Trial · NCT03535194
A Study to Assess if Mirikizumab is Effective and Safe Compared to Secukinumab and Placebo in Moderate to Severe Plaque Psoriasis (OASIS-2)
NCT03535194, Phase 3, Completed, Eli Lilly and Company; results first posted 2021-03-30
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Assess if Mirikizumab is Effective and Safe Compared to Secukinumab and Placebo in Moderate to Severe Plaque Psoriasis (OASIS-2). Trials, record NCT03535194. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03535194
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Assess if Mirikizumab is Effective and Safe Compared to Secukinumab and Placebo in Moderate to Severe Plaque Psoriasis (OASIS-2)
- NCT number
- NCT03535194
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,484 participants, actual
- Lead sponsor
- Eli Lilly and Company
- Conditions
- Psoriasis
- Interventions
- Mirikizumab, Placebo, Secukinumab
- First posted
- 2018-05-24
- Last updated
- 2021-03-30
- Other registries' IDs
- eudract:2017-003286-10
- Results first posted
- 2021-03-30
Source ClinicalTrials.gov
Registered outcomes17
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 (sPGA) of (0,1) With at Least a 2-point Improvement From Baseline | Week 16 | The sPGA is the physician's determination of the participant's psoriasis lesions overall at a given time point. Lesions were categorized by descriptions for induration, erythema, and scaling. Participant's psoriasis 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. |
| Primary | Percentage of Participants Achieving a ≥90% Improvement in Psoriasis Area and Severity Index (PASI 90) From Baseline | Week 16 | 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, yielding an overall score of 0 for no psoriasis (PsO) to 72 for the most severe disease. 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 75% Improvement in PASI 75 | Week 16 | 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, yielding an overall score of 0 for no psoriasis (PsO) to 72 for the most severe disease. 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 ≤1% of Body Surface Area (BSA) With Psoriasis Involvement | Week 16 | The BSA is the percentage involvement of psoriasis on each participant's body surface on a continuous scale from 0% (no involvement) to 100% (full involvement), in which 1% corresponds to the size of the participant's hand (including the palm, fingers, and thumb). The total BSA affected was the summation of individual regions affected. Percentage response is calculated by number of participants with a response divided by number of participants with non-missing values multiplied by 100. |
| Secondary | Percentage of Participants With a Psoriasis Symptoms Scale (PSS) Symptom Score of 0 in Those With PSS Symptom Score of ≥1 at Baseline | Week 16 | 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 signs score of 0 (no signs) to 30 (worst imaginable signs) will be reported. Percentage response is calculated by number of participants with a response divided by number of participants with non-missing values multiplied by 100. |
| 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 16 | 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". For all questions, if unanswered the question 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. Percentage response is calculated by number of participants with a response divided by number of participants with non-missing values multiplied by 100. |
| Secondary | Change From Baseline in Palmoplantar Psoriasis Severity Index (PPASI) Total Score in Participants With Palmoplantar Involvement at Baseline | Baseline, Week 16 | The Palmoplantar PASI 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. Least Squares Mean (LS Mean) was calculated using mixed model repeated measures (MMRM) model with treatment, baseline value, visit, the interaction of the baseline value-by-visit, the interaction of treatment by-visit, and previous exposure to biologic therapy (yes/no), body weight (\<100 kg or \>=100 kg), and geographic region (North America or Other) as covariates. |
| Secondary | Change in Psoriasis Scalp Severity Index (PSSI) Total Score in Participants With Scalp Involvement at Baseline | Baseline, Week 16 | 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 From Baseline in Nail Psoriasis Severity Index (NAPSI) Total Score in Participants With Fingernail Involvement at Baseline | Baseline, Week 16 | 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). |
| Secondary | Change From Baseline on the 36-Item Short-Form Health Survey (SF-36) Physical Component Summary (PCS) | Baseline, Week 16 | SF-36 consists of 36 questions measuring 8 health domains: physical functioning, bodily pain, role limitations due to physical problems, role limitations due to emotional problems, general health perceptions, mental health, social function, and vitality. The patient's responses are solicited using Likert scales that vary in length, with 3-6 response options per item. The SF-36 can be scored into the 8 health domains named above and two overall summary scores: physical component summary (PCS) and mental component summary (MCS) scores. The domain and summary scores range from 0 to 100; higher scores indicate better levels of function and/or better health. |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes17
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 (sPGA) of (0,1) With at Least a 2-point Improvement From Baseline | Week 16 | All randomized participants. | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants Achieving a ≥90% Improvement in Psoriasis Area and Severity Index (PASI 90) From Baseline | Week 16 | All randomized participants. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving a 75% Improvement in PASI 75 | Week 16 | All randomized participants | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With ≤1% of Body Surface Area (BSA) With Psoriasis Involvement | Week 16 | All randomized participants. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With a Psoriasis Symptoms Scale (PSS) Symptom Score of 0 in Those With PSS Symptom Score of ≥1 at Baseline | Week 16 | 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 16 | All randomized participants with baseline DLQI Total Score ≥5. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Palmoplantar Psoriasis Severity Index (PPASI) Total Score in Participants With Palmoplantar Involvement at Baseline | Baseline, Week 16 | All randomized participants who had palmoplantar involvement at baseline. | Score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change in Psoriasis Scalp Severity Index (PSSI) Total Score in Participants With Scalp Involvement at Baseline | Baseline, Week 16 | All randomized participants who had scalp Involvement at baseline. | Score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Total Score in Participants With Fingernail Involvement at Baseline | Baseline, Week 16 | All randomized participants who had Nail Psoriasis involvement at baseline. | Score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline on the 36-Item Short-Form Health Survey (SF-36) Physical Component Summary (PCS) | Baseline, Week 16 | All randomized participants. | Score on a scale | LEAST_SQUARES_MEAN |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 outcomesResults by group58
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 (sPGA) of (0,1) With at Least a 2-point Improvement From Baseline | Placebo | 6.3 | 95% Confidence Interval 1.8 to 10.7 | percentage of participants | |
| Percentage of Participants With a Static Physician's Global Assessment (sPGA) of (0,1) With at Least a 2-point Improvement From Baseline | 300mg Secukinumab | 76.3 | 95% Confidence Interval 72.4 to 80.3 | percentage of participants | |
| Percentage of Participants With a Static Physician's Global Assessment (sPGA) of (0,1) With at Least a 2-point Improvement From Baseline | 250mg Q4W Mirikizumab | 79.7 | 95% Confidence Interval 77.0 to 82.3 | percentage of participants | |
| Percentage of Participants Achieving a ≥90% Improvement in Psoriasis Area and Severity Index (PASI 90) From Baseline | Placebo | 6.3 | 95% Confidence Interval 1.8 to 10.7 | percentage of participants | |
| Percentage of Participants Achieving a ≥90% Improvement in Psoriasis Area and Severity Index (PASI 90) From Baseline | 300mg Secukinumab | 72.8 | 95% Confidence Interval 68.6 to 76.9 | percentage of participants | |
| Percentage of Participants Achieving a ≥90% Improvement in Psoriasis Area and Severity Index (PASI 90) From Baseline | 250mg Q4W Mirikizumab | 74.4 | 95% Confidence Interval 71.5 to 77.2 | percentage of participants | |
| Percentage of Participants Achieving a 75% Improvement in PASI 75 | Placebo | 8.0 | 95% Confidence Interval 3.0 to 13.1 | percentage of participants | |
| Percentage of Participants Achieving a 75% Improvement in PASI 75 | 300mg Secukinumab | 89.5 | 95% Confidence Interval 86.7 to 92.3 | percentage of participants | |
| Percentage of Participants Achieving a 75% Improvement in PASI 75 | 250mg Q4W Mirikizumab | 89.5 | 95% Confidence Interval 87.5 to 91.5 | percentage of participants | |
| Percentage of Participants With ≤1% of Body Surface Area (BSA) With Psoriasis Involvement | Placebo | 1.8 | 95% Confidence Interval 0.0 to 4.2 | percentage of participants |
1 to 10 of 58Source ClinicalTrials.gov
See all 58 results by groupParticipant flow50
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Induction Period | STARTED | 250mg Q4W/250mg Q8W Mirikizumab | 454 | |
| Induction Period | STARTED | 250mg Q4W/125mg Q8W Mirikizumab | 451 | |
| Induction Period | STARTED | Placebo/250mg Mirikizumab | 112 | |
| Induction Period | STARTED | 300mg Secukinumab | 448 | |
| Induction Period | STARTED | Japan GPP/EP | 19 | |
| Induction Period | Received at Least One Dose of Study Drug | 250mg Q4W/250mg Q8W Mirikizumab | 454 | |
| Induction Period | Received at Least One Dose of Study Drug | 250mg Q4W/125mg Q8W Mirikizumab | 450 | |
| Induction Period | Received at Least One Dose of Study Drug | Placebo/250mg Mirikizumab | 112 | |
| Induction Period | Received at Least One Dose of Study Drug | 300mg Secukinumab | 448 | |
| Induction Period | Received at Least One Dose of Study Drug | Japan GPP/EP | 19 |
1 to 10 of 50Source ClinicalTrials.gov
See all 50 participant flowAdverse events13,338
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 | Placebo / Induction Period | 0 | 112 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | 300mg Secukinumab / Induction Period | 0 | 448 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | 250mg Mirikizumab Q4W / Induction Period | 1 | 904 | 1 |
| other | Anaemia | Blood and lymphatic system disorders | 250mg Mirikizumab Q4W - Japan GPP/EP / Induction Period | 0 | 19 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | 300mg Secukinumab/Maintenance Period | 0 | 437 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | 125mg Mirikizumab Q8W / Maintenance Period | 2 | 434 | 2 |
| other | Anaemia | Blood and lymphatic system disorders | 250mg Mirikizumab Q8W / Maintenance Period | 0 | 443 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | 250mg Mirikizumab / Maintenance Period | 0 | 104 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | 250mg Mirikizumab Q8W - Japan GPP/EP / Maintenance Period | 0 | 18 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Placebo / Follow-up Period | 0 | 4 | 0 |
1 to 10 of 13,338Source ClinicalTrials.gov
See all 13,338 adverse eventsAdverse event totals54
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo / Induction Period | 0 | 112 |
| Total, all-cause mortality | 300mg Secukinumab / Induction Period | 0 | 448 |
| Total, all-cause mortality | 250mg Mirikizumab Q4W / Induction Period | 1 | 904 |
| Total, all-cause mortality | 250mg Mirikizumab Q4W - Japan GPP/EP / Induction Period | 0 | 19 |
| Total, all-cause mortality | 300mg Secukinumab/Maintenance Period | 0 | 437 |
| Total, all-cause mortality | 125mg Mirikizumab Q8W / Maintenance Period | 0 | 434 |
| Total, all-cause mortality | 250mg Mirikizumab Q8W / Maintenance Period | 0 | 443 |
| Total, all-cause mortality | 250mg Mirikizumab / Maintenance Period | 0 | 104 |
| Total, all-cause mortality | 250mg Mirikizumab Q8W - Japan GPP/EP / Maintenance Period | 0 | 18 |
| Total, all-cause mortality | Placebo / Follow-up Period | 0 | 4 |
1 to 10 of 54Source ClinicalTrials.gov
See all 54 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 38251498 | 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.
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