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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)

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ClinicalTrials.gov Identifier: NCT03556202
Recruitment Status : Not yet recruiting
First Posted : June 14, 2018
Last Update Posted : July 4, 2018
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

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.

Condition or disease Intervention/treatment Phase
Psoriasis Drug: Mirikizumab Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1816 participants
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
Official Title: 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
Estimated Study Start Date : September 25, 2018
Estimated Primary Completion Date : May 16, 2024
Estimated Study Completion Date : May 16, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
Experimental: Mirikizumab Dose 1
Mirikizumab administered subcutaneously (SC).
Drug: Mirikizumab
Administered SC
Other Name: LY3074828

Experimental: Mirikizumab Dose 2
Mirikizumab administered SC.
Drug: Mirikizumab
Administered SC
Other Name: LY3074828




Primary Outcome Measures :
  1. 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

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03556202


Contacts
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

  Show 195 Study Locations
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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

Additional Information:
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT03556202     History of Changes
Other Study ID Numbers: 16491
I6T-MC-AMAH ( Other Identifier: Eli Lilly and Company )
2017-003299-30 ( EudraCT Number )
First Posted: June 14, 2018    Key Record Dates
Last Update Posted: July 4, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
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.


Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Eli Lilly and Company:
IL-23
Interleukin-23
Psoriasis

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases