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CompletedNCT00975637Updated Jun 26, 2019Results posted

Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 827 in Subjects With Psoriasis

A Phase 2 interventional study of 70 mg SC and 210 mg SC in Psoriasis, sponsored by Bausch Health Americas, Inc.. Completed. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2019-06-26.

Sponsored by Bausch Health Americas, Inc. · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
198
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
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Study summary

The study evaluated the efficacy of AMG 827 compared with placebo as measured by the percent of improvement in PASI score at week 12.

Read the detailed description

The study evaluated the efficacy of AMG 827 compared with placebo as measured by the percent of improvement in PASI score at week 12. Subjects were randomized ina 1:1:1:1:1 ratio. Subjects randomized to receive AMG 827 received 70, 140, or 210 mg at day 1 and weeks 4 and 8.

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Conditions studied

  • Psoriasis

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03

In context

Psoriasis

1,899 studies on the registry are indexed under Psoriasis; 233 are open to participants now.

This study's enrollment of 198 is above the median of 70 across 1,447 interventional studies indexed under Psoriasis.

Browse Psoriasis studies →

Lead sponsor

Bausch Health Americas, Inc. is the lead sponsor of 209 studies on the registry; 9 are open to participants now.

Of its 23 completed or terminated interventional studies of FDA-regulated products, 16 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Subject has had stable moderate to severe plaque psoriasis for at least 6 months
  • Subject has received at least one previous phototherapy or systemic psoriasis therapy or has been a candidate to receive phototherapy or systemic psoriasis therapy in the opinion of the investigator.
  • Subject has involved BSA ≥ 10% and PASI ≥ 12 at screening and at baseline.

Exclusion criteria

Exclusion Criteria:

  • Subject diagnosed with erythrodermic psoriasis, pustular psoriasis, medication-induced, or medication-exacerbated psoriasis.
  • Evidence of skin conditions at the time of the screening visit (eg, eczema, guttate psoriasis) that would interfere with evaluations of the effect of IP on psoriasis.
  • Subject has any active CTCAE grade 2 or higher infection
  • Subject has a significant concurrent medical condition or laboratory abnormalities, as defined in the study protocol.
  • Subject has used the following therapies within 14 days of the first dose: UVB therapy or topical psoriasis therapies other than Class I or II topical steroids
  • Subject has used the following therapies within 28 days of the first dose: Class I or II topical steroids, UVA therapy (with or without psoralen), or systemic psoriasis therapies
  • Subject has used the following therapies within 3 months of the first dose: adalimumab, alefacept, etanercept, infliximab, certolizumab, or live vaccines
  • Subject has used an anti-IL12/IL23 inhibitor within 6 months of the first dose
  • Subject has previously used an anti-IL17 biologic therapy, efalizumab, or rituximab
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Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
198 participants (actual)

Study arms

  • Experimental
    140 mg SC

    140 mg SC

    Drug: 140 mg SC

  • Experimental
    70 mg SC

    70 mg SC

    Drug: 70 mg SC

  • Experimental
    280 mg SC

    280 mg SC

    Drug: 280 mg SC

  • Placebo comparator
    210 mg SC

    210 mg SC

    Drug: 210 mg SC

  • Experimental
    Placebo

    Placebo

    Drug: Placebo

Interventions

  • Drug70 mg SC

    70 mg SC

    Also known as: AMG 827

  • Drug210 mg SC

    210 mg SC

    Also known as: AMG 827

  • Drug140 mg SC

    140 mg SC

    Also known as: AMG 827

  • Drug280 mg SC

    280 mg SC

    Also known as: AMG 827

  • DrugPlacebo

    Placebo SC

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What researchers measure

Primary outcomes

  1. Dose-response Efficacy Profile of AMG 827 Compared With Placebo as Measured by the Percent Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 12

    At screening a subject would need to have a PASI score of equal to or greater than 12, so at week 12 they were assessed to see percentage of change from there baseline PASI score.

    Time frame: Baseline and 12 weeks

Secondary outcomes

  1. Change in Percent of Body Surface Area (BSA) Affected by Psoriasis

    To evaluate the efficacy of AMG 827 as measured by the following: Body surface area (BSA) involvement at weeks 12. At the baseline of the study the subject would need to have at least a 10% BSA; at week 12 they were again assessed to see what change in percentage of BSA has occurred.

    Time frame: Baseline and Week 12

07

Results

Posted Dec 30, 2016

Participant flow

Participant flow — Overall Study
Milestone210 mg140 mg280 mgPlacebo70 mg
Started4039423839
Completed3738403237
Not completed31262

Outcome measures

PrimaryDose-response Efficacy Profile of AMG 827 Compared With Placebo as Measured by the Percent Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 12

At screening a subject would need to have a PASI score of equal to or greater than 12, so at week 12 they were assessed to see percentage of change from there baseline PASI score.

Time frame:
Baseline and 12 weeks
Reported as:
Mean · percentage of psoriasis improvement
Dose-response Efficacy Profile of AMG 827 Compared With Placebo as Measured by the Percent Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 12
percentage of psoriasis improvementBroda 210 mgBroda 140 mgBroda 280 mgPlaceboBroda 70 mg
Dose-response Efficacy Profile of AMG 827 Compared With Placebo as Measured by the Percent Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 1286.3 ± 27.685.9 ± 22.576 ± 32.716 ± 2745 ± 41.7
SecondaryChange in Percent of Body Surface Area (BSA) Affected by Psoriasis

To evaluate the efficacy of AMG 827 as measured by the following: Body surface area (BSA) involvement at weeks 12. At the baseline of the study the subject would need to have at least a 10% BSA; at week 12 they were again assessed to see what change in percentage of BSA has occurred.

Time frame:
Baseline and Week 12
Reported as:
Mean · percentage improvement in BSA
Change in Percent of Body Surface Area (BSA) Affected by Psoriasis
percentage improvement in BSABroda 210 mgBroda 140 mgBroda 280 mgPlaceboBroda 70 mg
Change in Percent of Body Surface Area (BSA) Affected by Psoriasis22.1 ± 15.021.1 ± 16.916.1 ± 11.40.9 ± 9.79.2 ± 11.2

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Broda 210 mg—1/40 (2.5%)15/40 (37.5%)
Broda 140 mg—0/39 (0%)12/39 (30.8%)
Broda 280 mg—0/42 (0%)10/42 (23.8%)
Placebo—0/38 (0%)7/38 (18.4%)
Broda 70 mg—0/39 (0%)10/39 (25.6%)
Most frequent serious events
Most frequent serious events
EventBroda 210 mgBroda 140 mgBroda 280 mgPlaceboBroda 70 mg
NeutropeniaBlood and lymphatic system disorders1/400/390/420/380/39
Most frequent other events
Showing 10 of 31
Most frequent other events
EventBroda 210 mgBroda 140 mgBroda 280 mgPlaceboBroda 70 mg
Injection Site ErythemaGeneral disorders3/401/394/421/381/39
Injection Site PainGeneral disorders0/400/391/420/383/39
FatigueGeneral disorders2/402/390/420/381/39
Upper respiratory tract infectionInfections and infestations1/401/391/420/382/39
NasopharyngitisInfections and infestations0/400/390/420/382/39
Injection Site IndurationGeneral disorders1/400/392/420/380/39
Injection Site PruritusGeneral disorders0/401/391/421/380/39
ChillsGeneral disorders0/400/390/421/380/39
Oedema PeripheralGeneral disorders0/400/390/421/380/39
BronchitisInfections and infestations1/400/390/421/381/39

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Broda 210 mgBroda 140 mgBroda 280 mgPlaceboBroda 70 mgTotal
<=18 years000000
Between 18 and 65 years3938403538190
>=65 years112318
Age, Continuous
Age, Continuous(years)Broda 210 mgBroda 140 mgBroda 280 mgPlaceboBroda 70 mgTotal
Mean42.1 ± 12.244.0 ± 11.742.3 ± 12.241.8 ± 14.442.1 ± 11.142.6 ± 11.7
Sex: Female, Male
Sex: Female, Male(Participants)Broda 210 mgBroda 140 mgBroda 280 mgPlaceboBroda 70 mgTotal
Female151112161771
Male2528302222127
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Broda 210 mgBroda 140 mgBroda 280 mgPlaceboBroda 70 mgTotal
Hispanic or Latino210216
Not Hispanic or Latino3838413638191
Unknown or Not Reported001001
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Study locations

No study locations are listed for this record.

09

References and documents

Publications

  • Gordon KB, Kimball AB, Chau D, Viswanathan HN, Li J, Revicki DA, Kricorian G, Ortmeier BG. Impact of brodalumab treatment on psoriasis symptoms and health-related quality of life: use of a novel patient-reported outcome measure, the Psoriasis Symptom Inventory. Br J Dermatol. 2014 Mar;170(3):705-15. doi: 10.1111/bjd.12636. PubMed 24079852 ↗
  • Papp KA, Leonardi C, Menter A, Ortonne JP, Krueger JG, Kricorian G, Aras G, Li J, Russell CB, Thompson EH, Baumgartner S. Brodalumab, an anti-interleukin-17-receptor antibody for psoriasis. N Engl J Med. 2012 Mar 29;366(13):1181-9. doi: 10.1056/NEJMoa1109017. PubMed 22455412 ↗
  • Papp K, Menter A, Strober B, Kricorian G, Thompson EH, Milmont CE, Nirula A, Klekotka P. Efficacy and safety of brodalumab in subpopulations of patients with difficult-to-treat moderate-to-severe plaque psoriasis. J Am Acad Dermatol. 2015 Mar;72(3):436-439.e1. doi: 10.1016/j.jaad.2014.10.026. Epub 2014 Dec 29. PubMed 25553889 ↗
  • 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. PubMed 32207067 ↗
  • Papp K, Leonardi C, Menter A, Thompson EH, Milmont CE, Kricorian G, Nirula A, Klekotka P. Safety and efficacy of brodalumab for psoriasis after 120 weeks of treatment. J Am Acad Dermatol. 2014 Dec;71(6):1183-1190.e3. doi: 10.1016/j.jaad.2014.08.039. Epub 2014 Oct 11. PubMed 25313095 ↗

Individual participant data

Plan to share: Yes

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 26, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00975637
Lead sponsor
Bausch Health Americas, Inc.
Responsible party
Sponsor
First posted
Sep 11, 2009
Start date
Dec 2009
Primary completion
Jul 2010
Completion
Sep 2010
Results posted
Dec 30, 2016
Last update
Jun 26, 2019

Study contacts

MD
study director · Amgen
View the source record on ClinicalTrials.gov ↗

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