NCT04306315|CompletedPhase 4FDA Drug

Adjusted Brodalumab Dose Compared With Standard Brodalumab Dose in Subjects With Moderate-to-severe Plaque Psoriasis and ≥120 kg Body Weight

ADJUST

Adjustable Brodalumab Dosage Regimen Compared With Standard Brodalumab Treatment for 52 Weeks in Subjects With Moderate-to-severe Plaque Psoriasis and ≥120 kg Body Weight

LEO Pharma ClinicalTrials.gov

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4 other identifiers

LP0160-13292017-004998-13U1111-1282-45072023-509668-11-00

Study Type

interventional

Target

385

Locations

11 countries

Sites

Timeline

RegisteredMar 2020

StartedJul 2022

CompletionJan 2026

Brief Summary

This study investigates if an adjusted brodalumab dosage regimen will give improved efficacy in psoriasis in patients with a body weight of over 120 kg. The increased dosage regimen will be compared to the standard brodalumab treatment plus placebo.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

385

participants targeted

Target at P75+ for phase_4

Timeline

Completed

Started Jul 2022

Longer than P75 for phase_4

Geographic Reach

11 countries

81 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

3.5 years study duration

First Submitted

Initial submission to the registry

March 11, 2020

Completed

1 day until next milestone

First Posted

Study publicly available on registry

March 12, 2020

Completed

2.4 years until next milestone

Study Start

First participant enrolled

July 21, 2022

Completed

3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 25, 2025

Completed

4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 5, 2026

Completed

Last Updated

April 24, 2026

Status Verified

January 1, 2026

Enrollment Period

3.1 years

First QC Date

March 11, 2020

Last Update Submit

April 21, 2026

Conditions

Psoriasis Vulgaris

Outcome Measures

Primary Outcomes (1)

Having at least 90% lower Psoriasis Area and Severity Index (PASI) score relative to baseline (PASI 90 response) at Week 40.
The PASI score is the most widely used tool in clinical practice and clinical trials to assess the severity and extent of psoriasis. The assessment is done based on the condition of the disease at the time of evaluation and not in relation to the condition at a previous visit. The investigator will assess the severity of 3 psoriasis disease characteristics (redness, thickness, and scaliness) on each of the 4 body regions, head/neck, trunk, upper extremities, and lower extremities, according to a severity scale. The investigator will also assess the extent of psoriasis within each of the 4 body regions. This gives a composite score ranging from 0-72, with higher values indicating a more severe and/or more extensive condition.
Week 40

Secondary Outcomes (14)

Having static Physician's Global Assessment (sPGA) score of 0 or 1 at Week 40
Week 40
Having PASI 90 response at Week 52
Week 52
Having sPGA score of 0 or 1 at Week 52
Week 52
Having sPGA of genitalia (sPGA-G) score of 0 or 1 at both Week 40 and Week 52
Week 40 and 52
Having sPGA of genitalia (sPGA-G) score of 0 or 1 at Week 40
Week 40
+9 more secondary outcomes

Study Arms (2)

Brodalumab 210 mg + brodalumab 70 mg add-on* (adjusted brodalumab dosing regimen)

EXPERIMENTAL

Participants will receive 210 mg brodalumab subcutaneously at Week 0, Week 1, and Week 2, and then once every 2 weeks. \*Participants not fulfilling a predefined response at any visit with efficacy assessments after Week 16 will receive a dose adjustment to 280 mg brodalumab every 2 weeks.

Biological: Brodalumab

Brodalumab 210 mg + placebo add-on* (standard brodalumab treatment)

PLACEBO COMPARATOR

Participants will receive 210 mg brodalumab subcutaneously at Week 0, Week 1, and Week 2, and then once every 2 weeks. \*Participants not fulfilling a predefined response at any time visit with efficacy assessments Week 16 will receive a dose adjustment to 210 mg brodalumab + placebo every 2 weeks.

Biological: Brodalumab

Interventions

BrodalumabBIOLOGICAL

Brodalumab is an anti-IL-17 receptor antibody, which blocks the inflammatory effects of IL-17 in the skin.

Brodalumab 210 mg + brodalumab 70 mg add-on* (adjusted brodalumab dosing regimen)Brodalumab 210 mg + placebo add-on* (standard brodalumab treatment)

Eligibility Criteria

Age18 Years - 74 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Signed and dated informed consent has been obtained prior to any protocol-related procedures.
Age ≥18 to \<75 years at the time of screening.
Diagnosed with chronic plaque psoriasis at least 6 months before randomisation.
Body weight ≥120 kg at the time of screening.
Moderate-to-severe plaque psoriasis as defined by: BSA ≥10% and PASI ≥12 at screening and baseline.
No evidence of active or latent tuberculosis according to local standard of care.

You may not qualify if:

Diagnosed with erythrodermic psoriasis, pustular psoriasis, guttate psoriasis, medication-induced psoriasis, or other skin conditions (e.g., eczema) that would interfere with evaluations of the effect of the investigational medicinal product (IMP) on participants with plaque psoriasis.
Clinically important active infections or infestations, chronic, recurrent or latent infections or infestations, or is immunocompromised (e.g., human immunodeficiency virus, hepatitis B, and hepatitis C).
Any systemic disease considered by the investigator to be uncontrolled and either immunocompromising the participants and/or placing the participant at undue risk of intercurrent diseases (including, but not limited to, renal failure, heart failure, liver disease, diabetes, and anaemia).
History of Crohn's disease.
Myocardial infarction or stroke, or unstable angina pectoris within the past 12 months.
Any active malignancy.
History of malignancy within 5 years, except for treated and considered cured cutaneous squamous or basal cell carcinoma, in situ cervical cancer, or in situ breast ductal carcinoma.
History of suicidal behaviour (i.e., 'actual suicide attempt', 'interrupted attempt', 'aborted attempt', or 'preparatory acts or behaviour') based on the Columbia-Suicide Severity Rating Scale (C-SSRS) questionnaire at screening or at baseline.
Any suicidal ideation of category 4 or 5 ('active suicidal ideation with some intent to act, without specific plan' or ' active suicidal ideation with specific plan and intent') based on the C-SSRS questionnaire at screening or at baseline.
A Patient Health Questionnaire (PHQ)-8 score of ≥10 corresponding to moderate-to-severe depression at screening or at baseline.

Contact the study team to confirm eligibility.