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TerminatedNCT05366855GEMINI-2Updated Mar 27, 2026Results posted

Study to Evaluate the Long-Term Safety and Efficacy of Imsidolimab (ANB019) in the Treatment of Subjects With GPP

A Phase 3 interventional study of Double-blind 200 mg imsidolimab and Placebo in Generalized Pustular Psoriasis, sponsored by Vanda Pharmaceuticals. Terminated at 65 sites in 15 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-27.

Sponsored by Vanda Pharmaceuticals · Phase 3, Interventional, and Treatment

Why this study was terminated
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.
Phase
Phase 3
Study type
Interventional
Enrollment
42
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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 the detailed description

This study will also evaluate the pharmacokinetic (PK) profile of imsidolimab and explore the immunogenicity of imsidolimab in subjects with GPP.

02

Conditions studied

  • Generalized Pustular Psoriasis

Browse trials for

Keywords

  • IL-36 receptor
  • Imsidolimab
  • Interleukin-36
03

In context

Psoriasis

2,028 studies on the registry are indexed under Psoriasis; 275 are open to participants now.

This study's enrollment of 42 is below the median of 75 across 1,565 interventional studies indexed under Psoriasis.

Browse Psoriasis studies →

Lead sponsor

Vanda Pharmaceuticals is the lead sponsor of 82 studies on the registry; 17 are open to participants now.

Of its 33 completed or terminated interventional studies of FDA-regulated products, 22 (67%) have results posted.

Browse Vanda Pharmaceuticals studies →

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

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • Use of prohibited medications between the last visit of the ANB019-301 study and the Day 1 visit of the ANB019-302 study
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
42 participants (actual)

Study arms

  • Experimental
    ANB019-301 Imsidolimab Responder + ANB019-302 Imsidolimab 200 mg SC

    Randomized to subcutaneous 200 mg imsidolimab Q4W

    Drug: Double-blind 200 mg imsidolimab

  • Placebo comparator
    ANB019-301 Imsidolimab Responder + ANB019-302 Placebo SC

    Randomized to subcutaneous placebo Q4W

    Other: Placebo

  • Experimental
    ANB019-301 Imsidolimab Partial Responder + ANB019-302 Imsidolimab 200 mg SC

    Open-label subcutaneous 200 mg imsidolimab Q4W

    Drug: Open-label 200 mg imsidolimab

  • Active comparator
    ANB019-301 Imsidolimab Need for Rescue + ANB019-302 Any Therapy

    Any available therapy

    Other: Standard of Care (SOC)

  • Experimental
    ANB019-301 Placebo Responder + ANB019-302 Imsidolimab 200 mg SC

    Randomized to subcutaneous 200 mg imsidolimab Q4W

    Drug: Double-blind 200 mg imsidolimab

  • Placebo comparator
    ANB019-301 Placebo Responder + ANB019-302 Placebo SC

    Randomized to subcutaneous placebo SC Q4W

    Other: Placebo

  • Experimental
    ANB019-301 Placebo Partial Responder + ANB019-302 Imsidolimab 200 mg SC

    Open-label subcutaneous 200 mg imsidolimab Q4W

    Drug: Open-label 200 mg imsidolimab

  • Experimental
    ANB019-301 Placebo Need for Rescue + ANB019-302 Imsidolimab 750 mg IV/200 mg SC

    Intravenous imsidolimab 750 mg loading dose followed by subcutaneous 200 mg imsidolimab Q4W

    Drug: Imsidolimab 750 mg IV/200 mg SC

Interventions

  • DrugDouble-blind 200 mg imsidolimab

    Double-blind subcutaneous dosing

    Also known as: ANB019

  • OtherPlacebo

    Double-blind subcutaneous dosing

  • DrugOpen-label 200 mg imsidolimab

    Open-label subcutaneous dosing

    Also known as: ANB019

  • OtherStandard of Care (SOC)

    Any available therapy

  • DrugImsidolimab 750 mg IV/200 mg SC

    Drug page: Imsidolimab

    Intravenous loading dose followed by subcutaneous dosing

    Also known as: ANB019

06

What researchers measure

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

    Time frame: Week 24

  2. 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).

    Time frame: From Day 1 until termination of study

  3. 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)

    Time frame: Week 24

07

Results

Posted Mar 27, 2026

Participant flow

Participant flow — Overall Study
MilestoneANB019-301 Imsidolimab Responder + ANB019-302 Imsidolimab 200 mg SCANB019-301 Imsidolimab Responder + ANB019-302 Placebo SCANB019-301 Imsidolimab Partial Responder + ANB019-302 Imsidolimab 200 mg SCANB019-301 Imsidolimab Need for Rescue + ANB019-302 Any TherapyANB019-301 Placebo Responder + ANB019-302 Imsidolimab 200 mg SCANB019-301 Placebo Responder + ANB019-302 Placebo SCANB019-301 Placebo Partial Responder + ANB019-302 Imsidolimab 200 mg SCANB019-301 Placebo Need for Rescue + ANB019-302 Imsidolimab 750 mg IV/200 mg SC
Started87850149
Completed00050000
Not completed87800149
Withdrew: Withdrawal by subject01100011
Withdrew: Adverse event12000110
Withdrew: Physician decision74700027
Withdrew: Protocol violation00000001

Outcome measures

PrimaryIncidence 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.
Reported as:
Count of participants · Participants
Incidence of Adverse Events
ParticipantsANB019-301 Imsidolimab Responder + ANB019-302 Imsidolimab 200 mg SCANB019-301 Imsidolimab Responder + ANB019-302 Placebo SCANB019-301 Imsidolimab Partial Responder + ANB019-302 Imsidolimab 200 mg SCANB019-301 Imsidolimab Need for Rescue + ANB019-302 Any TherapyANB019-301 Placebo Responder + ANB019-302 Imsidolimab 200 mg SCANB019-301 Placebo Responder + ANB019-302 Placebo SCANB019-301 Placebo Partial Responder + ANB019-302 Imsidolimab 200 mg SCANB019-301 Placebo Need for Rescue + ANB019-302 Imsidolimab 750 mg IV/200 mg SC
Incidence of Adverse Events86710138
SecondaryPercentage 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.

Time frame:
Week 24
Reported as:
Number · Percentage of subjects (%)
Percentage of Subjects Maintaining GPPPGA Score of 0 or 1
Percentage of subjects (%)Double-blind 200 mg Imsidolimab SCDouble-blind Placebo SC
Percentage of Subjects Maintaining GPPPGA Score of 0 or 110064.4
Statistical analysis
  • Double-blind 200 mg Imsidolimab SC · Rubin's method · p = 0.0440 · Risk difference (rd): 35.6 · 95% CI 1.0 to 70.3Unadjusted risk difference with placebo. Rubin's interval and test unless no missing data, in which case they were the exact unconditional interval and mid-p exact test for risk difference.
SecondaryKaplan-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).

Time frame:
From Day 1 until termination of study
Reported as:
Median · Weeks
Kaplan-Meier Estimate for Time to First GPP Flare Recurrence (Weeks)
WeeksDouble-blind 200 mg Imsidolimab SCDouble-blind Placebo SC
Kaplan-Meier Estimate for Time to First GPP Flare Recurrence (Weeks)NA (NA to NA)42.3 (4.1 to 64.0)
Statistical analysis
  • Double-blind 200 mg Imsidolimab SC vs Double-blind Placebo SC · Log Rank · p = 0.0018
SecondaryPercentage 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)

Time frame:
Week 24
Reported as:
Number · Percentage of subjects (%)
Percentage of Subjects With Zero Recurrence of GPP Flare
Percentage of subjects (%)Double-blind 200 mg Imsidolimab SCDouble-blind Placebo SC
Percentage of Subjects With Zero Recurrence of GPP Flare100.0 (2.9 to 70.6)63.3 (NA to NA)
Statistical analysis
  • Double-blind 200 mg Imsidolimab SC · Rubin's method · p = 0.0334 · Risk difference (rd): 36.8 · 95% CI 2.9 to 70.6Unadjusted risk difference with placebo. Rubin's interval and test unless no missing data, in which case they were the exact unconditional interval and mid-p exact test for risk difference.

Adverse events

Collected over 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.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
ANB019-301 Imsidolimab Responder + ANB019-302 Imsidolimab 200 mg SC0/8 (0%)0/8 (0%)8/8 (100%)
ANB019-301 Imsidolimab Responder + ANB019-302 Placebo SC0/7 (0%)1/7 (14.3%)6/7 (85.7%)
ANB019-301 Imsidolimab Partial Responder + ANB019-302 Imsidolimab 200 mg SC0/8 (0%)2/8 (25%)7/8 (87.5%)
ANB019-301 Imsidolimab Need for Rescue + ANB019-302 Any Therapy0/5 (0%)0/5 (0%)1/5 (20%)
ANB019-301 Placebo Responder + ANB019-302 Imsidolimab 200 mg SC———
ANB019-301 Placebo Responder + ANB019-302 Placebo SC0/1 (0%)0/1 (0%)1/1 (100%)
ANB019-301 Placebo Partial Responder + ANB019-302 Imsidolimab 200 mg SC0/4 (0%)0/4 (0%)3/4 (75%)
ANB019-301 Placebo Need for Rescue + ANB019-302 Imsidolimab 750 mg IV/200 mg SC0/9 (0%)2/9 (22.2%)8/9 (88.9%)
Most frequent serious events
Most frequent serious events
EventANB019-301 Imsidolimab Responder + ANB019-302 Imsidolimab 200 mg SCANB019-301 Imsidolimab Responder + ANB019-302 Placebo SCANB019-301 Imsidolimab Partial Responder + ANB019-302 Imsidolimab 200 mg SCANB019-301 Imsidolimab Need for Rescue + ANB019-302 Any TherapyANB019-301 Placebo Responder + ANB019-302 Imsidolimab 200 mg SCANB019-301 Placebo Responder + ANB019-302 Placebo SCANB019-301 Placebo Partial Responder + ANB019-302 Imsidolimab 200 mg SCANB019-301 Placebo Need for Rescue + ANB019-302 Imsidolimab 750 mg IV/200 mg SC
Basal Cell CarcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps)0/81/70/80/5—0/10/40/9
Nephrogenic anaemiaBlood and lymphatic system disorders0/80/71/80/5—0/10/40/9
Blood creatine phosphokinase increasedInvestigations0/80/71/80/5—0/10/40/9
Arthritis bacterialInfections and infestations0/80/70/80/5—0/10/41/9
Pustular psoriasisSkin and subcutaneous tissue disorders0/80/70/80/5—0/10/41/9
Most frequent other events
Showing 10 of 79
Most frequent other events
EventANB019-301 Imsidolimab Responder + ANB019-302 Imsidolimab 200 mg SCANB019-301 Imsidolimab Responder + ANB019-302 Placebo SCANB019-301 Imsidolimab Partial Responder + ANB019-302 Imsidolimab 200 mg SCANB019-301 Imsidolimab Need for Rescue + ANB019-302 Any TherapyANB019-301 Placebo Responder + ANB019-302 Imsidolimab 200 mg SCANB019-301 Placebo Responder + ANB019-302 Placebo SCANB019-301 Placebo Partial Responder + ANB019-302 Imsidolimab 200 mg SCANB019-301 Placebo Need for Rescue + ANB019-302 Imsidolimab 750 mg IV/200 mg SC
BronchitisInfections and infestations1/80/71/80/5—1/10/40/9
Urinary tract candidiasisInfections and infestations0/80/70/80/5—1/10/40/9
LymphopeniaBlood and lymphatic system disorders1/80/70/80/5—1/10/40/9
Diabetes mellitusMetabolism and nutrition disorders0/80/71/80/5—1/10/40/9
Adrenal insufficiencyEndocrine disorders0/80/70/80/5—1/10/41/9
Upper respiratory tract infectionInfections and infestations1/82/71/80/5—0/12/43/9
PsoriasisSkin and subcutaneous tissue disorders1/82/70/80/5—0/12/42/9
Urinary tract infectionInfections and infestations1/82/70/80/5—0/11/40/9
COVID-19Infections and infestations0/82/70/80/5—0/10/41/9
HeadacheNervous system disorders0/82/70/80/5—0/11/40/9

Baseline characteristics

No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.

Age, Continuous
Age, Continuous(Years)ANB019-301 Imsidolimab Responder + ANB019-302 Imsidolimab 200 mg SCANB019-301 Imsidolimab Responder + ANB019-302 Placebo SCANB019-301 Imsidolimab Partial Responder + ANB019-302 Imsidolimab 200 mg SCANB019-301 Imsidolimab Need for Rescue + ANB019-302 Any TherapyANB019-301 Placebo Responder + ANB019-302 Imsidolimab 200 mg SCANB019-301 Placebo Responder + ANB019-302 Placebo SCANB019-301 Placebo Partial Responder + ANB019-302 Imsidolimab 200 mg SCANB019-301 Placebo Need for Rescue + ANB019-302 Imsidolimab 750 mg IV/200 mg SCTotal
Mean45 ± 15.7152 ± 18.3654.6 ± 14.7341 ± 12.21—22 ± NA31.0 ± 6.4832.3 ± 13.7842.9 ± 16.57
Sex: Female, Male
Sex: Female, Male(Participants)ANB019-301 Imsidolimab Responder + ANB019-302 Imsidolimab 200 mg SCANB019-301 Imsidolimab Responder + ANB019-302 Placebo SCANB019-301 Imsidolimab Partial Responder + ANB019-302 Imsidolimab 200 mg SCANB019-301 Imsidolimab Need for Rescue + ANB019-302 Any TherapyANB019-301 Placebo Responder + ANB019-302 Imsidolimab 200 mg SCANB019-301 Placebo Responder + ANB019-302 Placebo SCANB019-301 Placebo Partial Responder + ANB019-302 Imsidolimab 200 mg SCANB019-301 Placebo Need for Rescue + ANB019-302 Imsidolimab 750 mg IV/200 mg SCTotal
Female6645014632
Male2140000310
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)ANB019-301 Imsidolimab Responder + ANB019-302 Imsidolimab 200 mg SCANB019-301 Imsidolimab Responder + ANB019-302 Placebo SCANB019-301 Imsidolimab Partial Responder + ANB019-302 Imsidolimab 200 mg SCANB019-301 Imsidolimab Need for Rescue + ANB019-302 Any TherapyANB019-301 Placebo Responder + ANB019-302 Imsidolimab 200 mg SCANB019-301 Placebo Responder + ANB019-302 Placebo SCANB019-301 Placebo Partial Responder + ANB019-302 Imsidolimab 200 mg SCANB019-301 Placebo Need for Rescue + ANB019-302 Imsidolimab 750 mg IV/200 mg SCTotal
Asian5333003623
White3450011317
Black or African American000100001
Other000100001
Region of Enrollment
Region of Enrollment(Participants)ANB019-301 Imsidolimab Responder + ANB019-302 Imsidolimab 200 mg SCANB019-301 Imsidolimab Responder + ANB019-302 Placebo SCANB019-301 Imsidolimab Partial Responder + ANB019-302 Imsidolimab 200 mg SCANB019-301 Imsidolimab Need for Rescue + ANB019-302 Any TherapyANB019-301 Placebo Responder + ANB019-302 Imsidolimab 200 mg SCANB019-301 Placebo Responder + ANB019-302 Placebo SCANB019-301 Placebo Partial Responder + ANB019-302 Imsidolimab 200 mg SCANB019-301 Placebo Need for Rescue + ANB019-302 Imsidolimab 750 mg IV/200 mg SCTotal
Malaysia3310002312
Thailand101300139
Poland013000015
Morocco200001003
Turkey110000013
United States001100103
Taiwan101000002
Tunisia010000012
France000100001
Georgia001000001
Spain010000001
GPPPGA Score at Baseline
GPPPGA Score at Baseline(Participants)ANB019-301 Imsidolimab Responder + ANB019-302 Imsidolimab 200 mg SCANB019-301 Imsidolimab Responder + ANB019-302 Placebo SCANB019-301 Imsidolimab Partial Responder + ANB019-302 Imsidolimab 200 mg SCANB019-301 Imsidolimab Need for Rescue + ANB019-302 Any TherapyANB019-301 Placebo Responder + ANB019-302 Imsidolimab 200 mg SCANB019-301 Placebo Responder + ANB019-302 Placebo SCANB019-301 Placebo Partial Responder + ANB019-302 Imsidolimab 200 mg SCANB019-301 Placebo Need for Rescue + ANB019-302 Imsidolimab 750 mg IV/200 mg SCTotal
Moderate (3)5755003833
Severe (4)303001119
08

Study locations

65 sites
  • Site 10-109
    Largo, Florida 33770, United States
  • Site 10-105
    Louisville, Kentucky 40217, United States
  • Site 10-101
    Ann Arbor, Michigan 48109, United States
  • Site 10-108
    Dallas, Texas 75231, United States
  • Site 10-102
    Springville, Utah 84663, United States
  • Site 35-102
    Melbourne, Victoria 3128, Australia
  • Site 16-102
    Nantes, 44093, France
  • Site 16-101
    Paris, 75010, France
  • Site 59-104
    Batumi, 6000, Georgia
  • Site 59-102
    Tbilisi, 0112, Georgia
  • Site 59-101
    Tbilisi, 0160, Georgia
  • Site 59-105
    Tbilisi, 0160, Georgia
  • Site 59-103
    Tbilisi, 0179, Georgia
  • Site 17-102
    Bad Bentheim, 48455, Germany
  • Site 17-104
    Bonn, 53127, Germany
  • Site 17-103
    Hanau, 63450, Germany
  • Site 17-105
    Würzburg, 97080, Germany
  • Site 42-106
    Johor Bahru, Johor 80100, Malaysia
  • Site 42-107
    Johor Bahru, Johor 81100, Malaysia
  • Site 42-102
    Muar town, Johor 84000, Malaysia
  • Site 42-105
    Kota Bharu, Kelantan 15586, Malaysia
  • Site 42-108
    Kuching, Sarawak 93586, Malaysia
  • Site 42-109
    Batu Caves, Selangor 59100, Malaysia
  • Site 42-101
    Kuala Lumpur, 50586, Malaysia
  • Site 42-104
    Kuala Lumpur, 56000, Malaysia
  • Site 42-110
    Kuala Lumpur, 59100, Malaysia
  • Site 42-103
    Putrajaya, 62250, Malaysia
  • Site 64-103
    Casablanca, 20360, Morocco
  • Site 64-101
    Marrakesh, 40000, Morocco
  • Site 64-102
    Oujda, 60000, Morocco
  • Site 30-104
    Krakow, 30-074, Poland
  • Site 30-105
    Lodz, 90-265, Poland
  • Site 30-103
    Ossy, 42-624, Poland
  • Site 30-101
    Rzeszów, 35-055, Poland
  • Site 30-102
    Wroclaw, 50-566, Poland
  • Site 31-102
    Bucharest, 020125, Romania
  • Site 31-101
    Cluj-Napoca, 400006, Romania
  • Site 31-103
    Iași, 700111, Romania
  • Site 45-102
    Busan, 49241, South Korea
  • Site 45-104
    Seoul, 03722, South Korea
  • Site 45-101
    Seoul, 05505, South Korea
  • Site 45-103
    Seoul, 06591, South Korea
  • Site 24-101
    Barcelona, 08036, Spain
  • Site 24-104
    Las Palmas de Gran Canaria, 35010, Spain
  • Site 24-102
    Madrid, 28040, Spain
  • Site 24-103
    Madrid, 28041, Spain
  • Site 24-105
    Valencia, 46026, Spain
  • Site 63-101
    Kaohsiung City, 83301, Taiwan
  • Site 63-103
    New Taipei City, 23561, Taiwan
  • Site 63-105
    Taipei, 100225, Taiwan
  • Site 63-104
    Taipei, 11217, Taiwan
  • Site 63-102
    Taipei, 11696, Taiwan
  • Site 46-101
    Bangkok, 10400, Thailand
  • Site 46-102
    Chiang Mai, 50200, Thailand
  • Site 46-104
    Khon Kaen, 40002, Thailand
  • Site 46-103
    Pathum Thani, 12120, Thailand
  • Site 62-101
    Sfax, 3000, Tunisia
  • Site 62-102
    Sousse, 4000, Tunisia
  • Site 62-103
    Tunis, 1007, Tunisia
  • Site 33-102
    Ankara, 06560, Turkey (Türkiye)
  • Site 33-104
    Antalya, 07070, Turkey (Türkiye)
  • Site 33-103
    Bursa, 16059, Turkey (Türkiye)
  • Site 33-105
    Istanbul, 24093, Turkey (Türkiye)
  • Site 33-106
    Istanbul, 34010, Turkey (Türkiye)
  • Site 33-101
    Kayseri, 38039, Turkey (Türkiye)
09

References and documents

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 documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Apr 2022 to primary completion in Jul 2024, 26 months.

Results were first posted in Mar 2026, 1 year 8 months after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 25, 2022
First posted
May 9, 2022
StartActual
Apr 21, 2022
Primary completionActual
Jul 12, 2024
CompletionActual
Jul 12, 2024
Results first posted
Mar 27, 2026
Last update
Mar 27, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT05366855
Lead sponsor
Vanda Pharmaceuticals
Responsible party
Sponsor
First posted
May 9, 2022
Start date
Apr 21, 2022
Primary completion
Jul 12, 2024
Completion
Jul 12, 2024
Results posted
Mar 27, 2026
Last update
Mar 27, 2026

Oversight

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

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