PsoriasisPhase 1NCT01577550
Single Rising Dose Study of BI 655066 in Patients With Moderate and Severe Psoriasis
A Phase 1 study testing BI 655066 (very high i.v. dose), BI 655066 (high s.c. dose) and BI 655066 (low i.v. dose) in people with Psoriasis, run by AbbVie at 9 sites in 3 countries.
Trial summary
Safety, tolerability and efficacy of BI 655066 in male and female patients with moderate to severe psoriasis. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Psoriasis
- What is being tested?
- BI 655066 (very high i.v. dose), BI 655066 (high s.c. dose) and BI 655066 (low i.v. dose)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 39 participants
- Where
- 9 sitesin 3 countries
- Study dates
- Apr 2012to May 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients aged 18-75 years (inclusive)
- Chronic moderate to severe plaque psoriasis lasting =>6 months with involvement of Body Surface Area (BSA) =>10%, Psoriasis Area and Severity Index (PASI) =>12 and Static Physician Global Assessment (sPGA) score of moderate and above
- Body Mass Index (BMI) =>18.5 and <40 kg/m2
- Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and the local legislation
- Female patients must not be of childbearing potential (i.e., must be postmenopausal or surgically sterilized) and must have a negative pregnancy test at screening.
Who cannot join
- Evidence of current or previous clinically significant disease, medical condition other than psoriasis, or finding of the medical examination (including vital signs and Electrocardiogram (ECG)), that in the opinion of the Investigator, would compromise the safety of the patient or the quality of the data. This criterion provides an opportunity for the investigator to exclude patients based on clinical judgment, even if other eligibility criteria are satisfied (Psoriatic arthritis is not considered an exclusion.)
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders, diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders, chronic or relevant acute infections including hepatitis and tuberculosis (or a positive interferon-gamma release assay at screening) or history of orthostatic hypotension, fainting spells or blackouts, that in the investigator's judgement, could jeopardize the safe conduct of the study
- History of allergy/hypersensitivity to a systemically administered biologic agent or its excipients
- Use of biologic agents or psoralen and ultraviolet A (PUVA) within 12 weeks prior to Visit 2, ultraviolet B (UVB) phototherapy and oral anti-psoriatic medications within 4 weeks prior to Visit 2, or topical anti-psoriasis medications (except emollients) within 2 weeks prior to Visit 2
- Use of ustekinumab within 24 weeks prior to Visit 2
- Had a prior treatment of psoriasis with biologics with inadequate clinical response to therapy as assessed by a dermatologist or the investigator
Show all 15Show fewer
- Intake of restricted medications or drugs considered likely to interfere with the safe conduct of the study
- Use of drugs which might reasonably influence the results of the trial or that prolong the QT/QTc interval within 10 days prior to administration or during the trial
- Participation in another trial with an investigational drug within 4 weeks or 5 half-lives (whichever is greater) preceding Visit 2
- History of alcohol abuse within last 12 months (intake of more than 30 g/day)
- History of drug abuse within last 12 months or positive drug screen at screening or Visit 2
- Any blood donation or significant blood loss within 4 weeks prior to Visit 2
- Unwilling or not capable to abstain from alcoholic beverages one day prior and two days after Visit 2
- Excessive physical activities (within 1 week prior to Visit 2)
- Any laboratory value at the screening visit outside the reference range that is of clinical relevance based on physician investigator judgement
Trial locations and contacts
9 sites in 3 countries.
9 sites in 3 countries
United States7 sites
1311.1.0007 Boehringer Ingelheim Investigational Site
Burbank, California
1311.1.0006 Boehringer Ingelheim Investigational Site
Evansville, Indiana
1311.1.0008 Boehringer Ingelheim Investigational Site
Miami, Florida
1311.1.0005 Boehringer Ingelheim Investigational Site
Normal, Illinois
1311.1.0004 Boehringer Ingelheim Investigational Site
North Dartmouth, Massachusetts
1311.1.0002 Boehringer Ingelheim Investigational Site
Pittsburgh, Pennsylvania
1311.1.0003 Boehringer Ingelheim Investigational Site
Port Orange, Florida
United Kingdom1 site
1311.1.0009 Boehringer Ingelheim Investigational Site
Leeds
About this study
Official title: Safety, Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of Single Rising i.v. (Stage 1) and s.c. (Stage 2) Doses of BI 655066 in Male and Female Patients With Moderate to Severe Psoriasis (Randomised, Double-blind, Placebo-controlled Within Dose Groups)
Safety, tolerability and efficacy of BI 655066 in male and female patients with moderate to severe psoriasis.
- Conditions
- Psoriasis
- Being tested
- BI 655066 (very high i.v. dose), Placebo, i.v., BI 655066 (high s.c. dose), BI 655066 (low i.v. dose), BI 655066 (high medium i.v. dose)
- Keywords
- ABBV-066, BI 655066, risankizumab
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BI 655066 (very high i.v. dose)Drug
Also called ABBV-066, risankizumab
Single very high i.v. dose BI 655066
Placebo, i.v.Drug
Single i.v. administration of placebo
BI 655066 (high s.c. dose)Drug
Also called ABBV-066, risankizumab
Single high s.c. dose BI 655066
BI 655066 (low i.v. dose)Drug
Also called ABBV-066, risankizumab
Single low i.v. dose BI 655066
BI 655066 (high medium i.v. dose)Drug
Also called ABBV-066, risankizumab
Single high medium i.v. dose BI 655066
BI 655066 (very low i.v. dose)Drug
Also called ABBV-066, risankizumab
Single very low i.v. dose BI 655066
BI 655066 (low s.c. dose)Drug
Also called ABBV-066, risankizumab
Single low s.c. dose BI 655066
BI 655066 (high i.v. dose)Drug
Also called ABBV-066, risankizumab
Single high i.v. dose BI 655066
Placebo, s.c.Drug
Also called ABBV-066, risankizumab
Single s.c. administration of placebo
BI 655066 (low medium i.v. dose)Drug
Also called ABBV-066, risankizumab
Single low medium i.v. dose BI 655066
| Study group | Role | What they receive |
|---|---|---|
| i.v. BI 655066 | Experimental | A subject to receive a single i.v. dose of BI 655066 Receives: Drug: BI 655066 (very high i.v. dose); Drug: BI 655066 (low i.v. dose); Drug: BI 655066 (high medium i.v. dose); Drug: BI 655066 (very low i.v. dose); Drug: BI 655066 (high i.v. dose); Drug: BI 655066 (low medium i.v. dose) |
| i.v. placebo | Placebo comparator | A subject to receive a single i.v. dose of placebo Receives: Drug: Placebo, i.v. |
| s.c. BI 655066 | Experimental | A subject to receive a single s.c. dose of BI 655066 Receives: Drug: BI 655066 (high s.c. dose); Drug: BI 655066 (low s.c. dose) |
| s.c. placebo | Placebo comparator | A subject to receive a single s.c. dose of placebo Receives: Drug: Placebo, s.c. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with good and satisfactory assessment of global tolerability by investigator
Measured: 24 weeks
Number of patients without any symptoms at the drug administration site, at per local assessment of tolerability by investigator
Measured: up to 1 week
Number of participants with adverse events
Measured: up to 24 weeks
Number of participants with clinically relevant findings in vital signs
Measured: up to 24 weeks
Number of participants with clinically significant abnormalities in electrocardiogramm (ECG) results
Measured: up to 24 weeks
Number of participants with significant changes from baseline laboratory measurements
Measured: up to 24 weeks
Secondary outcomes (6)
Psoriasis Area and Severity Index (absolute score)
Measured: up to 24 weeks
Percentage of participants with Static Physicians Global Assessment (clear and almost clear)
Measured: up to 24 weeks
Cmax (maximum measured concentration of the analyte in plasma)
Measured: up to 24 weeks
tmax (time from dosing to maximum measured concentration)
Measured: up to 24 weeks
AUC0-infinity (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
Measured: 24 weeks
Psoriasis Area and Severity Index (percentage change from baseline)
Measured: up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2012 (estimated)
- Study startApr 2012
- Primary completionOct 2013
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Boehringer Ingelheim
- Responsible party
- Sponsor
- Investigators
- AbbVie Inc, Study chair, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01577550
- Sponsor's protocol ID
- 1311.1
- Other IDs
- 2012-000081-37
- Status last verified
- Nov 2016
- First submitted
- 10 Apr 2012
- Last updated
- 16 Nov 2016
- Results posted
- No
Publications
Suleiman AA, Minocha M, Khatri A, Pang Y, Othman AA. Population Pharmacokinetics of Risankizumab in Healthy Volunteers and Subjects with Moderate to Severe Plaque Psoriasis: Integrated Analyses of Phase I-III Clinical Trials. Clin Pharmacokinet. 2019 Oct;58(10):1309-1321. doi: 10.1007/s40262-019-00759-z.
PubMed 31054118
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of Single Rising i.v. (Stage 1) and s.c. (Stage 2) Doses of BI 655066 in Male and Female Patients With Moderate to Severe Psoriasis (Randomised, Double-blind, Placebo-controlled Within Dose Groups)
- ClinicalTrials.gov ID
- NCT01577550
- Acronym / sponsor ID
- 1311.1
- Conditions
- Psoriasis
- Keywords
- ABBV-066, BI 655066, risankizumab
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Collaborators
- Boehringer Ingelheim
- Study start
- Apr 2012
- Primary completion
- Oct 2013 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 16 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Safety, tolerability and efficacy of BI 655066 in male and female patients with moderate to severe psoriasis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| i.v. BI 655066 | Experimental | Drug: BI 655066 (very high i.v. dose), Drug: BI 655066 (low i.v. dose), Drug: BI 655066 (high medium i.v. dose), Drug: BI 655066 (very low i.v. dose), Drug: BI 655066 (high i.v. dose), Drug: BI 655066 (low medium i.v. dose)A subject to receive a single i.v. dose of BI 655066 |
| i.v. placebo | Placebo comparator | Drug: Placebo, i.v.A subject to receive a single i.v. dose of placebo |
| s.c. BI 655066 | Experimental | Drug: BI 655066 (high s.c. dose), Drug: BI 655066 (low s.c. dose)A subject to receive a single s.c. dose of BI 655066 |
| s.c. placebo | Placebo comparator | Drug: Placebo, s.c.A subject to receive a single s.c. dose of placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female patients aged 18-75 years (inclusive)
- Chronic moderate to severe plaque psoriasis lasting =>6 months with involvement of Body Surface Area (BSA) =>10%, Psoriasis Area and Severity Index (PASI) =>12 and Static Physician Global Assessment (sPGA) score of moderate and above
- Body Mass Index (BMI) =>18.5 and <40 kg/m2
- Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and the local legislation
- Female patients must not be of childbearing potential (i.e., must be postmenopausal or surgically sterilized) and must have a negative pregnancy test at screening.
Key exclusion criteria (15 listed)
- Evidence of current or previous clinically significant disease, medical condition other than psoriasis, or finding of the medical examination (including vital signs and Electrocardiogram (ECG)), that in the opinion of the Investigator, would compromise the safety of the patient or the quality of the data. This criterion provides an opportunity for the investigator to exclude patients based on clinical judgment, even if other eligibility criteria are satisfied (Psoriatic arthritis is not considered an exclusion.)
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders, diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders, chronic or relevant acute infections including hepatitis and tuberculosis (or a positive interferon-gamma release assay at screening) or history of orthostatic hypotension, fainting spells or blackouts, that in the investigator's judgement, could jeopardize the safe conduct of the study
- History of allergy/hypersensitivity to a systemically administered biologic agent or its excipients
- Use of biologic agents or psoralen and ultraviolet A (PUVA) within 12 weeks prior to Visit 2, ultraviolet B (UVB) phototherapy and oral anti-psoriatic medications within 4 weeks prior to Visit 2, or topical anti-psoriasis medications (except emollients) within 2 weeks prior to Visit 2
- Use of ustekinumab within 24 weeks prior to Visit 2
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BI 655066 (very high i.v. dose)Also: ABBV-066, risankizumabSingle very high i.v. dose BI 655066 | Drug | i.v. BI 655066 |
| Placebo, i.v.Single i.v. administration of placebo | Drug | i.v. placebo |
| BI 655066 (high s.c. dose)Also: ABBV-066, risankizumabSingle high s.c. dose BI 655066 | Drug | s.c. BI 655066 |
| BI 655066 (low i.v. dose)Also: ABBV-066, risankizumabSingle low i.v. dose BI 655066 | Drug | i.v. BI 655066 |
| BI 655066 (high medium i.v. dose)Also: ABBV-066, risankizumabSingle high medium i.v. dose BI 655066 | Drug | i.v. BI 655066 |
| BI 655066 (very low i.v. dose)Also: ABBV-066, risankizumabSingle very low i.v. dose BI 655066 | Drug | i.v. BI 655066 |
| BI 655066 (low s.c. dose)Also: ABBV-066, risankizumabSingle low s.c. dose BI 655066 | Drug | s.c. BI 655066 |
| BI 655066 (high i.v. dose)Also: ABBV-066, risankizumabSingle high i.v. dose BI 655066 | Drug | i.v. BI 655066 |
| Placebo, s.c.Also: ABBV-066, risankizumabSingle s.c. administration of placebo | Drug | s.c. placebo |
| BI 655066 (low medium i.v. dose)Also: ABBV-066, risankizumabSingle low medium i.v. dose BI 655066 | Drug | i.v. BI 655066 |
Primary outcome
Number of patients with good and satisfactory assessment of global tolerability by investigator
Time frame: 24 weeks
Number of patients without any symptoms at the drug administration site, at per local assessment of tolerability by investigator
Time frame: up to 1 week
Number of participants with adverse events
Time frame: up to 24 weeks
Number of participants with clinically relevant findings in vital signs
Time frame: up to 24 weeks
Number of participants with clinically significant abnormalities in electrocardiogramm (ECG) results
Time frame: up to 24 weeks
Number of participants with significant changes from baseline laboratory measurements
Time frame: up to 24 weeks
6 secondary outcomes
Psoriasis Area and Severity Index (absolute score)
Time frame: up to 24 weeks
Percentage of participants with Static Physicians Global Assessment (clear and almost clear)
Time frame: up to 24 weeks
Cmax (maximum measured concentration of the analyte in plasma)
Time frame: up to 24 weeks
tmax (time from dosing to maximum measured concentration)
Time frame: up to 24 weeks
AUC0-infinity (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
Time frame: 24 weeks
Psoriasis Area and Severity Index (percentage change from baseline)
Time frame: up to 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2016.
- Derived from this study: PubMed 31054118Suleiman AA, Minocha M, Khatri A, Pang Y, Othman AA. Population Pharmacokinetics of Risankizumab in Healthy Volunteers and Subjects with Moderate to Severe Plaque Psoriasis: Integrated Analyses of Phase I-III Clinical Trials. Clin Pharmacokinet. 2019 Oct;58(10):1309-1321. doi: 10.1007/s40262-019-00759-z.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
AbbVie Inc study chair
AbbVie
9 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BI 655066 (very high i.v. dose), BI 655066 (high s.c. dose) and BI 655066 (low i.v. dose) in people with Psoriasis, run by AbbVie at 9 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States, Germany, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with good and satisfactory assessment of global tolerability by investigator (time frame: 24 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01577550, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2016.