A Study to Test the Effect and Safety of Brodalumab Compared With Placebo and the Results of Stopping and Restarting Brodalumab Treatment in People with Moderate to Severe Plaque Psoriasis: AMAGINE-1

• Register: EUCTR
• Last refreshed on: 14 March 2016
• Main ID: EUCTR2012-000651-13-PL
• Date of registration: 18/05/2012
• Prospective Registration: Yes
• Primary sponsor: Amgen Inc.
• Public title: A Study to Test the Effect and Safety of Brodalumab Compared With Placebo and the Results of Stopping and Restarting Brodalumab Treatment in People with Moderate to Severe Plaque Psoriasis: AMAGINE-1
• Scientific title: A Phase 3 Study to Evaluate the Efficacy, Safety, and Effect of Withdrawal and Retreatment With Brodalumab in Subjects With Moderate to Severe Plaque Psoriasis: AMAGINE-1 - AMAGINE-1
• Date of first enrolment: 27/06/2012
• Target sample size: 600
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2012-000651-13
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: yes Other trial design description: double-blind induction phase followed by withdrawal and retreatment and long-term extension phase If controlled, specify comparator, Other Medicinial Product: yes Placebo: yes Other: no Number of treatment arms in the trial: 3

Countries of recruitment

Canada, France, Germany, Poland, Switzerland, United States

Contacts

• Name: IHQ Medical Info - Clinical Trials
• Affiliation: Amgen (EUROPE) GmbH

• Name: IHQ Medical Info - Clinical Trials
• Affiliation: Amgen (EUROPE) GmbH

Key inclusion & exclusion criteria

Inclusion criteria:
- Subject has provided informed consent.

- Subject is = 18 and = 75 years of age at time of screening.

- Subject has had stable moderate to severe plaque psoriasis for at least 6 months before first dose of IP (eg, no morphology changes or significant flares of disease activity in the opinion of the investigator).

- Subject must be considered, in the opinion of the investigator, to be a suitable candidate for treatment with a biologic per regional labeling.

- Subject has involved body surface area (BSA) = 10%, PASI = 12, and sPGA = 3 at screening and at baseline.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 570
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion criteria:
- Subject has any systemic disease (eg, renal failure, heart failure, hypertension, liver disease, diabetes, anemia) considered by the investigator to be clinically significant and uncontrolled.

- Subject has any concurrent medical condition that, in the opinion of the
investigator, could cause this study to be detrimental to the subject.

- Subject has used anti-IL-17 biologic therapy ever, or other experimental or commercially available biologic immune modulator(s) within 12 weeks prior to the first IP dose.

- Subject currently is enrolled in another investigational device or drug
study, or less than 30 days since ending another investigational device or
drug study(s), or receiving other investigational agent(s).

- Other investigational procedures are excluded.

- Subject has known sensitivity to any of the products or components to be
administered during dosing.

- For women: pregnant or breast feeding, or planning to become pregnant
while enrolled in the study and for 8 weeks after the last dose of IP.




Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

Moderate to severe plaque psoriasis
MedDRA version: 18.0 Level: PT Classification code 10037153 Term: Psoriasis System Organ Class: 10040785 - Skin and subcutaneous tissue disorders

Intervention(s)

Product Name: brodalumab (140 mg/ml)
Product Code: AMG 827
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: brodalumab
CAS Number: 1174395-19-7
Current Sponsor code: AMG 827
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 140-
Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe
Route of administration of the placebo: Subcutaneous use

Product Name: brodalumab (70 mg/0.5 ml)
Product Code: AMG 827
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: brodalumab
CAS Number: 1174395-19-7
Current Sponsor code: AMG 827
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 140-
Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe
Route of administration of the placebo: Subcutaneous use

Primary Outcome(s)

Primary end point(s): Co-Primary:
- PASI 75 at week 12
- sPGA success at week 12

Secondary Objective: Compared with placebo:
- To evaluate the efficacy of brodalumab (210 mg Q2W; and 140 mg Q2W) in clearing psoriasis, as measured by the proportion of subjects achieving PASI 100 at week 12
- To evaluate the efficacy of brodalumab (210 mg Q2W; and 140 mg Q2W) in clearing psoriasis, as measured by the proportion of subjects achieving sPGA of 0 at week 12
- To evaluate maintenance of effect with continued brodalumab treatment (210 mg Q2W; and 140 mg Q2W), as measured by the proportion of subjects achieving sPGA success at week 52
- To evaluate the effect of brodalumab (210 mg Q2W; and 140 mg Q2W) on patient-reported symptoms of psoriasis, as measured by the proportion of subjects who meet the responder definition for the Psoriasis Symptom Inventory (total score = 8, with no item scores > 1) at
week 12

Timepoint(s) of evaluation of this end point: Week 12

Main Objective: Compared with placebo:
- To evaluate the efficacy of brodalumab (210 mg every 2 weeks [Q2W]; and 140 mg Q2W) in subjects with moderate to severe plaque psoriasis, as measured by the proportion of subjects achieving 75% improvement in Psoriasis Area and Severity Index (PASI; PASI 75) at week 12.

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

Secondary Outcome(s)

Secondary end point(s): Key Secondary:
- PASI 100 at week 12
- sPGA 0 at week 12
- sPGA success at week 52 (in rerandomized subjects)
- Psoriasis Symptom Inventory responder definition at week 12


For other secondary endpoints, please refer to section 10.1.1 in the protocol.

Timepoint(s) of evaluation of this end point: - Week 12 for PASI 100; sPGA 0 and Psoriasis Symptom Inventory responder definition.

- Week 52 for sPGA success (in rerandomized subjects)

Secondary ID(s)

20120102

Source(s) of Monetary Support

Amgen Inc