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A Study to Assess the Safety and Efficacy of Risankizumab for Maintenance in Moderate to Severe Plaque Type Psoriasis ( LIMMITLESS ) (LIMMITLESS)

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. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03047395
Recruitment Status : Active, not recruiting
First Posted : February 9, 2017
Last Update Posted : May 23, 2019
Sponsor:
Information provided by (Responsible Party):
AbbVie

Brief Summary:
The purpose of this study is to investigate the long-term safety and efficacy of risankizumab in the treatment of moderate to severe chronic plaque psoriasis.

Condition or disease Intervention/treatment Phase
Psoriasis Biological: risankizumab Phase 3

Detailed Description:
This is a Phase 3, single-arm, multicenter OLE study designed to investigate the long-term safety and efficacy of 150 mg risankizumab in the treatment of moderate to severe chronic plaque psoriasis. Approximately 2200 subjects who meet the entry criteria are planned to be enrolled in this study, rolling over from the preceding Phase 2/3 studies.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2179 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Open Label Study to Assess the Safety and Efficacy of Risankizumab for Maintenance in Moderate to Severe Plaque Type Psoriasis (LIMMITLESS)
Actual Study Start Date : February 27, 2017
Estimated Primary Completion Date : January 27, 2022
Estimated Study Completion Date : January 27, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
Experimental: Risankizumab
Participants will receive risankizumab administered by subcutaneous injection.
Biological: risankizumab
Risankizumab 150 mg administered by subcutaneous injection every 12 weeks.
Other Name: ABBV-066 BI 655066




Primary Outcome Measures :
  1. Percentage of Participants Achieving an sPGA Score of Clear [ Time Frame: Weeks 0, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and End of Observation visit (up to week 172) ]
    The sPGA is based on the physician's assessment of the average thickness, erythema, and scaling of all psoriatic lesions.

  2. Percentage of Participants Achieving At Least 100% Reduction in PASI Score From Baseline (PASI 100) [ Time Frame: Weeks 0, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and End of Observation visit (up to week 172) ]
    The PASI score is an established measure of clinical efficacy for psoriasis medications.

  3. Percentage of Participants Achieving At Least 75% Reduction in PASI Score From Baseline (PASI 75) [ Time Frame: Weeks 0, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and End of Observation visit (up to week 172) ]
    The PASI score is an established measure of clinical efficacy for psoriasis medications.

  4. Percentage of Participants Achieving At Least 90% Reduction in Psoriasis Area and Severity Index (PASI) Score From Baseline (PASI 90) [ Time Frame: Weeks 0, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and End of Observation visit (up to week 172) ]
    The PASI score is an established measure of clinical efficacy for psoriasis medications.

  5. Percentage of Participants Achieving a Static Physician Global Assessment (sPGA) Score of Clear or Almost Clear [ Time Frame: Weeks 0, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and End of Observation visit (up to week 172) ]
    The sPGA is based on the physician's assessment of the average thickness, erythema, and scaling of all psoriatic lesions.



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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:

  • Subjects with a history of moderate to severe chronic plaque psoriasis, who have completed one of the preceding studies.
  • Subjects must be candidates for prolonged open label risankizumab treatment according to investigator judgment.
  • Females of childbearing potential must have a negative urine pregnancy test result at Baseline.

If female, subject must be either postmenopausal, OR permanently surgically sterile OR for women of childbearing potential practicing at least one protocol specified method of birth control, starting at Baseline through at least 20 weeks after the last dose of study drug.

  • Subjects must have signed and dated a written informed consent in accordance with Good Clinical Practice (GCP) and local legislation prior to admission into the study.

Exclusion Criteria:

  • Premature discontinuation for any reason in the preceding study.
  • Subjects who have developed guttate, erythrodermic, pustular or drug-induced psoriasis as diagnosed by the investigator during the preceding study.
  • Use of any prohibited medication or any drug considered likely to interfere with the safe conduct of the study, as assessed by the investigator.
  • Known tuberculosis (TB) or evidence of TB infection. Subjects with a positive QuantiFERON® TB test or a positive purified protein derivate (PPD) skin test result may participate in the study if further work up (according to local practice/guidelines) establishes conclusively that the subject has no evidence of active TB.
  • Subjects who have developed active or suspected malignancy during the preceding study, except appropriately treated basal cell or squamous cell carcinoma of the skin or in situ carcinoma of uterine cervix.
  • Subjects who have laboratory evidence of Human Immunodeficiency Virus (HIV), hepatitis B or hepatitis C viral infection from laboratory testing within the preceding clinical trial or any other source.
  • Evidence of a current or previous disease, medical condition (including chronic alcohol or drug abuse) other than psoriasis, surgical procedure (i.e., organ transplant), medical examination finding (including vital signs and ECG), or laboratory value outside the reference range that in the opinion of the investigator is clinically significant and would make the study participant unreliable to adhere to the protocol or to complete the study, compromise the safety of the subject, or compromise the quality of the data.
  • History of allergy/hypersensitivity to a systemically administered biologic agent or its excipients.
  • Previous enrollment in this study.
  • Female subject who is pregnant, breastfeeding or is considering becoming pregnant during the study or within 20 weeks after the last dose of study drug.
  • Time elapsed is > 8 weeks since the completion visit in the preceding study.
  • Subject is considered by the investigator for any reason, to be an unsuitable candidate for the study and not able to comply with the study protocol.

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): NCT03047395


  Show 233 Study Locations
Sponsors and Collaborators
AbbVie
Investigators
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Study Director: AbbVie Inc. AbbVie

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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT03047395     History of Changes
Other Study ID Numbers: M15-997
2016-003046-87 ( EudraCT Number )
1311.31 ( Other Grant/Funding Number: Boehringer Ingelheim )
First Posted: February 9, 2017    Key Record Dates
Last Update Posted: May 23, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
URL: https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by AbbVie:
ABBV-066
BI 655066

Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs