BI 655066 Dose Ranging in Psoriasis, Active Comparator Ustekinumab

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT02054481
• Date of registration: 03/02/2014
• Prospective Registration: No
• Primary sponsor: Boehringer Ingelheim
• Public title: BI 655066 Dose Ranging in Psoriasis, Active Comparator Ustekinumab
• Scientific 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)
• Date of first enrolment: February 2014
• Target sample size: 166
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02054481
• Study type: Interventional
• Phase: Phase 2

Countries of recruitment

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

Contacts

• Name: Boehringer Ingelheim
• Affiliation: Boehringer Ingelheim

Key inclusion & exclusion 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 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



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Psoriasis

Intervention(s)

Drug: BI 655066

Drug: Ustekinumab

Primary Outcome(s)

Achievement of =90% Reduction From Baseline PASI Score (PASI90) at Week 12 [Time Frame: Baseline and Week 12]

Secondary Outcome(s)

Achievement of =75% Reduction From Baseline in PASI Score (PASI75) at Weeks 12 and 24 [Time Frame: Baseline, Week 12 and Week 24]

Time to Loss of PASI50 Response [Time Frame: From first drug administration until end of follow-up period, up to 48 weeks]

Achievement of 100% Reduction From Baseline in PASI Score (PASI100) at Week 12 [Time Frame: Baseline and Week 12]

Percentage Change in PASI Score From Baseline at Week 12 [Time Frame: Baseline and Week 12]

Achievement of PASI90 at Week 24 [Time Frame: Week 24]

Achievement of sPGA Clear or Almost Clear at Week 12 [Time Frame: Week 12]

Achievement of =50% Reduction From Baseline in PASI Score (PASI50) at Week 12 [Time Frame: Baseline and Week 12]

Secondary ID(s)

1311.2

2012-004384-48

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 19/09/2016
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02054481