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Not yet recruiting NCT07432854

A Clinical Study Evaluating the Efficacy and Safety of CMS-D001 Tablets in the Treatment of Adult Patients With Moderate to Severe Plaque-type Psoriasis

Phase II / Phase III Interventional Moderate to Severe Plaque Psoriasis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: CMS-D001 50mg, CMS-D001 100mg, Placebo.
Who it may be relevant to
Registry conditions: Moderate to Severe Plaque Psoriasis. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase Ⅱ/Ⅲ Clinical Study to Evaluate the Efficacy and Safety of CMS-D001 Tablets in Adult Patients With Moderate to Severe Plaque Psoriasis

Overview

This study adopted a multicenter, randomized, double-blind, placebo-controlled phase II/III operation seamless adaptive design, aiming to evaluate the efficacy, safety and tolerability of CMS-D001 tablets in the treatment of patients with moderate to severe plaque psoriasis. The trial consists of two parts, including the Phase II clinical research stage and the Phase III clinical research stage.

Detailed description

In the Phase II clinical research stage, a multi-center, randomized, double-blind, placebo-controlled design will be adopted, with a planned enrollment of 120 participants. After providing written informed consent and completing all screening evaluations, eligible participants will be randomly assigned in a 1:1:1 ratio to Trial Group 1, Trial Group 2, and the placebo group, with 40 participants in each group.All randomly assigned participants will undergo a 12-week double-blind treatment and continue to be followed up until the 16th week. The study is divided into three phases: the screening period (up to 4 weeks), the treatment period (12 weeks, approximately 85 ± 3 days), and the follow-up period (2 weeks after the last dose).

In the Phase III clinical research stage, a multi-center, randomized, double-blind, placebo-controlled design will be adopted. It is planned to continue enrolling participants in the Phase III study after the completion of the Phase II clinical trial enrollment, based on the Phase II dose groups (or the recommended dose groups determined based on the Phase II study results) and the placebo group. A total of 420 participants are planned to be enrolled. After providing written informed consent and completing all screening evaluations, eligible participants will be randomly assigned in a 2:2:1 ratio to the CMS-D001 tablet 50 mg QD, 100 mg QD, and placebo control groups. Each treatment group will have a maximum of 168 participants (excluding those who switch from the placebo group), and the placebo group will have a maximum of 84 participants.The research was divided into 4 phases, namely the screening phase (up to 4 weeks), the base phase (16 weeks), the expansion phase (36 weeks), and the follow-up phase (4 weeks after the last administration).

Interventions

  • Drug CMS-D001 50mg
    CMS-D001 50mg QD
  • Drug CMS-D001 100mg
    CMS-D001 100mg QD
  • Drug Placebo
    Placebo QD

Primary outcome measures

  • Phase Ⅱ:Number of participants achieving at least 75% improvement in Psoriasis Area and Severity Index (PASI 75) [Time frame: At week 12]
  • Phase Ⅲ:Number of participants achieving at least 75% improvement in Psoriasis Area and Severity Index (PASI 75) [Time frame: At week 16]
  • Phase Ⅲ:Number of participants achieving a Physician Global Assessment (PGA) score of 0 (clear) or 1 (almost clear) (PGA-TS) [Time frame: At week 16]
Secondary outcome measures (12)
  • PhaseⅡ:Number of participants achieving at least 75% improvement in Psoriasis Area and Severity Index (PASI 75) [Time frame: At week 2, 4, 8]
  • PhaseⅡ:Number of participants achieving a Physicians Global Assessment (PGA) score of 0 or 1. [Time frame: At week 2, 4, 8, 12]
  • PhaseⅡ:Number of participants achieving at least 50%, 90%, or 100% improvement in PASI (PASI 50/90/100) [Time frame: At week 2, 4, 8, 12]
  • PhaseⅡ:Change and percentage change from baseline in the Psoriasis Area and Severity Index (PASI) score. [Time frame: At week 2, 4, 8, 12]
  • PhaseⅡ:Change and percentage change in affected Body Surface Area (BSA) from baseline [Time frame: At week 2, 4, 8, 12]
  • PhaseⅡ:Change in Dermatology Life Quality Index (DLQI) score from baseline [Time frame: At week 2, 4, 8, 12]
  • Phase Ⅲ:Number of participants achieving at least 75% improvement in PASI (PASI 75) [Time frame: At weeks 2, 4, 8, 12 and at each visit in the extension period]
  • Phase Ⅲ:Number of participants achieving at least 90% or 100% improvement in PASI (PASI 90/100) [Time frame: At weeks 2, 4, 8, 12, 16 and at each visit in the extension period]
  • Phase Ⅲ:Number of participants achieving a Physician Global Assessment (PGA) score of 0 (clear) or 1 (almost clear) [Time frame: At weeks 2, 4, 8, 12 and at each visit in the extension period]
  • Phase Ⅲ:Change and percentage change in PASI score from baseline [Time frame: At weeks 2, 4, 8, 12, 16 and at each visit in the extension period]
  • Phase Ⅲ:Change and percentage change in affected Body Surface Area (BSA) from baseline [Time frame: At weeks 2, 4, 8, 12, 16 and at each visit in the extension period]
  • Phase Ⅲ:Change in Dermatology Life Quality Index (DLQI) score from baseline [Time frame: At weeks 2, 4, 8, 12, 16 and at each visit in the extension period]

Eligibility criteria

Inclusion criteria

  • Aged 18-75 years, willing to sign the ICF
  • Diagnosed with plaque psoriasis for at least 6 months prior to screening.
  • At screening and baseline, PASI score ≥ 12 points, BSA ≥ 10%, sPGA ≥ 3
  • Be eligible for phototherapy or systemic therapy.

Exclusion criteria

  • Non-plaque psoriasis (ie, guttate, pustular, erythrodermic, or inverse psoriasis) within 3 months prior to baseline.
  • Other skin diseases at screening or baseline Drug-induced psoriasis.
  • History of severe herpes zoster or severe herpes simplex or current herpes simplex/zoster infection.
  • History of a serious bacterial, fungal, or viral infection requiring hospitalization or intravenous antimicrobial therapy within 3 months prior to the first dose.
  • History of a bacterial, fungal, or viral infection requiring oral antimicrobial therapy within 4 weeks prior to the first dose.
  • Active infection or acute illness within 7 days prior to the first dose. Chronic or recurrent infectious diseases at screening or baseline that, in the investigator's judgment, may increase safety risks.
  • Evidence of active TB. Patients with evidence of latent tuberculosis may enter the trial after sufficient treatment had initiated and maintained according to protocol.
  • History of a major or unstable clinical condition within 6 months prior to the first dose, which would compromise participation.
  • History of malignant tumour within 5 years before screening.
  • Previous or current autoimmune diseases.
  • Positive results of confirmatory test for hepatitis B, hepatitis C, human immunodeficiency virus (HIV) or syphilis.
  • Allergic to any component of the investigational drug.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

China · 21 centers
  • The First Affiliated Hospital of Bengbu Medical College — Bengbu
  • The First Affiliated Hospital of Wannan Medical College (Yijishan) — Wuhu
  • Southern Medical University Dermatology Hospital — Guangzhou
  • Zhujiang Hospital of Southern Medical University — Guangzhou
  • Affiliated Hospital of Chengde Medical College — Chengde
  • Affiliated Hospital of Hebei University of Engineering — Handan
  • Shijiazhuang Traditional Chinese Medicine Hospital — Shijiazhuang
  • The Fourth Affiliated Hospital of Hebei Medical University — Shijiazhuang
  • … and 13 more centers

Identifiers

NCT: NCT07432854 · D001-02-002

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗