Trial Outcomes & Findings for A Study of the Safety and Efficacy of Risankizumab in Adult Participants With Plaque Psoriasis Who Have Had a Suboptimal Response to Secukinumab or Ixekizumab (NCT NCT04102007)

NCT ID: NCT04102007

Last Updated: 2023-11-27

Results Overview

The sPGA is a 5-point score ranging from 0 to 4, based on the physician's assessment of the average thickness, erythema, and scaling of all psoriatic lesions. A lower score indicates less body coverage, with 0 being clear and 1 being almost clear.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 244 participants
• Primary outcome timeframe: At Week 16
• Results posted on: 2023-11-27

Participant Flow

Significant site non-compliance for this study was identified at one site since interim results were posted. As a result of this finding, participants enrolled in this trial site were not included in any final analysis. Adverse events or lab abnormalities were reported in 1 participant from this site. The participant was on risankizumab and had a non serious event of headache (assessed as mild), which did not lead to study drug discontinuation

Participant milestones

Measure	Risankizumab Risankizumab is administered as a subcutaneous (SC) injection in pre-filled syringe (PFS)
Overall Study STARTED	244
Overall Study COMPLETED	205
Overall Study NOT COMPLETED	39

Reasons for withdrawal

Measure	Risankizumab Risankizumab is administered as a subcutaneous (SC) injection in pre-filled syringe (PFS)
Overall Study Adverse Event	4
Overall Study Lost to Follow-up	3
Overall Study Withdrawal by Subject	12
Overall Study Eligibility Violation	5
Overall Study Lack of Efficacy	6
Overall Study Protocol Deviation	5
Overall Study Protocol Compliance	1
Overall Study Withdrew Treatment	2
Overall Study Pregnancy	1

Baseline Characteristics

A Study of the Safety and Efficacy of Risankizumab in Adult Participants With Plaque Psoriasis Who Have Had a Suboptimal Response to Secukinumab or Ixekizumab

Baseline characteristics by cohort

Measure	Risankizumab n=244 Participants Risankizumab is administered as a subcutaneous (SC) injection in pre-filled syringe (PFS)
Age, Continuous	49.2 years STANDARD_DEVIATION 12.81 • n=5 Participants
Age, Customized < 40 years	65 Participants n=5 Participants
Age, Customized 40 - 65 years	150 Participants n=5 Participants
Age, Customized ≥ 65 years	29 Participants n=5 Participants
Sex: Female, Male Female	63 Participants n=5 Participants
Sex: Female, Male Male	181 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	17 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	227 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants
Race (NIH/OMB) Asian	27 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	214 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	64 participants n=5 Participants
Region of Enrollment Germany	65 participants n=5 Participants
Region of Enrollment Italy	27 participants n=5 Participants
Region of Enrollment Spain	17 participants n=5 Participants
Region of Enrollment United Kingdom	12 participants n=5 Participants
Region of Enrollment Israel	34 participants n=5 Participants
Region of Enrollment Australia	3 participants n=5 Participants
Region of Enrollment Taiwan	22 participants n=5 Participants

PRIMARY outcome

Timeframe: At Week 16

Population: Intent-to-Treat (ITT) Population, which is defined as all subjects who had at least 1 dose of study drug

The sPGA is a 5-point score ranging from 0 to 4, based on the physician's assessment of the average thickness, erythema, and scaling of all psoriatic lesions. A lower score indicates less body coverage, with 0 being clear and 1 being almost clear.

Outcome measures

Measure	Risankizumab n=244 Participants Risankizumab is administered as a subcutaneous (SC) injection in pre-filled syringe (PFS)
Proportion of Participants Achieving Static Physician Global Assessment (sPGA) 0/1	140 Participants

SECONDARY outcome

Timeframe: At Week 16

Population: Intent-to-Treat (ITT) Population, which is defined as all subjects who had at least 1 dose of study drug

The sPGA is a 5-point score ranging from 0 to 4, based on the physician's assessment of the average thickness, erythema, and scaling of all psoriatic lesions. A lower score indicates less body coverage, with 0 being clear and 1 being almost clear.

Outcome measures

Measure	Risankizumab n=244 Participants Risankizumab is administered as a subcutaneous (SC) injection in pre-filled syringe (PFS)
Proportion of Participants Achieving a sPGA Clear Response (sPGA 0)	50 Participants

SECONDARY outcome

Timeframe: At Week 16

Population: Intent-to-Treat (ITT) Population, which is defined as all subjects who had at least 1 dose of study drug

The DLQI is a self-administered, 10-question questionnaire covering 6 domains (symptoms and feelings, daily activities, leisure, work and school, personal relationships, and bother with psoriasis treatment). The response options range from 0, not affected at all, to 3, very much affected. This gives an overall range of 0 to 30 where lower scores mean better quality of life.

Outcome measures

Measure	Risankizumab n=244 Participants Risankizumab is administered as a subcutaneous (SC) injection in pre-filled syringe (PFS)
Proportion of Participants Achieving a Dermatology Life Quality Index (DLQI) 0/1	98 Participants

SECONDARY outcome

Timeframe: At Week 16

Population: Intent-to-Treat (ITT) Population, which is defined as all subjects who had at least 1 dose of study drug

The PSS is a 4-item patient-reported outcome (PRO) instrument that assesses the severity of psoriasis symptoms in patients with moderate to severe psoriasis (Appendix 8.2). The symptoms included are:

pain, redness, itching and burning from psoriasis. Current symptom severity is assessed as a daily diary, using a 5-point scale ranging from 0 (none) to 4 (very severe).

Outcome measures

Measure	Risankizumab n=244 Participants Risankizumab is administered as a subcutaneous (SC) injection in pre-filled syringe (PFS)
Proportion of Participants Achieving a Psoriasis Symptoms Scale (PSS) 0	51 Participants

SECONDARY outcome

Timeframe: At Week 52

Population: Intent-to-Treat (ITT) Population, which is defined as all subjects who had at least 1 dose of study drug

The sPGA is a 5-point score ranging from 0 to 4, based on the physician's assessment of the average thickness, erythema, and scaling of all psoriatic lesions. A lower score indicates less body coverage, with 0 being clear and 1 being almost clear.

Outcome measures

Measure	Risankizumab n=244 Participants Risankizumab is administered as a subcutaneous (SC) injection in pre-filled syringe (PFS)
Proportion of Participants Achieving Static Physician Global Assessment (sPGA) 0/1	152 Participants

SECONDARY outcome

Timeframe: At Week 52

Population: Intent-to-Treat (ITT) Population, which is defined as all subjects who had at least 1 dose of study drug

The sPGA is a 5-point score ranging from 0 to 4, based on the physician's assessment of the average thickness, erythema, and scaling of all psoriatic lesions. A lower score indicates less body coverage, with 0 being clear and 1 being almost clear.

Outcome measures

Measure	Risankizumab n=244 Participants Risankizumab is administered as a subcutaneous (SC) injection in pre-filled syringe (PFS)
Proportion of Participants Achieving a sPGA Clear Response (sPGA 0)	66 Participants

SECONDARY outcome

Timeframe: At Week 52

Population: Intent-to-Treat (ITT) Population, which is defined as all subjects who had at least 1 dose of study drug

The DLQI is a self-administered, 10-question questionnaire covering 6 domains (symptoms and feelings, daily activities, leisure, work and school, personal relationships, and bother with psoriasis treatment). The response options range from 0, not affected at all, to 3, very much affected. This gives an overall range of 0 to 30 where lower scores mean better quality of life.

Outcome measures

Measure	Risankizumab n=244 Participants Risankizumab is administered as a subcutaneous (SC) injection in pre-filled syringe (PFS)
Proportion of Participants Achieving a Dermatology Life Quality Index (DLQI) 0/1	115 Participants

SECONDARY outcome

Timeframe: At Week 52

Population: Intent-to-Treat (ITT) Population, which is defined as all subjects who had at least 1 dose of study drug

The PSS is a 4-item patient-reported outcome (PRO) instrument that assesses the severity of psoriasis symptoms in patients with moderate to severe psoriasis (Appendix 8.2). The symptoms included are:

pain, redness, itching and burning from psoriasis. Current symptom severity is assessed as a daily diary, using a 5-point scale ranging from 0 (none) to 4 (very severe).

Outcome measures

Measure	Risankizumab n=244 Participants Risankizumab is administered as a subcutaneous (SC) injection in pre-filled syringe (PFS)
Proportion of Participants Achieving a PSS 0	67 Participants

SECONDARY outcome

Timeframe: Up to Week 52

Population: Intent-to-Treat (ITT) Population, which is defined as all subjects who had at least 1 dose of study drug

The sPGA is a 5-point score ranging from 0 to 4, based on the physician's assessment of the average thickness, erythema, and scaling of all psoriatic lesions. A lower score indicates less body coverage, with 0 being clear and 1 being almost clear.

Outcome measures

Measure	Risankizumab n=244 Participants Risankizumab is administered as a subcutaneous (SC) injection in pre-filled syringe (PFS)
Time to Achieve sPGA 0/1 25th	30 Days Interval 29.0 to 38.0
Time to Achieve sPGA 0/1 Median	57 Days Interval 57.0 to 110.0
Time to Achieve sPGA 0/1 75th	199 Days Interval 134.0 to 282.0

SECONDARY outcome

Timeframe: Up to Week 52

Population: Intent-to-Treat (ITT) Population, which is defined as all subjects who had at least 1 dose of study drug

The sPGA is a 5-point score ranging from 0 to 4, based on the physician's assessment of the average thickness, erythema, and scaling of all psoriatic lesions. A lower score indicates less body coverage, with 0 being clear and 1 being almost clear.

Outcome measures

Measure	Risankizumab n=244 Participants Risankizumab is administered as a subcutaneous (SC) injection in pre-filled syringe (PFS)
Time to Achieve sPGA 0 25th	121 Days Interval 113.0 to 201.0
Time to Achieve sPGA 0 Median	370 Days Interval 366.0 to If a participant never attained the endpoint, then the outcome was censored at the last visit where variable was measured
Time to Achieve sPGA 0 75th	NA Days If a participant never attained the endpoint, then the outcome was censored at the last visit where variable was measured

Adverse Events

Risankizumab

Serious events: 17 serious events

Other events: 31 other events

Deaths: 0 deaths

Serious adverse events

Measure	Risankizumab n=244 participants at risk Risankizumab is administered as a subcutaneous (SC) injection in pre-filled syringe (PFS)
Cardiac disorders CORONARY ARTERY DISEASE	0.41% 1/244 • Number of events 1 • From Baseline Day 1 up to Week 52 The Safety Analysis Set, which is defined as all subjects who received at least one dose of study drug in Study M19-164, was used for all safety analyses. In this study, the Safety Analysis Set is the same as the ITT population.
Cardiac disorders MYOCARDIAL INFARCTION	0.82% 2/244 • Number of events 2 • From Baseline Day 1 up to Week 52 The Safety Analysis Set, which is defined as all subjects who received at least one dose of study drug in Study M19-164, was used for all safety analyses. In this study, the Safety Analysis Set is the same as the ITT population.
Gastrointestinal disorders LARGE INTESTINAL HAEMORRHAGE	0.41% 1/244 • Number of events 1 • From Baseline Day 1 up to Week 52 The Safety Analysis Set, which is defined as all subjects who received at least one dose of study drug in Study M19-164, was used for all safety analyses. In this study, the Safety Analysis Set is the same as the ITT population.
Gastrointestinal disorders OEDEMATOUS PANCREATITIS	0.41% 1/244 • Number of events 1 • From Baseline Day 1 up to Week 52 The Safety Analysis Set, which is defined as all subjects who received at least one dose of study drug in Study M19-164, was used for all safety analyses. In this study, the Safety Analysis Set is the same as the ITT population.
Gastrointestinal disorders OESOPHAGEAL VARICES HAEMORRHAGE	0.41% 1/244 • Number of events 1 • From Baseline Day 1 up to Week 52 The Safety Analysis Set, which is defined as all subjects who received at least one dose of study drug in Study M19-164, was used for all safety analyses. In this study, the Safety Analysis Set is the same as the ITT population.
Hepatobiliary disorders CHOLELITHIASIS	0.41% 1/244 • Number of events 1 • From Baseline Day 1 up to Week 52 The Safety Analysis Set, which is defined as all subjects who received at least one dose of study drug in Study M19-164, was used for all safety analyses. In this study, the Safety Analysis Set is the same as the ITT population.
Infections and infestations APPENDICITIS	0.41% 1/244 • Number of events 1 • From Baseline Day 1 up to Week 52 The Safety Analysis Set, which is defined as all subjects who received at least one dose of study drug in Study M19-164, was used for all safety analyses. In this study, the Safety Analysis Set is the same as the ITT population.
Infections and infestations DIVERTICULITIS	0.41% 1/244 • Number of events 1 • From Baseline Day 1 up to Week 52 The Safety Analysis Set, which is defined as all subjects who received at least one dose of study drug in Study M19-164, was used for all safety analyses. In this study, the Safety Analysis Set is the same as the ITT population.
Infections and infestations POSTOPERATIVE WOUND INFECTION	0.41% 1/244 • Number of events 1 • From Baseline Day 1 up to Week 52 The Safety Analysis Set, which is defined as all subjects who received at least one dose of study drug in Study M19-164, was used for all safety analyses. In this study, the Safety Analysis Set is the same as the ITT population.
Injury, poisoning and procedural complications MULTIPLE INJURIES	0.41% 1/244 • Number of events 1 • From Baseline Day 1 up to Week 52 The Safety Analysis Set, which is defined as all subjects who received at least one dose of study drug in Study M19-164, was used for all safety analyses. In this study, the Safety Analysis Set is the same as the ITT population.
Musculoskeletal and connective tissue disorders MUSCULAR WEAKNESS	0.41% 1/244 • Number of events 1 • From Baseline Day 1 up to Week 52 The Safety Analysis Set, which is defined as all subjects who received at least one dose of study drug in Study M19-164, was used for all safety analyses. In this study, the Safety Analysis Set is the same as the ITT population.
Musculoskeletal and connective tissue disorders OSTEOARTHRITIS	0.82% 2/244 • Number of events 2 • From Baseline Day 1 up to Week 52 The Safety Analysis Set, which is defined as all subjects who received at least one dose of study drug in Study M19-164, was used for all safety analyses. In this study, the Safety Analysis Set is the same as the ITT population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) NON-SMALL CELL LUNG CANCER	0.41% 1/244 • Number of events 1 • From Baseline Day 1 up to Week 52 The Safety Analysis Set, which is defined as all subjects who received at least one dose of study drug in Study M19-164, was used for all safety analyses. In this study, the Safety Analysis Set is the same as the ITT population.
Nervous system disorders APHASIA	0.41% 1/244 • Number of events 1 • From Baseline Day 1 up to Week 52 The Safety Analysis Set, which is defined as all subjects who received at least one dose of study drug in Study M19-164, was used for all safety analyses. In this study, the Safety Analysis Set is the same as the ITT population.
Nervous system disorders EPILEPSY	0.41% 1/244 • Number of events 1 • From Baseline Day 1 up to Week 52 The Safety Analysis Set, which is defined as all subjects who received at least one dose of study drug in Study M19-164, was used for all safety analyses. In this study, the Safety Analysis Set is the same as the ITT population.
Renal and urinary disorders ACUTE KIDNEY INJURY	0.41% 1/244 • Number of events 1 • From Baseline Day 1 up to Week 52 The Safety Analysis Set, which is defined as all subjects who received at least one dose of study drug in Study M19-164, was used for all safety analyses. In this study, the Safety Analysis Set is the same as the ITT population.
Injury, poisoning and procedural complications FIBULA FRACTURE	0.41% 1/244 • Number of events 1 • From Baseline Day 1 up to Week 52 The Safety Analysis Set, which is defined as all subjects who received at least one dose of study drug in Study M19-164, was used for all safety analyses. In this study, the Safety Analysis Set is the same as the ITT population.
Injury, poisoning and procedural complications HAND FRACTURE	0.41% 1/244 • Number of events 1 • From Baseline Day 1 up to Week 52 The Safety Analysis Set, which is defined as all subjects who received at least one dose of study drug in Study M19-164, was used for all safety analyses. In this study, the Safety Analysis Set is the same as the ITT population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) PROSTATE CANCER STAGE I	0.41% 1/244 • Number of events 1 • From Baseline Day 1 up to Week 52 The Safety Analysis Set, which is defined as all subjects who received at least one dose of study drug in Study M19-164, was used for all safety analyses. In this study, the Safety Analysis Set is the same as the ITT population.

Other adverse events

Measure	Risankizumab n=244 participants at risk Risankizumab is administered as a subcutaneous (SC) injection in pre-filled syringe (PFS)
Infections and infestations NASOPHARYNGITIS	5.7% 14/244 • Number of events 18 • From Baseline Day 1 up to Week 52 The Safety Analysis Set, which is defined as all subjects who received at least one dose of study drug in Study M19-164, was used for all safety analyses. In this study, the Safety Analysis Set is the same as the ITT population.
Infections and infestations COVID-19	8.6% 21/244 • Number of events 21 • From Baseline Day 1 up to Week 52 The Safety Analysis Set, which is defined as all subjects who received at least one dose of study drug in Study M19-164, was used for all safety analyses. In this study, the Safety Analysis Set is the same as the ITT population.

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