Trial intelligence / Profile preview

Metformin + Secukinumab in Overweight/Obese Chinese Patients with Psoriasis

NCT07485764Phase 4

Key facts

Status
Not yet recruiting
Start
Jun 2026
Primary completion
Jun 2026
Countries
1
Modality
Small Molecules
Conditions
plaque psoriasis
01

Overview

Phase 4, randomised, double-blind trial of liquid metformin (Aspargo Labs) in plaque psoriasis (2 arms). Primary endpoints: Proportion of Participants Achieving >=75% Improvement in Psoriasis Area and Severity Index at 24 weeks and Proportion of Participants Achieving Investigator's Global Assessment Score of 0 or 1 at 24 weeks. Planned start Jun 2026; status: not yet recruiting.

02

Design

2 arms
Study design
RandomizedDouble-blind
  • Metformin + Secukinumab

    Secukinumab 300 mg s.c. + Metformin oral (titrated to max 2000 mg/day)

  • Placebo + Secukinumab

    Secukinumab 300 mg s.c. + Placebo oral

03

Who it enrols

Overweight or obese adults with moderate-to-severe chronic plaque psoriasis uncontrolled by topical, phototherapy, or prior systemic therapy, excluding those with recent use of certain biologics or systemic treatments, active infections, or history of malignancy.

04

Endpoints

Primary

  • Proportion of Participants Achieving >=75% Improvement in Psoriasis Area and Severity Index

  • Proportion of Participants Achieving Investigator's Global Assessment Score of 0 or 1

Secondary

  • Proportion of Participants Achieving >=90% Improvement in Psoriasis Area and Severity Index

  • Proportion of Participants Achieving PASI75, PASI90, or PASI100

  • Proportion of Participants Achieving Investigator's Global Assessment Score of 0 or 1

  • Change in Dermatology Life Quality Index

  • Proportion of Participants with DLQI Score of 0 or 1

  • Change in Pruritus Numeric Rating Scale

  • Proportion of Participants with >=2.5% Weight Loss

  • Proportion of Participants Achieving PASI75/90/100 at Week 52 Among Those Who Achieved PASI50 but Not PASI75 at Week 24

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