Extension Trial Assessing the Safety and Efficacy of BI 655066/ABBV-066/Risankizumab in Patients With Moderate to Severe Chronic Plaque Psoriasis
Status: | Completed |
---|---|
Conditions: | Psoriasis |
Therapuetic Areas: | Dermatology / Plastic Surgery |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 9/9/2018 |
Start Date: | November 20, 2014 |
End Date: | September 4, 2018 |
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
The primary objective of the study is to investigate long-term safety and efficacy of BI
655066/ABBV-066/risankizumab, in patients with moderate to severe chronic plaque psoriasis,
during open-label treatment.
655066/ABBV-066/risankizumab, in patients with moderate to severe chronic plaque psoriasis,
during open-label treatment.
Inclusion criteria:
- Patients with moderate to severe chronic plaque psoriasis, who have successfully
completed the preceding trial, 1311.2. Successful completion of preceding trial 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
- Patient 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 patients:
- 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 trial. Medically accepted methods of
contraceptions are: ethinyl estradiol containing contraceptives, diaphragm with
spermicide substance, and intra-uterine-device.
OR Female patients which have vasectomized sexual partner(s) (vasectomy at least
1 year prior to enrolment).
OR
- Surgically sterilized female patients 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:
- Patients who experienced any drug related Serious Adverse Event in the preceding trial
- Patients who have developed guttate, erythrodermic or pustular psoriasis or
drug-induced psoriasis (as diagnosed by the investigator), during the preceding trial
1311.2.
- 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 patient or the quality of the data.
- Known clinically important acute or chronic infections including hepatitis, HIV. In
regards to Tuberculosis the following applies:
- Signs or symptoms suggestive of current active or latent tuberculosis 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 patients 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 tuberculosis has not been ruled out.
This does not apply to patients with history of latent tuberculosis with documented
completion of an adequate treatment regimen, at least 6 months prior to the first
administration of study agent.
- Patients who have developed malignancy, or suspicion of active malignant disease
during the preceding trial 1311.2 (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 the 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 lab
results received during the preceding trial (according to the investigator's medical
assessment)
- Pre-menopausal woman who is pregnant or nursing
We found this trial at
12
sites
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