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A Long-term Study to Evaluate Safety and Maintenance of Treatment Effect of LY3074828 in Participants With Moderate-to-Severe Plaque Psoriasis (OASIS-3)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03556202
Recruitment Status : Recruiting
First Posted : June 14, 2018
Last Update Posted : March 17, 2020
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Tracking Information
First Submitted Date  ICMJE June 4, 2018
First Posted Date  ICMJE June 14, 2018
Last Update Posted Date March 17, 2020
Actual Study Start Date  ICMJE October 1, 2018
Estimated Primary Completion Date May 16, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 4, 2018)
  • Percentage of Participants with a Static Physician's Global Assessment Among Those who Entered the Study with a sPGA of 0,1(sPGA) of (0,1) [ Time Frame: Baseline through Study Completion (Estimated up to Week 208) ]
    Percentage of participants with an sPGA of (0,1) among those who entered the study with a sPGA of 0,1
  • 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 [ Time Frame: Baseline through Study Completion (Estimated up to Week 208) ]
    Percentage of participants who maintained a ≥90% improvement in PASI 90 among those who entered the study with a PASI 90.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 4, 2018)
  • Percentage of Participants Achieving a 100% Improvement in Psoriasis Area and Severity Index (PASI 100) [ Time Frame: Baseline through Study Completion (Estimated up to Week 208) ]
    Percentage of patients achieving a 100% improvement in PASI 100.
  • 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 [ Time Frame: Baseline through Study Completion (Estimated up to Week 208) ]
    Percentage of participants with a PSS symptom score of 0 (free of itch, pain, stinging, and burning) in those with a PSS symptoms score ≥1 at baseline.
  • Percentage of Participants Achieving Dermatology Life Quality Index (DLQI) Score of 0,1 with Baseline Score >1 [ Time Frame: Baseline through Study Completion (Estimated up to Week 208) ]
    Percentage of participants achieving Dermatology Life Quality Index (DLQI) score of 0,1 with baseline score >1.
  • Percent Change from Baseline in Palmoplantar Psoriasis Severity Index (PPASI) Total Score in Participants with Palmoplantar Involvement at Baseline [ Time Frame: Baseline, End of Study (Estimated Week 208) ]
    Percent change from baseline in PPASI total score in participants with palmoplantar involvement at baseline.
  • Percent Change from Baseline in Psoriasis Scalp Severity Index (PSSI) Total Score in Participants with Scalp Involvement at Baseline. [ Time Frame: Baseline, End of Study (Estimated Week 208) ]
    Percent change from baseline in PSSI total score in participants with scalp involvement at baseline.
  • Percent Change from Baseline in Nail Psoriasis Severity Index (NAPSI) Total Score in Participants with Fingernail Involvement at Baseline [ Time Frame: Baseline, End of Study (Estimated Week 208) ]
    Percent change from baseline in NAPSI total score in participants with fingernail involvement at baseline.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Long-term Study to Evaluate Safety and Maintenance of Treatment Effect of LY3074828 in Participants With Moderate-to-Severe Plaque Psoriasis (OASIS-3)
Official Title  ICMJE A Multicenter, Long-Term Extension to Evaluate the Long-term Safety and Maintenance of Treatment Effect of LY3074828 in Patients With Moderate-to-Severe Plaque Psoriasis OASIS-3
Brief Summary The purpose of this study is to evaluate the long-term safety and maintenance of efficacy of mirikizumab in participants with moderate-to-severe plaque psoriasis.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Masking Description:
Initially double-blind (until original, pivotal studies AMAK [NCT03482011] and AMAJ [NCT03535194] are locked and unblinded), then open-label.
Primary Purpose: Treatment
Condition  ICMJE Psoriasis
Intervention  ICMJE Drug: Mirikizumab
Administered SC
Other Name: LY3074828
Study Arms  ICMJE
  • Experimental: Mirikizumab Dose 1
    Mirikizumab administered subcutaneously (SC).
    Intervention: Drug: Mirikizumab
  • Experimental: Mirikizumab Dose 2
    Mirikizumab administered SC.
    Intervention: Drug: Mirikizumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 4, 2018)
1816
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 16, 2024
Estimated Primary Completion Date May 16, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Participant must have completed the last visit of an eligible study period of originating study.
  • Participant must be willing to follow the birth control measures during and after study treatment if woman of childbearing potential.

Exclusion Criteria:

  • Participant must not have an unstable or uncontrolled illness, including but not limited to a cerebro-cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, or neurologic disease or abnormal lab results, that the study investigator thinks makes it unsafe or inappropriate for the participant to participate in this study.
  • Participant must not have stopped taking mirikizumab during a previous study if the study investigator does not think the participant should resume taking mirikizumab.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 ClinicalTrials.gov@lilly.com
Listed Location Countries  ICMJE Argentina,   Australia,   Canada,   Czechia,   France,   Germany,   Hungary,   Israel,   Italy,   Japan,   Korea, Republic of,   Mexico,   Poland,   Puerto Rico,   Russian Federation,   Spain,   Taiwan,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03556202
Other Study ID Numbers  ICMJE 16491
I6T-MC-AMAH ( Other Identifier: Eli Lilly and Company )
2017-003299-30 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description:

Lilly provides access to the individual patient data from studies on approved medicines and indications as defined by the sponsor specific information on ClinicalStudyDataRequest.com.

This access is provided in a timely fashion after the primary publication is accepted. Researchers need to have an approved research proposal submitted through ClinicalStudyDataRequest.com. Access to the data will be provided in a secure data sharing environment after signing a data sharing agreement.

Responsible Party Eli Lilly and Company
Study Sponsor  ICMJE Eli Lilly and Company
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: 1-877-CTLILLY (1-877-285-4559) or Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
PRS Account Eli Lilly and Company
Verification Date March 15, 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP