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Not yet recruitingNCT06374979Updated Feb 10, 2025

Efficacy and Safety of Ixekizumab in Patients with Refractory Guttate Psoriasis

A Phase 2/3 interventional study of Ixekizumab in Guttate Psoriasis, sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. Not yet recruiting. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-02-10.

Sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University · Phase 2/3, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jun 2025, 1 year 4 months ago, but the record still lists the study as not yet recruiting.
Phase
Phase 2/3
Study type
Interventional
Enrollment
50
Allocation
Not applicable
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

Read the detailed description

This study was a single-arm, open-label, single-center multi-dose trial. Approximately 50 participants are scheduled to receive subcutaneous injection of ixekizumab for 12 weeks, with follow-up every 2 weeks during the treatment period. After the treatment period, the primary endpoint was assessed at week 16, and patients who achieved PASI 90 response were followed up at week 34 and week 52 to the medical center to assess disease recurrence or progression. To evaluate the efficacy of ixekizumab in the treatment of refractory guttate psoriasis.

02

Conditions studied

  • Guttate Psoriasis

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03

In context

Psoriasis

1,899 studies on the registry are indexed under Psoriasis; 233 are open to participants now.

This study's planned enrollment of 50 is below the median of 70 across 1,447 interventional studies indexed under Psoriasis.

Browse Psoriasis studies →

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University is the lead sponsor of 1,058 studies on the registry; 511 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Patients voluntarily participate in the study and sign an informed consent form;
  2. Age between 18 and 70 years, both genders are eligible;
  3. Clinically diagnosed with guttate psoriasis;
  4. Previously treated with traditional therapies for plaque psoriasis for more than 4 weeks (including antibiotics, topical corticosteroids, topical calcipotriene, phototherapy);
  5. Current PASI score ≥ 3 or DLQI score ≥ 6;
  6. Investigator assesses participants's suitability for treatment with ixekizumab;
  7. No prior use of biologic agents for treatment;
  8. 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;
  9. Agree to receive regular treatment, follow-up, and undergo relevant examinations according to the clinical research protocol.

Exclusion criteria

Exclusion Criteria:

  1. Presence of other psoriasis phenotypes such as plaque, pustular, erythrodermic, or psoriatic arthritis;
  2. Concomitant severe skin diseases, tumors, other systemic diseases (such as inflammatory bowel disease), or mental disorders;
  3. Concurrent infections such as tuberculosis, HIV, hepatitis B, hepatitis C, etc.;
  4. Allergy to ixekizumab;
  5. 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.);
  6. Participation in another clinical trial within the past 3 months;
  7. Pregnant, lactating women, or those planning to become pregnant during the trial;
  8. Other circumstances deemed inappropriate for inclusion by the investigator.
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    Ixekizumab Group

    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

  • BiologicalIxekizumab

    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.

06

What researchers measure

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.

    Time frame: Week 16

Secondary outcomes

  1. PGA 0/1 response

    The proportion of participants with PGA score 0 or 1 after 12 weeks of treatment.

    Time frame: Week 16

  2. PASI 100 response

    The proportion of participants achieving PASI 100 after 12 weeks of treatment.

    Time frame: Week 16

  3. Relapse

    Among the participants who reached PASI 90 after 12 weeks of treatment, the proportion of participants who relapsed within 52 weeks after withdrawal.

    Time frame: Week 52

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 10, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06374979
Lead sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Responsible party
Sponsor
First posted
Apr 19, 2024
Start date
May 2025 (estimated)
Primary completion
Jun 2025 (estimated)
Completion
Jun 2026 (estimated)
Last update
Feb 10, 2025

Study contacts

Man Xiao-Yong, Ph.D.
Contact
manxy@zju.edu.cn
+86 13600516219
Zhao Gao-yuan, B.A.
Contact
3160105603@zju.edu.cn
+86 18868103443

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.

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