severe Plaque Psoriasis (OASIS-3). Trials, record NCT03556202. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03556202
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Long-term Study to Evaluate Safety and Maintenance of Treatment Effect of LY3074828 in Participants With Moderate-to-Severe Plaque Psoriasis (OASIS-3)
- NCT number
- NCT03556202
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 1,936 participants, actual
- Lead sponsor
- Eli Lilly and Company
- Conditions
- Psoriasis
- Interventions
- Mirikizumab
- First posted
- 2018-06-14
- Last updated
- 2023-03-21
- Other registries' IDs
- eudract:2017-003299-30
- Results first posted
- 2023-03-21
- Limitations and caveats
- This study was terminated before completion of the long-term extension trial, due to strategic business decision made by the company.
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With a Static Physician's Global Assessment Among Those Who Entered the Study With a sPGA of 0,1 | Week 104 | The sPGA is the physician's determination of the participant's psoriasis (PsO) lesions overall at a given time point. Lesions were categorized by descriptions for induration, erythema, and scaling. Participant's PsO was assessed as 0 (clear), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe), or 5 (very severe). An sPGA responder was defined as having a post-baseline sPGA score of "0" or "1" with at least a 2-point improvement from baseline. Participants who did not meet the clinical response criteria or had missing data at Week 104 were considered non-responders for non-responder Imputation (NRI) analysis. |
| Primary | Percentage of Participants Who Maintained a ≥90% Improvements in Psoriasis Area and Severity Index (PASI) 90 Among Those Who Entered the Study With a PASI 90 | Week 104 | PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of scaling, redness, and plaque induration/infiltration (thickness) in each region. For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored separately and the scores then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region \* area score \* weighing factor \[head (0.1), upper limbs (0.2), trunk (0.3), lower limbs (0.4)\]. Overall scores range from 0 (no PsO) to 72 (the most severe disease). |
| Secondary | Percentage of Participants Achieving a 100% Improvement in Psoriasis Area and Severity Index (PASI 100) | Week 104 | PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of scaling, redness, and plaque induration/infiltration (thickness) in each region. For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored separately and the scores then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region \* area score \* weighing factor \[head (0.1), upper limbs (0.2), trunk (0.3), lower limbs (0.4)\]. Overall scores range from 0 (no PsO) to 72 (the most severe disease). |
| Secondary | Percentage of Participants With a Psoriasis Symptoms Scale (PSS) Symptom Score of 0 (Free of Itch, Pain, Stinging, and Burning) in Those With a PSS Symptoms Score ≥1 at Baseline | Week 104 | PSS is a patient-administered assessment of 4 symptoms (itch, pain, stinging, and burning); 3 signs (redness, scaling, and cracking); and 1 item on the discomfort related to symptoms/signs. The overall severity for each individual symptom/sign from the patient's psoriasis is indicated by selecting the number from a numeric rating scale (NRS) of 0 to 10 that best describes the worst level of each symptom/sign in the past 24 hours, where 0=no symptom/sign and 10=worst imaginable symptom/sign. In addition, a symptoms score ranging from 0 (no symptoms) to 40 (worst imaginable symptoms), and a sign score of 0 (no signs) to 30 (worst imaginable signs) will be reported. |
| Secondary | Percentage of Participants Achieving a Dermatology Life Quality Index (DLQI) Total Score of (0,1) With at Least a 5-Point Improvement (Reduction) From Baseline in Participants With a Baseline DLQI Total Score ≥5 | Week 104 | The DLQI is a patient-reported, 10-question, quality-of-life questionnaire that covers 6 domains including symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. Response categories include "Not at all," "A little," "A lot," and "Very much," with corresponding scores of 0, 1, 2, and 3 respectively. Questions 3-10 also have an additional response category of "Not relevant" which is scored as "0". Totals range from 0 to 30 (less to more impairment). A DLQI total score of 0 to 1 is considered as having no effect on a patient's health-related quality of life (HRQoL), and a 5-point change from baseline is considered as the minimal clinically important difference (MCID) threshold. |
| Secondary | Change in Palmoplantar Psoriasis Severity Index (PPASI) Total Score in Participants With Palmoplantar Involvement at Baseline | Baseline, Week 104 | The PPASI is a composite score derived from the sum scores for erythema, induration, and desquamation multiplied by a score for the extent of palm and sole area involvement, ranging from 0 (no PPASI) to 72 (most severe PPASI). The PPASI was only assessed if participants have palmoplantar psoriasis at baseline. |
| Secondary | Change in Psoriasis Scalp Severity Index (PSSI) Total Score in Participants With Scalp Involvement at Baseline | Baseline, Week 104 | The PSSI is a physician assessment of erythema, induration and desquamation and percent of scalp that is covered with a scores range from 0 (none) to 4 (very severe). The composite score is derived from the sum of scores for erythema, induration, and desquamation multiplied by the score recorded for the extent of the scalp area involved, 1 (\<10%) to 6 (90%-100%) with a total score ranging from 0 (less severity) to 72 (more severity). |
| Secondary | Change in Nail Psoriasis Severity Index (NAPSI) Total Score in Participants With Fingernail Involvement at Baseline | Baseline, Week 104 | The NAPSI scale is used to evaluate the severity of fingernail bed Ps and fingernail matrix PsO by area of involvement. The fingernail is divided into quadrants. Each fingernail is given a score for fingernail bed PsO 0 (none) to 4 (PsO in 4 quadrants of the fingernail) and fingernail matrix PsO 0 (none) to 4 (Ps in 4 quadrants of the matrix), depending on the presence (score of 1) or absence (score of 0) of any of the features of fingernail bed or matrix PsO in each quadrant. The sum of all fingernails equals the total NAPSI score range is from 0 (no effect) to 80 (more severe psoriasis). |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With a Static Physician's Global Assessment Among Those Who Entered the Study With a sPGA of 0,1 | Week 104 | All randomized participants who received at least one dose of drug and who entered Study AMAH with sPGA (0,1). | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants Who Maintained a ≥90% Improvements in Psoriasis Area and Severity Index (PASI) 90 Among Those Who Entered the Study With a PASI 90 | Week 104 | All randomized participants who received at least one dose of study drug and who entered AMAH with PASI 90 Response. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving a 100% Improvement in Psoriasis Area and Severity Index (PASI 100) | Week 104 | All randomized participants who received at least one dose of study drug. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With a Psoriasis Symptoms Scale (PSS) Symptom Score of 0 (Free of Itch, Pain, Stinging, and Burning) in Those With a PSS Symptoms Score ≥1 at Baseline | Week 104 | All randomized participants with PSS symptom score of ≥1 at baseline. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving a Dermatology Life Quality Index (DLQI) Total Score of (0,1) With at Least a 5-Point Improvement (Reduction) From Baseline in Participants With a Baseline DLQI Total Score ≥5 | Week 104 | All randomized participants who had a baseline DLQI Total Score ≥5. | percentage of participants | NUMBER |
| SECONDARY | Change in Palmoplantar Psoriasis Severity Index (PPASI) Total Score in Participants With Palmoplantar Involvement at Baseline | Baseline, Week 104 | All randomized participants who had palmoplantar involvement at baseline. | score on a scale | MEAN |
| SECONDARY | Change in Psoriasis Scalp Severity Index (PSSI) Total Score in Participants With Scalp Involvement at Baseline | Baseline, Week 104 | All randomized participants who had Scalp Involvement at baseline. | score on a scale | MEAN |
| SECONDARY | Change in Nail Psoriasis Severity Index (NAPSI) Total Score in Participants With Fingernail Involvement at Baseline | Baseline, Week 104 | All randomized participants who had Nail Psoriasis involvement at baseline. | score on a scale | MEAN |
Source ClinicalTrials.gov
Results by group24
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With a Static Physician's Global Assessment Among Those Who Entered the Study With a sPGA of 0,1 | 125 Milligram (mg) Mirikizumab Q8W | 46.7 | 95% Confidence Interval 42.2 to 51.2 | percentage of participants | |
| Percentage of Participants With a Static Physician's Global Assessment Among Those Who Entered the Study With a sPGA of 0,1 | 250 mg Mirikizumab Q8W Excluding Secukinumab | 55.7 | 95% Confidence Interval 52.3 to 59.1 | percentage of participants | |
| Percentage of Participants With a Static Physician's Global Assessment Among Those Who Entered the Study With a sPGA of 0,1 | Secukinumab/250 mg Mirikizumab Q8W | 38.9 | 95% Confidence Interval 33.3 to 44.4 | percentage of participants | |
| Percentage of Participants Who Maintained a ≥90% Improvements in Psoriasis Area and Severity Index (PASI) 90 Among Those Who Entered the Study With a PASI 90 | 125 Milligram (mg) Mirikizumab Q8W | 49.3 | 95% Confidence Interval 44.8 to 53.9 | percentage of participants | |
| Percentage of Participants Who Maintained a ≥90% Improvements in Psoriasis Area and Severity Index (PASI) 90 Among Those Who Entered the Study With a PASI 90 | 250 mg Mirikizumab Q8W Excluding Secukinumab | 56.8 | 95% Confidence Interval 53.4 to 60.2 | percentage of participants | |
| Percentage of Participants Who Maintained a ≥90% Improvements in Psoriasis Area and Severity Index (PASI) 90 Among Those Who Entered the Study With a PASI 90 | Secukinumab/250 mg Mirikizumab Q8W | 39.4 | 95% Confidence Interval 33.9 to 44.9 | percentage of participants | |
| Percentage of Participants Achieving a 100% Improvement in Psoriasis Area and Severity Index (PASI 100) | 125 Milligram (mg) Mirikizumab Q8W | 30.4 | 95% Confidence Interval 26.4 to 34.3 | percentage of participants | |
| Percentage of Participants Achieving a 100% Improvement in Psoriasis Area and Severity Index (PASI 100) | 250 mg Mirikizumab Q8W Excluding Secukinumab | 36.4 | 95% Confidence Interval 33.4 to 39.3 | percentage of participants | |
| Percentage of Participants Achieving a 100% Improvement in Psoriasis Area and Severity Index (PASI 100) | Secukinumab/250 mg Mirikizumab Q8W | 22.6 | 95% Confidence Interval 18.5 to 26.8 | percentage of participants | |
| Percentage of Participants With a Psoriasis Symptoms Scale (PSS) Symptom Score of 0 (Free of Itch, Pain, Stinging, and Burning) in Those With a PSS Symptoms Score ≥1 at Baseline | 125 Milligram (mg) Mirikizumab Q8W | 31.1 | 95% Confidence Interval 27.1 to 35.1 | percentage of participants |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 results by groupParticipant flow30
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Extension Treatment Period | STARTED | 125 Milligram (mg) Mirikizumab Q8W | 527 | |
| Extension Treatment Period | STARTED | 250 mg Mirikizumab Q8W Excluding Secukinumab | 1,020 | |
| Extension Treatment Period | STARTED | Secukinumab/250 mg Mirikizumab Q8W | 389 | |
| Extension Treatment Period | Received at Least One Dose of Study Drug | 125 Milligram (mg) Mirikizumab Q8W | 527 | |
| Extension Treatment Period | Received at Least One Dose of Study Drug | 250 mg Mirikizumab Q8W Excluding Secukinumab | 1,020 | |
| Extension Treatment Period | Received at Least One Dose of Study Drug | Secukinumab/250 mg Mirikizumab Q8W | 389 | |
| Extension Treatment Period | From AMAF | 125 Milligram (mg) Mirikizumab Q8W | 35 | |
| Extension Treatment Period | From AMAF | 250 mg Mirikizumab Q8W Excluding Secukinumab | 132 | |
| Extension Treatment Period | From AMAF | Secukinumab/250 mg Mirikizumab Q8W | 0 | |
| Extension Treatment Period | From AMAK | 125 Milligram (mg) Mirikizumab Q8W | 83 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 participant flowAdverse events6,714
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 | Anaemia | Blood and lymphatic system disorders | 125 Milligram (mg) Mirikizumab Q8W | 4 | 527 | 4 |
| other | Anaemia | Blood and lymphatic system disorders | 250 mg Mirikizumab Q8W Excluding Secukinumab | 14 | 1,020 | 16 |
| other | Anaemia | Blood and lymphatic system disorders | Secukinumab/250 mg Mirikizumab Q8W | 2 | 389 | 2 |
| other | Anaemia | Blood and lymphatic system disorders | 125 Milligram (mg) Mirikizumab Q8W Follow-up Period | 0 | 453 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | 250 mg Mirikizumab Q8W Excluding Secukinumab Follow-up Period | 1 | 861 | 1 |
| other | Anaemia | Blood and lymphatic system disorders | Secukinumab/250 mg Mirikizumab Q8W Follow-up Period | 0 | 333 | 0 |
| other | Anaemia macrocytic | Blood and lymphatic system disorders | 125 Milligram (mg) Mirikizumab Q8W | 0 | 527 | 0 |
| other | Anaemia macrocytic | Blood and lymphatic system disorders | 250 mg Mirikizumab Q8W Excluding Secukinumab | 1 | 1,020 | 1 |
| other | Anaemia macrocytic | Blood and lymphatic system disorders | Secukinumab/250 mg Mirikizumab Q8W | 0 | 389 | 0 |
| other | Anaemia macrocytic | Blood and lymphatic system disorders | 125 Milligram (mg) Mirikizumab Q8W Follow-up Period | 0 | 453 | 0 |
1 to 10 of 6,714Source ClinicalTrials.gov
See all 6,714 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 125 Milligram (mg) Mirikizumab Q8W | 2 | 527 |
| Total, all-cause mortality | 250 mg Mirikizumab Q8W Excluding Secukinumab | 6 | 1,020 |
| Total, all-cause mortality | Secukinumab/250 mg Mirikizumab Q8W | 0 | 389 |
| Total, all-cause mortality | 125 Milligram (mg) Mirikizumab Q8W Follow-up Period | 1 | 453 |
| Total, all-cause mortality | 250 mg Mirikizumab Q8W Excluding Secukinumab Follow-up Period | 0 | 861 |
| Total, all-cause mortality | Secukinumab/250 mg Mirikizumab Q8W Follow-up Period | 0 | 333 |
| Total, other adverse events | 125 Milligram (mg) Mirikizumab Q8W | 388 | 527 |
| Total, other adverse events | 250 mg Mirikizumab Q8W Excluding Secukinumab | 756 | 1,020 |
| Total, other adverse events | Secukinumab/250 mg Mirikizumab Q8W | 288 | 389 |
| Total, other adverse events | 125 Milligram (mg) Mirikizumab Q8W Follow-up Period | 70 | 453 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 39073712 | DERIVED |
Source PubMed
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/NCT03556202
GET https://conductscience.org/api/trials/v1/NCT03556202/results?page=2