BI 655066 Dose Ranging in Psoriasis, Active Comparator Ustekinumab

NCT02054481 | Completed Phase 2 Results

• 2 other identifiers: 1311.22012-004384-48
• Study Type: interventional
• Target: 166
• Locations: 7 countries
• Sites: 32

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

Outcome Measures

Primary Outcomes (1)

• 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).

  Baseline and Week 12

Secondary Outcomes (7)

• Achievement of ≥75% Reduction From Baseline in PASI Score (PASI75) at Weeks 12 and 24

  Baseline, Week 12 and Week 24

• Achievement of 100% Reduction From Baseline in PASI Score (PASI100) at Week 12

  Baseline and Week 12

• Achievement of ≥50% Reduction From Baseline in PASI Score (PASI50) at Week 12

  Baseline and Week 12

• Achievement of PASI90 at Week 24

  Week 24

• Percentage Change in PASI Score From Baseline at Week 12

  Baseline and Week 12

Study Arms (4)

Arm 1

EXPERIMENTAL

BI 655066 s.c.

Drug: BI 655066

Arm 2

EXPERIMENTAL

BI 655066 s.c.

Drug: BI 655066

Arm 3

EXPERIMENTAL

BI 655066 s.c.

Drug: BI 655066

Arm 4

ACTIVE COMPARATOR

Ustekinumab s.c.

Drug: Ustekinumab

Interventions

BI 655066 DRUG

Medium dose

Arm 2

Ustekinumab DRUG

Arm 4

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients with guttate, erythrodermic, or pustular psoriasis and patients with drug-induced psoriasis, as diagnosed by the investigator
• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (32)

1311.2.10010 Boehringer Ingelheim Investigational Site

Los Angeles, California, United States

Location

1311.2.10013 Boehringer Ingelheim Investigational Site

Port Orange, Florida, United States

Location

1311.2.10003 Boehringer Ingelheim Investigational Site

Arlington Hts, Illinois, United States

Location

1311.2.10002 Boehringer Ingelheim Investigational Site

Bay City, Michigan, United States

Location

1311.2.10004 Boehringer Ingelheim Investigational Site

Fridley, Minnesota, United States

Location

1311.2.10001 Boehringer Ingelheim Investigational Site

East Windsor, New Jersey, United States

Location

1311.2.10009 Boehringer Ingelheim Investigational Site

Verona, New Jersey, United States

Location

1311.2.10007 Boehringer Ingelheim Investigational Site

Raleigh, North Carolina, United States

Location

1311.2.10005 Boehringer Ingelheim Investigational Site

Portland, Oregon, United States

Location

1311.2.10006 Boehringer Ingelheim Investigational Site

Dallas, Texas, United States

Location

1311.2.10011 Boehringer Ingelheim Investigational Site

Houston, Texas, United States

Location

1311.2.10012 Boehringer Ingelheim Investigational Site

Spokane, Washington, United States

Location

1311.2.20002 Boehringer Ingelheim Investigational Site

Markham, Ontario, Canada

Location

1311.2.20005 Boehringer Ingelheim Investigational Site

Peterborough, Ontario, Canada

Location

1311.2.20003 Boehringer Ingelheim Investigational Site

Waterloo, Ontario, Canada

Location

1311.2.20004 Boehringer Ingelheim Investigational Site

Sainte-Foy, Quebec, Canada

Location

1311.2.35802 Boehringer Ingelheim Investigational Site

Helsinki, Finland

Location

1311.2.35801 Boehringer Ingelheim Investigational Site

Turku, Finland

Location

1311.2.33005 Boehringer Ingelheim Investigational Site

Marseille, France

Location

1311.2.33002 Boehringer Ingelheim Investigational Site

Nice, France

Location

1311.2.33001 Boehringer Ingelheim Investigational Site

Paris, France

Location

1311.2.33004 Boehringer Ingelheim Investigational Site

Pessac, France

Location

1311.2.33003 Boehringer Ingelheim Investigational Site

Rouen, France

Location

1311.2.33006 Boehringer Ingelheim Investigational Site

Toulouse, France

Location

1311.2.49001 Boehringer Ingelheim Investigational Site

Berlin, Germany

Location

1311.2.49003 Boehringer Ingelheim Investigational Site

Dresden, Germany

Location

1311.2.49005 Boehringer Ingelheim Investigational Site

Lübeck, Germany

Location

1311.2.49002 Boehringer Ingelheim Investigational Site

Mainz, Germany

Location

1311.2.49004 Boehringer Ingelheim Investigational Site

Münster, Germany

Location

1311.2.47002 Boehringer Ingelheim Investigational Site

Ålesund, Norway

Location

1311.2.47001 Boehringer Ingelheim Investigational Site

Oslo, Norway

Location

1311.2.46001 Boehringer Ingelheim Investigational Site

Stockholm, Sweden

Location

Related Publications (3)

• 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.

  PMID: 31667790 DERIVED

• 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.

  PMID: 31054118 DERIVED

• 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.

  PMID: 28423301 DERIVED

MeSH Terms

Conditions

Psoriasis

Interventions

risankizumab; Ustekinumab

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Boehringer Ingelheim Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2014
• First Posted: February 4, 2014
• Study Start: February 1, 2014
• Primary Completion: November 1, 2014
• Study Completion: July 1, 2015
• Last Updated: September 19, 2016
• Results First Posted: September 19, 2016

Record last verified: 2016-07

Locations

FR (6); DE (5); FI (2); NO (2); SE (1); CA (4); US (12)