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Extension Trial Assessing the Safety and Efficacy of BI 655066/ABBV-066/Risankizumab in Patients With Moderate to Severe Chronic Plaque Psoriasis | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Extension Trial Assessing the Safety and Efficacy of BI 655066/ABBV-066/Risankizumab in Patients With Moderate to Severe Chronic Plaque Psoriasis

An Open Label Extension Trial Assessing the Safety and Efficacy of BI 655066/ ABBV-066/Risankizumab Administered Subcutaneously in Patients With Moderate to Severe Chronic Plaque Psoriasis

NCT02203851•AbbVie

View on ClinicalTrials.gov

Summary

The primary objective of Study M16-009 was to investigate the safety of risankizumab in participants with moderate to severe chronic plaque psoriasis who were receiving long-term treatment. Additional study objectives were to further investigate the long-term efficacy, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of risankizumab.

Detailed Description

Participants who had successfully completed Study 1311.2 (NCT02054481; the lead-in study) and met the eligibility criteria for Study M16-009 (extension study) had the option to enter the extension study. Participants were allowed to have the End of Study Visit in the lead in study combined with the Week 0 Visit for the extension study. At the Week 12 visit, participants were assigned to treatment based on 90% improvement in Psoriasis Area and Severity Index (PASI90) Score: participants with ≥PASI90 Score at Week 12 continued to receive risankizumab 90 mg by subcutaneous (SC) injection; participants with \<PASI90 Score at Week 12 switched to risankizumab 180 mg by SC injection. Efficacy results are summarized by the 4 treatment groups from the lead-in study, which included the following: Participants who received risankizumab 18 mg in the lead-in study and risankizumab in the extension study (Risankizumab 18 mg/Risankizumab); participants who received risankizumab 90 mg in the lead-in study and risankizumab in the extension study (Risankizumab 90 mg/Risankizumab); participants who received risankizumab 180 mg in the lead-in study and risankizumab in the extension study (Risankizumab 180 mg/Risankizumab); and participants who received ustekinumab (Stelara) 45 or 90 mg in the lead-in study and risankizumab in the extension study (Ustekinumab/Risankizumab).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Participants with moderate to severe chronic plaque psoriasis, who have successfully completed Study 1311.2 (NCT02054481; the lead-in study). Successful completion of the lead-in study is defined as either of the following:
•1. Completion of the entire follow up period, thus reaching End-of-study (EOS) visit.
•2. Loss of response, defined as decrease in response to achieving \< 50% improvement in Psoriasis Area and Severity Index Score (PASI50) at any time from Week 24.
•Participant must give informed consent and sign an approved consent form prior to any study procedures in accordance with Good Clinical Practice (GCP) and local legislation
•Applicable only for female participants:
•Negative urine pregnancy dip stick test at the roll-over visit, and if available at roll-over visit, negative Serum ß-Human Chorionic Gonadotropin (ß-HCG) test.
•In addition:
•Women of childbearing potential (not surgically sterilized and between menarche and 1 year postmenopausal), that, if sexually active agree to use one of the appropriate medically accepted methods of birth control in addition to the consistent and correct use of a condom from date of the roll-over visit until 12 weeks after last treatment in this study. Medically accepted methods of contraception are: ethinyl estradiol containing contraceptives, diaphragm with spermicide substance, and intra-uterine-device.
•OR
•Female participants which have vasectomized sexual partner(s) (vasectomy at least 1 year prior to enrollment).
+4 more criteria

Exclusion Criteria

•Participants who experienced any drug related serious adverse event (SAE) in the lead-in study
•Participants who have developed guttate, erythrodermic or pustular psoriasis or drug-induced psoriasis (as diagnosed by the investigator), during the lead-in study.
•Evidence of current or previous clinically significant disease, medical condition other than psoriasis, or finding of the medical examination (including vital signs and electrocardiography \[ECG\]), that in the opinion of the investigator, would compromise the safety of the participant or the quality of the data.
•Known clinically important acute or chronic infections including hepatitis, human immunodeficiency virus (HIV). In regards to tuberculosis (TB), the following applies:
•Signs or symptoms suggestive of current active or latent TB upon medical history, physical examination and/or a chest radiograph (both posterior-anterior and lateral views, taken within 3 months prior to the first administration of study drug and read by a qualified radiologist).
•History of latent or active TB prior to screening, except for participants with documented completion of an adequate treatment regimen, at least 6 months prior to the first administration of study agent.
•Positive QuantiFERON-TB Gold In-Tube test (IGRA) within 2 months prior to the roll-over visit (if available), in which active TB has not been ruled out. This does not apply to participants with history of latent TB with documented completion of an adequate treatment regimen, at least 6 months prior to the first administration of study agent.
•Participants who have developed malignancy, or suspicion of active malignant disease during the lead-in study (except treated cutaneous squamous cell or basal cell carcinoma or carcinoma in situ of the cervix that have been adequately treated).
•Intake of restricted medications or other drugs considered likely to interfere with the safe conduct of this study, as assessed by the investigator.
•Alcohol or drug abuse within 3 months prior to the roll-over visit that would interfere with trial participation or any ongoing condition leading to a decreased compliance to study procedures in the opinion of the investigator.
+2 more criteria

Key Dates

Start Date

November 20, 2014

Primary Completion Date

September 4, 2018

Completion Date

September 4, 2018

Last Updated

November 8, 2019

Enrollment

110

ACTUAL participants

Conditions

Psoriasis

Interventions

Risankizumab

DRUG

A Study of Guselkumab After Switching From Ustekinumab in Participants With Moderate to Severe Psoriasis

NCT07449234

Psoriasis

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RECRUITINGPHASE3

Long-Term Safety Study of Deucravacitinib Versus Ustekinumab in Participants With Psoriasis (PRAGMATYK)

NCT07116967

Plaque Psoriasis

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RECRUITINGPHASE3

A Long-Term Study of Zasocitinib in Children and Teenagers With Plaque Psoriasis

NCT07250802

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 8, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Extension Trial Assessing the Safety and Efficacy of BI 655066/ABBV-066/Risankizumab in Patients With Moderate to Severe Chronic Plaque Psoriasis

Inclusion Criteria

Exclusion Criteria

A Study of Guselkumab After Switching From Ustekinumab in Participants With Moderate to Severe Psoriasis

Long-Term Safety Study of Deucravacitinib Versus Ustekinumab in Participants With Psoriasis (PRAGMATYK)

A Long-Term Study of Zasocitinib in Children and Teenagers With Plaque Psoriasis

An Open-Label Extension Study of ORKA-001 in Participants With Plaque Psoriasis

Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis

Real-Life Evaluation of Guselkumab Dosing Interval Adjustments