Health TrialsbyHealthPanel

Phase II Clinical Trial of SHR-1139 Injection in Patients With Psoriasis

ConditionPsoriasis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorGuangdong Hengrui Pharmaceutical Co., Ltd

About this trial

This study is a randomized, double-blind, multi-center, parallel, phase II clinical trial, aiming to evaluate the efficacy and safety of SHR-1139 injection for adult patients with psoriasis. The trial includes a 4-week screening period, a 52-week treatment period, and a 12-week safety follow-up period. Approximately 60 patients with psoriasis are expected to participate.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

During the screening process, the body mass index (BMI = weight (kg) / height² (m²)) was ≥ 18 kg/m²;

History of plaque psoriasis for more than 6 months before randomization；

The PASI score, sPGA score, and BSA at the screening and baseline required certain requirements;

Participants suitable for phototherapy or systemic psoriasis treatment for moderate to severe plaque psoriasis;

Disqualifiers

The diagnosed psoriasis at the screening or baseline stage is not chronic plaque-type psoriasis;

Has drug-induced psoriasis;

Has other skin problems that the investigator considers would interfere with the assessment of psoriasis;

Has concurrent other active autoimmune diseases, including but not limited to rheumatoid arthritis, systemic lupus erythematosus, scleroderma, polymyositis, multiple sclerosis or other central demyelinating diseases, primary Sjögren's syndrome, etc.;

Trial design

Design model

Parallel

Treatments tested in this trial

  • The SHR-1139 injection

    Drug

    The SHR-1139 injection

  • placebo

    Drug

    placebo

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Treatment group A: SHR-1139 injection/placeboExperimental treatment 2 interventions
Group B: Treatment group B: SHR-1139 injection/placeboExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

The proportion of participants who achieved a 100% improvement in the Psoriasis Area and Severity Index (PASI) score compared to the baseline by the 12th week (PASI 100).

Time frame
12th week

Secondary outcomes

1

The proportion of participants who achieved a minimum improvement of at least 75% in PASI compared to the baseline (PASI 75) in the 12th week;

Time frame
12th week
2

The proportion of participants who achieved a minimum improvement of at least 90% in PASI compared to the baseline (PASI 90) in the 12th week

Time frame
12th week
3

The proportion of participants who achieved a sPGA response of 0 or 1 (sPGA 0/1) as assessed by the static physician in the 12th week

Time frame
12th week
4

The proportion of participants who achieved a sPGA response of 0 (sPGA 0) in the 12th week

Time frame
12th week

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Guangdong Hengrui Pharmaceutical Co., Ltd

Lead sponsor

Source ClinicalTrials.gov
Apply now