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Establishment of Precision Medicine and Individualized Standardized Treatment Pathway for Psoriasis in China Subtopic 2: Exploring the Efficacy, Safety Evaluation, and Individualized Protocol Exploration of Low dose Targeted IL-17 Axis Biological Agents Combined with Apremilast Tablets in the Treatment of Adult Moderate to Severe Psoriasis Vulgaris

Establishment of Precision Medicine and Individualized Standardized Treatment Pathway for Psoriasis in China Subtopic 2: Exploring the Efficacy, Safety Evaluation, and Individualized Protocol Exploration of Low dose Targeted IL-17 Axis Biological Agents Combined with Apremilast Tablets in the Treatment of Adult Moderate to Severe Psoriasis Vulgaris

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400087472
Enrollment
Unknown
Registered
2024-07-29
Start date
2024-08-01
Completion date
Unknown
Last updated
2024-08-05

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

Conditions

Psoriasis

Interventions

Secukinumab full dose administration group:During the induction period of week 0, 1, 2, 3, and 4, administer once every 300mg (2 injections) for a total of 10 injections
The instruction manual is recommended for patients weighing over 60kg. The maintenance period adopts a dosing method of once every 4 weeks, with 2 injections given each time until the skin lesions are
Secukinumab low dose administration group:During the induction period of week 0, 2, and 4, 300mg of medication was administered once each time, for a total of 6 injections. During the maintenance peri
Low dose combination of Secuknumab and apremilast group:During the induction period of week 0, week 2, and week 4, administer 300mg once each time for a total of 6 injections. During the maintenance p

Sponsors

Department of Dermatology, Huashan Hospital, Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: (1) Psoriasis patients who regularly visit psoriasis specialist clinics for treatment; (2) Age 18-70 years old, both male and female are eligible; (3) Weight = 60kg; (4) Voluntarily accepting biologics targeting the IL-17 axis for treatment; (5) Qualified biological agent screening: no active tuberculosis, hepatitis B, AIDS, tumor, etc; (6) Moderate to severe psoriasis vulgaris (PASI score = 12 or BSA involvement = 10%), may be accompanied by joint damage (7) Voluntarily sign the informed consent form.

Exclusion criteria

Exclusion criteria: (1) Prior to enrollment, have received treatment with other biologics and are within the 5 half lives of the biologics; (2) During screening, ALT or AST levels are greater than three times the upper limit of normal; (3) During the follow-up process, topical medications with therapeutic effects such as steroids, calcitriol, tacatine, and tazarotene were received, which affected the assessment of therapeutic efficacy; (4) During the follow-up process, other systemic treatments such as traditional Chinese medicine and phototherapy were combined; (5) Other types of psoriasis: erythrodermic psoriasis, pustular psoriasis (palmoplantar pustulosis and continuous acrodermatitis).

Design outcomes

Primary

MeasureTime frame
PASI 75;

Secondary

MeasureTime frame
PASI 90;PASI 100;

Countries

China

Contacts

Public Contactxu jinhua, han ling, Qin weiwei

Fudan University Affiliated Huashan Hospital

Xjhhsyy@163.com+86 138 1897 8539

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026