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Study to Assess the Efficacy, Safety and Tolerability of Secukinumab in Japanese Subjects With Generalized Pustular Psoriasis (GPP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01952015
Recruitment Status : Completed
First Posted : September 27, 2013
Results First Posted : March 15, 2019
Last Update Posted : March 15, 2019
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Psoriasis
Intervention Biological: Secukinumab
Enrollment 12
Recruitment Details  
Pre-assignment Details A total of 15 patients were screened, and 12 patients entered the induction period. The reason for all screen failures was patient/guardian decisions
Arm/Group Title AIN457
Hide Arm/Group Description

All subjects were assigned to receive 150 mg secukinumab (AIN457) by subcutaneous injections. AIN457 was administered at baseline, weeks 1, 2, 3, 4. Prior to receiving the week 8 dose, all subjects were assigned to the following treatment group based on clinical components of their Clinical Global Impression (CGI) evaluation at week 8.

  • “No up-titration” group received 1 injection of 150 mg AIN457 at weeks 8, 12, and each visit from week 16 until week 48.
  • “Up-titration” group received 2 injections of 150 mg AIN457 at weeks 8, 9, 12 and each visit from week 16 until week 48.

Subjects who received 150 mg AIN457 can be up-titrated to 300 mg AIN 457 at any visit starting at week 16 based on clinical components of their CGI evaluation and investigator’s discretion.

Period Title: Induction
Started 12
Completed 11
Not Completed 1
Reason Not Completed
Protocol Violation             1
Period Title: Maintenance
Started 11
Completed 9
Not Completed 2
Reason Not Completed
Adverse Event             2
Period Title: Treatment Period 3
Started 9
Completed 0
Not Completed 9
Reason Not Completed
Physician Decision             9
Arm/Group Title AIN457
Hide Arm/Group Description

All subjects were assigned to receive 150 mg secukinumab (AIN457) by subcutaneous injections. AIN457 was administered at baseline, weeks 1, 2, 3, 4. Prior to receiving the week 8 dose, all subjects were assigned to the following treatment group based on clinical components of their Clinical Global Impression (CGI) evaluation at week 8.

  • “No up-titration” group received 1 injection of 150 mg AIN457 at weeks 8, 12, and each visit from week 16 until week 48.
  • “Up-titration” group received 2 injections of 150 mg AIN457 at weeks 8, 9, 12 and each visit from week 16 until week 48.

Subjects who received 150 mg AIN457 can be up-titrated to 300 mg AIN 457 at any visit starting at week 16 based on clinical components of their CGI evaluation and investigator’s discretion.

Overall Number of Baseline Participants 12
Hide Baseline Analysis Population Description
Safety set: The safety set included all patients who took at least one dose of study treatment during the treatment period.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 12 participants
56.3  (15.33)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
Female
4
  33.3%
Male
8
  66.7%
1.Primary Outcome
Title Number of Patients With Treatment Success at Week 16 Using Non-responder Imputation (Full Analysis Set)
Hide Description

Treatment success was defined as "Minimally improved", "Much improved" or "Very much improved" in Clinical global impression (CGI).

Non-responder imputation assigns a value of nonresponse to missing data points, any patient who drops out is assumed to be a non-responder.

Time Frame 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS): The FAS was comprised of all patients who entered into the induction period.
Arm/Group Title AIN457
Hide Arm/Group Description:

All subjects were assigned to receive 150 mg secukinumab (AIN457) by subcutaneous injections. AIN457 was administered at baseline, weeks 1, 2, 3, 4. Prior to receiving the week 8 dose, all subjects were assigned to the following treatment group based on clinical components of their Clinical Global Impression (CGI) evaluation at week 8.

  • “No up-titration” group received 1 injection of 150 mg AIN457 at weeks 8, 12, and each visit from week 16 until week 48.
  • “Up-titration” group received 2 injections of 150 mg AIN457 at weeks 8, 9, 12 and each visit from week 16 until week 48.

Subjects who received 150 mg AIN457 can be up-titrated to 300 mg AIN 457 at any visit starting at week 16 based on clinical components of their CGI evaluation and investigator’s discretion.

Overall Number of Participants Analyzed 12
Measure Type: Number
Unit of Measure: Participants
Treatment success - Yes 10
Treatment success - No 2
Very much improved 9
Much improved 1
Minimally improved 0
No change 1
Worse 0
Missing 1
2.Secondary Outcome
Title Number of Patients With Treatment Success at Week 52 Using Non-responder Imputation (Full Analysis Set)
Hide Description

Ten patients showed treatment success at week 52 with clinical global impression (CGI) evaluated as "very much improved", "much improved", "minimally improved".

Two patients did not achieve treatment success at week 52 with CGI evaluated as "missing" and both were imputed as "no treatment success".

Time Frame 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS): The FAS was comprised of all patients who entered into the induction period.
Arm/Group Title AIN457
Hide Arm/Group Description:

All subjects were assigned to receive 150 mg secukinumab (AIN457) by subcutaneous injections. AIN457 was administered at baseline, weeks 1, 2, 3, 4. Prior to receiving the week 8 dose, all subjects were assigned to the following treatment group based on clinical components of their Clinical Global Impression (CGI) evaluation at week 8.

  • “No up-titration” group received 1 injection of 150 mg AIN457 at weeks 8, 12, and each visit from week 16 until week 48.
  • “Up-titration” group received 2 injections of 150 mg AIN457 at weeks 8, 9, 12 and each visit from week 16 until week 48.

Subjects who received 150 mg AIN457 can be up-titrated to 300 mg AIN 457 at any visit starting at week 16 based on clinical components of their CGI evaluation and investigator’s discretion.

Overall Number of Participants Analyzed 12
Measure Type: Number
Unit of Measure: Participants
Treatment success - Yes 10
Treatment success - No 2
CGI - very much improved 7
CGI - much improved 2
CGI - minimally improved 1
CGI - No change 0
CGI - worse 2
3.Secondary Outcome
Title Number of Patients With Treatment Success at End of Trial Using Non-responder Imputation (Full Analysis Set)
Hide Description Clinical global impression (CGI) evaluated as "very much improved", "much improved", "Minimally improved".
Time Frame week 148
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS): The FAS was comprised of all patients who entered into the induction period.
Arm/Group Title AIN457
Hide Arm/Group Description:

All subjects were assigned to receive 150 mg secukinumab (AIN457) by subcutaneous injections. AIN457 was administered at baseline, weeks 1, 2, 3, 4. Prior to receiving the week 8 dose, all subjects were assigned to the following treatment group based on clinical components of their Clinical Global Impression (CGI) evaluation at week 8.

  • “No up-titration” group received 1 injection of 150 mg AIN457 at weeks 8, 12, and each visit from week 16 until week 48.
  • “Up-titration” group received 2 injections of 150 mg AIN457 at weeks 8, 9, 12 and each visit from week 16 until week 48.

Subjects who received 150 mg AIN457 can be up-titrated to 300 mg AIN 457 at any visit starting at week 16 based on clinical components of their CGI evaluation and investigator’s discretion.

Overall Number of Participants Analyzed 12
Measure Type: Number
Unit of Measure: Participants
Very much improved Number Analyzed 9 participants
8
Much improved Number Analyzed 9 participants
1
Minimally improved Number Analyzed 9 participants
0
No change Number Analyzed 9 participants
0
Worse Number Analyzed 9 participants
0
Missing Number Analyzed 9 participants
0
4.Secondary Outcome
Title Summary of Clinical Global Impression up to End of Trial
Hide Description

Clinical Global Impression (CGI) has five categories: Very much improved, much improved, minimally improved, no change and worsened.

Two patients did not achieve treatment success at week 52 with CGI evaluated as missing and both were imputed as "no treatment success".

Time Frame up to week 148 (End of Trial)
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS): The FAS was comprised of all patients who entered into the induction period.
Arm/Group Title Very Much Improved Much Improved Minimally Improved No Change Worse Missing
Hide Arm/Group Description:

All subjects were assigned to receive 150 mg secukinumab (AIN457) by subcutaneous injections.

Clinical global impression (CGI) was evaluated as very much improved, much improved, minimally improved, no change, worse, and missing.

All subjects were assigned to receive 150 mg secukinumab (AIN457) by subcutaneous injections.

Clinical global impression (CGI) was evaluated as very much improved, much improved, minimally improved, no change, worse, and missing.

All subjects were assigned to receive 150 mg secukinumab (AIN457) by subcutaneous injections.

Clinical global impression (CGI) was evaluated as very much improved, much improved, minimally improved, no change, worse, and missing.

All subjects were assigned to receive 150 mg secukinumab (AIN457) by subcutaneous injections.

Clinical global impression (CGI) was evaluated as very much improved, much improved, minimally improved, no change, worse, and missing.

All subjects were assigned to receive 150 mg secukinumab (AIN457) by subcutaneous injections.

Clinical global impression (CGI) was evaluated as very much improved, much improved, minimally improved, no change, worse, and missing.

All subjects were assigned to receive 150 mg secukinumab (AIN457) by subcutaneous injections.

Clinical global impression (CGI) was evaluated as very much improved, much improved, minimally improved, no change, worse, and missing.

Overall Number of Participants Analyzed 12 12 12 12 12 12
Measure Type: Number
Unit of Measure: Participants
Week 1 Number Analyzed 11 participants 11 participants 11 participants 11 participants 11 participants 11 participants
4 5 1 1 0 0
Week 2 Number Analyzed 11 participants 11 participants 11 participants 11 participants 11 participants 11 participants
7 4 0 0 0 0
Week 3 Number Analyzed 11 participants 11 participants 11 participants 11 participants 11 participants 11 participants
10 1 0 0 0 0
Week 4 Number Analyzed 12 participants 12 participants 12 participants 12 participants 12 participants 12 participants
10 2 0 0 0 0
Week 8 Number Analyzed 12 participants 12 participants 12 participants 12 participants 12 participants 12 participants
9 2 0 1 0 0
Week 16 Number Analyzed 11 participants 11 participants 11 participants 11 participants 11 participants 11 participants
9 1 0 1 0 0
Week 24 Number Analyzed 11 participants 11 participants 11 participants 11 participants 11 participants 11 participants
8 1 1 0 1 0
Week 36 Number Analyzed 11 participants 11 participants 11 participants 11 participants 11 participants 11 participants
7 3 0 1 0 0
Week 52 Number Analyzed 10 participants 10 participants 10 participants 10 participants 10 participants 10 participants
7 2 1 0 0 0
Week 64 Number Analyzed 9 participants 9 participants 9 participants 9 participants 9 participants 9 participants
8 1 0 0 0 0
Week 80 Number Analyzed 9 participants 9 participants 9 participants 9 participants 9 participants 9 participants
7 2 0 0 0 0
Week 96 Number Analyzed 9 participants 9 participants 9 participants 9 participants 9 participants 9 participants
8 1 0 0 0 0
Week 112 Number Analyzed 5 participants 5 participants 5 participants 5 participants 5 participants 5 participants
4 1 0 0 0 0
Week 128 Number Analyzed 2 participants 2 participants 2 participants 2 participants 2 participants 2 participants
2 0 0 0 0 0
Week 140 Number Analyzed 9 participants 9 participants 9 participants 9 participants 9 participants 9 participants
8 1 0 0 0 0
5.Secondary Outcome
Title Summary of JDA Total Score Category for GPP by Visit up to End of Trial
Hide Description Japanese dermatological association (JDA) severity index for generalized pustular psoriasis (GPP) included 3 categories (mild, moderate, and severe) in the severity index.
Time Frame up to week 148 (End of Trial)
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS): The FAS was comprised of all patients who entered into the induction period.
Arm/Group Title None Mild Moderate Severe Missing
Hide Arm/Group Description:
All subjects were assigned to receive 150 mg secukinumab (AIN457) by subcutaneous injections. The category of JDA severity index was defined by 3 categories: mild, moderate, and severe.
All subjects were assigned to receive 150 mg secukinumab (AIN457) by subcutaneous injections. The category of JDA severity index was defined by 3 categories: mild, moderate, and severe.
All subjects were assigned to receive 150 mg secukinumab (AIN457) by subcutaneous injections. The category of JDA severity index was defined by 3 categories: mild, moderate, and severe.
All subjects were assigned to receive 150 mg secukinumab (AIN457) by subcutaneous injections. The category of JDA severity index was defined by 3 categories: mild, moderate, and severe.
All subjects were assigned to receive 150 mg secukinumab (AIN457) by subcutaneous injections. The category of JDA severity index was defined by 3 categories: mild, moderate, and severe.
Overall Number of Participants Analyzed 12 12 12 12 12
Measure Type: Number
Unit of Measure: Participants
Baseline Number Analyzed 12 participants 12 participants 12 participants 12 participants 12 participants
0 9 3 0 0
Week 1 Number Analyzed 11 participants 11 participants 11 participants 11 participants 11 participants
0 10 1 0 0
Week 2 Number Analyzed 11 participants 11 participants 11 participants 11 participants 11 participants
0 11 0 0 0
Week 3 Number Analyzed 11 participants 11 participants 11 participants 11 participants 11 participants
0 11 0 0 0
Week 4 Number Analyzed 12 participants 12 participants 12 participants 12 participants 12 participants
1 11 0 0 0
Week 8 Number Analyzed 12 participants 12 participants 12 participants 12 participants 12 participants
0 12 0 0 0
Week 16 Number Analyzed 11 participants 11 participants 11 participants 11 participants 11 participants
0 11 0 0 0
Week 24 Number Analyzed 11 participants 11 participants 11 participants 11 participants 11 participants
1 9 1 0 0
Week 36 Number Analyzed 11 participants 11 participants 11 participants 11 participants 11 participants
1 10 0 0 0
Week 52 Number Analyzed 10 participants 10 participants 10 participants 10 participants 10 participants
1 9 0 0 0
Week 64 Number Analyzed 9 participants 9 participants 9 participants 9 participants 9 participants
1 8 0 0 0
Week 80 Number Analyzed 9 participants 9 participants 9 participants 9 participants 9 participants
3 6 0 0 0
Week 96 Number Analyzed 9 participants 9 participants 9 participants 9 participants 9 participants
2 7 0 0 0
Week 112 Number Analyzed 5 participants 5 participants 5 participants 5 participants 5 participants
0 5 0 0 0
Week 128 Number Analyzed 2 participants 2 participants 2 participants 2 participants 2 participants
0 2 0 0 0
Week 144 Number Analyzed 9 participants 9 participants 9 participants 9 participants 9 participants
2 7 0 0 0
6.Secondary Outcome
Title The Japanese Dermatological Association (JDA) Component Score for GPP Over Time
Hide Description

The following components of the JDA severity index for generalized pustular psoriasis (GPP) were reported: body surface area (SA)covered with total erythema with pustules, body SA covered with total erythema, body SA covered with edema, fever, white blood cell (WBC) count, C-reactive protein, serum albumin.

The total score of JDA severity index was assigned a score of 0-17. Assessment of skin lesions: area of erythema with pustules, area of erythema, and area of edema; each score 0-3. Assessment of systemic manifestations and laboratory findings: fever, WBC count, CRP and serum albumin; each score 0-2.

The higher the JDA severity index for GPP score the worse the outcome.

Time Frame up to week 148 (end of trial)
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS): The FAS was comprised of all patients who entered into the induction period.
Arm/Group Title AIN457
Hide Arm/Group Description:

All subjects were assigned to receive 150 mg secukinumab (AIN457) by subcutaneous injections. AIN457 was administered at baseline, weeks 1, 2, 3, 4. Prior to receiving the week 8 dose, all subjects were assigned to the following treatment group based on clinical components of their Clinical Global Impression (CGI) evaluation at week 8.

  • “No up-titration” group received 1 injection of 150 mg AIN457 at weeks 8, 12, and each visit from week 16 until week 48.
  • “Up-titration” group received 2 injections of 150 mg AIN457 at weeks 8, 9, 12 and each visit from week 16 until week 48.

Subjects who received 150 mg AIN457 can be up-titrated to 300 mg AIN 457 at any visit starting at week 16 based on clinical components of their CGI evaluation and investigator’s discretion.

Overall Number of Participants Analyzed 12
Mean (Standard Deviation)
Unit of Measure: mean scores on a scale
Body SA w/ erythema with pustules - Baseline Number Analyzed 12 participants
2  (0.00)
Body SA w/ erythema with pustules - Week 24 Number Analyzed 11 participants
0.3  (0.65)
Body SA w/ erythema with pustules - Week 52 Number Analyzed 10 participants
0.0  (0.00)
Body SA w/ erythema w/ pustules - End of Treatment Number Analyzed 9 participants
0.0  (0.00)
Body SA w/ total erythema - Baseline Number Analyzed 12 participants
1.6  (0.67)
Body SA w/ total erythema - Week 24 Number Analyzed 11 participants
1.1  (0.54)
Body SA w/ total erythema - Week 52 Number Analyzed 10 participants
0.8  (0.42)
Body SA w/ total erythema - End of Treatment Number Analyzed 9 participants
0.7  (0.50)
Body SA w/ edema - Baseline Number Analyzed 12 participants
1.3  (0.89)
Body SA w/ edema - Week 24 Number Analyzed 11 participants
0.4  (0.67)
Body SA w/ edema - Week 52 Number Analyzed 10 participants
0.3  (0.48)
Body SA w/ edema - End of Treatment Number Analyzed 9 participants
0.1  (0.33)
Fever - Baseline Number Analyzed 12 participants
0.2  (0.39)
Fever - Week 24 Number Analyzed 11 participants
0.2  (0.40)
Fever - Week 52 Number Analyzed 10 participants
0.4  (0.52)
Fever - End of Treatment Number Analyzed 9 participants
0.1  (0.33)
White blood cell (WBC) count - Baseline Number Analyzed 12 participants
0.3  (0.65)
White blood cell (WBC) count - Week 24 Number Analyzed 11 participants
0.1  (0.30)
White blood cell (WBC) count - Week 52 Number Analyzed 10 participants
0.1  (0.32)
White blood cell (WBC) count - End of Treatment Number Analyzed 9 participants
0.0  (0.00)
C-reactive protein - Baseline Number Analyzed 12 participants
0.5  (0.67)
C-reactive protein - Week 24 Number Analyzed 11 participants
0.2  (0.40)
C-reactive protein - Week 52 Number Analyzed 10.0 participants
0.2  (0.42)
C-reactive protein - End of Treatment Number Analyzed 9 participants
0.3  (0.50)
Serum albumin - Baseline Number Analyzed 12 participants
0.0  (0.00)
Serum albumin - Week 24 Number Analyzed 11 participants
0.0  (0.00)
Serum albumin - Week 52 Number Analyzed 10 participants
0.1  (0.32)
Serum albumin - End of Treatment Number Analyzed 9 participants
0.0  (0.00)
7.Secondary Outcome
Title Change From Baseline in Observed Value of Components of the JDA Severity Index for GPP
Hide Description

The observed value for the following components of the JDA severity index for GPP were reported: percentage of body surface area covered with erythema with pustules, percentage of body surface area covered with total erythema, percentage of body surface area covered with edema, fever (body temperature,°C), white blood cell (WBC) count (/μL), C-reactive protein (mg/L), serum albumin (g/dL).

Percent change=100 x Absolute change/post baseline.

Time Frame up to week 148 (end of trial)
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS): The FAS was comprised of all patients who entered into the induction period.
Arm/Group Title AIN457
Hide Arm/Group Description:
All subjects were assigned to receive 150 mg secukinumab (AIN457) by subcutaneous injections.
Overall Number of Participants Analyzed 12
Mean (Standard Deviation)
Unit of Measure: Percent change
Area of erythema with pustules (Week 24) -89.09  (33.001)
Area of erythema with pustules (Week 52) -100.00  (0.000)
Area of erythema with pustules (Week 148) -100.00  (0.000)
Area of Erythema (Week 24) -63.56  (46.693)
Area of Erythema (Week 52) -83.60  (24.442)
Area of Erythema (Week 148) -87.01  (15.826)
Area of Edema (Week 24) -47.92  (107.200)
Area of Edema (Week 52) -69.17  (69.733)
Area of Edema (Week 148) -99.05  (2.520)
Body temperature (Week 24) -0.27  (1.071)
Body temperature (Week 52) 0.08  (1.076)
Body temperature (Week 148) -0.87  (1.473)
WBC (Week 24) -15.16  (23.120)
WBC (Week 52) -22.16  (28.009)
WBC (Week 148) -25.63  (18.838)
CRP (Week 24) 18.12  (197.270)
CRP (Week 52) 34.21  (245.564)
CRP (Week 148) 30.60  (146.990)
Serum Albumin (Week 24) 0.73  (7.952)
Serum Albumin (Week 52) 0.63  (12.952)
Serum Albumin (Week 148) 1.64  (3.688)
8.Secondary Outcome
Title Mean Health-related Quality of Life (The Dermatology Life Quality Index [DLQI] and Short Form Health Survey [SF-36]) Over Time
Hide Description DLQI is a 10-item general dermatology disability index designed to assess HRQL in adults with skin diseases (Finlay & Khan 94). The measure is self-admin. & includes domains of daily activities, leisure, personal relationships, symptoms and feelings, treatment, and work/school. DLQI total score is the sum of the 10 questions. Each item has four response categories, ranging from 0 (not at all) to 3 (very much). Scores range from 0 to 30 9higher scores indicate greater health-related quality of-life impairment). SF-36 is a widely used and extensively studied instrument to measure HRQL among healthy subjects with acute & chronic conditions (Ware et al. 93, 94). It consists of 8 subscales (based on a scale of 0-100) that can be scored individually: Two overall summary scores for SF-36, the Physical Component Summary (PCS) and the Mental Component Summary (MCS), were computed. DLQI total score decreases and SF-36 increases with improvement of quality of life.
Time Frame Up to week 148 (end of treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS): The FAS was comprised of all patients who entered into the induction period.
Arm/Group Title AIN457
Hide Arm/Group Description:

All subjects were assigned to receive 150 mg secukinumab (AIN457) by subcutaneous injections. AIN457 was administered at baseline, weeks 1, 2, 3, 4. Prior to receiving the week 8 dose, all subjects were assigned to the following treatment group based on clinical components of their Clinical Global Impression (CGI) evaluation at week 8.

  • “No up-titration” group received 1 injection of 150 mg AIN457 at weeks 8, 12, and each visit from week 16 until week 48.
  • “Up-titration” group received 2 injections of 150 mg AIN457 at weeks 8, 9, 12 and each visit from week 16 until week 48.

Subjects who received 150 mg AIN457 can be up-titrated to 300 mg AIN 457 at any visit starting at week 16 based on clinical components of their CGI evaluation and investigator’s discretion.

Overall Number of Participants Analyzed 12
Mean (Standard Deviation)
Unit of Measure: scores on a scale
DLQI total score at Baseline Number Analyzed 12 participants
8.4  (6.88)
DLQI total score at Week 24 Number Analyzed 11 participants
4.5  (5.16)
DLQI total score at Week 52 Number Analyzed 10 participants
2.7  (2.41)
DLQI total score at end of treatment Number Analyzed 9 participants
4.7  (8.25)
SF-36 - MCS at Baseline Number Analyzed 12 participants
43.69  (17.472)
SF-36 - MCS at Week 24 Number Analyzed 11 participants
46.70  (9.9696)
SF-36 - MCS at Week 52 Number Analyzed 10 participants
46.27  (11.768)
SF-36 - MCS at end of trial Number Analyzed 9 participants
47.70  (13.457)
SF-36 - PCS at Baseline Number Analyzed 12 participants
50.61  (3.258)
SF-36 - PCS at Week 24 Number Analyzed 11 participants
52.39  (4.438)
SF-36 - PCS at Week 52 Number Analyzed 10 participants
50.20  (4.670)
SF-36 - PCS at end of treatment Number Analyzed 9 participants
49.82  (6.528)
9.Secondary Outcome
Title Number of Patients With GPP-related Systemic and Topical Co-medication Over Time
Hide Description Use of systemic and topical co-medication to treat generalized pustular psoriasis (GPP), in subjects who have active GPP treatment at baseline.
Time Frame up to week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS): The FAS was comprised of all patients who entered into the induction period.
Arm/Group Title AIN457
Hide Arm/Group Description:

All subjects were assigned to receive 150 mg secukinumab (AIN457) by subcutaneous injections. AIN457 was administered at baseline, weeks 1, 2, 3, 4. Prior to receiving the week 8 dose, all subjects were assigned to the following treatment group based on clinical components of their Clinical Global Impression (CGI) evaluation at week 8.

  • “No up-titration” group received 1 injection of 150 mg AIN457 at weeks 8, 12, and each visit from week 16 until week 48.
  • “Up-titration” group received 2 injections of 150 mg AIN457 at weeks 8, 9, 12 and each visit from week 16 until week 48.

Subjects who received 150 mg AIN457 can be up-titrated to 300 mg AIN 457 at any visit starting at week 16 based on clinical components of their CGI evaluation and investigator’s discretion.

Overall Number of Participants Analyzed 12
Measure Type: Number
Unit of Measure: Participants
Topical co-medication related to GPP 12
Systemic co-medication related to GPP 8
Time Frame Adverse events are collected from first patient first visit (FPFV) until last patient last visit (LPLV). All adverse events reported in this record are from the late of first patient first treatment until last patient last visit, approximately 3 years.
Adverse Event Reporting Description AE additional description
 
Arm/Group Title AIN457
Hide Arm/Group Description

All subjects were assigned to receive 150 mg secukinumab (AIN457) by subcutaneous injections. AIN457 was administered at baseline, weeks 1, 2, 3, 4. Prior to receiving the week 8 dose, all subjects were assigned to the following treatment group based on clinical components of their Clinical Global Impression (CGI) evaluation at week 8.

  • “No up-titration” group received 1 injection of 150 mg AIN457 at weeks 8, 12, and each visit from week 16 until week 48.
  • “Up-titration” group received 2 injections of 150 mg AIN457 at weeks 8, 9, 12 and each visit from week 16 until week 48.

Subjects who received 150 mg AIN457 can be up-titrated to 300 mg AIN 457 at any visit starting at week 16 based on clinical components of their CGI evaluation and investigator’s discretion.

All-Cause Mortality
AIN457
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
AIN457
Affected / at Risk (%)
Total   3/12 (25.00%) 
Gastrointestinal disorders   
UPPER GASTROINTESTINAL HAEMORRHAGE  1  1/12 (8.33%) 
Hepatobiliary disorders   
DRUG-INDUCED LIVER INJURY  1  1/12 (8.33%) 
HEPATIC FUNCTION ABNORMAL  1  1/12 (8.33%) 
Infections and infestations   
CELLULITIS  1  1/12 (8.33%) 
ERYSIPELAS  1  1/12 (8.33%) 
Metabolism and nutrition disorders   
HYPOGLYCAEMIA  1  1/12 (8.33%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
BOWEN'S DISEASE  1  1/12 (8.33%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (19.0)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
AIN457
Affected / at Risk (%)
Total   12/12 (100.00%) 
Blood and lymphatic system disorders   
ANAEMIA  1  1/12 (8.33%) 
Cardiac disorders   
ARRHYTHMIA SUPRAVENTRICULAR  1  1/12 (8.33%) 
SINUS TACHYCARDIA  1  1/12 (8.33%) 
Eye disorders   
CATARACT  1  1/12 (8.33%) 
CONJUNCTIVAL HAEMORRHAGE  1  1/12 (8.33%) 
CONJUNCTIVITIS ALLERGIC  1  1/12 (8.33%) 
Gastrointestinal disorders   
ABDOMINAL PAIN UPPER  1  1/12 (8.33%) 
DUODENITIS  1  1/12 (8.33%) 
GASTRIC ULCER  1  1/12 (8.33%) 
GASTROOESOPHAGEAL REFLUX DISEASE  1  1/12 (8.33%) 
HAEMORRHOIDS  1  1/12 (8.33%) 
LARGE INTESTINE POLYP  1  1/12 (8.33%) 
General disorders   
PYREXIA  1  1/12 (8.33%) 
Hepatobiliary disorders   
HEPATIC FUNCTION ABNORMAL  1  1/12 (8.33%) 
HYPERBILIRUBINAEMIA  1  1/12 (8.33%) 
Infections and infestations   
CELLULITIS  1  1/12 (8.33%) 
ECZEMA IMPETIGINOUS  1  1/12 (8.33%) 
ERYTHRASMA  1  1/12 (8.33%) 
FOLLICULITIS  1  1/12 (8.33%) 
GENITAL CANDIDIASIS  1  1/12 (8.33%) 
HELICOBACTER INFECTION  1  1/12 (8.33%) 
IMPETIGO  1  1/12 (8.33%) 
NASOPHARYNGITIS  1  7/12 (58.33%) 
OTITIS EXTERNA  1  1/12 (8.33%) 
PARONYCHIA  1  1/12 (8.33%) 
PHARYNGITIS  1  1/12 (8.33%) 
SINUSITIS  1  1/12 (8.33%) 
STREPTOCOCCAL INFECTION  1  1/12 (8.33%) 
URINARY TRACT INFECTION  1  1/12 (8.33%) 
Injury, poisoning and procedural complications   
FALL  1  1/12 (8.33%) 
RIB FRACTURE  1  1/12 (8.33%) 
SPINAL COMPRESSION FRACTURE  1  1/12 (8.33%) 
Investigations   
C-REACTIVE PROTEIN INCREASED  1  1/12 (8.33%) 
WEIGHT DECREASED  1  1/12 (8.33%) 
Metabolism and nutrition disorders   
DIABETES MELLITUS  1  2/12 (16.67%) 
HYPOVOLAEMIA  1  1/12 (8.33%) 
Musculoskeletal and connective tissue disorders   
ARTHRALGIA  1  2/12 (16.67%) 
BACK PAIN  1  1/12 (8.33%) 
LUMBAR SPINAL STENOSIS  1  1/12 (8.33%) 
MUSCLE SPASMS  1  1/12 (8.33%) 
MYALGIA  1  1/12 (8.33%) 
SYNOVIAL CYST  1  1/12 (8.33%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
SKIN PAPILLOMA  1  1/12 (8.33%) 
Nervous system disorders   
BURNING SENSATION  1  1/12 (8.33%) 
DIZZINESS  1  1/12 (8.33%) 
NEUROPATHY PERIPHERAL  1  1/12 (8.33%) 
RESTLESS LEGS SYNDROME  1  1/12 (8.33%) 
SOMNOLENCE  1  1/12 (8.33%) 
Psychiatric disorders   
INSOMNIA  1  1/12 (8.33%) 
Renal and urinary disorders   
RENAL IMPAIRMENT  1  1/12 (8.33%) 
Reproductive system and breast disorders   
BREAST CYST  1  1/12 (8.33%) 
Respiratory, thoracic and mediastinal disorders   
COUGH  1  1/12 (8.33%) 
Skin and subcutaneous tissue disorders   
DERMATITIS CONTACT  1  1/12 (8.33%) 
ECZEMA  1  1/12 (8.33%) 
ECZEMA ASTEATOTIC  1  1/12 (8.33%) 
PEMPHIGOID  1  1/12 (8.33%) 
PURPURA SENILE  1  1/12 (8.33%) 
SOLAR DERMATITIS  1  1/12 (8.33%) 
URTICARIA  1  2/12 (16.67%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (19.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigators from publishing. Any publications from a single-site are postponed until the publication of the pooled data (o.e., data from all sites) in the clinical trial.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
Phone: 862-778-8300
Layout table for additonal information
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01952015    
Other Study ID Numbers: CAIN457A1302
First Submitted: September 24, 2013
First Posted: September 27, 2013
Results First Submitted: March 15, 2017
Results First Posted: March 15, 2019
Last Update Posted: March 15, 2019