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; ADJUST - Phase 4 – efficacy, A randomised, double-blind, controlled, parallel group, multi-centre trial

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-509668-11-00

Acronym

LP0160-1329

Enrollment

352

Registered

2024-06-06

Start date

2022-06-15

Completion date

2026-01-05

Last updated

2025-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Moderate-to-severe plaque psoriasis and a body weight ≥120 kg.

Brief summary

Having at least 90% lower Psoriasis Area and Severity Index (PASI) score relative to baseline (PASI 90 response) at Week 40.

Detailed description

Having static Physician’s Global Assessment (sPGA) score of 0 or 1 at Week 40., Having PASI 90 response at Week 52., Having sPGA score of 0 or 1 at Week 52., Having sPGA of genitalia (sPGA-G) of 0 or 1 at both Weeks 40 and 52., Having sPGA-G score of 0 or 1 at Week 40., Having sPGA-G score of 0 or 1 at Week 52., Having PASI 100 response at Week 40., Having PASI 100 response at Week 52., Change from baseline at Weeks 40 and 52 in PASI score., Change from baseline at Weeks 40 and 52 in affected body surface area (BSA)., Having Dermatology Life Quality Index (DLQI) total score of 0 or 1 at Week 40., Having DLQI total score of 0 or 1 at Week 52., Change from baseline at Weeks 40 and 52 in DLQI total score.

Interventions

DRUGBrodalumab 70 mg

DRUGThe placebo presentation is a pre-filled syringe containing the same excipients in the same amounts as the IMP

DRUGwithout the active substance.

DRUGKyntheum 210 mg solution for injection in pre-filled syringe

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Having at least 90% lower Psoriasis Area and Severity Index (PASI) score relative to baseline (PASI 90 response) at Week 40.	—

Secondary

Measure	Time frame
Having static Physician’s Global Assessment (sPGA) score of 0 or 1 at Week 40., Having PASI 90 response at Week 52., Having sPGA score of 0 or 1 at Week 52., Having sPGA of genitalia (sPGA-G) of 0 or 1 at both Weeks 40 and 52., Having sPGA-G score of 0 or 1 at Week 40., Having sPGA-G score of 0 or 1 at Week 52., Having PASI 100 response at Week 40., Having PASI 100 response at Week 52., Change from baseline at Weeks 40 and 52 in PASI score., Change from baseline at Weeks 40 and 52 in affected body surface area (BSA)., Having Dermatology Life Quality Index (DLQI) total score of 0 or 1 at Week 40., Having DLQI total score of 0 or 1 at Week 52., Change from baseline at Weeks 40 and 52 in DLQI total score.	—

Measure

Time frame

—

Countries

Belgium, Czechia, France, Germany, Greece, Hungary, Italy, Poland, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026