Overview

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

Status:
Completed
Trial end date:
2018-09-04
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
AbbVie
Collaborator:
Boehringer Ingelheim
Criteria
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).

OR

Surgically sterilized female participants with documentation of prior hysterectomy, tubal
ligation or complete bilateral oophorectomy.

OR

Postmenopausal women with postmenopausal is defined as permanent cessation ≥ 1 year of
previously occurring menses.

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.

- Any clinically significant laboratory abnormalities based on the last available
laboratory results received during the lead-in study (according to the investigator's
medical assessment).

- Pre-menopausal woman who is pregnant or nursing.