Trial Outcomes & Findings for Efficacy and Safety Study of Tildrakizumab in the Treatment of Nail Psoriasis (NCT NCT03897075)

NCT ID: NCT03897075

Last Updated: 2026-04-01

Results Overview

Primary Efficacy Endpoint

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

99 participants

Primary outcome timeframe

Week 28

Results posted on

2026-04-01

Participant Flow

Participant milestones

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

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=5 Participants
46.4 years
STANDARD_DEVIATION 13.43 • n=10 Participants
Sex: Female, Male
Female
16 Participants
n=5 Participants
13 Participants
n=5 Participants
29 Participants
n=10 Participants
Sex: Female, Male
Male
32 Participants
n=5 Participants
38 Participants
n=5 Participants
70 Participants
n=10 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
20 Participants
n=5 Participants
18 Participants
n=5 Participants
38 Participants
n=10 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
28 Participants
n=5 Participants
33 Participants
n=5 Participants
61 Participants
n=10 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
0 Participants
n=5 Participants
0 Participants
n=10 Participants

PRIMARY outcome

Timeframe: Week 28

Primary Efficacy Endpoint

Outcome measures

Outcome measures
Measure
Tildrakizumab 100 mg
n=51 Participants
Subjects received Tildrakizumab 100 mg up to week 52
Placebo
n=48 Participants
Subjects received placebo up to Week 28. At Week 28, participants initially randomized to placebo switched over to receive Tildrakizumab 100 mg.
The Proportion of Subjects Who Achieve at Least a 75% Improvement From Baseline in Total mNAPSI at Week 28.
0.255 proportion of subjects
0.042 proportion of subjects

SECONDARY outcome

Timeframe: Week 28

Outcome measures

Outcome measures
Measure
Tildrakizumab 100 mg
n=51 Participants
Subjects received Tildrakizumab 100 mg up to week 52
Placebo
n=48 Participants
Subjects received placebo up to Week 28. At Week 28, participants initially randomized to placebo switched over to receive Tildrakizumab 100 mg.
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.
0.294 Proportion of subjects
0.042 Proportion of subjects

SECONDARY outcome

Timeframe: Week 28

Population: The number of subjects analysed represents the Intent-to-Treat population with baseline nail pain NRS ≥ 3

Outcome measures

Outcome measures
Measure
Tildrakizumab 100 mg
n=33 Participants
Subjects received Tildrakizumab 100 mg up to week 52
Placebo
n=35 Participants
Subjects received placebo up to Week 28. At Week 28, participants initially randomized to placebo switched over to receive Tildrakizumab 100 mg.
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
0.455 proportion of subjects
0.257 proportion of subjects

OTHER_PRE_SPECIFIED outcome

Timeframe: Week 72

Primary Safety Endpoint. Total Number Affected by serious and non-serious adverse events from Baseline through Week 72

Outcome measures

Outcome measures
Measure
Tildrakizumab 100 mg
n=51 Participants
Subjects received Tildrakizumab 100 mg up to week 52
Placebo
n=48 Participants
Subjects received placebo up to Week 28. At Week 28, participants initially randomized to placebo switched over to receive Tildrakizumab 100 mg.
The Percentage of Subjects With Incidence, Seriousness, and Severity of All Adverse Events.
Subjects with any TEAE
54.9 percentage of participants
39.6 percentage of participants
The Percentage of Subjects With Incidence, Seriousness, and Severity of All Adverse Events.
Subjects with any Serious TEAE
5.9 percentage of participants
4.2 percentage of participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Week 52

Primary Safety Endpoint.

Outcome measures

Outcome measures
Measure
Tildrakizumab 100 mg
n=48 Participants
Subjects received Tildrakizumab 100 mg up to week 52
Placebo
n=51 Participants
Subjects received placebo up to Week 28. At Week 28, participants initially randomized to placebo switched over to receive Tildrakizumab 100 mg.
The Percentage of Subjects With Severe Infections Whether or Not Reported as a Serious Event Defined as Any Infection Meeting the Regulatory Definition of a Serious Adverse Event, or Any Infection Requiring Intravenous Antibiotics.
0 percentage of participant
0 percentage of participant

OTHER_PRE_SPECIFIED outcome

Timeframe: Week 52

Primary Safety Endpoint

Outcome measures

Outcome measures
Measure
Tildrakizumab 100 mg
n=51 Participants
Subjects received Tildrakizumab 100 mg up to week 52
Placebo
n=48 Participants
Subjects received placebo up to Week 28. At Week 28, participants initially randomized to placebo switched over to receive Tildrakizumab 100 mg.
The Percentage of Subjects With Malignancies (Excluding Carcinoma in Situ of the Cervix).
0 percentage of participants
2.1 percentage of participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Week 52

Primary Safety Endpoint

Outcome measures

Outcome measures
Measure
Tildrakizumab 100 mg
n=51 Participants
Subjects received Tildrakizumab 100 mg up to week 52
Placebo
n=48 Participants
Subjects received placebo up to Week 28. At Week 28, participants initially randomized to placebo switched over to receive Tildrakizumab 100 mg.
The Percentage of Subjects With Non-melanoma Skin Cancer.
0 percentage of participants
0 percentage of participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Week 52

Primary Safety Endpoint

Outcome measures

Outcome measures
Measure
Tildrakizumab 100 mg
n=51 Participants
Subjects received Tildrakizumab 100 mg up to week 52
Placebo
n=48 Participants
Subjects received placebo up to Week 28. At Week 28, participants initially randomized to placebo switched over to receive Tildrakizumab 100 mg.
The Percentage of Subjects With Major Adverse Cardiovascular Events.
0 percentage of participants
0 percentage of participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Week 52

Primary Safety Endpoint

Outcome measures

Outcome measures
Measure
Tildrakizumab 100 mg
n=51 Participants
Subjects received Tildrakizumab 100 mg up to week 52
Placebo
n=48 Participants
Subjects received placebo up to Week 28. At Week 28, participants initially randomized to placebo switched over to receive Tildrakizumab 100 mg.
The Percentage of Subjects With Melanoma Skin Cancer.
0 percentage of participants
0 percentage of participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Week 52

Primary Safety Endpoint

Outcome measures

Outcome measures
Measure
Tildrakizumab 100 mg
n=51 Participants
Subjects received Tildrakizumab 100 mg up to week 52
Placebo
n=48 Participants
Subjects received placebo up to Week 28. At Week 28, participants initially randomized to placebo switched over to receive Tildrakizumab 100 mg.
The Percentage of Subjects With Injection Site Reactions (eg. Pain, Erythema, Edema Etc)
2.0 percentage of participants
4.2 percentage of participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Week 52

Primary Safety Endpoint

Outcome measures

Outcome measures
Measure
Tildrakizumab 100 mg
n=51 Participants
Subjects received Tildrakizumab 100 mg up to week 52
Placebo
n=48 Participants
Subjects received placebo up to Week 28. At Week 28, participants initially randomized to placebo switched over to receive Tildrakizumab 100 mg.
The Percentage of Subjects With Study Treatment Related Hypersensitivity Reactions (eg, Anaphylaxis, Urticaria, Angioedema, Etc).
0 percentage of participants
0 percentage of participants

Adverse Events

Tildrakizumab 100mg

Serious events: 3 serious events
Other events: 28 other events
Deaths: 0 deaths

Placebo

Serious events: 2 serious events
Other events: 19 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Tildrakizumab 100mg
n=51 participants at risk
Subjects received Tildrakizumab 100 mg up to week 52
Placebo
n=48 participants at risk
Subjects received placebo up to Week 28. At Week 28, participants initially randomized to placebo switched over to receive Tildrakizumab 100 mg.
Renal and urinary disorders
Nephrolithiasis
2.0%
1/51 • 72 Weeks
0.00%
0/48 • 72 Weeks
Renal and urinary disorders
Renal injury
2.0%
1/51 • 72 Weeks
0.00%
0/48 • 72 Weeks
Renal and urinary disorders
Ureteric rupture
2.0%
1/51 • 72 Weeks
0.00%
0/48 • 72 Weeks
General disorders
Injection site reaction
0.00%
0/51 • 72 Weeks
2.1%
1/48 • 72 Weeks
Infections and infestations
Influenza
2.0%
1/51 • 72 Weeks
0.00%
0/48 • 72 Weeks
Infections and infestations
Viral diarrhoea
2.0%
1/51 • 72 Weeks
0.00%
0/48 • 72 Weeks
Metabolism and nutrition disorders
Dehydration
2.0%
1/51 • 72 Weeks
0.00%
0/48 • 72 Weeks
Infections and infestations
Kidney infection
2.0%
1/51 • 72 Weeks
0.00%
0/48 • 72 Weeks
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer metastatic
0.00%
0/51 • 72 Weeks
2.1%
1/48 • 72 Weeks
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive breast carcinoma
0.00%
0/51 • 72 Weeks
2.1%
1/48 • 72 Weeks

Other adverse events

Other adverse events
Measure
Tildrakizumab 100mg
n=51 participants at risk
Subjects received Tildrakizumab 100 mg up to week 52
Placebo
n=48 participants at risk
Subjects received placebo up to Week 28. At Week 28, participants initially randomized to placebo switched over to receive Tildrakizumab 100 mg.
Injury, poisoning and procedural complications
Injection related reaction
2.0%
1/51 • 72 Weeks
0.00%
0/48 • 72 Weeks
Injury, poisoning and procedural complications
Ligament sprain
2.0%
1/51 • 72 Weeks
0.00%
0/48 • 72 Weeks
Nervous system disorders
Headache
2.0%
1/51 • 72 Weeks
0.00%
0/48 • 72 Weeks
Nervous system disorders
Migraine
0.00%
0/51 • 72 Weeks
2.1%
1/48 • 72 Weeks
Blood and lymphatic system disorders
Neutropenia
2.0%
1/51 • 72 Weeks
0.00%
0/48 • 72 Weeks
Cardiac disorders
Tachycardia
0.00%
0/51 • 72 Weeks
4.2%
2/48 • 72 Weeks
General disorders
Injection site rash
0.00%
0/51 • 72 Weeks
2.1%
1/48 • 72 Weeks
Immune system disorders
Allergy to chemicals
2.0%
1/51 • 72 Weeks
0.00%
0/48 • 72 Weeks
Investigations
Alanine aminotransferase increased
0.00%
0/51 • 72 Weeks
2.1%
1/48 • 72 Weeks
Musculoskeletal and connective tissue disorders
Neck pain
0.00%
0/51 • 72 Weeks
2.1%
1/48 • 72 Weeks
Psychiatric disorders
Anxiety
2.0%
1/51 • 72 Weeks
0.00%
0/48 • 72 Weeks
Reproductive system and breast disorders
Benign prostatic hyperplasia
2.0%
1/51 • 72 Weeks
0.00%
0/48 • 72 Weeks
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
2.0%
1/51 • 72 Weeks
0.00%
0/48 • 72 Weeks
Infections and infestations
Bacterial labyrinthitis
2.0%
1/51 • 72 Weeks
0.00%
0/48 • 72 Weeks
Infections and infestations
Ear infection
2.0%
1/51 • 72 Weeks
0.00%
0/48 • 72 Weeks
Infections and infestations
Gastroenteritis viral
2.0%
1/51 • 72 Weeks
0.00%
0/48 • 72 Weeks
Infections and infestations
Lower respiratory tract infection
2.0%
1/51 • 72 Weeks
0.00%
0/48 • 72 Weeks
Infections and infestations
Nasopharyngitis
0.00%
0/51 • 72 Weeks
2.1%
1/48 • 72 Weeks
Infections and infestations
Otitis media
2.0%
1/51 • 72 Weeks
0.00%
0/48 • 72 Weeks
Infections and infestations
Pharyngitis
2.0%
1/51 • 72 Weeks
0.00%
0/48 • 72 Weeks
Infections and infestations
Pharyngitis streptococcal
0.00%
0/51 • 72 Weeks
2.1%
1/48 • 72 Weeks
Infections and infestations
Respiratory tract infection
0.00%
0/51 • 72 Weeks
2.1%
1/48 • 72 Weeks
Infections and infestations
Viral pharyngitis
0.00%
0/51 • 72 Weeks
2.1%
1/48 • 72 Weeks
Infections and infestations
Metabolism and nutrition disorders
5.9%
3/51 • 72 Weeks
12.5%
6/48 • 72 Weeks
Infections and infestations
Skin and subcutaneous tissue disorders
9.8%
5/51 • 72 Weeks
4.2%
2/48 • 72 Weeks
Skin and subcutaneous tissue disorders
Alopecia
2.0%
1/51 • 72 Weeks
0.00%
0/48 • 72 Weeks
Skin and subcutaneous tissue disorders
Dermatitis contact
0.00%
0/51 • 72 Weeks
2.1%
1/48 • 72 Weeks
Skin and subcutaneous tissue disorders
Rosacea
2.0%
1/51 • 72 Weeks
0.00%
0/48 • 72 Weeks
Infections and infestations
Injury, poisoning and procedural complications
5.9%
3/51 • 72 Weeks
4.2%
2/48 • 72 Weeks
Injury, poisoning and procedural complications
Epicondylitis
2.0%
1/51 • 72 Weeks
0.00%
0/48 • 72 Weeks
Injury, poisoning and procedural complications
Limb injury
0.00%
0/51 • 72 Weeks
2.1%
1/48 • 72 Weeks
Injury, poisoning and procedural complications
Tooth fracture
0.00%
0/51 • 72 Weeks
2.1%
1/48 • 72 Weeks
Injury, poisoning and procedural complications
Vaccination complication
0.00%
0/51 • 72 Weeks
2.1%
1/48 • 72 Weeks
Infections and infestations
Gastrointestinal disorders
3.9%
2/51 • 72 Weeks
4.2%
2/48 • 72 Weeks
Gastrointestinal disorders
Gastrooesophageal reflux disease
0.00%
0/51 • 72 Weeks
2.1%
1/48 • 72 Weeks
Infections and infestations
Vascular disorders
3.9%
2/51 • 72 Weeks
4.2%
2/48 • 72 Weeks
Infections and infestations
Investigations
3.9%
2/51 • 72 Weeks
2.1%
1/48 • 72 Weeks
Infections and infestations
Blood creatine phosphokinase increased
2.0%
1/51 • 72 Weeks
0.00%
0/48 • 72 Weeks
Investigations
Blood triglycerides increased
2.0%
1/51 • 72 Weeks
0.00%
0/48 • 72 Weeks
Infections and infestations
Cardiac disorders
0.00%
0/51 • 72 Weeks
4.2%
2/48 • 72 Weeks
Infections and infestations
Musculoskeletal and connective tissue disorders
2.0%
1/51 • 72 Weeks
2.1%
1/48 • 72 Weeks
Musculoskeletal and connective tissue disorders
Arthritis
2.0%
1/51 • 72 Weeks
0.00%
0/48 • 72 Weeks
Musculoskeletal and connective tissue disorders
Costochondritis
0.00%
0/51 • 72 Weeks
2.1%
1/48 • 72 Weeks
Musculoskeletal and connective tissue disorders
Tendon disorder
2.0%
1/51 • 72 Weeks
0.00%
0/48 • 72 Weeks
Psychiatric disorders
Nightmare
2.0%
1/51 • 72 Weeks
0.00%
0/48 • 72 Weeks
Respiratory, thoracic and mediastinal disorders
Emphysema
2.0%
1/51 • 72 Weeks
0.00%
0/48 • 72 Weeks
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
2.0%
1/51 • 72 Weeks
0.00%
0/48 • 72 Weeks
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin cancer
2.0%
1/51 • 72 Weeks
0.00%
0/48 • 72 Weeks
Infections and infestations
Tooth abscess
2.0%
1/51 • 72 Weeks
2.1%
1/48 • 72 Weeks
Infections and infestations
Bronchitis
0.00%
0/51 • 72 Weeks
2.1%
1/48 • 72 Weeks
Infections and infestations
Chlamydial infection
2.0%
1/51 • 72 Weeks
0.00%
0/48 • 72 Weeks
Infections and infestations
Pneumonia
0.00%
0/51 • 72 Weeks
2.1%
1/48 • 72 Weeks
Infections and infestations
Pseudomonas infection
2.0%
1/51 • 72 Weeks
0.00%
0/48 • 72 Weeks
Infections and infestations
Pyuria
2.0%
1/51 • 72 Weeks
0.00%
0/48 • 72 Weeks
Infections and infestations
Rhinitis
2.0%
1/51 • 72 Weeks
0.00%
0/48 • 72 Weeks
Infections and infestations
Staphylococcal skin infection
0.00%
0/51 • 72 Weeks
2.1%
1/48 • 72 Weeks
Infections and infestations
Tooth infection
0.00%
0/51 • 72 Weeks
2.1%
1/48 • 72 Weeks
Infections and infestations
Viral diarrhoea
2.0%
1/51 • 72 Weeks
0.00%
0/48 • 72 Weeks
Infections and infestations
Viral infection
2.0%
1/51 • 72 Weeks
0.00%
0/48 • 72 Weeks
Infections and infestations
Wound infection
2.0%
1/51 • 72 Weeks
0.00%
0/48 • 72 Weeks
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
0.00%
0/51 • 72 Weeks
2.1%
1/48 • 72 Weeks
Metabolism and nutrition disorders
Dyslipidaemia
2.0%
1/51 • 72 Weeks
0.00%
0/48 • 72 Weeks
Metabolism and nutrition disorders
Gout
0.00%
0/51 • 72 Weeks
2.1%
1/48 • 72 Weeks
Metabolism and nutrition disorders
Hypercholesterolaemia
0.00%
0/51 • 72 Weeks
2.1%
1/48 • 72 Weeks
Metabolism and nutrition disorders
Hyperlipidaemia
0.00%
0/51 • 72 Weeks
4.2%
2/48 • 72 Weeks
Metabolism and nutrition disorders
Hypertriglyceridaemia
2.0%
1/51 • 72 Weeks
0.00%
0/48 • 72 Weeks
Metabolism and nutrition disorders
Type 2 diabetes mellitus
0.00%
0/51 • 72 Weeks
6.2%
3/48 • 72 Weeks
Metabolism and nutrition disorders
Vitamin D deficiency
2.0%
1/51 • 72 Weeks
0.00%
0/48 • 72 Weeks
Vascular disorders
Hypertension
3.9%
2/51 • 72 Weeks
4.2%
2/48 • 72 Weeks
Gastrointestinal disorders
Constipation
2.0%
1/51 • 72 Weeks
2.1%
1/48 • 72 Weeks
Gastrointestinal disorders
Diarrhoea
2.0%
1/51 • 72 Weeks
0.00%
0/48 • 72 Weeks
Gastrointestinal disorders
Large intestine polyp
0.00%
0/51 • 72 Weeks
2.1%
1/48 • 72 Weeks
Skin and subcutaneous tissue disorders
Pruritus
3.9%
2/51 • 72 Weeks
0.00%
0/48 • 72 Weeks
Skin and subcutaneous tissue disorders
Onychoclasis
2.0%
1/51 • 72 Weeks
0.00%
0/48 • 72 Weeks
Skin and subcutaneous tissue disorders
Psoriasis
2.0%
1/51 • 72 Weeks
2.1%
1/48 • 72 Weeks
Infections and infestations
COVID-19
11.8%
6/51 • 72 Weeks
10.4%
5/48 • 72 Weeks
Infections and infestations
Upper respiratory tract infection
9.8%
5/51 • 72 Weeks
8.3%
4/48 • 72 Weeks
Infections and infestations
Cellulitis
3.9%
2/51 • 72 Weeks
2.1%
1/48 • 72 Weeks
Infections and infestations
Urinary tract infection
5.9%
3/51 • 72 Weeks
0.00%
0/48 • 72 Weeks
Infections and infestations
Viral upper respiratory tract infection
2.0%
1/51 • 72 Weeks
6.2%
3/48 • 72 Weeks
Infections and infestations
Gastroenteritis
0.00%
0/51 • 72 Weeks
4.2%
2/48 • 72 Weeks
Infections and infestations
Hordeolum
3.9%
2/51 • 72 Weeks
0.00%
0/48 • 72 Weeks
Infections and infestations
Influenza
3.9%
2/51 • 72 Weeks
2.1%
1/48 • 72 Weeks

Additional Information

Head-Regulatory Affairs

Sun Pharmaceutical Industries Limited

Phone: 0226645

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place