Psoriasis
Conditions
Keywords
ABBV-066, BI 655066
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.
Detailed description
This is a Phase 3, single-arm, multicenter open label extension (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 participants who meet the entry criteria are planned to be enrolled in this study, rolling over from the preceding Phase 2/3 studies.
Interventions
BIOLOGICALrisankizumab
Risankizumab 150 mg administered by subcutaneous injection every 12 weeks.
Sponsors
AbbVie
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participants with a history of moderate to severe chronic plaque psoriasis, who have completed one of the preceding studies. * Participants 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, participant 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. \- Participants 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. * Participants 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. * 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. * 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. * Participant 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Serious Adverse Events and Non-Serious Adverse Events | Median follow-up time of 1905 days | An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. A serious adverse event is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. |
Countries
Australia, Austria, Belgium, Canada, Czechia, Finland, France, Germany, Japan, Mexico, Poland, Portugal, South Korea, Spain, Sweden, Taiwan, United States
Participant flow
Recruitment details
Participants from Studies M16-008 (NCT02684370), M16-010 (NCT02694523), M15-995 (NCT02684357), M16-178 (NCT03255382), M16-009 (NCT02203851), M15-992 (NCT02672852), and M16-004 (NCT03000075) entered this open-label extension (OLE) study from 232 sites across 17 countries (Australia, Austria, Belgium, Canada, Czech Republic, Finland, France, Germany, Japan, Mexico, Poland, Portugal, Republic of Korea, Spain, Sweden, Taiwan, and US).
Participants by arm
| Arm | Count |
|---|---|
| Risankizumab 150 mg Risankizumab 150 mg administered by subcutaneous injection every 12 weeks | 2,170 |
| Total | 2,170 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 142 |
| Overall Study | COVID-19 Infection | 2 |
| Overall Study | COVID-19 Logistical Restrictions | 9 |
| Overall Study | Lost to Follow-up | 144 |
| Overall Study | Other, Not Specified | 117 |
| Overall Study | Withdrawal by Subject | 155 |
Baseline characteristics
| Characteristic | Risankizumab 150 mg |
|---|---|
| Age, Customized 40 - < 65 years | 1264 Participants |
| Age, Customized < 40 years | 658 Participants |
| Age, Customized >= 65 years | 248 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 257 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1913 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 15 Participants |
| Race (NIH/OMB) Asian | 466 Participants |
| Race (NIH/OMB) Black or African American | 50 Participants |
| Race (NIH/OMB) More than one race | 8 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 9 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 1622 Participants |
| Sex: Female, Male Female | 634 Participants |
| Sex: Female, Male Male | 1536 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 28 / 2,170 |
| other Total, other adverse events | 1,215 / 2,170 |
| serious Total, serious adverse events | 435 / 2,170 |
Outcome results
Primary
Number of Participants With Serious Adverse Events and Non-Serious Adverse Events
An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. A serious adverse event is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above.
Time frame: Median follow-up time of 1905 days
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Risankizumab 150 mg | Number of Participants With Serious Adverse Events and Non-Serious Adverse Events | Serious Adverse Events | 435 Participants |
| Risankizumab 150 mg | Number of Participants With Serious Adverse Events and Non-Serious Adverse Events | Non-serious Adverse Events | 1215 Participants |