PsoriasisPhase 2NCT02054481

BI 655066 Dose Ranging in Psoriasis, Active Comparator Ustekinumab

A Phase 2 study testing BI 655066 and Ustekinumab in people with Psoriasis, run by Boehringer Ingelheim at 32 sites in 7 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The overall purpose of this trial is to assess clinical efficacy and safety of different subcutaneous doses of BI 655066 in adult patients with chronic plaque psoriasis in order to select doses for further clinical trials. 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 and Ustekinumab
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 166 participants
Where: 32 sitesin 7 countries
Study dates: Feb 2014to Jul 2015
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Body Mass Index (BMI) >/= 18.5 and < 40 kg/m²
Patients with stable moderate to severe chronic plaque-type psoriasis with or without psoriatic arthritis involving >/= 10% body surface area, with disease severity PASI >/= 12 and sPGA score of moderate and above (score of at least 3) at screening visit and visit 2 (randomisation), as assessed by the investigator
Psoriasis disease duration of at least 6 months prior to screening, as assessed by the investigator
Patients must be candidates for systemic psoriasis treatment or phototherapy, as assessed by the investigator
Patients must be suitable candidates for ustekinumab (Stelara®) therapy as given in the local labelling
Patient must give informed consent and sign an approved consent form prior to any study procedures in accordance with GCP and local legislation

Who cannot join

Patients with guttate, erythrodermic, or pustular psoriasis and patients with drug-induced psoriasis, as diagnosed by the investigator
Evidence of current or previous clinically significant disease, medical condition other than psoriasis, or finding of the medical examination (including vital signs and 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 criterion)
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, or history of orthostatic hypotension, fainting spells or blackouts, that in the investigator's judgement, could jeopardize the safe conduct of the study.
Clinically important acute or chronic infections including hepatitis and HIV.
With regards to tuberculosis the following applies:
Have 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).

Show all 13Show fewer

Have history of latent or active TB prior to screening, except for patients who have documentation of having completed an adequate treatment regimen at least 6 months prior to the first administration of study agent.
Have positive IGRA testing (QuantiFERON-TB Gold) within 2 months prior to or during screening, in which active TB has not been ruled out, except for patients with history of latent TB and documentation of having completed an adequate treatment regimen at least 6 months prior to the first administration of study agent.
Have had a live vaccination </= 12 weeks prior to randomisation (visit 2). Patients must agree not to receive a live vaccination during the study. No BCG vaccines should be given for one year prior to randomisation (visit 2), during the study and for one year after last administration of study drug (according to the Stelara® SPC).
History of clinically significant hypersensitivity to a systemically administered biologic agent or its excipients
History of malignancy in the past 5 years or suspicion of active malignant disease except treated cutaneous squamous cell or basal cell carcinoma
Has received any therapeutic agent directly targeted to IL-12, IL-23 (including ustekinumab (Stelara®))
Use of biologic agents within 12 weeks (infliximab, etanercept, adalimumab, other biologics) prior to treatment, systemic anti-psoriatic medications or phototherapy within 4 weeks prior to treatment, or topical anti-psoriasis medications within 2 weeks prior to treatment

Trial locations and contacts

32 sites in 7 countries.

Country

City, postcode or hospital

32 sites in 7 countries

United States12 sites

1311.2.10003 Boehringer Ingelheim Investigational Site
Arlington Hts, Illinois
1311.2.10002 Boehringer Ingelheim Investigational Site
Bay City, Michigan
1311.2.10006 Boehringer Ingelheim Investigational Site
Dallas, Texas
1311.2.10001 Boehringer Ingelheim Investigational Site
East Windsor, New Jersey
1311.2.10004 Boehringer Ingelheim Investigational Site
Fridley, Minnesota
1311.2.10011 Boehringer Ingelheim Investigational Site
Houston, Texas
1311.2.10010 Boehringer Ingelheim Investigational Site
Los Angeles, California
1311.2.10013 Boehringer Ingelheim Investigational Site
Port Orange, Florida
1311.2.10005 Boehringer Ingelheim Investigational Site
Portland, Oregon
1311.2.10007 Boehringer Ingelheim Investigational Site
Raleigh, North Carolina
1311.2.10012 Boehringer Ingelheim Investigational Site
Spokane, Washington
1311.2.10009 Boehringer Ingelheim Investigational Site
Verona, New Jersey

Other trials in United States

France6 sites

1311.2.33005 Boehringer Ingelheim Investigational Site
Marseille
1311.2.33002 Boehringer Ingelheim Investigational Site
Nice
1311.2.33001 Boehringer Ingelheim Investigational Site
Paris
1311.2.33004 Boehringer Ingelheim Investigational Site
Pessac
1311.2.33003 Boehringer Ingelheim Investigational Site
Rouen
1311.2.33006 Boehringer Ingelheim Investigational Site
Toulouse

Other trials in France

Germany5 sites

1311.2.49001 Boehringer Ingelheim Investigational Site
Berlin
1311.2.49003 Boehringer Ingelheim Investigational Site
Dresden
1311.2.49005 Boehringer Ingelheim Investigational Site
Lübeck
1311.2.49002 Boehringer Ingelheim Investigational Site
Mainz
1311.2.49004 Boehringer Ingelheim Investigational Site
Münster

Other trials in Germany

Canada4 sites

1311.2.20002 Boehringer Ingelheim Investigational Site
Markham, Ontario
1311.2.20005 Boehringer Ingelheim Investigational Site
Peterborough, Ontario
1311.2.20004 Boehringer Ingelheim Investigational Site
Sainte-Foy, Quebec
1311.2.20003 Boehringer Ingelheim Investigational Site
Waterloo, Ontario

Other trials in Canada

Finland2 sites

1311.2.35802 Boehringer Ingelheim Investigational Site
Helsinki
1311.2.35801 Boehringer Ingelheim Investigational Site
Turku

Other trials in Finland

Norway2 sites

1311.2.47002 Boehringer Ingelheim Investigational Site
Ålesund
1311.2.47001 Boehringer Ingelheim Investigational Site
Oslo

Other trials in Norway

Sweden1 site

1311.2.46001 Boehringer Ingelheim Investigational Site
Stockholm

Other trials in Sweden

About this study

Official title: A 48 Weeks Study of Three Different Dose Regimens of BI 655066 Administered Subcutaneously in Patients With Moderate to Severe Chronic Plaque Psoriasis (Randomised, Dose-ranging, Active-comparator-controlled (Ustekinumab), Double-blind Within Dose Groups of BI 655066)

Conditions: Psoriasis
Being tested: BI 655066, Ustekinumab
Medical subject headings: Psoriasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BI 655066Drug
Medium dose
BI 655066Drug
High dose
UstekinumabDrug
BI 655066Drug
Low dose

Study groups in NCT02054481
Study group	Role	What they receive
Arm 1	Experimental	BI 655066 s.c. Receives: Drug: BI 655066
Arm 2	Experimental	BI 655066 s.c. Receives: Drug: BI 655066
Arm 3	Experimental	BI 655066 s.c. Receives: Drug: BI 655066
Arm 4	Active comparator	Ustekinumab s.c. Receives: Drug: Ustekinumab

What is being measured

The primary outcome is the main question the study is designed to answer.

Achievement of ≥90% Reduction From Baseline PASI Score (PASI90) at Week 12
Percentage of participants who achieved ≥90% reduction from baseline in Psoriasis Area and Severity Index score (PASI90) at Week 12.
PASI score ranges from 0 (best) to 72 (worst).
Measured: Baseline and Week 12

Secondary outcomes (7)

Achievement of ≥75% Reduction From Baseline in PASI Score (PASI75) at Weeks 12 and 24
Percentage of participants who achieved ≥75% reduction from baseline in Psoriasis Area and Severity Index score (PASI75) at Weeks 12 and 24.
PASI score ranges from 0 (best) to 72 (worst).
Measured: Baseline, Week 12 and Week 24
Achievement of 100% Reduction From Baseline in PASI Score (PASI100) at Week 12
Percentage of participants who achieved 100% reduction from baseline in Psoriasis Area and Severity Index score (PASI100) at Week 12.
PASI score ranges from 0 (best) to 72 (worst).
Measured: Baseline and Week 12
Achievement of ≥50% Reduction From Baseline in PASI Score (PASI50) at Week 12
Percentage of participants who achieved ≥50% reduction from baseline in Psoriasis Area and Severity Index score (PASI50) at Week 12.
PASI score ranges from 0 (best) to 72 (worst).
Measured: Baseline and Week 12
Achievement of PASI90 at Week 24
Percentage of participants who achieved PASI90 at Week 24.
PASI score ranges from 0 (best) to 72 (worst).
Measured: Week 24
Percentage Change in PASI Score From Baseline at Week 12
Percentage change in Psoriasis Area and Severity Index (PASI) from baseline at Week 12.
PASI score ranges from 0 (best) to 72 (worst).
Measured: Baseline and Week 12
Achievement of sPGA Clear or Almost Clear at Week 12
Percentage of participants who achieved static Physician Global Assessment (sPGA) clear or almost clear at Week 12.
sPGA is assessed on a six-point scale from 0 (clear) to 5 (severe).
Measured: Week 12
Time to Loss of PASI50 Response
Time to loss of PASI50 response.
Measured: From first drug administration until end of follow-up period, up to 48 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2014Jul 2015

First posted4 Feb 2014 (estimated)
Study startFeb 2014
Primary completionNov 2014
Study completionJul 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for PsoriasisStudies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Enrolment: 166 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02054481
Sponsor's protocol ID: 1311.2
Other IDs: 2012-004384-48
Status last verified: Jul 2016
First submitted: 3 Feb 2014
Last updated: 19 Sep 2016
Results posted: Yes, on ClinicalTrials.gov

Publications

Suleiman AA, Khatri A, Oberoi RK, Othman AA. Exposure-Response Relationships for the Efficacy and Safety of Risankizumab in Japanese Subjects with Psoriasis. Clin Pharmacokinet. 2020 May;59(5):575-589. doi: 10.1007/s40262-019-00829-2.
PubMed 31667790
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
Papp KA, Blauvelt A, Bukhalo M, Gooderham M, Krueger JG, Lacour JP, Menter A, Philipp S, Sofen H, Tyring S, Berner BR, Visvanathan S, Pamulapati C, Bennett N, Flack M, Scholl P, Padula SJ. Risankizumab versus Ustekinumab for Moderate-to-Severe Plaque Psoriasis. N Engl J Med. 2017 Apr 20;376(16):1551-1560. doi: 10.1056/NEJMoa1607017.
PubMed 28423301

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 2
Extension Study of Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic Arthritis (CDDY391A12201-extension)
Moderate to Severe Psoriatic Arthritis
Recruiting
Efficacy of a Self-Management Smartphone App to Improve Safety Skills in Patients With Inflammatory Arthritis
Rhumatoid Arthisis, Spondyloarthritis (SA)
Active, not recruitingPhase 2
Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis
Plaque Psoriasis
RecruitingPhase 1
A Study of HB0017 Injection in Healthy Volunteers to Evaluate Safety and Tolerability of a Single Subcutaneous Injection in Low-Body-Weight Subjects; and Pharmacokinetics at Different Subcutaneous Injection Sites at the Same Dose
Psoriasis, Ankylosing Spondylitis
RecruitingPhase 1
A Study to Learn if Bimekizumab Given in Different Ways is Safe and Moves Similarly Throughout the Body Over Time in Adults
Psoriatic Arthritis, Axial Spondyloarthritis

All Psoriasis trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A 48 Weeks Study of Three Different Dose Regimens of BI 655066 Administered Subcutaneously in Patients With Moderate to Severe Chronic Plaque Psoriasis (Randomised, Dose-ranging, Active-comparator-controlled (Ustekinumab), Double-blind Within Dose Groups of BI 655066)
ClinicalTrials.gov ID: NCT02054481
Acronym / sponsor ID: 1311.2
Conditions: Psoriasis
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 166 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Feb 2014
Primary completion: Nov 2014 (actual)
Study completion: Jul 2015 (actual)
First posted: 4 Feb 2014 (estimated)
Results: Posted 19 Sep 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Number of arms: 4

Arm	Type	Receives
Arm 1	Experimental	Drug: BI 655066BI 655066 s.c.
Arm 2	Experimental	Drug: BI 655066BI 655066 s.c.
Arm 3	Experimental	Drug: BI 655066BI 655066 s.c.
Arm 4	Active comparator	Drug: UstekinumabUstekinumab s.c.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Body Mass Index (BMI) >/= 18.5 and < 40 kg/m²
Patients with stable moderate to severe chronic plaque-type psoriasis with or without psoriatic arthritis involving >/= 10% body surface area, with disease severity PASI >/= 12 and sPGA score of moderate and above (score of at least 3) at screening visit and visit 2 (randomisation), as assessed by the investigator
Psoriasis disease duration of at least 6 months prior to screening, as assessed by the investigator
Patients must be candidates for systemic psoriasis treatment or phototherapy, as assessed by the investigator
Patients must be suitable candidates for ustekinumab (Stelara®) therapy as given in the local labelling

Key exclusion criteria (13 listed)

Patients with guttate, erythrodermic, or pustular psoriasis and patients with drug-induced psoriasis, as diagnosed by the investigator
Evidence of current or previous clinically significant disease, medical condition other than psoriasis, or finding of the medical examination (including vital signs and 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 criterion)
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, or history of orthostatic hypotension, fainting spells or blackouts, that in the investigator's judgement, could jeopardize the safe conduct of the study.
Clinically important acute or chronic infections including hepatitis and HIV.
Have 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).

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 655066Medium dose	Drug	Arm 2
BI 655066High dose	Drug	Arm 3
Ustekinumab	Drug	Arm 4
BI 655066Low dose	Drug	Arm 1

Primary outcome

Achievement of ≥90% Reduction From Baseline PASI Score (PASI90) at Week 12
Time frame: Baseline and Week 12
Percentage of participants who achieved ≥90% reduction from baseline in Psoriasis Area and Severity Index score (PASI90) at Week 12. PASI score ranges from 0 (best) to 72 (worst).

7 secondary outcomes

Achievement of ≥75% Reduction From Baseline in PASI Score (PASI75) at Weeks 12 and 24
Time frame: Baseline, Week 12 and Week 24
Achievement of 100% Reduction From Baseline in PASI Score (PASI100) at Week 12
Time frame: Baseline and Week 12
Achievement of ≥50% Reduction From Baseline in PASI Score (PASI50) at Week 12
Time frame: Baseline and Week 12
Achievement of PASI90 at Week 24
Time frame: Week 24
Percentage Change in PASI Score From Baseline at Week 12
Time frame: Baseline and Week 12
Achievement of sPGA Clear or Almost Clear at Week 12
Time frame: Week 12
Time to Loss of PASI50 Response
Time frame: From first drug administration until end of follow-up period, up to 48 weeks

Results and safety

Results posted to the registry on 19 Sep 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
BI 655066 18 mg	43	39
BI 655066 90 mg	41	39
BI 655066 180 mg	42	40
Stelara	40	39

Primary outcome: Achievement of ≥90% Reduction From Baseline PASI Score (PASI90) at Week 12

Time frame: Baseline and Week 12. Number (95% Confidence Interval). Unit: Percentage of participants

Measure	BI 655066 18 mg n = 43	BI 655066 90 mg n = 41	BI 655066 180 mg n = 42	BI 655066 90+180 mg n = 83	Stelara n = 40
Value	32.6 (19.1 to 48.5)	73.2 (57.1 to 85.8)	81.0 (65.9 to 91.4)	77.1 (66.6 to 85.6)	40.0 (24.9 to 56.7)

BI 655066 90+180 mg vs Stelara: Mean Difference (Net): 36.4 (95% CI 19.0 to 53.8), p <0.0001, Cochran-Mantel-Haenszel

Population analysed: Full Analysis Set (FAS) which included all randomised patients who received at least 1 dose of trial medication and was based on the randomised treatment.

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: From first drug administration until 15 weeks after the last drug administration, up to 231 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
BI 655066 18 mg	5 of 43 (11.6%)	23 of 43 (53.5%)	Not reported
BI 655066 90 mg	6 of 41 (14.6%)	22 of 41 (53.7%)	Not reported
BI 655066 180 mg	0 of 42 (0%)	20 of 42 (47.6%)	Not reported
Stelara	3 of 40 (7.5%)	17 of 40 (42.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 31667790Suleiman AA, Khatri A, Oberoi RK, Othman AA. Exposure-Response Relationships for the Efficacy and Safety of Risankizumab in Japanese Subjects with Psoriasis. Clin Pharmacokinet. 2020 May;59(5):575-589. doi: 10.1007/s40262-019-00829-2.
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.
Derived from this study: PubMed 28423301Papp KA, Blauvelt A, Bukhalo M, Gooderham M, Krueger JG, Lacour JP, Menter A, Philipp S, Sofen H, Tyring S, Berner BR, Visvanathan S, Pamulapati C, Bennett N, Flack M, Scholl P, Padula SJ. Risankizumab versus Ustekinumab for Moderate-to-Severe Plaque Psoriasis. N Engl J Med. 2017 Apr 20;376(16):1551-1560. doi: 10.1056/NEJMoa1607017.
Related InfoLink provided by the sponsor.

Related trials for Psoriasis

Not yet recruitingPhase 2
Extension Study of Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic Arthritis (CDDY391A12201-extension)
Moderate to Severe Psoriatic Arthritis
Recruiting
Efficacy of a Self-Management Smartphone App to Improve Safety Skills in Patients With Inflammatory Arthritis
Rhumatoid Arthisis, Spondyloarthritis (SA)
Active, not recruitingPhase 2
Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis
Plaque Psoriasis
RecruitingPhase 1
A Study of HB0017 Injection in Healthy Volunteers to Evaluate Safety and Tolerability of a Single Subcutaneous Injection in Low-Body-Weight Subjects; and Pharmacokinetics at Different Subcutaneous Injection Sites at the Same Dose
Psoriasis, Ankylosing Spondylitis
RecruitingPhase 1
A Study to Learn if Bimekizumab Given in Different Ways is Safe and Moves Similarly Throughout the Body Over Time in Adults
Psoriatic Arthritis, Axial Spondyloarthritis

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.

Boehringer Ingelheim study chair

Boehringer Ingelheim

32 sites in 7 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BI 655066 and Ustekinumab in people with Psoriasis, run by Boehringer Ingelheim at 32 sites in 7 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 6 inclusion and 13 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 19 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 32 sites in United States, France, Germany, Canada, Finland and 2 more countries. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Sep 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Achievement of ≥90% Reduction From Baseline PASI Score (PASI90) at Week 12 (time frame: Baseline and Week 12). 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 NCT02054481, which also lists 3 linked publications.

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 19 Sep 2016.