Brief 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

205

participants targeted

Target at P75+ for phase_2

Timeline

Completed

Started Sep 2016

Geographic Reach

6 countries

40 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.6 years study duration

First Submitted

Initial submission to the registry

September 9, 2016

Completed

5 days until next milestone

First Posted

Study publicly available on registry

September 14, 2016

Completed

Same day until next milestone

Study Start

First participant enrolled

September 14, 2016

Completed

9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 19, 2017

Completed

1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 8, 2019

Completed

1.1 years until next milestone

Results Posted

Study results publicly available

June 18, 2020

Completed

Last Updated

June 18, 2020

Status Verified

August 15, 2019

Enrollment Period

9 months

First QC Date

September 9, 2016

Results QC Date

May 5, 2020

Last Update Submit

June 5, 2020

Conditions

Plaque Psoriasis

Keywords

IL-23dermatology

Outcome Measures

Primary Outcomes (1)

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).
Week 16

Secondary Outcomes (8)

Percentage of Participants With a 100% Improvement in Psoriasis Area and Severity Index (PASI 100)
Week 16
Percentage of Participants With a ≥75% Improvement in Psoriasis Area and Severity Index (PASI 75)
Week 16
Percentage of Participants With a Static Physician Global Assessment (sPGA) 0 and 0/1
Week 16
Mean Change From Baseline on the Psoriasis Symptom Scale (PSS) Total Score
Baseline, Week 16
Mean Change (Improvement) From Baseline on the Patient Global Assessment
Baseline, Week 16
+3 more secondary outcomes

Study Arms (4)

30 mg Mirikizumab

EXPERIMENTAL

30 mg Mirikizumab administered subcutaneously (SC) every 8 weeks (Q8W).

Drug: Mirikizumab

100 mg Mirikizumab

EXPERIMENTAL

100 mg Mirikizumab administered SC Q8W.

Drug: Mirikizumab

300 mg Mirikizumab

EXPERIMENTAL

300 mg Mirikizumab administered SC Q8W.

Drug: Mirikizumab

Placebo

PLACEBO COMPARATOR

Placebo administered SC Q8W.

Drug: Placebo

Interventions

MirikizumabDRUG

Administered SC

Also known as: LY3074828

100 mg Mirikizumab30 mg Mirikizumab300 mg Mirikizumab

PlaceboDRUG

Administered SC

Placebo

Eligibility Criteria

Age18 Years - 75 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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.

You may not qualify if:

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.
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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Eli Lilly and Companylead

Study Sites (40)

Renstar Medical Research

Ocala, Florida, 34471, United States

Location

Forward Clinical Trials, Inc

Tampa, Florida, 33624, United States

Location

The Indiana Clinical Trials Center, PC

Plainfield, Indiana, 46168, United States

Location

The South Bend Clinic

South Bend, Indiana, 46617, United States

Location

DS Research

Louisville, Kentucky, 40241, United States

Location

Dr. Shondra Smith MD

Lake Charles, Louisiana, 70605, United States

Location

Central Dermatology PC

St Louis, Missouri, 63117, United States

Location

Psoriasis Treatment Center of Central New Jersey

East Windsor, New Jersey, 08520, United States

Location

Oregon Dermatology and Research Center

Portland, Oregon, 97210, United States

Location

Clinical Partners LLC

Johnston, Rhode Island, 02919, United States

Location

Menter Dermatology Research Institute

Dallas, Texas, 75246, United States

Location

Dermatology Associates

Seattle, Washington, 98101, United States

Location

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, Canada

Location

Halifax, B3H1Z2, Canada

Location

Montreal, H2K4L5, Canada

Location

Peterborough, K9J 5K2, Canada

Location

Richmond Hill, L4B 1A5, Canada

Location

Waterloo, N2J 1C4, Canada

Location

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.

Frankfurt am Main, 60590, Germany

Location

Hamburg, 20354, Germany

Location

Mahlow, 15831, Germany

Location

Gifu, 501-1194, Japan

Location

Kurume, 830-0011, Japan

Location

Morioka, 020-8505, Japan

Location

Nagoya, 467-8602, Japan

Location

Osaka, 545-8586, Japan

Location

Shinagawa-KU, 141-8625, Japan

Location

Shinjuku-ku, 169-0073, Japan

Location

Takaoka-shi, 9330871, Japan

Location

Tsu, 514-8507, Japan

Location

Bialystok, 15-017, Poland

Location

Bialystok, 15-351, Poland

Location

Lodz, 90-242, Poland

Location

Lodz, 90-265, Poland

Location

Świdnik, 21-040, Poland

Location

Warsaw, 01-518, Poland

Location

Warsaw, 02-507, Poland

Location

Wroclaw, 51-318, Poland

Location

Grupo Dermatologico de Carolina

Carolina, 00985, Puerto Rico

Location

Ponce School of Medicine CAIMED Center

Ponce, 00716, Puerto Rico

Location

MeSH Terms

Interventions

mirikizumab

Results Point of Contact

Title: Chief Medical Officer
Organization: Eli Lilly and Company

Study Officials

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)
Eli Lilly and Company
STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee: No
Restriction Type: GT60
Restrictive Agreement: Yes

Study Design

Study Type: interventional
Phase: phase 2
Allocation: RANDOMIZED
Masking: DOUBLE
Who Masked: PARTICIPANT, INVESTIGATOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

September 9, 2016

First Posted

September 14, 2016

Study Start

September 14, 2016

Primary Completion

June 19, 2017

Study Completion

May 8, 2019

Last Updated

June 18, 2020

Results First Posted

June 18, 2020

Record last verified: 2019-08-15

Data Sharing

IPD Sharing: Will share
Shared Documents: STUDY PROTOCOL, SAP, CSR
Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

Locations

CA(6)US(12)DE(3)JP(9)PR(2)PL(8)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (8)

Study Arms (4)

30 mg Mirikizumab

100 mg Mirikizumab

300 mg Mirikizumab

Placebo

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (40)

MeSH Terms

Interventions

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Data Sharing

Locations