Study to Evaluate the Long-Term Safety and Efficacy of Im... | NCT05366855 | Trialant
NCT05366855
Sponsor
Vanda Pharmaceuticals
Status
Terminated
Last Update Posted
Mar 27, 2026Actual
Enrollment
42Actual
Phase
Phase 3
Conditions
Generalized Pustular Psoriasis
Interventions
Double-blind 200 mg imsidolimab
Placebo
Open-label 200 mg imsidolimab
Standard of Care (SOC)
Imsidolimab 750 mg IV/200 mg SC
Countries
United States
Australia
France
Georgia
Germany
Malaysia
Morocco
Poland
Romania
South Korea
Spain
Taiwan
Thailand
Tunisia
Turkey (Türkiye)
Protocol Section
Identification Module
NCT ID
NCT05366855
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
ANB019-302
Secondary IDs
Not provided
Brief Title
Study to Evaluate the Long-Term Safety and Efficacy of Imsidolimab (ANB019) in the Treatment of Subjects With GPP
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
Acronym
GEMINI-2
Organization
Vanda PharmaceuticalsINDUSTRY
Status Module
Record Verification Date
Mar 2026
Overall Recruitment Status or Expanded Access Status
Terminated
Last Known Status
Not provided
Delayed Posting
Not provided
Why 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.
Expanded Access Info
No
Start Date
Apr 21, 2022Actual
Primary Completion Date
Jul 12, 2024Actual
Completion Date
Jul 12, 2024Actual
First Submitted Date
Apr 25, 2022
First Submission Date that Met QC Criteria
May 5, 2022
First Posted Date
May 9, 2022Actual
Results Waived
Not provided
Results First Submitted Date
Feb 5, 2026
Results First Submitted that Met QC Criteria
Mar 6, 2026
Results First Posted Date
Mar 27, 2026Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Mar 6, 2026
Last Update Posted Date
Mar 27, 2026Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Vanda PharmaceuticalsINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief 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).
Detailed Description
This study will also evaluate the pharmacokinetic (PK) profile of imsidolimab and explore the immunogenicity of imsidolimab in subjects with GPP.
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
Measure
Description
Time Frame
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).
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:
Use of prohibited medications between the last visit of the ANB019-301 study and the Day 1 visit of the ANB019-302 study
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.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
Plan to Share IPD
No
Description
Not provided
Types
Not provided
Time Frame
Not provided
Access Criteria
Not provided
URL
Not provided
Results Section
Participant Flow Module
Pre-assignment Details
Subjects who completed the Week 4 Visit of Study ANB019-301 and had a GPPPGA score of 0 or 1 on Day 1 were randomized 1:1 to receive imsidolimab or placebo in a double-blind manner. Subjects who completed the Week 4 Visit but did not have a GPPPGA score of 0 or 1 received open-label imsidolimab. Subjects who exited the study at the Week 1 Visit (after primary endpoint assessment) or later received open-label rescue therapy.
Subjects who completed the Week 4 Visit of Study ANB019-301 and had a GPPPGA score of 0 or 1 on Day 1 were randomized 1:1 to receive imsidolimab or placebo in a double-blind manner.
Subjects who completed the Week 4 Visit but did not have a GPPPGA score of 0 or 1 received open-label imsidolimab.
Subjects who exited the study at the Week 1 Visit (after primary endpoint assessment) or later received open-label rescue therapy.
ANB019-301 Imsidolimab Need for Rescue + ANB019-302 Any Therapy
Imsidolimab 750 mg IV/200 mg SC
Drug
Intravenous loading dose followed by subcutaneous dosing
ANB019-301 Placebo Need for Rescue + ANB019-302 Imsidolimab 750 mg IV/200 mg SC
ANB019
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).
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)
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
Posted
Count of Participants
Participants
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.
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
Units
Counts
Participants
OG0008
OG0017
OG0028
OG003
Title
Denominators
Categories
Title
Measurements
OG0008
OG0016
OG0027
OG003
Secondary
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).
The modified intent-to-treat (mITT) population including all participants that were randomized (1:1) to treatment (imsidolimab or placebo) in a double-blinded manner.
Posted
Number
Percentage of subjects (%)
Week 24
ID
Title
Description
OG000
Double-blind 200 mg Imsidolimab SC
Randomized to subcutaneous 200 mg imsidolimab Q4W
OG001
Double-blind Placebo SC
Randomized to subcutaneous placebo Q4W
Units
Counts
Participants
Secondary
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).
The modified intent-to-treat (mITT) population including all participants that were randomized (1:1) to treatment (imsidolimab or placebo) in a double-blinded manner.
Posted
Median
95% Confidence Interval
Weeks
From Day 1 until termination of study
ID
Title
Description
OG000
Double-blind 200 mg Imsidolimab SC
Randomized to subcutaneous 200 mg imsidolimab Q4W
OG001
Double-blind Placebo SC
Randomized to subcutaneous placebo Q4W
Units
Counts
Participants
OG000
Secondary
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)
The modified intent-to-treat (mITT) population including all participants that were randomized (1:1) to treatment (imsidolimab or placebo) in a double-blinded manner.
Posted
Number
Percentage of subjects (%)
Week 24
ID
Title
Description
OG000
Double-blind 200 mg Imsidolimab SC
Randomized to subcutaneous 200 mg imsidolimab Q4W
OG001
Double-blind Placebo SC
Randomized to subcutaneous placebo Q4W
Units
Counts
Participants
OG000
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.
Description
No ANB019-301 placebo responders were randomized to receive imsidolimab 200 mg SC.
BG00522± NAThe standard deviation was not calculated because the study arm had only one participant.
BG00631.0± 6.48
BG00732.3± 13.78
BG00842.9± 16.57
4
BG0035
BG0040
BG0051
BG0064
BG0076
BG00832
Male
BG0002
BG0011
BG0024
BG0030
BG0040
BG0050
BG0060
BG0073
BG00810
3
BG0033
BG0040
BG0050
BG0063
BG0076
BG00823
White
Title
Measurements
BG0003
BG0014
BG0025
BG0030
BG0040
BG0051
BG0061
BG0073
BG00817
Black or African American
Title
Measurements
BG0000
BG0010
BG0020
BG0031
BG0040
BG0050
BG0060
BG0070
BG0081
Other
Title
Measurements
BG0000
BG0010
BG0020
BG0031
BG0040
BG0050
BG0060
BG0070
BG0081
1
BG0030
BG0040
BG0050
BG0062
BG0073
BG00812
Thailand
Title
Measurements
BG0001
BG0010
BG0021
BG0033
BG0040
BG0050
BG0061
BG0073
BG0089
Poland
Title
Measurements
BG0000
BG0011
BG0023
BG0030
BG0040
BG0050
BG0060
BG0071
BG0085
Morocco
Title
Measurements
BG0002
BG0010
BG0020
BG0030
BG0040
BG0051
BG0060
BG0070
BG0083
Turkey
Title
Measurements
BG0001
BG0011
BG0020
BG0030
BG0040
BG0050
BG0060
BG0071
BG0083
United States
Title
Measurements
BG0000
BG0010
BG0021
BG0031
BG0040
BG0050
BG0061
BG0070
BG0083
Taiwan
Title
Measurements
BG0001
BG0010
BG0021
BG0030
BG0040
BG0050
BG0060
BG0070
BG0082
Tunisia
Title
Measurements
BG0000
BG0011
BG0020
BG0030
BG0040
BG0050
BG0060
BG0071
BG0082
France
Title
Measurements
BG0000
BG0010
BG0020
BG0031
BG0040
BG0050
BG0060
BG0070
BG0081
Georgia
Title
Measurements
BG0000
BG0010
BG0021
BG0030
BG0040
BG0050
BG0060
BG0070
BG0081
Spain
Title
Measurements
BG0000
BG0011
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0081
5
BG0035
BG0040
BG0050
BG0063
BG0078
BG00833
Severe (4)
BG0003
BG0010
BG0023
BG0030
BG0040
BG0051
BG0061
BG0071
BG0089
5
OG0040
OG0051
OG0064
OG0079
1
OG0040
OG0051
OG0063
OG0078
OG000
8
OG0018
Title
Denominators
Categories
Title
Measurements
OG000100
OG00164.4
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
Using FCS imputation.
Rubin's method
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.
0.0440
Risk Difference (RD)
35.6
2-Sided
95
1.0
70.3
Unadjusted 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.
Superiority
8
OG0018
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)Not applicable as there were no events in the time-to-event analysis.
OG00142.3(4.1 to 64.0)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Confidence limits were computed by the Brookmeyer-Crowley method.
Log Rank
0.0018
Superiority
8
OG0018
Title
Denominators
Categories
Title
Measurements
OG000100.0(2.9 to 70.6)
OG00163.3(NA to NA)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
Using FCS imputation.
Rubin's method
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.
0.0334
Risk Difference (RD)
36.8
95
2.9
70.6
Unadjusted 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.