BI 655066 Dose Ranging in Psoriasis, Active Comparator Ustekinumab

NCT ID: NCT02054481

Last Updated: 2016-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 166 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-28
• Study Completion Date: 2015-07-31

Brief 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.

Conditions

Psoriasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Arm 1

BI 655066 s.c.

Group Type: EXPERIMENTAL

BI 655066

Intervention Type: DRUG

Low dose

Arm 2

BI 655066 s.c.

Group Type: EXPERIMENTAL

BI 655066

Intervention Type: DRUG

Medium dose

Arm 3

BI 655066 s.c.

Group Type: EXPERIMENTAL

BI 655066

Intervention Type: DRUG

High dose

Arm 4

Ustekinumab s.c.

Group Type: ACTIVE_COMPARATOR

Ustekinumab

Intervention Type: DRUG

Interventions

BI 655066

Medium dose

Intervention Type: DRUG

BI 655066

High dose

Intervention Type: DRUG

Ustekinumab

Intervention Type: DRUG

BI 655066

Low dose

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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).

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

1311.2.10010 Boehringer Ingelheim Investigational Site

Los Angeles, California, United States

1311.2.10013 Boehringer Ingelheim Investigational Site

Port Orange, Florida, United States

1311.2.10003 Boehringer Ingelheim Investigational Site

Arlington Hts, Illinois, United States

1311.2.10002 Boehringer Ingelheim Investigational Site

Bay City, Michigan, United States

1311.2.10004 Boehringer Ingelheim Investigational Site

Fridley, Minnesota, United States

1311.2.10001 Boehringer Ingelheim Investigational Site

East Windsor, New Jersey, United States

1311.2.10009 Boehringer Ingelheim Investigational Site

Verona, New Jersey, United States

1311.2.10007 Boehringer Ingelheim Investigational Site

Raleigh, North Carolina, United States

1311.2.10005 Boehringer Ingelheim Investigational Site

Portland, Oregon, United States

1311.2.10006 Boehringer Ingelheim Investigational Site

Dallas, Texas, United States

1311.2.10011 Boehringer Ingelheim Investigational Site

Houston, Texas, United States

1311.2.10012 Boehringer Ingelheim Investigational Site

Spokane, Washington, United States

1311.2.20002 Boehringer Ingelheim Investigational Site

Markham, Ontario, Canada

1311.2.20005 Boehringer Ingelheim Investigational Site

Peterborough, Ontario, Canada

1311.2.20003 Boehringer Ingelheim Investigational Site

Waterloo, Ontario, Canada

1311.2.20004 Boehringer Ingelheim Investigational Site

Sainte-Foy, Quebec, Canada

1311.2.35802 Boehringer Ingelheim Investigational Site

Helsinki, , Finland

1311.2.35801 Boehringer Ingelheim Investigational Site

Turku, , Finland

1311.2.33005 Boehringer Ingelheim Investigational Site

Marseille, , France

1311.2.33002 Boehringer Ingelheim Investigational Site

Nice, , France

1311.2.33001 Boehringer Ingelheim Investigational Site

Paris, , France

1311.2.33004 Boehringer Ingelheim Investigational Site

Pessac, , France

1311.2.33003 Boehringer Ingelheim Investigational Site

Rouen, , France

1311.2.33006 Boehringer Ingelheim Investigational Site

Toulouse, , France

1311.2.49001 Boehringer Ingelheim Investigational Site

Berlin, , Germany

1311.2.49003 Boehringer Ingelheim Investigational Site

Dresden, , Germany

1311.2.49005 Boehringer Ingelheim Investigational Site

Lübeck, , Germany

1311.2.49002 Boehringer Ingelheim Investigational Site

Mainz, , Germany

1311.2.49004 Boehringer Ingelheim Investigational Site

Münster, , Germany

1311.2.47002 Boehringer Ingelheim Investigational Site

Ålesund, , Norway

1311.2.47001 Boehringer Ingelheim Investigational Site

Oslo, , Norway

1311.2.46001 Boehringer Ingelheim Investigational Site

Stockholm, , Sweden

Countries

United States; Canada; Finland; France; Germany; Norway; Sweden

References

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.

Reference Type: DERIVED

PMID: 31667790 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 31054118 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 28423301 (View on PubMed)

Other Identifiers

2012-004384-48

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1311.2

Identifier Type: -

Identifier Source: org_study_id