Trial Outcomes & Findings for Efficacy and Safety Study of Tildrakizumab in the Treatment of Nail Psoriasis (NCT NCT03897075)
NCT ID: NCT03897075
Last Updated: 2025-06-06
Results Overview
Primary Efficacy Endpoint
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
99 participants
Primary outcome timeframe
Week 28
Results posted on
2025-06-06
Participant Flow
Participant milestones
| Measure |
Placebo
Subjects received placebo up to Week 28
|
Tildrakizumab 100 mg
Subjects received Tildrakizumab 100 mg upto week 16.
|
|---|---|---|
|
Overall Study
STARTED
|
48
|
51
|
|
Overall Study
COMPLETED
|
35
|
43
|
|
Overall Study
NOT COMPLETED
|
13
|
8
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy and Safety Study of Tildrakizumab in the Treatment of Nail Psoriasis
Baseline characteristics by cohort
| Measure |
Placebo
n=48 Participants
Subjects received placebo up to Week 28
|
Tildrakizumab 100 mg
n=51 Participants
Subjects received Tildrakizumab 100 mg upto week 16.
|
Total
n=99 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
46.2 years
STANDARD_DEVIATION 15.14 • n=5 Participants
|
46.6 years
STANDARD_DEVIATION 11.74 • n=7 Participants
|
46.4 years
STANDARD_DEVIATION 13.43 • n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
20 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
28 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 28Primary Efficacy Endpoint
Outcome measures
| Measure |
Placebo
n=48 Participants
Subjects received placebo up to Week 28
|
Tildrakizumab 100 mg
n=51 Participants
Subjects received Tildrakizumab 100 mg up to week 16
|
|---|---|---|
|
The Proportion of Subjects Who Achieve at Least a 75% Improvement From Baseline in Total mNAPSI at Week 28.
|
0.042 proportion of subjects
|
0.255 proportion of subjects
|
SECONDARY outcome
Timeframe: Week 28Outcome measures
| Measure |
Placebo
n=48 Participants
Subjects received placebo up to Week 28
|
Tildrakizumab 100 mg
n=51 Participants
Subjects received Tildrakizumab 100 mg up to week 16
|
|---|---|---|
|
The Proportion of Subjects With a Score of "0 - Normal" or "1 - Minimal Nail Psoriasis" and at Least a 2-point Decrease From Baseline at Week 28 as Measured by the ViSENPsO.
|
0.042 Proportion of subjects
|
0.294 Proportion of subjects
|
SECONDARY outcome
Timeframe: Week 28Population: The number of subjects analysed represents the Intent-to-Treat population with baseline nail pain NRS ≥ 3
Outcome measures
| Measure |
Placebo
n=35 Participants
Subjects received placebo up to Week 28
|
Tildrakizumab 100 mg
n=33 Participants
Subjects received Tildrakizumab 100 mg up to week 16
|
|---|---|---|
|
The Proportion of Subjects With at Least 3 Point Decrease From Baseline, in Nail Pain NRS Score in Subjects With Baseline Nail Pain NRS Score of >3
|
0.257 proportion of subjects
|
0.455 proportion of subjects
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 52Primary Safety Endpoint
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 52Primary Safety Endpoint
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 52Primary Safety Endpoint
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 52Primary Safety Endpoint
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 52Primary Safety Endpoint
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 52Primary Safety Endpoint
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 52Primary Safety Endpoint
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 52Primary Safety Endpoint
Outcome measures
Outcome data not reported
Adverse Events
Tildrakizumab 100mg
Serious events: 2 serious events
Other events: 24 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Tildrakizumab 100mg
n=51 participants at risk
Subjects received Tildrakizumab 100 mg up to week 16
|
Placebo
n=48 participants at risk
Subjects received placebo up to Week 28
|
|---|---|---|
|
Renal and urinary disorders
Nephrolithiasis
|
2.0%
1/51 • 28 Weeks
|
0.00%
0/48 • 28 Weeks
|
|
Renal and urinary disorders
Renal injury
|
2.0%
1/51 • 28 Weeks
|
0.00%
0/48 • 28 Weeks
|
|
Renal and urinary disorders
Ureteric rupture
|
2.0%
1/51 • 28 Weeks
|
0.00%
0/48 • 28 Weeks
|
|
General disorders
Injection site reaction
|
0.00%
0/51 • 28 Weeks
|
2.1%
1/48 • 28 Weeks
|
|
Infections and infestations
Influenza
|
2.0%
1/51 • 28 Weeks
|
0.00%
0/48 • 28 Weeks
|
|
Infections and infestations
Viral diarrhoea
|
2.0%
1/51 • 28 Weeks
|
0.00%
0/48 • 28 Weeks
|
|
Metabolism and nutrition disorders
Dehydration
|
2.0%
1/51 • 28 Weeks
|
0.00%
0/48 • 28 Weeks
|
Other adverse events
| Measure |
Tildrakizumab 100mg
n=51 participants at risk
Subjects received Tildrakizumab 100 mg up to week 16
|
Placebo
n=48 participants at risk
Subjects received placebo up to Week 28
|
|---|---|---|
|
Infections and infestations
COVID-19
|
7.8%
4/51 • 28 Weeks
|
8.3%
4/48 • 28 Weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
7.8%
4/51 • 28 Weeks
|
2.1%
1/48 • 28 Weeks
|
|
Infections and infestations
Cellulitis
|
3.9%
2/51 • 28 Weeks
|
2.1%
1/48 • 28 Weeks
|
|
Infections and infestations
Urinary tract infection
|
5.9%
3/51 • 28 Weeks
|
0.00%
0/48 • 28 Weeks
|
|
Infections and infestations
Viral upper respiratory tract infection
|
2.0%
1/51 • 28 Weeks
|
4.2%
2/48 • 28 Weeks
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/51 • 28 Weeks
|
4.2%
2/48 • 28 Weeks
|
|
Infections and infestations
Hordeolum
|
3.9%
2/51 • 28 Weeks
|
0.00%
0/48 • 28 Weeks
|
|
Infections and infestations
Influenza
|
2.0%
1/51 • 28 Weeks
|
2.1%
1/48 • 28 Weeks
|
|
Infections and infestations
Tooth abscess
|
2.0%
1/51 • 28 Weeks
|
2.1%
1/48 • 28 Weeks
|
|
Infections and infestations
Bronchitis
|
0.00%
0/51 • 28 Weeks
|
2.1%
1/48 • 28 Weeks
|
|
Infections and infestations
Chlamydial infection
|
2.0%
1/51 • 28 Weeks
|
0.00%
0/48 • 28 Weeks
|
|
Infections and infestations
Pneumonia
|
0.00%
0/51 • 28 Weeks
|
2.1%
1/48 • 28 Weeks
|
|
Infections and infestations
Pseudomonas infection
|
2.0%
1/51 • 28 Weeks
|
0.00%
0/48 • 28 Weeks
|
|
Infections and infestations
Pyuria
|
2.0%
1/51 • 28 Weeks
|
0.00%
0/48 • 28 Weeks
|
|
Infections and infestations
Rhinitis
|
2.0%
1/51 • 28 Weeks
|
0.00%
0/48 • 28 Weeks
|
|
Infections and infestations
Staphylococcal skin infection
|
0.00%
0/51 • 28 Weeks
|
2.1%
1/48 • 28 Weeks
|
|
Infections and infestations
Tooth infection
|
0.00%
0/51 • 28 Weeks
|
2.1%
1/48 • 28 Weeks
|
|
Infections and infestations
Viral diarrhoea
|
2.0%
1/51 • 28 Weeks
|
0.00%
0/48 • 28 Weeks
|
|
Infections and infestations
Viral infection
|
2.0%
1/51 • 28 Weeks
|
0.00%
0/48 • 28 Weeks
|
|
Infections and infestations
Wound infection
|
2.0%
1/51 • 28 Weeks
|
0.00%
0/48 • 28 Weeks
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.00%
0/51 • 28 Weeks
|
2.1%
1/48 • 28 Weeks
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
2.0%
1/51 • 28 Weeks
|
0.00%
0/48 • 28 Weeks
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/51 • 28 Weeks
|
2.1%
1/48 • 28 Weeks
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/51 • 28 Weeks
|
2.1%
1/48 • 28 Weeks
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.00%
0/51 • 28 Weeks
|
2.1%
1/48 • 28 Weeks
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
2.0%
1/51 • 28 Weeks
|
0.00%
0/48 • 28 Weeks
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/51 • 28 Weeks
|
2.1%
1/48 • 28 Weeks
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
2.0%
1/51 • 28 Weeks
|
0.00%
0/48 • 28 Weeks
|
|
Vascular disorders
Hypertension
|
3.9%
2/51 • 28 Weeks
|
4.2%
2/48 • 28 Weeks
|
|
Gastrointestinal disorders
Constipation
|
2.0%
1/51 • 28 Weeks
|
0.00%
0/48 • 28 Weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
2.0%
1/51 • 28 Weeks
|
0.00%
0/48 • 28 Weeks
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.00%
0/51 • 28 Weeks
|
2.1%
1/48 • 28 Weeks
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
3.9%
2/51 • 28 Weeks
|
0.00%
0/48 • 28 Weeks
|
|
Skin and subcutaneous tissue disorders
Onychoclasis
|
2.0%
1/51 • 28 Weeks
|
0.00%
0/48 • 28 Weeks
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/51 • 28 Weeks
|
2.1%
1/48 • 28 Weeks
|
|
Injury, poisoning and procedural complications
Injection related reaction
|
2.0%
1/51 • 28 Weeks
|
0.00%
0/48 • 28 Weeks
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
2.0%
1/51 • 28 Weeks
|
0.00%
0/48 • 28 Weeks
|
|
Nervous system disorders
Headache
|
2.0%
1/51 • 28 Weeks
|
0.00%
0/48 • 28 Weeks
|
|
Nervous system disorders
Migraine
|
0.00%
0/51 • 28 Weeks
|
2.1%
1/48 • 28 Weeks
|
|
Blood and lymphatic system disorders
Neutropenia
|
2.0%
1/51 • 28 Weeks
|
0.00%
0/48 • 28 Weeks
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/51 • 28 Weeks
|
2.1%
1/48 • 28 Weeks
|
|
General disorders
Injection site rash
|
0.00%
0/51 • 28 Weeks
|
2.1%
1/48 • 28 Weeks
|
|
Immune system disorders
Allergy to chemicals
|
2.0%
1/51 • 28 Weeks
|
0.00%
0/48 • 28 Weeks
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/51 • 28 Weeks
|
2.1%
1/48 • 28 Weeks
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/51 • 28 Weeks
|
2.1%
1/48 • 28 Weeks
|
|
Psychiatric disorders
Anxiety
|
2.0%
1/51 • 28 Weeks
|
0.00%
0/48 • 28 Weeks
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
2.0%
1/51 • 28 Weeks
|
0.00%
0/48 • 28 Weeks
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
2.0%
1/51 • 28 Weeks
|
0.00%
0/48 • 28 Weeks
|
Additional Information
Head-Regulatory Affairs
Sun Pharmaceutical Industries Limited
Phone: 2266455645
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place