Generalized Pustular PsoriasisPhase 3GEMINI-1NCT05352893
Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in the Treatment of Subjects With GPP
A Phase 3 study testing 750 mg Imsidolimab and 300 mg Imsidolimab in people with Generalized Pustular Psoriasis, run by Vanda Pharmaceuticals at 65 sites in 15 countries.
Trial summary
This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of imsidolimab compared with placebo in adult subjects with generalized pustular psoriasis (GPP). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Generalized Pustular Psoriasis
- What is being tested?
- 750 mg Imsidolimab and 300 mg Imsidolimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 65 sitesin 15 countries
- Study dates
- 14 Apr 2022to 17 Aug 2023
- Phase
- Phase 3
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject has a BSA affected with pustules (excluding palms and soles) ≥ 5%, a GPPPGA score ≥ 3 (moderate severity), and a PRS score ≥ 3 (moderate severity) at Day 1
Who cannot join
- Subject has other form of psoriasis excluding psoriasis vulgaris
- Subject flare is so severe that patient's life is at risk
Trial locations and contacts
65 sites in 15 countries.
65 sites in 15 countries
Malaysia10 sites
Site 42-109
Batu Caves, Selangor, 59100
Site 42-106
Johor Bahru, Johor, 80100
Site 42-107
Johor Bahru, Johor, 81100
Site 42-105
Kota Bharu, Kelantan, 15586
Site 42-101
Kuala Lumpur, 50586
Site 42-104
Kuala Lumpur, 56000
Site 42-110
Kuala Lumpur, 59100
Site 42-108
Kuching, Sarawak, 93586
Site 42-102
Muar town, Johor, 84000
Site 42-103
Putrajaya, 62250
Turkey (Türkiye)6 sites
Site 33-102
Ankara, 06560
Site 33-104
Antalya, 07070
Site 33-103
Bursa, 16059
Site 33-105
Istanbul, 24093
Site 33-106
Istanbul, 34010
Site 33-101
Kayseri, 38039
United States5 sites
Site 10-101
Ann Arbor, Michigan, 48109
Site 10-108
Dallas, Texas, 75231
Site 10-109
Largo, Florida, 33770
Site 10-105
Louisville, Kentucky, 40217
Site 10-102
Springville, Utah, 84663
Georgia5 sites
Site 59-104
Batumi, 6000
Site 59-102
Tbilisi, 0112
Site 59-101
Tbilisi, 0160
Site 59-105
Tbilisi, 0160
Site 59-103
Tbilisi, 0179
Poland5 sites
Site 30-104
Krakow, 30-074
Site 30-105
Lodz, 90-265
Site 30-103
Ossy, 42-624
Site 30-101
Rzeszów, 35-055
Site 30-102
Wroclaw, 50-566
Spain5 sites
Site 24-101
Barcelona, 08036
Site 24-104
Las Palmas de Gran Canaria, 35010
Site 24-102
Madrid, 28040
Site 24-103
Madrid, 28041
Sie 24-105
Valencia, 46026
Taiwan5 sites
Site 63-101
Kaohsiung City, 83301
Site 63-103
New Taipei City, 23561
Site 63-105
Taipei, 100225
Site 63-104
Taipei, 11217
Site 63-102
Taipei, 11696
Germany4 sites
Site 17-102
Bensheim, 48455
Site 17-104
Bonn, 53127
Site 17-103
Hanau, 63450
Site 17-105
Würzburg, 97080
South Korea4 sites
Site 45-102
Busan, 49241
Site 45-104
Seoul, 03722
Site 45-101
Seoul, 05505
Site 45-103
Seoul, 06591
Thailand4 sites
Site 46-101
Bangkok, 10400
Site 46-102
Chiang Mai, 50200
Site 46-104
Khon Kaen, 40002
Site 46-103
Pathum Thani, 12120
Morocco3 sites
Site 64-103
Casablanca, 20360
Site 64-101
Marrakesh, 40000
Site 64-102
Oujda, 60000
Romania3 sites
Site 31-102
Bucharest, 020125
Site 31-101
Cluj-Napoca, 400006
Site 31-103
Iași, 700111
Tunisia3 sites
Site 62-101
Sfax, 3000
Site 62-102
Sousse, 4000
Site 62-103
Tunis, 1007
About this study
Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in the Treatment of Adult Subjects With Generalized Pustular Psoriasis
This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of imsidolimab compared with placebo in adult subjects with generalized pustular psoriasis (GPP).
Read the detailed description
This study will also characterize the pharmacokinetic (PK) profile of imsidolimab and explore the immunogenicity of imsidolimab in subjects with GPP.
- Conditions
- Generalized Pustular Psoriasis
- Being tested
- 750 mg Imsidolimab, 300 mg Imsidolimab, Placebo
- Keywords
- IL-36 Receptor, Imsidolimab, Interleukin-36
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
750 mg ImsidolimabDrug
Also called ANB019
Intravenous
300 mg ImsidolimabDrug
Also called ANB019
Intravenous
PlaceboOther
Intravenous
| Study group | Role | What they receive |
|---|---|---|
| 750 mg Imsidolimab | Experimental | Not described Receives: Drug: 750 mg Imsidolimab |
| 300 mg Imsidolimab | Experimental | Not described Receives: Drug: 300 mg Imsidolimab |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Patients Achieving a GPPPGA Score of 0 (Clear) or 1 (Almost Clear)
The Generalized Pustular Psoriasis Physician's Global Assessment (GPPPGA) is a physician-based assessment of the overall disease severity of GPP at the time of evaluation (specifically pustules, erythema, and scaling/crusting of pustular psoriasis lesions). The GPPPGA is graded on a 5-point scale, ranging from 0 (clear) to 4 (severe).
GPPPGA Scale: 0 = Clear, 1 = Almost clear, 2 = Mild, 3 = Moderate, 4 = Severe.
Measured: Week 4
Secondary outcomes (1)
Percentage of Patients Achieving a PRS Score of 0 (Clear) or 1 (Almost Clear)
The Pustulation Rating Scale (PRS) is is a physician-based assessment of the severity of GPP pustulation. Pustulation is graded on a 5-point scale, ranging from 0 (clear) to 4 (severe).
PRS Scale: 0 = Clear, 1 = Almost Clear, 2 = Mild, 3 = Moderate, 4 = Severe.
Measured: Week 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2022
- Study start14 Apr 2022
- Primary completion17 Aug 2023
- Study completion17 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Generalized Pustular PsoriasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanda Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05352893
- Sponsor's protocol ID
- ANB019-301
- Acronym
- GEMINI-1
- Status last verified
- Feb 2026
- First submitted
- 25 Apr 2022
- Last updated
- 17 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Smieszek S, Przychodzen B, Tyner C, Johnson C, Bushman M, Brzezynski J, Reich A, Bachelez H, Yap EWY, Borlu M, Chaowattanapanit S, Denguezli M, Gudjonsson JE, Lizzul P, Dahl M, Parmley S, Randazzo B, Severtson A, Raina P, Saikali K, Xiao C, Polymeropoulos C, Birznieks G, Polymeropoulos M. Efficacy and Safety of Imsidolimab for Generalized Pustular Psoriasis. NEJM Evid. 2026 May;5(5):EVIDoa2500272. doi: 10.1056/EVIDoa2500272. Epub 2026 Apr 28.
PubMed 42047557