Efficacy and Safety of Ixekizumab in Patients with Refractory Guttate Psoriasis

NCT06374979 | Not Yet Recruiting Phase 2

• 1 other identifier: 2024-0047
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this clinical trial is to analyse efficacy and safety of ixekizumab in participants with refractory guttate psoriasis. The main question it aims to answer is: What percentage of participants achieved more than 90% reduction from baseline in Psoriasis Area Index （PASI 90） after 12 weeks of ixekizumab treatment? Participants will receive a 12-week treatment of ixekizumab, with follow-up visits every 2 weeks during the treatment period. Keep a diary of their symptoms and Psoriasis Area Index.

Conditions

Guttate Psoriasis

Outcome Measures

Primary Outcomes (1)

• PASI 90 response

  The proportion of participants achieving more than 90% reduction from baseline in Psoriasis Area Index (PASI 90) after 12 weeks of ixekizumab treatment.

  Week 16

Secondary Outcomes (3)

• PGA 0/1 response

  Week 16

• PASI 100 response

  Week 16

• Relapse

  Week 52

Study Arms (1)

Ixekizumab Group

EXPERIMENTAL

Participants will receive an initial dose of 160 mg (two injections of 80 mg) Ixekizumab subcutaneously at week 0, followed by 80 mg at weeks 2, 4, 6, 8, 10, and 12.

Biological: Ixekizumab

Interventions

Ixekizumab BIOLOGICAL

Participants will receive an initial dose of 160 mg (two injections of 80 mg) ixekizumab subcutaneously at week 0, followed by 80 mg at weeks 2, 4, 6, 8, 10, and 12.

Ixekizumab Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients voluntarily participate in the study and sign an informed consent form;
• Age between 18 and 70 years, both genders are eligible;
• Clinically diagnosed with guttate psoriasis;
• Previously treated with traditional therapies for plaque psoriasis for more than 4 weeks (including antibiotics, topical corticosteroids, topical calcipotriene, phototherapy);
• Current PASI score ≥ 3 or DLQI score ≥ 6;
• Investigator assesses participants's suitability for treatment with ixekizumab;
• No prior use of biologic agents for treatment;
• Basic understanding of the purpose of the trial, its effects, and potential adverse events, and willing to sign the informed consent form according to the principles of the Helsinki Declaration;
• Agree to receive regular treatment, follow-up, and undergo relevant examinations according to the clinical research protocol.

You may not qualify if:

• Presence of other psoriasis phenotypes such as plaque, pustular, erythrodermic, or psoriatic arthritis;
• Concomitant severe skin diseases, tumors, other systemic diseases (such as inflammatory bowel disease), or mental disorders;
• Concurrent infections such as tuberculosis, HIV, hepatitis B, hepatitis C, etc.;
• Allergy to ixekizumab;
• Received systemic corticosteroids or immunosuppressive/immunomodulatory drugs for psoriasis treatment within the previous 4 weeks (including but not limited to methotrexate, cyclosporine, acitretin, azathioprine, hydroxychloroquine, apremilast, JAK inhibitors, etc.);
• Participation in another clinical trial within the past 3 months;
• Pregnant, lactating women, or those planning to become pregnant during the trial;

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

MeSH Terms

Conditions

Guttate Psoriasis

Interventions

ixekizumab

Condition Hierarchy (Ancestors)

Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Man Xiao-Yong, Ph.D.

CONTACT

+86 13600516219; manxy@zju.edu.cn

Zhao Gao-yuan, B.A.

CONTACT

+86 18868103443; 3160105603@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2024
• First Posted: April 19, 2024
• Study Start: May 1, 2025
• Primary Completion: June 1, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: February 10, 2025

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share