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Generalized Pustular PsoriasisPhase 2GPPNCT03619902

A Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in Adults With Generalized Pustular Psoriasis

A Phase 2 study testing Imsidolimab in people with Generalized Pustular Psoriasis, run by Vanda Pharmaceuticals at 13 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The main objectives of this study are to evaluate the efficacy, safety and tolerability of imsidolimab in adults with active GPP. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Generalized Pustular Psoriasis
What is being tested?
Imsidolimab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
8 participants
Where
13 sitesin 4 countries
Study dates
30 Jan 2019to 20 Jan 2021
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosis of active GPP
  • Japanese Dermatology Association (JDA) severity index total score of at least 6 and erythema with pustules accounting for at least 10% of body surface area or a moderate severity score on Generalized Pustular Psoriasis Physician's Global Assessment (GPPPGA)
  • Must be candidates for systemic therapy or phototherapy

Who cannot join

  • Erythrodermic, guttate psoriasis, drug induced GPP
  • Any other ongoing inflammatory disease that interfere with the Investigator's ability to evaluate the subject's response to therapy
  • History of recurrent or chronic infection
  • ongoing use of psoriasis prohibited medication
  • Other protocol-defined inclusion/exclusion criteria may apply

Trial locations and contacts

13 sites in 4 countries.

13 sites in 4 countries

United States5 sites

  • Site 100

    Ann Arbor, Michigan, 48109

  • Site 102

    Encino, California, 91436

  • Site 101

    Indianapolis, Indiana, 46250

  • Site 105

    Largo, Florida, 33771

  • Site 104

    Miami, Florida, 33316

Other trials in United States

Poland4 sites

  • Site 303

    Lodz, 90-436

  • Site 302

    Lodz

  • Site 304

    Olsztyn, 10-229

  • Site 301

    Rzeszów, 35-055

Other trials in Poland

United Kingdom3 sites

  • Site 201

    London

  • Site 203

    Newcastle upon Tyne

  • Site 202

    Salford

Other trials in United Kingdom

South Korea1 site

  • Site 501

    Seoul, 03722

Other trials in South Korea

About this study

Official title: A Single Arm Multiple Dose Study to Assess the Efficacy and Safety of ANB019 in Subjects With Generalized Pustular Psoriasis

The main objectives of this study are to evaluate the efficacy, safety and tolerability of imsidolimab in adults with active GPP.

Read the detailed description

Single arm, multiple-dose study evaluating the use of imsidolimab for the treatment of GPP.

Being tested
Imsidolimab
Keywords
GPP
Medical subject headings
Psoriasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ImsidolimabBiological

    Also called ANB019

    Humanized monoclonal antibody

Study groups in NCT03619902
Study groupRoleWhat they receive
ImsidolimabExperimentalParticipants received imsidolimab 750 mg intravenously (IV) on Day 1 followed by administration of 3 doses of subcutaneous (SC) imsidolimab 100 mg on Days 29, 57, and 85.
Receives: Biological: Imsidolimab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants Achieving Clinical Response on the Clinical Global Impression (CGI) Scale

    Clinical response was defined as "Very much improved," "Much Improved," or "Minimally Improved" on the CGI scale according to the Modified Japanese Dermatological Association Severity Index (JDA-SI) total score.

    The JDA-SI includes assessment of skin lesions (area of erythema with pustules, area of erythema total, and area of edema) and fever, white blood cell count, C-reactive protein and serum albumin levels. The total score ranges from 0 to 17 (severe).

    CGI was assessed based on the JDA-SI according to the following:

    • Very Much Improved: Reduction in JDA-SI total score by 3 or > points;
    • Much improved: Reduction in JDA-SI total score by 1 or 2 points;
    • Minimally improved: No change in JDA-SI total score and area of erythema with pustules reduced by <20% or clinically meaningful improvement in at least 1 other component of the modified JDA-SI.

    Measured: Week 4 and Week 16

  2. Percent Change From Baseline in Body Surface Area of Erythema With Pustules at Week 1, Week 4, and Week 16

    Excluding palms and soles from 0% to 100%. The palmar surface of one hand (using the subject's hand and including the fingers) represents 1% of his or her total BSA.

    Measured: Baseline, Week 1, Week 4, and Week 16

Secondary outcomes (3)

  1. Percent Change From Baseline in Modified Japanese Dermatological Association - Severity Index (mJDA-SI) Total Skin Lesions Score at Week 1, Week 4, and Week 16

    The area of erythema with pustules, area of total erythema and area of edema were assessed by the Investigator and scored from 0 to 3 on the following scale:

    • 0: 0% body surface area (BSA) affected;
    • 1: > 0%, < 10% BSA affected;
    • 2: ≥ 10%, < 50% BSA affected;
    • 3: ≥ 50% BSA affected.

    The JDA-SI Total Skin Lesions Score is the sum of the area of erythema with pustules score, area of total erythema score and area of edema score and ranges between 0 and 9 (worst). A negative change from Baseline indicates improvement.

    Measured: Baseline, Week 1, Week 4, and Week 16

  2. Percentage of Participants Achieving a Generalized Pustular Psoriasis Physician's Global Assessment (GPPPGA) Score of 0 or 1 at Week 1, Week 4, and Week 16

    The GPPPGA scale was used to assess the impact and severity of GPP on the following scale:

    • 0: Clear (normal skin or post-inflammatory hyperpigmentation, no visible pustules, no scaling or crusting).
    • 1: Almost clear (faint, diffuse pink or slight red erythema, low density occasional small discrete pustules (noncoalescent), superficial focal scaling or crusting restricted to periphery of lesions).
    • 2: Mild (light red erythema, moderate density grouped discrete small pustules (noncoalescent), predominantly fine scaling or crusting).
    • 3: Moderate (bright red erythema, high density pustules with some coalescence, moderate scaling or crusting covering most or all lesions).
    • 4: Severe (deep fiery red erythema, very high density pustules with pustular lakes, severe scaling or crusting covering most or all lesions).

    Measured: Week 1, Week 4, and Week 16

  3. Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 1, Week 4, and Week 16

    The DLQI is a 10-item questionnaire that asks participants to evaluate the degree that their skin problem has affected their quality of life in the last week in the following 6 aspects: symptoms and feelings, daily activities, leisure, work or school activities, personal relationships and treatment related feelings. Participants answer the 10 questions on a scale from 0 (not at all) to 3 (very much). The DLQI is calculated by summing the scores of the 10 questions, resulting in a maximum of 30 and a minimum of 0 with higher scores indicating more impaired quality of life. A negative change from Baseline indicates improvement.

    Measured: Baseline and Week 1, Week 4, and Week 16

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Aug 2018
  2. Study start30 Jan 2019
  3. Primary completion20 Jan 2021
  4. Study completion20 Jan 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03619902
Sponsor's protocol ID
ANB019-002
Other IDs
2017-004021-33, 2017
Acronym
GPP
Status last verified
Mar 2022
First submitted
19 Jul 2018
Last updated
16 Sep 2025
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Imsidolimab in people with Generalized Pustular Psoriasis, run by Vanda Pharmaceuticals at 13 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in United States, Poland, United Kingdom, South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Mar 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Achieving Clinical Response on the Clinical Global Impression (CGI) Scale (time frame: Week 4 and Week 16). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03619902.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2025.

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