BI 655066 Dose Ranging in Psoriasis, Active Comparator Us... | NCT02054481

NCT02054481

ID	Type	Description	Link
2012-004384-48	EudraCT Number	EudraCT

Status Module

Sponsor/Collaborators Module

Oversight Module

No data available

No data is available for this block.

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
BI 655066	Drug	Medium dose	Arm 2
BI 655066

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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).	Baseline, Week 12 and Week 24

Eligibility Module

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 \

Contacts/Locations Module

Name	Affiliation	Role
Boehringer Ingelheim	Boehringer Ingelheim	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
1311.2.10010 Boehringer Ingelheim Investigational Site		Los Angeles	California		United States
1311.2.10013 Boehringer Ingelheim Investigational Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
31667790	Derived	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.
31054118	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.

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	BI 655066 18 mg	18 mg BI 655066 administered by subcutaneous injection plus two placebo matching BI 655066 injections at Week 0, followed by two placebo matching BI 655066 injections each at Weeks 4 and 16.
FG001	BI 655066 90 mg

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

90 mg BI 655066 administered by subcutaneous injection plus two placebo matching BI 655066 injections at Week 0, followed 90mg BI 655066 plus one placebo matching BI 655066 injection at Weeks 4 and 16.

Safety Set (SAF) which Included all randomised patients who received at least 1 dose of trial medication and was based on the first treatment received.

Arm/Group Information

ID	Title	Description
BG000	BI 655066 18 mg	18 mg BI 655066 administered by subcutaneous injection plus two placebo matching BI 655066 injections at Week 0, followed by two placebo matching BI 655066 injections each at Weeks 4 and 16.
BG001	BI 655066 90 mg	90 mg BI 655066 administered by subcutaneous injection plus two placebo matching BI 655066 injections at Week 0, followed 90mg BI 655066 plus one placebo matching BI 655066 injection at Weeks 4 and 16.
BG002	BI 655066 180 mg	180 mg BI 655066 administered by subcutaneous injection as two injections plus a placebo matching BI 655066 injection at Week 0, followed 180 mg BI 655066 administered as two injections at Weeks 4 and 16.
BG003	Stelara	Stelara administered by subcutaneous injection plus two saline injections at Week 0, Stelara injection plus one saline injection at Weeks 4 and 16. Stelara dose was 45 mg for patients with body weight ≤100 kg at randomisation or 90 mg for patients with body weight >100 kg at randomisation.
BG004	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

Years

Title

Denominators

Categories

Title	Measurements
	OG00032.6(19.1 to 48.5) OG00173.2(57.1 to 85.8) OG00281.0(65.9 to 91.4) OG003

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG003 OG004		Cochran-Mantel-Haenszel	Adjusted for weight (=<100kg vs >100kg) & prior exposure to 2 or more tumour necrosis factor antagonists with discontinuation due to lack of efficacy	<0.0001		Mean Difference (Net)	36.4			2-Sided	95	19.0	53.8			Difference calculated as BI 90+180 mg minus Stelara	No	Superiority or Other

Secondary

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).

FAS

Posted

Number

95% Confidence Interval

Percentage of participants

Baseline, Week 12 and Week 24

ID	Title	Description
OG000	BI 655066 18 mg	18 mg BI 655066 administered by subcutaneous injection plus two placebo matching BI 655066 injections at Week 0, followed by two placebo matching BI 655066 injections each at Weeks 4 and 16.
OG001	BI 655066 90 mg	90 mg BI 655066 administered by subcutaneous injection plus two placebo matching BI 655066 injections at Week 0, followed 90mg BI 655066 plus one placebo matching BI 655066 injection at Weeks 4 and 16.
OG002	BI 655066 180 mg	180 mg BI 655066 administered by subcutaneous injection as two injections plus a placebo matching BI 655066 injection at Week 0, followed 180 mg BI 655066 administered as two injections at Weeks 4 and 16.
OG003

Secondary

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).

FAS

Posted

Number

95% Confidence Interval

Percentage of participants

Baseline and Week 12

ID	Title	Description
OG000	BI 655066 18 mg	18 mg BI 655066 administered by subcutaneous injection plus two placebo matching BI 655066 injections at Week 0, followed by two placebo matching BI 655066 injections each at Weeks 4 and 16.
OG001	BI 655066 90 mg	90 mg BI 655066 administered by subcutaneous injection plus two placebo matching BI 655066 injections at Week 0, followed 90mg BI 655066 plus one placebo matching BI 655066 injection at Weeks 4 and 16.
OG002	BI 655066 180 mg	180 mg BI 655066 administered by subcutaneous injection as two injections plus a placebo matching BI 655066 injection at Week 0, followed 180 mg BI 655066 administered as two injections at Weeks 4 and 16.
OG003

Secondary

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).

FAS

Posted

Number

95% Confidence Interval

Percentage of participants

Baseline and Week 12

ID	Title	Description
OG000	BI 655066 18 mg	18 mg BI 655066 administered by subcutaneous injection plus two placebo matching BI 655066 injections at Week 0, followed by two placebo matching BI 655066 injections each at Weeks 4 and 16.
OG001	BI 655066 90 mg	90 mg BI 655066 administered by subcutaneous injection plus two placebo matching BI 655066 injections at Week 0, followed 90mg BI 655066 plus one placebo matching BI 655066 injection at Weeks 4 and 16.
OG002	BI 655066 180 mg	180 mg BI 655066 administered by subcutaneous injection as two injections plus a placebo matching BI 655066 injection at Week 0, followed 180 mg BI 655066 administered as two injections at Weeks 4 and 16.
OG003

Secondary

Achievement of PASI90 at Week 24

Percentage of participants who achieved PASI90 at Week 24.

PASI score ranges from 0 (best) to 72 (worst).

FAS

Posted

Number

95% Confidence Interval

Percentage of participants

Week 24

ID	Title	Description
OG000	BI 655066 18 mg	18 mg BI 655066 administered by subcutaneous injection plus two placebo matching BI 655066 injections at Week 0, followed by two placebo matching BI 655066 injections each at Weeks 4 and 16.
OG001	BI 655066 90 mg	90 mg BI 655066 administered by subcutaneous injection plus two placebo matching BI 655066 injections at Week 0, followed 90mg BI 655066 plus one placebo matching BI 655066 injection at Weeks 4 and 16.
OG002	BI 655066 180 mg	180 mg BI 655066 administered by subcutaneous injection as two injections plus a placebo matching BI 655066 injection at Week 0, followed 180 mg BI 655066 administered as two injections at Weeks 4 and 16.
OG003	BI 655066 90+180 mg

Secondary

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).

FAS including patients with available data.

Posted

Mean

Standard Deviation

Percentage of PASI score

Baseline and Week 12

ID	Title	Description
OG000	BI 655066 18 mg	18 mg BI 655066 administered by subcutaneous injection plus two placebo matching BI 655066 injections at Week 0, followed by two placebo matching BI 655066 injections each at Weeks 4 and 16.
OG001	BI 655066 90 mg	90 mg BI 655066 administered by subcutaneous injection plus two placebo matching BI 655066 injections at Week 0, followed 90mg BI 655066 plus one placebo matching BI 655066 injection at Weeks 4 and 16.
OG002	BI 655066 180 mg	180 mg BI 655066 administered by subcutaneous injection as two injections plus a placebo matching BI 655066 injection at Week 0, followed 180 mg BI 655066 administered as two injections at Weeks 4 and 16.
OG003	BI 655066 90+180 mg

Secondary

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).

FAS

Posted

Number

95% Confidence Interval

Percentage of participants

Week 12

ID	Title	Description
OG000	BI 655066 18 mg	18 mg BI 655066 administered by subcutaneous injection plus two placebo matching BI 655066 injections at Week 0, followed by two placebo matching BI 655066 injections each at Weeks 4 and 16.
OG001	BI 655066 90 mg	90 mg BI 655066 administered by subcutaneous injection plus two placebo matching BI 655066 injections at Week 0, followed 90mg BI 655066 plus one placebo matching BI 655066 injection at Weeks 4 and 16.
OG002	BI 655066 180 mg	180 mg BI 655066 administered by subcutaneous injection as two injections plus a placebo matching BI 655066 injection at Week 0, followed 180 mg BI 655066 administered as two injections at Weeks 4 and 16.
OG003	BI 655066 90+180 mg

Secondary

Time to Loss of PASI50 Response

Time to loss of PASI50 response.

FAS

Posted

Median

95% Confidence Interval

Days

From first drug administration until end of follow-up period, up to 48 weeks

ID	Title	Description
OG000	BI 655066 18 mg	18 mg BI 655066 administered by subcutaneous injection plus two placebo matching BI 655066 injections at Week 0, followed by two placebo matching BI 655066 injections each at Weeks 4 and 16.
OG001	BI 655066 90 mg	90 mg BI 655066 administered by subcutaneous injection plus two placebo matching BI 655066 injections at Week 0, followed 90mg BI 655066 plus one placebo matching BI 655066 injection at Weeks 4 and 16.
OG002	BI 655066 180 mg	180 mg BI 655066 administered by subcutaneous injection as two injections plus a placebo matching BI 655066 injection at Week 0, followed 180 mg BI 655066 administered as two injections at Weeks 4 and 16.
OG003	BI 655066 90+180 mg	90 mg BI 655066 or 180mg BI 655066 administered by subcutaneous injection at Weeks 0, 4 and 16, plus matching placebos.

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	BI 655066 18 mg	18 mg BI 655066 administered by subcutaneous injection plus two placebo matching BI 655066 injections at Week 0, followed by two placebo matching BI 655066 injections each at Weeks 4 and 16.	5	43	23	43
EG001	BI 655066 90 mg	90 mg BI 655066 administered by subcutaneous injection plus two placebo matching BI 655066 injections at Week 0, followed 90mg BI 655066 plus one placebo matching BI 655066 injection at Weeks 4 and 16.	6	41	22	41
EG002	BI 655066 180 mg	180 mg BI 655066 administered by subcutaneous injection as two injections plus a placebo matching BI 655066 injection at Week 0, followed 180 mg BI 655066 administered as two injections at Weeks 4 and 16.	0	42	20	42
EG003	Stelara	Stelara administered by subcutaneous injection plus two saline injections at Week 0, Stelara injection plus one saline injection at Weeks 4 and 16. Stelara dose was 45 mg for patients with body weight ≤100 kg at randomisation or 90 mg for patients with body weight >100 kg at randomisation.	3	40	17	40

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA 18.1	Systematic Assessment	EG0000 affected43 at risk EG0011 affected41 at risk EG0020 affected42 at risk EG0030 affected40 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA 18.1	Systematic Assessment	EG0000 affected43 at risk EG0011 affected41 at risk EG0020 affected42 at risk EG003
Coronary artery occlusion	Cardiac disorders	MedDRA 18.1	Systematic Assessment	EG0000 affected43 at risk EG0011 affected41 at risk EG0020 affected42 at risk EG003
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0000 affected43 at risk EG0011 affected41 at risk EG0020 affected42 at risk EG003
Allergy to arthropod bite	Immune system disorders	MedDRA 18.1	Systematic Assessment	EG0001 affected43 at risk EG0010 affected41 at risk EG0020 affected42 at risk EG003
Bronchitis	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0000 affected43 at risk EG0010 affected41 at risk EG0020 affected42 at risk EG003
Diverticulitis	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0000 affected43 at risk EG0010 affected41 at risk EG0020 affected42 at risk EG003
Perineal abscess	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0001 affected43 at risk EG0010 affected41 at risk EG0020 affected42 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0000 affected43 at risk EG0010 affected41 at risk EG0020 affected42 at risk EG003
Pelvic fracture	Injury, poisoning and procedural complications	MedDRA 18.1	Systematic Assessment	EG0001 affected43 at risk EG0010 affected41 at risk EG0020 affected42 at risk EG003
Rib fracture	Injury, poisoning and procedural complications	MedDRA 18.1	Systematic Assessment	EG0001 affected43 at risk EG0010 affected41 at risk EG0020 affected42 at risk EG003
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.1	Systematic Assessment	EG0001 affected43 at risk EG0011 affected41 at risk EG0020 affected42 at risk EG003
Salivary gland neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.1	Systematic Assessment	EG0000 affected43 at risk EG0011 affected41 at risk EG0020 affected42 at risk EG003
Cerebrovascular accident	Nervous system disorders	MedDRA 18.1	Systematic Assessment	EG0000 affected43 at risk EG0011 affected41 at risk EG0020 affected42 at risk EG003
Headache	Nervous system disorders	MedDRA 18.1	Systematic Assessment	EG0001 affected43 at risk EG0010 affected41 at risk EG0020 affected42 at risk EG003
Transient ischaemic attack	Nervous system disorders	MedDRA 18.1	Systematic Assessment	EG0001 affected43 at risk EG0010 affected41 at risk EG0020 affected42 at risk EG003
Erythema multiforme	Skin and subcutaneous tissue disorders	MedDRA 18.1	Systematic Assessment	EG0001 affected43 at risk EG0010 affected41 at risk EG0020 affected42 at risk EG003
Abortion induced	Surgical and medical procedures	MedDRA 18.1	Systematic Assessment	EG0001 affected43 at risk EG0010 affected41 at risk EG0020 affected42 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Folliculitis	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0003 affected43 at risk EG0011 affected41 at risk EG0021 affected42 at risk EG0030 affected40 at risk
Gastroenteritis	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0001 affected43 at risk EG0014 affected41 at risk EG0020 affected42 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG00015 affected43 at risk EG00114 affected41 at risk EG00211 affected42 at risk EG003
Rhinitis	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0000 affected43 at risk EG0013 affected41 at risk EG0021 affected42 at risk EG003
Sinusitis	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0001 affected43 at risk EG0010 affected41 at risk EG0021 affected42 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0000 affected43 at risk EG0013 affected41 at risk EG0021 affected42 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 18.1	Systematic Assessment	EG0001 affected43 at risk EG0012 affected41 at risk EG0023 affected42 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 18.1	Systematic Assessment	EG0002 affected43 at risk EG0014 affected41 at risk EG0021 affected42 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 18.1	Systematic Assessment	EG0000 affected43 at risk EG0011 affected41 at risk EG0023 affected42 at risk EG003
Headache	Nervous system disorders	MedDRA 18.1	Systematic Assessment	EG0005 affected43 at risk EG0012 affected41 at risk EG0023 affected42 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 18.1	Systematic Assessment	EG0001 affected43 at risk EG0011 affected41 at risk EG0023 affected42 at risk EG003
Psoriasis	Skin and subcutaneous tissue disorders	MedDRA 18.1	Systematic Assessment	EG0003 affected43 at risk EG0011 affected41 at risk EG0020 affected42 at risk EG003

ID	Term
D011565	Psoriasis

ID	Term
C000601773	risankizumab
D000069549	Ustekinumab

Ancestor Terms

ID	Term
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins
D007162	Immunoproteins
D001798	Blood Proteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins
D012712	Serum Globulins
D005916	Globulins

OG00440.0(24.9 to 56.7)

90 mg BI 655066 or 180mg BI 655066 administered by subcutaneous injection at Weeks 0, 4 and 16, plus matching placebos.

OG00470.0(53.5 to 83.4)

ID	Term
D017444	Skin Diseases, Papulosquamous
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases