Plaque PsoriasisPhase 2NCT02899988

A Study of Mirikizumab (LY3074828) in Participants With Moderate to Severe Plaque Psoriasis

A Phase 2 study testing Mirikizumab in people with Plaque Psoriasis, run by Eli Lilly and Company at 40 sites in 6 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The main purpose of this study is to evaluate the efficacy of the study drug mirikizumab in participants with moderate to severe plaque psoriasis. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Plaque Psoriasis
What is being tested?: Mirikizumab
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 205 participants
Where: 40 sitesin 6 countries
Study dates: 14 Sep 2016to 8 May 2019
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Present with chronic plaque psoriasis based on an investigator confirmed diagnosis of chronic psoriasis vulgaris for at least 6 months prior to baseline and meet the following criteria:
plaque psoriasis involving ≥10% body surface area (BSA) and absolute PASI score ≥12 in affected skin at screening and baseline
sPGA score of ≥3 at screening and baseline
Candidate for biologic treatment for psoriasis.

Who cannot join

Have a history or presence of cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematological, neurological, or neuropsychiatric disorders or any other serious and/or unstable illness that, in the opinion of the investigator, could constitute a risk when taking investigational product or could interfere with the interpretation of data.
Breastfeeding or nursing (lactating) women.
Have had serious, opportunistic, or chronic/recurring infection within 6 months prior to screening.
Have received live vaccine(s) (included attenuated live vaccines) within 1 month of screening or intend to during the study.
Have any other skin conditions (excluding psoriasis) that would affect interpretation of the results.
Have received systemic nonbiologic psoriasis therapy or phototherapy within 28 days prior to baseline.

Show all 9Show fewer

Have received topical psoriasis treatment within 14 days prior to baseline.
Have received anti-tumor necrosis factor (TNF) biologics, or anti-interleukin (IL)-17 targeting biologics within 8 weeks prior to baseline.
Have previous exposure to any biologic therapy targeting IL-23 (including ustekinumab), either licensed or investigational (previous briakinumab use is permitted).

Trial locations and contacts

40 sites in 6 countries.

Country

City, postcode or hospital

40 sites in 6 countries

United States12 sites

Menter Dermatology Research Institute
Dallas, Texas, 75246
Psoriasis Treatment Center of Central New Jersey
East Windsor, New Jersey, 08520
Clinical Partners LLC
Johnston, Rhode Island, 02919
Dr. Shondra Smith MD
Lake Charles, Louisiana, 70605
DS Research
Louisville, Kentucky, 40241
Renstar Medical Research
Ocala, Florida, 34471
The Indiana Clinical Trials Center, PC
Plainfield, Indiana, 46168
Oregon Dermatology and Research Center
Portland, Oregon, 97210
Dermatology Associates
Seattle, Washington, 98101
The South Bend Clinic
South Bend, Indiana, 46617
Central Dermatology PC
St Louis, Missouri, 63117
Forward Clinical Trials, Inc
Tampa, Florida, 33624

Other trials in United States

Japan9 sites

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Gifu, 501-1194
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Kurume, 830-0011
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Morioka, 020-8505
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Nagoya, 467-8602
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Osaka, 545-8586
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Shinagawa-KU, 141-8625
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Shinjuku-ku, 169-0073
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Takaoka-shi, 9330871
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Tsu, 514-8507

Other trials in Japan

Poland8 sites

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Bialystok, 15-017
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Bialystok, 15-351
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Lodz, 90-242
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Lodz, 90-265
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Świdnik, 21-040
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Warsaw, 01-518
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Warsaw, 02-507
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Wroclaw, 51-318

Other trials in Poland

Canada6 sites

For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.
Calgary, T2G 1B1
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Halifax, B3H1Z2
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Montreal, H2K4L5
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Peterborough, K9J 5K2
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Richmond Hill, L4B 1A5
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Waterloo, N2J 1C4

Other trials in Canada

Germany3 sites

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Frankfurt am Main, 60590
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Hamburg, 20354
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Mahlow, 15831

Other trials in Germany

Puerto Rico2 sites

Grupo Dermatologico de Carolina
Carolina, 00985
Ponce School of Medicine CAIMED Center
Ponce, 00716

Other trials in Puerto Rico

About this study

Official title: A Phase 2, Multicenter, Randomized, Parallel-Arm, Placebo- Controlled Study of LY3074828 in Subjects With Moderate-to- Severe Plaque Psoriasis

The main purpose of this study is to evaluate the efficacy of the study drug mirikizumab in participants with moderate to severe plaque psoriasis.

Conditions: Plaque Psoriasis
Being tested: Mirikizumab, Placebo
Keywords: IL-23, dermatology

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MirikizumabDrug
Also called LY3074828
Administered SC
PlaceboDrug
Administered SC

Study groups in NCT02899988
Study group	Role	What they receive
30 mg Mirikizumab	Experimental	30 mg Mirikizumab administered subcutaneously (SC) every 8 weeks (Q8W). Receives: Drug: Mirikizumab
100 mg Mirikizumab	Experimental	100 mg Mirikizumab administered SC Q8W. Receives: Drug: Mirikizumab
300 mg Mirikizumab	Experimental	300 mg Mirikizumab administered SC Q8W. Receives: Drug: Mirikizumab
Placebo	Placebo comparator	Placebo administered SC Q8W. Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Participants With a ≥90% Improvement in Psoriasis Area and Severity Index (PASI 90)
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).
Measured: Week 16

Secondary outcomes (8)

Percentage of Participants With a 100% Improvement in Psoriasis Area and Severity Index (PASI 100)
The 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 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).
Measured: Week 16
Percentage of Participants With a ≥75% Improvement in Psoriasis Area and Severity Index (PASI 75)
The 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 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).
Measured: Week 16
Percentage of Participants With a Static Physician Global Assessment (sPGA) 0 and 0/1
The sPGA is the physician's determination of the participant's 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 16 were considered non-responders for non-responder Imputation (NRI) analysis.
Measured: Week 16
Mean Change From Baseline on the Psoriasis Symptom Scale (PSS) Total Score
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. The total score was calculated by summing the 8 individual items and ranged from 0 to 80, higher scores indicated greater symptom/sign severity. Least Square(LS) Mean was calculated using Mixed Model Repeated Measures (MMRM) model with treatment, geographic region [United States/Outside United States (US/OUS)], previous therapy (yes/no), baseline value, visit, and the interaction treatment-by-visit as fixed factors, covariance structure = heterogeneous autoregressive.
Measured: Baseline, Week 16
Mean Change (Improvement) From Baseline on the Patient Global Assessment
The Patient's Global Assessment of Disease Severity is a single-item participant-reported outcome measure on which participants are asked to rate the severity of their psoriasis "today" from 0 (Clear) = no psoriasis, to 5 (Severe) = the worst their psoriasis has ever been. Least Square (LS) Mean was calculated using Mixed Model Repeated Measures (MMRM) model with treatment, geographic region (US/OUS), previous therapy (yes/no), baseline value, visit, and the interaction treatment-by-visit as fixed factors, covariance structure = unstructured.
Measured: Baseline, Week 16
Mean Change From Baseline on the Dermatology Life Quality Index (DLQI) Total Score
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). Least Square (LS) Mean was calculated using Mixed Model Repeated Measures (MMRM) model with treatment, geographic region (US/OUS), previous therapy (yes/no), baseline value, visit, and the interaction treatment-by-visit as fixed factors, covariance structure = unstructured.
Measured: Baseline, Week 16
Mean Change From Baseline on the 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores
The SF-36 is a health-related survey that assesses participant's quality of life and consists of 36 questions covering 8 health domains: physical functioning, bodily pain, role limitations due to physical problems and emotional problems, general health, mental health, social functioning, vitality, and 2 component scores (MCS and PCS). MCS consisted of social functioning, vitality, mental health, and role-emotional scales. PCS consisted of physical functioning, bodily pain, role-physical, and general health scales. Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale with higher scores indicating better health status or functioning. Least Squares Mean (LS Mean) was calculated using Analysis of covariance (ANCOVA) model with treatment, geographic region (US/OUS), and previous therapy (yes/no) as fixed factors and baseline value as covariate.
Measured: Baseline, Week 16
Pharmacokinetics (PK): Area Under the Curve (AUC) of Mirikizumab From Baseline Through Week 104
Pharmacokinetics (PK): Area Under the Curve (AUC) of Mirikizumab From Baseline through Week 104
Measured: Week 0, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 32, Week 40, Week 48, Week 52, Week 56, Week 64, Week 72, Week 80, Week 88, Week 96, Week 100, Week 104

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Sep 20168 May 2019

First posted14 Sep 2016 (estimated)
Study start14 Sep 2016
Primary completion19 Jun 2017
Study completion8 May 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Plaque PsoriasisStudies of the same condition, open and under way.
More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 205 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02899988
Sponsor's protocol ID: 16481
Other IDs: I6T-MC-AMAF, 2016-001098-34, 2016
Status last verified: 15 Aug 2019
First submitted: 9 Sep 2016
Last updated: 18 Jun 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: 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.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 2
Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis
Plaque Psoriasis
RecruitingPhase 1/2
A Study to Evaluate the Efficacy and Safety of CS32582 in Participants With Moderate to Severe Plaque Psoriasis
Plaque Psoriasis
Not yet recruitingPhase 3
A Study of Zasocitinib in Adults With Non-pustular Palmoplantar Psoriasis
Palmoplantar Psoriasis
RecruitingPhase 4
A Study to Investigate the Effectiveness of Tirzepatide (LY3298176) Following Initiation of Ixekizumab (LY2439821) in Participants With Moderate-to-Severe Plaque PsO and Obesity or Overweight in Clinical Practice (TOGETHER AMPLIFY-PsO)
Psoriasis, Overweight or Obesity
Active, not recruitingPhase 3
A Study of JNJ-77242113 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis
Plaque Psoriasis

All Plaque Psoriasis trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2, Multicenter, Randomized, Parallel-Arm, Placebo- Controlled Study of LY3074828 in Subjects With Moderate-to- Severe Plaque Psoriasis
ClinicalTrials.gov ID: NCT02899988
Acronym / sponsor ID: 16481
Conditions: Plaque Psoriasis
Keywords: IL-23, dermatology
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 205 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: 14 Sep 2016 (actual)
Primary completion: 19 Jun 2017 (actual)
Study completion: 8 May 2019 (actual)
First posted: 14 Sep 2016 (estimated)
Results: Posted 18 Jun 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The main purpose of this study is to evaluate the efficacy of the study drug mirikizumab in participants with moderate to severe plaque psoriasis.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
30 mg Mirikizumab	Experimental	Drug: Mirikizumab30 mg Mirikizumab administered subcutaneously (SC) every 8 weeks (Q8W).
100 mg Mirikizumab	Experimental	Drug: Mirikizumab100 mg Mirikizumab administered SC Q8W.
300 mg Mirikizumab	Experimental	Drug: Mirikizumab300 mg Mirikizumab administered SC Q8W.
Placebo	Placebo comparator	Drug: PlaceboPlacebo administered SC Q8W.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Present with chronic plaque psoriasis based on an investigator confirmed diagnosis of chronic psoriasis vulgaris for at least 6 months prior to baseline and meet the following criteria:
Candidate for biologic treatment for psoriasis.

Key exclusion criteria (9 listed)

Have a history or presence of cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematological, neurological, or neuropsychiatric disorders or any other serious and/or unstable illness that, in the opinion of the investigator, could constitute a risk when taking investigational product or could interfere with the interpretation of data.
Breastfeeding or nursing (lactating) women.
Have had serious, opportunistic, or chronic/recurring infection within 6 months prior to screening.
Have received live vaccine(s) (included attenuated live vaccines) within 1 month of screening or intend to during the study.
Have any other skin conditions (excluding psoriasis) that would affect interpretation of the results.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
MirikizumabAlso: LY3074828Administered SC	Drug	100 mg Mirikizumab, 30 mg Mirikizumab, 300 mg Mirikizumab
PlaceboAdministered SC	Drug	Placebo

Primary outcome

Percentage of Participants With a ≥90% Improvement in Psoriasis Area and Severity Index (PASI 90)
Time frame: 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).

8 secondary outcomes

Percentage of Participants With a 100% Improvement in Psoriasis Area and Severity Index (PASI 100)
Time frame: Week 16
Percentage of Participants With a ≥75% Improvement in Psoriasis Area and Severity Index (PASI 75)
Time frame: Week 16
Percentage of Participants With a Static Physician Global Assessment (sPGA) 0 and 0/1
Time frame: Week 16
Mean Change From Baseline on the Psoriasis Symptom Scale (PSS) Total Score
Time frame: Baseline, Week 16
Mean Change (Improvement) From Baseline on the Patient Global Assessment
Time frame: Baseline, Week 16
Mean Change From Baseline on the Dermatology Life Quality Index (DLQI) Total Score
Time frame: Baseline, Week 16
Mean Change From Baseline on the 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores
Time frame: Baseline, Week 16
Pharmacokinetics (PK): Area Under the Curve (AUC) of Mirikizumab From Baseline Through Week 104
Time frame: Week 0, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 32, Week 40, Week 48, Week 52, Week 56, Week 64, Week 72, Week 80, Week 88, Week 96, Week 100, Week 104

Results and safety

Results posted to the registry on 18 Jun 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Induction: Placebo	52	50
Induction: 30 mg Mirikizumab Q8W	51	49
Induction:100 mg Mirikizumab Q8W	51	51
Induction: 300 mg Mirikizumab Q8W	51	49
Maintenance: 30 mg Mirikizumab Q8W to 30 mg Mirikizumab PRN	0	0
Maintenance: 100 mg Mirikizumab Q8W to 100 mg Mirikizumab PRN	0	0
Maintenance: 300 mg Mirikizumab Q8W to 300 mg Mirikizumab PRN	0	0
Maintenance: Placebo to 300 mg Mirikizumab Q8W	0	0
Maintenance: 30 mg Mirikizumab Q8W to 300 mg Mirikizumab Q8W	0	0
Maintenance: 100 mg Mirikizumab Q8W to 300 mg MirikizumabQ8W	0	0
Maintenance: 300 mg Mirikizumab Q8W	0	0

Primary outcome: Percentage of Participants With a ≥90% Improvement in Psoriasis Area and Severity Index (PASI 90)

Time frame: Week 16. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Induction: Placebo n = 52	Induction: 30 mg Mirikizumab n = 51	Induction: 100 mg Mirikizumab n = 51	Induction: 300 mg Mirikizumab n = 51
Value	0 (0 to 0)	29.4 (16.9 to 41.9)	58.8 (45.3 to 72.3)	66.7 (53.7 to 79.6)

Induction: Placebo vs Induction: 30 mg Mirikizumab: Risk Difference (RD): 29.4 (95% CI 16.9 to 41.9), p = 0.009, Regression, Logistic
Induction: Placebo vs Induction: 100 mg Mirikizumab: Risk Difference (RD): 58.8 (95% CI 45.3 to 72.3), p <0.001, Regression, Logistic
Induction: Placebo vs Induction: 300 mg Mirikizumab: Risk Difference (RD): 66.7 (95% CI 53.7 to 79.6), p <0.001, Regression, Logistic

Population analysed: All participants who received at least one dose of study drug.

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up To 120 Weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Induction: Placebo	1 of 52 (1.9%)	19 of 52 (36.5%)	0 of 52
Induction: 30 mg Mirikizumab Q8W	1 of 51 (2%)	24 of 51 (47.1%)	0 of 51
Induction:100 mg Mirikizumab Q8W	0 of 51 (0%)	19 of 51 (37.3%)	0 of 51
Induction: 300 mg Mirikizumab Q8W	1 of 51 (2%)	19 of 51 (37.3%)	0 of 51
Maintenance: 30 mg Mirikizumab Q8W to 30 mg Mirikizumab PRN	1 of 15 (6.7%)	13 of 15 (86.7%)	0 of 15
Maintenance: 100 mg Mirikizumab Q8W to 100 mg Mirikizumab PRN	2 of 30 (6.7%)	20 of 30 (66.7%)	0 of 30
Maintenance: 300 mg Mirikizumab Q8W to 300 mg Mirikizumab PRN	1 of 34 (2.9%)	23 of 34 (67.6%)	0 of 34
Maintenance: Placebo to 300 mg Mirikizumab Q8W	2 of 50 (4%)	38 of 50 (76%)	0 of 50
Maintenance: 30 mg Mirikizumab Q8W to 300 mg Mirikizumab Q8W	2 of 34 (5.9%)	28 of 34 (82.4%)	0 of 34
Maintenance: 100 mg Mirikizumab Q8W to 300 mg MirikizumabQ8W	2 of 21 (9.5%)	18 of 21 (85.7%)	0 of 21
Maintenance: 300 mg Mirikizumab Q8W	3 of 15 (20%)	13 of 15 (86.7%)	0 of 15
300 mg Mirikizumab Q8W-Rescue	1 of 10 (10%)	9 of 10 (90%)	0 of 10
30 mg Mirikizumab Q8W to 30 mg Mirikizumab PRN-Follow-up	0 of 2 (0%)	0 of 2 (0%)	0 of 2
100 mg Mirikizumab Q8W to 100 mg Mirikizumab PRN-Follow-up	0 of 4 (0%)	1 of 4 (25%)	0 of 4
300 mg Mirikizumab Q8W to 300 mg Mirikizumab PRN-Follow-up	0 of 3 (0%)	0 of 3 (0%)	0 of 3
Placebo to 300 mg Mirikizumab Q8W-Follow-up	0 of 3 (0%)	0 of 3 (0%)	0 of 3
30 mg Mirikizumab Q8W to 300 mg Mirikizumab Q8W-Follow-up	0 of 6 (0%)

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) study director

Eli Lilly and Company

40 sites in 6 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Mirikizumab in people with Plaque Psoriasis, run by Eli Lilly and Company at 40 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 40 sites in United States, Japan, Poland, Canada, Germany and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Jun 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With a ≥90% Improvement in Psoriasis Area and Severity Index (PASI 90) (time frame: Week 16). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02899988.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2020.