Generalized Pustular PsoriasisPhase 3GEMINI-2NCT05366855
Study to Evaluate the Long-Term Safety and Efficacy of Imsidolimab (ANB019) in the Treatment of Subjects With GPP
A Phase 3 study testing Double-blind 200 mg imsidolimab, Open-label 200 mg imsidolimab and Imsidolimab 750 mg IV/200 mg SC in people with Generalized Pustular Psoriasis, run by Vanda Pharmaceuticals at 65 sites in 15 countries.
Trial summary
This is a Phase 3, long term extension study to evaluate the safety and efficacy of imsidolimab compared with placebo in adult subjects with generalized pustular psoriasis (GPP). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Generalized Pustular Psoriasis
- What is being tested?
- Double-blind 200 mg imsidolimab, Open-label 200 mg imsidolimab and Imsidolimab 750 mg IV/200 mg SC
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 65 sitesin 15 countries
- Study dates
- 21 Apr 2022to 12 Jul 2024
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject participated in the preceding placebo-controlled Phase 3 study ANB019-301 and completed at least the Week 1 visit of the ANB019-301 study without the use of rescue/prohibited medication for GPP
- Subject must be a candidate for prolonged GPP treatment according to the Investigator's judgment
Who cannot join
- Use of prohibited medications between the last visit of the ANB019-301 study and the Day 1 visit of the ANB019-302 study
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
Site 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
Bad Bentheim, 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, Long-Term Extension Study to Evaluate the Safety and Efficacy of Imsidolimab (ANB019) in the Treatment of Adult Subjects With Generalized Pustular Psoriasis
This is a Phase 3, long term extension study to evaluate the safety and efficacy of imsidolimab compared with placebo in adult subjects with generalized pustular psoriasis (GPP).
Read the detailed description
This study will also evaluate the pharmacokinetic (PK) profile of imsidolimab and explore the immunogenicity of imsidolimab in subjects with GPP.
- Conditions
- Generalized Pustular Psoriasis
- Being tested
- Double-blind 200 mg imsidolimab, Placebo, Open-label 200 mg imsidolimab, Standard of Care (SOC), Imsidolimab 750 mg IV/200 mg SC
- 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.
Double-blind 200 mg imsidolimabDrug
Also called ANB019
Double-blind subcutaneous dosing
PlaceboOther
Double-blind subcutaneous dosing
Open-label 200 mg imsidolimabDrug
Also called ANB019
Open-label subcutaneous dosing
Standard of Care (SOC)Other
Any available therapy
Imsidolimab 750 mg IV/200 mg SCDrug
Also called ANB019
Intravenous loading dose followed by subcutaneous dosing
| Study group | Role | What they receive |
|---|---|---|
| ANB019-301 Imsidolimab Responder + ANB019-302 Imsidolimab 200 mg SC | Experimental | Randomized to subcutaneous 200 mg imsidolimab Q4W Receives: Drug: Double-blind 200 mg imsidolimab |
| ANB019-301 Imsidolimab Responder + ANB019-302 Placebo SC | Placebo comparator | Randomized to subcutaneous placebo Q4W Receives: Other: Placebo |
| ANB019-301 Imsidolimab Partial Responder + ANB019-302 Imsidolimab 200 mg SC | Experimental | Open-label subcutaneous 200 mg imsidolimab Q4W Receives: Drug: Open-label 200 mg imsidolimab |
| ANB019-301 Imsidolimab Need for Rescue + ANB019-302 Any Therapy | Active comparator | Any available therapy Receives: Other: Standard of Care (SOC) |
| ANB019-301 Placebo Responder + ANB019-302 Imsidolimab 200 mg SC | Experimental | Randomized to subcutaneous 200 mg imsidolimab Q4W Receives: Drug: Double-blind 200 mg imsidolimab |
| ANB019-301 Placebo Responder + ANB019-302 Placebo SC | Placebo comparator | Randomized to subcutaneous placebo SC Q4W Receives: Other: Placebo |
| ANB019-301 Placebo Partial Responder + ANB019-302 Imsidolimab 200 mg SC | Experimental | Open-label subcutaneous 200 mg imsidolimab Q4W Receives: Drug: Open-label 200 mg imsidolimab |
| ANB019-301 Placebo Need for Rescue + ANB019-302 Imsidolimab 750 mg IV/200 mg SC | Experimental | Intravenous imsidolimab 750 mg loading dose followed by subcutaneous 200 mg imsidolimab Q4W Receives: Drug: Imsidolimab 750 mg IV/200 mg SC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events
Measured: All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
Secondary outcomes (3)
Percentage of Subjects Maintaining GPPPGA Score of 0 or 1
Percentages are calculated using FCS imputation. 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 24
Kaplan-Meier Estimate for Time to First GPP Flare Recurrence (Weeks)
GPP flare was defined by a GPPPGA ≥3 (moderate) in subjects who had previously achieved a GPPPGA score of 0 (clear) or 1 (almost clear).
Measured: From Day 1 until termination of study
Percentage of Subjects With Zero Recurrence of GPP Flare
Percentages are calculated using FCS imputation. GPP flare was defined by a GPPPGA ≥3 (moderate) in subjects who had previously achieved a GPPPGA score of 0 (clear) or 1 (almost clear)
Measured: Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2022
- Study start21 Apr 2022
- Primary completion12 Jul 2024
- Study completion12 Jul 2024
Why it stopped: AnaptysBio has concluded the GEMINI-2 trial, with all trial participants having been treated with imsidolimab for approximately six months and the furthest subject having been treated through 104 weeks.
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
- 42 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
- NCT05366855
- Sponsor's protocol ID
- ANB019-302
- Acronym
- GEMINI-2
- Status last verified
- Mar 2026
- First submitted
- 25 Apr 2022
- Last updated
- 27 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
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Long-Term Extension Study to Evaluate the Safety and Efficacy of Imsidolimab (ANB019) in the Treatment of Adult Subjects With Generalized Pustular Psoriasis
- ClinicalTrials.gov ID
- NCT05366855
- Acronym / sponsor ID
- GEMINI-2 / ANB019-302
- Conditions
- Generalized Pustular Psoriasis
- Keywords
- IL-36 receptor, Imsidolimab, Interleukin-36
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: AnaptysBio has concluded the GEMINI-2 trial, with all trial participants having been treated with imsidolimab for approximately six months and the furthest subject having been treated through 104 weeks.
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Vanda PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 21 Apr 2022 (actual)
- Primary completion
- 12 Jul 2024 (actual)
- Study completion
- 12 Jul 2024 (actual)
- First posted
- 9 May 2022 (actual)
- Results
- Posted 27 Mar 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase 3, long term extension study to evaluate the safety and efficacy of imsidolimab compared with placebo in adult subjects with generalized pustular psoriasis (GPP).
Detailed description
This study will also evaluate the pharmacokinetic (PK) profile of imsidolimab and explore the immunogenicity of imsidolimab in subjects with GPP.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| ANB019-301 Imsidolimab Responder + ANB019-302 Imsidolimab 200 mg SC | Experimental | Drug: Double-blind 200 mg imsidolimabRandomized to subcutaneous 200 mg imsidolimab Q4W |
| ANB019-301 Imsidolimab Responder + ANB019-302 Placebo SC | Placebo comparator | Other: PlaceboRandomized to subcutaneous placebo Q4W |
| ANB019-301 Imsidolimab Partial Responder + ANB019-302 Imsidolimab 200 mg SC | Experimental | Drug: Open-label 200 mg imsidolimabOpen-label subcutaneous 200 mg imsidolimab Q4W |
| ANB019-301 Imsidolimab Need for Rescue + ANB019-302 Any Therapy | Active comparator | Other: Standard of Care (SOC)Any available therapy |
| ANB019-301 Placebo Responder + ANB019-302 Imsidolimab 200 mg SC | Experimental | Drug: Double-blind 200 mg imsidolimabRandomized to subcutaneous 200 mg imsidolimab Q4W |
| ANB019-301 Placebo Responder + ANB019-302 Placebo SC | Placebo comparator | Other: PlaceboRandomized to subcutaneous placebo SC Q4W |
| ANB019-301 Placebo Partial Responder + ANB019-302 Imsidolimab 200 mg SC | Experimental | Drug: Open-label 200 mg imsidolimabOpen-label subcutaneous 200 mg imsidolimab Q4W |
| ANB019-301 Placebo Need for Rescue + ANB019-302 Imsidolimab 750 mg IV/200 mg SC | Experimental | Drug: Imsidolimab 750 mg IV/200 mg SCIntravenous imsidolimab 750 mg loading dose followed by subcutaneous 200 mg imsidolimab Q4W |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subject participated in the preceding placebo-controlled Phase 3 study ANB019-301 and completed at least the Week 1 visit of the ANB019-301 study without the use of rescue/prohibited medication for GPP
- Subject must be a candidate for prolonged GPP treatment according to the Investigator's judgment
Key exclusion criteria (1 listed)
- Use of prohibited medications between the last visit of the ANB019-301 study and the Day 1 visit of the ANB019-302 study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Double-blind 200 mg imsidolimabAlso: ANB019Double-blind subcutaneous dosing | Drug | ANB019-301 Imsidolimab Responder + ANB019-302 Imsidolimab 200 mg SC, ANB019-301 Placebo Responder + ANB019-302 Imsidolimab 200 mg SC |
| PlaceboDouble-blind subcutaneous dosing | Other | ANB019-301 Imsidolimab Responder + ANB019-302 Placebo SC, ANB019-301 Placebo Responder + ANB019-302 Placebo SC |
| Open-label 200 mg imsidolimabAlso: ANB019Open-label subcutaneous dosing | Drug | ANB019-301 Imsidolimab Partial Responder + ANB019-302 Imsidolimab 200 mg SC, ANB019-301 Placebo Partial Responder + ANB019-302 Imsidolimab 200 mg SC |
| Standard of Care (SOC)Any available therapy | Other | ANB019-301 Imsidolimab Need for Rescue + ANB019-302 Any Therapy |
| Imsidolimab 750 mg IV/200 mg SCAlso: ANB019Intravenous loading dose followed by subcutaneous dosing | Drug | ANB019-301 Placebo Need for Rescue + ANB019-302 Imsidolimab 750 mg IV/200 mg SC |
Primary outcome
Incidence of Adverse Events
Time frame: All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
3 secondary outcomes
Percentage of Subjects Maintaining GPPPGA Score of 0 or 1
Time frame: Week 24
Kaplan-Meier Estimate for Time to First GPP Flare Recurrence (Weeks)
Time frame: From Day 1 until termination of study
Percentage of Subjects With Zero Recurrence of GPP Flare
Time frame: Week 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42047557Smieszek 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
65 sites in 15 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Double-blind 200 mg imsidolimab, Open-label 200 mg imsidolimab and Imsidolimab 750 mg IV/200 mg SC in people with Generalized Pustular Psoriasis, run by Vanda Pharmaceuticals at 65 sites in 15 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 2 inclusion and 1 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: stopped early, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 65 sites in Malaysia, Turkey (Türkiye), United States, Georgia, Poland and 10 more countries. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 27 Mar 2026). 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?
Incidence of Adverse Events (time frame: All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.). 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 NCT05366855, which also lists 1 linked publication.
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 27 Mar 2026.