Trial Outcomes & Findings for Comparison of Secukinumab Versus Guselkumab in Clearing Psoriatic Plaques Refractory to Ustekinumab (NCT NCT03553823)
NCT ID: NCT03553823
Last Updated: 2021-10-11
Results Overview
Total clinical score: number (%) of subjects who responded at Week 16 (FAS)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
40 participants
Primary outcome timeframe
16 week
Results posted on
2021-10-11
Participant Flow
The Screening Phase was completed by 40 (95.2%) of the 42 subjects screened. One (2.4%) subject was rescreened and 2 (4.8%) subjects failed screening
39 (97.5%) subjects completed this trial
Participant milestones
| Measure |
Secukinumab
20 subjects with plaque psoriasis with an inadequate response to ustekinumab self-administered 300 mg secukinumab as two 150-mg s.c. injections at Baseline, Weeks 1, 2, 3, 4 and then every 4 weeks until Week 12 inclusive
|
Guselkumab
20 subjects with plaque psoriasis with an inadequate response to ustekinumab self-administered guselkumab as 100 mg s.c. injections at Baseline, Weeks 4, and 12.
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
|
Overall Study
COMPLETED
|
20
|
19
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Secukinumab
20 subjects with plaque psoriasis with an inadequate response to ustekinumab self-administered 300 mg secukinumab as two 150-mg s.c. injections at Baseline, Weeks 1, 2, 3, 4 and then every 4 weeks until Week 12 inclusive
|
Guselkumab
20 subjects with plaque psoriasis with an inadequate response to ustekinumab self-administered guselkumab as 100 mg s.c. injections at Baseline, Weeks 4, and 12.
|
|---|---|---|
|
Overall Study
Physician Decision
|
0
|
1
|
Baseline Characteristics
Comparison of Secukinumab Versus Guselkumab in Clearing Psoriatic Plaques Refractory to Ustekinumab
Baseline characteristics by cohort
| Measure |
Secukinumab
n=20 Participants
20 subjects with plaque psoriasis with an inadequate response to ustekinumab self-administered 300 mg secukinumab as two 150-mg s.c. injections at Baseline, Weeks 1, 2, 3, 4 and then every 4 weeks until Week 12 inclusive
|
Guselkumab
n=20 Participants
20 subjects with plaque psoriasis with an inadequate response to ustekinumab self-administered guselkumab as 100 mg s.c. injections at Baseline, Weeks 4, and 12.
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
17 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
36 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Age, Continuous
|
47.6 Years
STANDARD_DEVIATION 15.10 • n=99 Participants
|
48.5 Years
STANDARD_DEVIATION 12.30 • n=107 Participants
|
48.1 Years
STANDARD_DEVIATION 13.60 • n=206 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
29 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
17 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
37 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 16 weekPopulation: The Full Analysis Set (FAS) comprised all subjects to whom study treatment had been assigned by randomization. According to the intent-to-treat principle, subjects were analyzed according to the treatment they were assigned to during the randomization procedure.
Total clinical score: number (%) of subjects who responded at Week 16 (FAS)
Outcome measures
| Measure |
Secukinumab
n=20 Participants
20 subjects with plaque psoriasis with an inadequate response to ustekinumab self-administered 300 mg secukinumab as two 150-mg s.c. injections at Baseline, Weeks 1, 2, 3, 4 and then every 4 weeks until Week 12 inclusive
|
Guselkumab
n=20 Participants
20 subjects with plaque psoriasis with an inadequate response to ustekinumab self-administered guselkumab as 100 mg s.c. injections at Baseline, Weeks 4, and 12.
|
|---|---|---|
|
Proportion of Subjects Whose Plaque Achieves "Clear" or "Almost Clear" Status (TCS = 0-2)
|
12 Participants
|
8 Participants
|
Adverse Events
Secukinumab
Serious events: 2 serious events
Other events: 11 other events
Deaths: 0 deaths
Guselkumab
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Secukinumab
n=20 participants at risk
Secukinumab
|
Guselkumab
n=20 participants at risk
Guselkumab
|
|---|---|---|
|
Gastrointestinal disorders
Gastritis
|
5.0%
1/20 • Adverse Events were collected for duration of study to week 16
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment period
|
0.00%
0/20 • Adverse Events were collected for duration of study to week 16
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment period
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/20 • Adverse Events were collected for duration of study to week 16
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment period
|
5.0%
1/20 • Adverse Events were collected for duration of study to week 16
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment period
|
|
Infections and infestations
Pneumonia
|
5.0%
1/20 • Adverse Events were collected for duration of study to week 16
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment period
|
0.00%
0/20 • Adverse Events were collected for duration of study to week 16
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment period
|
Other adverse events
| Measure |
Secukinumab
n=20 participants at risk
Secukinumab
|
Guselkumab
n=20 participants at risk
Guselkumab
|
|---|---|---|
|
Eye disorders
Dacryostenosis acquired
|
5.0%
1/20 • Adverse Events were collected for duration of study to week 16
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment period
|
0.00%
0/20 • Adverse Events were collected for duration of study to week 16
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment period
|
|
Infections and infestations
Bronchitis
|
0.00%
0/20 • Adverse Events were collected for duration of study to week 16
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment period
|
5.0%
1/20 • Adverse Events were collected for duration of study to week 16
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment period
|
|
Infections and infestations
Erysipelas
|
5.0%
1/20 • Adverse Events were collected for duration of study to week 16
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment period
|
0.00%
0/20 • Adverse Events were collected for duration of study to week 16
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment period
|
|
Infections and infestations
Herpes zoster
|
5.0%
1/20 • Adverse Events were collected for duration of study to week 16
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment period
|
0.00%
0/20 • Adverse Events were collected for duration of study to week 16
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment period
|
|
Infections and infestations
Nasopharyngitis
|
10.0%
2/20 • Adverse Events were collected for duration of study to week 16
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment period
|
5.0%
1/20 • Adverse Events were collected for duration of study to week 16
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment period
|
|
Infections and infestations
Postoperative wound infection
|
5.0%
1/20 • Adverse Events were collected for duration of study to week 16
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment period
|
0.00%
0/20 • Adverse Events were collected for duration of study to week 16
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment period
|
|
Infections and infestations
Sepsis
|
5.0%
1/20 • Adverse Events were collected for duration of study to week 16
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment period
|
0.00%
0/20 • Adverse Events were collected for duration of study to week 16
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment period
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
5.0%
1/20 • Adverse Events were collected for duration of study to week 16
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment period
|
0.00%
0/20 • Adverse Events were collected for duration of study to week 16
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment period
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
5.0%
1/20 • Adverse Events were collected for duration of study to week 16
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment period
|
0.00%
0/20 • Adverse Events were collected for duration of study to week 16
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment period
|
|
Investigations
Blood bilirubin increased
|
5.0%
1/20 • Adverse Events were collected for duration of study to week 16
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment period
|
0.00%
0/20 • Adverse Events were collected for duration of study to week 16
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment period
|
|
Metabolism and nutrition disorders
Gout
|
10.0%
2/20 • Adverse Events were collected for duration of study to week 16
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment period
|
0.00%
0/20 • Adverse Events were collected for duration of study to week 16
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment period
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
5.0%
1/20 • Adverse Events were collected for duration of study to week 16
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment period
|
0.00%
0/20 • Adverse Events were collected for duration of study to week 16
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment period
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/20 • Adverse Events were collected for duration of study to week 16
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment period
|
5.0%
1/20 • Adverse Events were collected for duration of study to week 16
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment period
|
|
Renal and urinary disorders
Acute kidney injury
|
5.0%
1/20 • Adverse Events were collected for duration of study to week 16
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment period
|
0.00%
0/20 • Adverse Events were collected for duration of study to week 16
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment period
|
|
Reproductive system and breast disorders
Balanoposthitis
|
5.0%
1/20 • Adverse Events were collected for duration of study to week 16
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment period
|
0.00%
0/20 • Adverse Events were collected for duration of study to week 16
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment period
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
5.0%
1/20 • Adverse Events were collected for duration of study to week 16
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment period
|
0.00%
0/20 • Adverse Events were collected for duration of study to week 16
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment period
|
|
Skin and subcutaneous tissue disorders
Dyshidrotic eczema
|
0.00%
0/20 • Adverse Events were collected for duration of study to week 16
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment period
|
5.0%
1/20 • Adverse Events were collected for duration of study to week 16
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment period
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/20 • Adverse Events were collected for duration of study to week 16
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment period
|
5.0%
1/20 • Adverse Events were collected for duration of study to week 16
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment period
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/20 • Adverse Events were collected for duration of study to week 16
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment period
|
5.0%
1/20 • Adverse Events were collected for duration of study to week 16
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment period
|
|
Skin and subcutaneous tissue disorders
Miliaria
|
5.0%
1/20 • Adverse Events were collected for duration of study to week 16
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment period
|
0.00%
0/20 • Adverse Events were collected for duration of study to week 16
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment period
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER