Efficacy, Safety, and Withdrawal and Retreatment With Bro... | NCT01708590

ID	Type	Description	Link
2012-000651-13	EudraCT Number

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
210 mg brodalumab	Experimental	Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to placebo or continued treatment. Participants are retreated at return of disease.	Drug: 210 mg brodalumab Drug: placebo
140 mg brodalumab	Experimental	Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to placebo or continued treatment. Participants are retreated at return of disease.	Drug: 140 mg brodalumab Drug: placebo
placebo	Placebo Comparator	Administered by SC injection until week 12. At week 12 particpants are assigned to 210 mg brodalumab.	Drug: 210 mg brodalumab Drug: placebo

Name	Type	Description	Arm Group Labels	Other Names
210 mg brodalumab	Drug	210 mg brodalumab administered subcutaneous (SC)	210 mg brodalumab placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Participants With Psoriasis Area and Severity Index (PASI) 75 at Week 12	to evaluate the efficacy of brodalumab (210mg Q2W, 140mg Q2W) in subjects with moderate to severe plaque psoriasis, as measured by the proportion of subjects who achieved 75% improvement in Psoriasis Area Severity Index (PASI75) at week 12.	0-12 weeks
Percentage of Participants With Static Physician Global Assessment (sPGA) Score Success (Score of 0 or 1) at Week 12	To evaluate the efficacy of brodalumab (210mg Q2W, 140mg Q2W) in subjects with moderate to severe plaque psoriasis , as measured by the proportion of subjects who achieved success (clear [0] or almost clear [1]) on the static physicians global assessment (sPGA) at week 12	0 - 12 Weeks

Secondary Outcomes

Measure	Description	Time Frame
Percentage of Participants With Static Physicians Global Assessment (sPGA) Score Success (Score of 0 or 1) at Week 52	to evaluate maintenance of effect with continued brodalumab treatment (210mg Q2W, 140mg Q2W) as measured by the proportion of subjects achieving success (clear[0] or almost clear [1]) at week 52.	Week 0 - Week 52

Eligibility Module

Name	Affiliation	Role
MD	Amgen	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Phoenix	Arizona	85023	United States
Research Site

PubMed Identifier	Type	Citation	Retractions
32207067	Derived	Gottlieb A, Lebwohl M, Liu C, Israel RJ, Jacobson A. Malignancy Rates in Brodalumab Clinical Studies for Psoriasis. Am J Clin Dermatol. 2020 Jun;21(3):421-430. doi: 10.1007/s40257-020-00512-4.

Label	URL
AmgenTrials clinical trials website	View source

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Induction Phase: 210 mg Brodalumab	Administered by subcutaneous (SC) injection until week 12. 210 mg brodalumab: 210 mg brodalumab administered subcutaneous (SC)
FG001	Induction Phase: 140 mg Brodalumab

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	210 mg Brodalumab	Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to placebo or continued treatment. Participants are retreated at return of disease. 210 mg brodalumab: 210 mg brodalumab administered subcutaneous (SC) placebo: Placebo administered subcutaneous (SC)
BG001	140 mg Brodalumab	Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to placebo or continued treatment. Participants are retreated at return of disease. 140 mg brodalumab: 140 mg brodalumab administered subcutaneous (SC) placebo: Placebo administered subcutaneous (SC)
BG002	Placebo	Administered by SC injection until week 12. At week 12 participants are assigned to 210 mg brodalumab. 210 mg brodalumab: 210 mg brodalumab administered subcutaneous (SC) placebo: Placebo administered subcutaneous (SC)
BG003	Total	Total of all reporting groups

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Percentage of Participants With Psoriasis Area and Severity Index (PASI) 75 at Week 12

to evaluate the efficacy of brodalumab (210mg Q2W, 140mg Q2W) in subjects with moderate to severe plaque psoriasis, as measured by the proportion of subjects who achieved 75% improvement in Psoriasis Area Severity Index (PASI75) at week 12.

Data collected is based off of the data from the induction phase.

Posted

Count of Participants

Participants

0-12 weeks

ID	Title	Description
OG000	Induction Phase: 210 mg Brodalumab	Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to placebo or continued treatment. Participants are retreated at return of disease. 210 mg brodalumab: 210 mg brodalumab administered subcutaneous (SC) placebo: Placebo administered subcutaneous (SC)
OG001	Induction Phase: 140 mg Brodalumab	Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to placebo or continued treatment. Participants are retreated at return of disease. 140 mg brodalumab: 140 mg brodalumab administered subcutaneous (SC) placebo: Placebo administered subcutaneous (SC)
OG002	Induction Phase: Placebo	Administered by SC injection until week 12. placebo: Placebo administered subcutaneous (SC)

Units	Counts
Participants	OG000222 OG001219 OG002220

Title

Denominators

Categories

Title	Measurements
	OG000185 OG001132 OG0026

Primary

Percentage of Participants With Static Physician Global Assessment (sPGA) Score Success (Score of 0 or 1) at Week 12

To evaluate the efficacy of brodalumab (210mg Q2W, 140mg Q2W) in subjects with moderate to severe plaque psoriasis , as measured by the proportion of subjects who achieved success (clear [0] or almost clear [1]) on the static physicians global assessment (sPGA) at week 12

Data reported is based off of the data collected from the induction phase

Posted

Count of Participants

Participants

0 - 12 Weeks

ID	Title	Description
OG000	Induction Phase: 210 mg Brodalumab	Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to placebo or continued treatment. Participants are retreated at return of disease. 210 mg brodalumab: 210 mg brodalumab administered subcutaneous (SC) placebo: Placebo administered subcutaneous (SC)
OG001	Induction Phase: 140 mg Brodalumab	Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to placebo or continued treatment. Participants are retreated at return of disease. 140 mg brodalumab: 140 mg brodalumab administered subcutaneous (SC) placebo: Placebo administered subcutaneous (SC)
OG002	Induction Phase: Placebo

Secondary

Percentage of Participants With Static Physicians Global Assessment (sPGA) Score Success (Score of 0 or 1) at Week 52

to evaluate maintenance of effect with continued brodalumab treatment (210mg Q2W, 140mg Q2W) as measured by the proportion of subjects achieving success (clear[0] or almost clear [1]) at week 52.

Only subjects with efficacy data available at Week 52 were included in the analysis.

Posted

Count of Participants

Participants

Week 0 - Week 52

ID	Title	Description
OG000	Withdrawal Phase: Placebo (140mg)	Administered SC injection Week 12 - Week 52
OG001	Withdrawal Phase: 140mg Brodalumab Q2W	Administered SC injection, Week 12 - Week 52
OG002	Withdrawal Phase: Placebo (210mg)	Administered SC, Week 12 - Week 52
OG003	Withdrawl Phase: 210mg Brodalumab Q2W	Administered SC injection, Week 12- Week 16

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	210 mg Brodalumab	Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to placebo or continued treatment. Participants are retreated at return of disease. 210 mg brodalumab: 210 mg brodalumab administered subcutaneous (SC) placebo: Placebo administered subcutaneous (SC)	4	222	85	222
EG001	140 mg Brodalumab	Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to placebo or continued treatment. Participants are retreated at return of disease. 140 mg brodalumab: 140 mg brodalumab administered subcutaneous (SC) placebo: Placebo administered subcutaneous (SC)	6	219	91	219
EG002	Placebo	Administered by SC injection until week 12. At week 12 participants are assigned to 210 mg brodalumab. 210 mg brodalumab: 210 mg brodalumab administered subcutaneous (SC) placebo: Placebo administered subcutaneous (SC)	3	220	46	220

Serious Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Cellulitis	Infections and infestations	Non-systematic Assessment	EG0001 events1 affected222 at risk EG0011 events1 affected219 at risk EG0020 events0 affected220 at risk
Diverticulitis	Infections and infestations	Non-systematic Assessment	EG0000 events0 affected222 at risk EG0011 events1 affected219 at risk EG0020 events0 affected220 at risk
Pancreatitis Acute	Infections and infestations	Non-systematic Assessment	EG0000 events0 affected222 at risk EG0011 events1 affected219 at risk EG0020 events0 affected220 at risk
Volvulus of Small Bowel	Gastrointestinal disorders	Non-systematic Assessment	EG0000 events0 affected222 at risk EG0011 events1 affected219 at risk EG0020 events0 affected220 at risk
Back Pain	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0001 events1 affected222 at risk EG0010 events0 affected219 at risk EG0020 events0 affected220 at risk
Invertebral Disk Intusion	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0000 events0 affected222 at risk EG0011 events1 affected219 at risk EG0020 events0 affected220 at risk
Pyrexia	Infections and infestations	Non-systematic Assessment	EG0000 events0 affected222 at risk EG0011 events1 affected219 at risk EG0020 events0 affected220 at risk
Cholecystitis acute	Infections and infestations	Non-systematic Assessment	EG0001 events1 affected222 at risk EG0010 events0 affected219 at risk EG0020 events0 affected220 at risk
Diabetes mellitus	Immune system disorders	Non-systematic Assessment	EG0001 events1 affected222 at risk EG0010 events0 affected219 at risk EG0020 events0 affected220 at risk
Psoriasis	Immune system disorders	Non-systematic Assessment	EG0000 events0 affected222 at risk EG0010 events0 affected219 at risk EG0022 events2 affected220 at risk
COPD	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0000 events0 affected222 at risk EG0010 events0 affected219 at risk EG0021 events1 affected220 at risk

Other Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Upper Respiratory Tract Infection	Infections and infestations	Non-systematic Assessment	EG00018 events18 affected222 at risk EG00118 events18 affected219 at risk EG00214 events14 affected220 at risk
Headache	Nervous system disorders	Non-systematic Assessment	EG00011 events11 affected222 at risk EG00112 events12 affected219 at risk EG0027 events7 affected220 at risk
Arthralgia	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0006 events6 affected222 at risk EG00110 events10 affected219 at risk EG0026 events6 affected220 at risk
Hypertension	Cardiac disorders	Non-systematic Assessment	EG0002 events2 affected222 at risk EG0018 events8 affected219 at risk EG0024 events4 affected220 at risk
Back Pain	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0006 events6 affected222 at risk EG0012 events2 affected219 at risk EG0024 events4 affected220 at risk
Nausea	Gastrointestinal disorders	Non-systematic Assessment	EG0005 events5 affected222 at risk EG0015 events5 affected219 at risk EG0022 events2 affected220 at risk
Rhinitis	Infections and infestations	Non-systematic Assessment	EG0005 events5 affected222 at risk EG0012 events2 affected219 at risk EG0022 events2 affected220 at risk
Tooth Infection	Infections and infestations	Non-systematic Assessment	EG0001 events1 affected222 at risk EG0016 events6 affected219 at risk EG0022 events2 affected220 at risk
Diarrhoea	Infections and infestations	Non-systematic Assessment	EG0004 events4 affected222 at risk EG0014 events4 affected219 at risk EG0021 events1 affected220 at risk
Cough	General disorders	Non-systematic Assessment	EG0003 events3 affected222 at risk EG0016 events6 affected219 at risk EG0020 events0 affected220 at risk
Vomiting	Infections and infestations	Non-systematic Assessment	EG0002 events2 affected222 at risk EG0014 events4 affected219 at risk EG0021 events1 affected220 at risk
Conjunctivitis	Infections and infestations	Non-systematic Assessment	EG0005 events5 affected222 at risk EG0012 events2 affected219 at risk EG0020 events0 affected220 at risk
Influenza	Immune system disorders	Non-systematic Assessment	EG0004 events4 affected222 at risk EG0011 events1 affected219 at risk EG0021 events1 affected220 at risk
Myalgia	Infections and infestations	Non-systematic Assessment	EG0004 events4 affected222 at risk EG0012 events2 affected219 at risk EG0020 events0 affected220 at risk
Influenza like illness	Infections and infestations	Non-systematic Assessment	EG0004 events4 affected222 at risk EG0010 events0 affected219 at risk EG0021 events1 affected220 at risk
Ligament Sprain	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0000 events0 affected222 at risk EG0013 events3 affected219 at risk EG0021 events1 affected220 at risk
Rash	Infections and infestations	Non-systematic Assessment	EG0004 events4 affected222 at risk EG0010 events0 affected219 at risk EG0020 events0 affected220 at risk
UTI	Infections and infestations	Non-systematic Assessment	EG0001 events1 affected222 at risk EG0013 events3 affected219 at risk EG0020 events0 affected220 at risk
Dizziness	General disorders	Non-systematic Assessment	EG0000 events0 affected222 at risk EG0013 events3 affected219 at risk EG0020 events0 affected220 at risk

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