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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03897088




Registration number
NCT03897088
Ethics application status
Date submitted
27/03/2019
Date registered
1/04/2019

Titles & IDs
Public title
Efficacy and Safety of Tildrakizumab in the Treatment of Scalp Psoriasis
Scientific title
A Multicenter, Randomized, Double Blind, Placebo Controlled Clinical Study to Assess the Efficacy and Safety of Tildrakizumab in the Treatment of Moderate to Severe Plaque Psoriasis of the Scalp
Secondary ID [1] 0 0
TILD-18-20
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Scalp Psoriasis 0 0
Condition category
Condition code
Skin 0 0 0 0
Dermatological conditions
Skin 0 0 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - PART 1: Double-blind Placebo-controlled
Treatment: Drugs - PART 2: Double-blind Active Treatment Extension

Experimental: Tildrakizumab -

Placebo comparator: Placebo -

No intervention: PART 3: Observational Safety Follow-up - The subjects will not receive study treatment during the follow-up period


Treatment: Drugs: PART 1: Double-blind Placebo-controlled
all eligible subjects will receive either tildrakizumab or placebo

Treatment: Drugs: PART 2: Double-blind Active Treatment Extension
subjects initially on placebo will be switched over to receive tildrakizumab while subjects initially on tildrakizumab will continue to receive tildrakizumab as per defined schedule
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The Proportion of Subjects With Investigator Global Assessment Mod 2011 (Scalp) Score of "Clear" and "Almost Clear" With at Least 2-point Reduction From Baseline at Week 16
Timepoint [1] 0 0
Week 16
Primary outcome [2] 0 0
The Percentage of Subjects With Incidence, Seriousness and Severity of All Adverse Events.
Timepoint [2] 0 0
Week 72
Primary outcome [3] 0 0
The Percentage of Subjects With Severe Infections, Whether or Not Reported as a Serious Event
Timepoint [3] 0 0
Week 72
Primary outcome [4] 0 0
The Percentage of Subjects With Malignancies (Excluding Carcinoma in Situ of the Cervix).
Timepoint [4] 0 0
Week 72
Primary outcome [5] 0 0
The Percentage of Subjects With Melanoma Skin Cancer.
Timepoint [5] 0 0
Week 72
Primary outcome [6] 0 0
The Percentage of Subjects With Major Adverse Cardiovascular Events
Timepoint [6] 0 0
Week 72
Primary outcome [7] 0 0
The Percentage of Subjects With Study Treatment-related Hypersensitivity Reactions (eg, Anaphylaxis, Urticaria, Angioedema, Etc.).
Timepoint [7] 0 0
Week 72
Primary outcome [8] 0 0
The Percentage of Subjects With Injection Site Reactions (eg, Pain, Erythema, Edema Etc).
Timepoint [8] 0 0
Week 72
Primary outcome [9] 0 0
The Percentage of Subjects With Non-melanoma Skin Cancer
Timepoint [9] 0 0
Week 72
Secondary outcome [1] 0 0
The Proportion of Subjects With at Least 90% Improvement From Baseline in the Psoriasis Scalp Severity Index at Week 16
Timepoint [1] 0 0
Week 16
Secondary outcome [2] 0 0
Mean Percentage Change in Psoriasis Scalp Severity Index Score From Baseline to Week 16.
Timepoint [2] 0 0
Week 16
Secondary outcome [3] 0 0
The Proportion of Subjects Achieving Psoriasis Scalp Severity Index 75 at Week 16
Timepoint [3] 0 0
Week 16
Secondary outcome [4] 0 0
The Proportion of Subjects Achieving Psoriasis Scalp Severity Index 100 at Week 16
Timepoint [4] 0 0
Week 16
Secondary outcome [5] 0 0
Mean Percentage Change in Scalp Surface Area (SSA) Involvement From Baseline to Week 16
Timepoint [5] 0 0
Week 16
Secondary outcome [6] 0 0
Time to 75% Reduction in Psoriasis Scalp Severity Index During 16-week Placebo-controlled Treatment Period.
Timepoint [6] 0 0
Week 16
Secondary outcome [7] 0 0
Time to Investigator Global Assessment Mod 2011 (Scalp ) Response During the 16-week Placebo-controlled Treatment Period.
Timepoint [7] 0 0
Week 16
Secondary outcome [8] 0 0
Proportion of Subjects Achieving a 4-point Reduction in Itch Numeric Rating Scale Score From Baseline to Week 16
Timepoint [8] 0 0
Week 16
Secondary outcome [9] 0 0
The Proportion of Subjects Achieving Psoriasis Area and Severity Index (PASI) 75, Psoriasis Area and Severity Index 90, and Psoriasis Area and Severity Index 100 at Week 16
Timepoint [9] 0 0
Week 16
Secondary outcome [10] 0 0
The Proportion of Subjects With Physician's Global Assessment Score (Whole Body) Score of "Clear" or "Almost Clear" With at Least a 2-point Reduction From Baseline to Week 16
Timepoint [10] 0 0
Week 16
Secondary outcome [11] 0 0
Mean Percentage Change in Total Body Surface Area (BSA) Involvement From Baseline to Week 16
Timepoint [11] 0 0
Week 16
Secondary outcome [12] 0 0
The Proportion of Subjects With Investigator Global Assessment (Scalp Only) Score of "Clear" and "Almost Clear" With at Least 2-point Reduction From Baseline at Week 16.
Timepoint [12] 0 0
Week 16
Secondary outcome [13] 0 0
The Proportion of Subjects With Investigator Global Assessment Mod 2011 Score (Whole Body) of "Clear" and "Almost Clear" With at Least 2-point Reduction From Baseline at Week 16
Timepoint [13] 0 0
Week 16
Secondary outcome [14] 0 0
The Proportion of Subjects With IGA Mod 2011 (Scalp) Score of "Clear" and "Almost Clear" With at Least 2-point Reduction From Baseline
Timepoint [14] 0 0
Week 12
Secondary outcome [15] 0 0
The Proportion of Subjects With at Least 90% Improvement From Baseline in the Psoriasis Scalp Severity Index
Timepoint [15] 0 0
week 12
Secondary outcome [16] 0 0
Change in Investigator Global Assessment Mod 2011 (Scalp) From Baseline at Week 52
Timepoint [16] 0 0
Week 52
Secondary outcome [17] 0 0
Change in IGA Mod 2011 (Whole-body) From Baseline at Week 52
Timepoint [17] 0 0
Week 52
Secondary outcome [18] 0 0
Mean Change in Psoriasis Scalp Severity Index Score From Baseline at Week 52
Timepoint [18] 0 0
Week 52
Secondary outcome [19] 0 0
Change From Baseline in Investigator Global Assessment (Scalp Only) at Week 52
Timepoint [19] 0 0
Week 52
Secondary outcome [20] 0 0
Change From Baseline in Scalp Itch Numeric Rating Scale (NRS) Score at Week 52
Timepoint [20] 0 0
Week 52
Secondary outcome [21] 0 0
Mean Change in PASI Score From Baseline at Week 52
Timepoint [21] 0 0
Week 52
Secondary outcome [22] 0 0
Change in Physician Global Assessment for Skin (Whole Body) From Baseline at Week 52
Timepoint [22] 0 0
Week 52

Eligibility
Key inclusion criteria
1. Subjects should be 18 years or older at the time of signing the informed consent during the Screening visit.
2. Subjects with a clinical diagnosis of chronic plaque psoriasis of at least 6 months (as determined by-subject interview and confirmation of diagnosis through physical examination by Investigator).
3. Subjects must have moderate to severe plaque psoriasis of the scalp at Screening and at Baseline, defined by:

* Scalp Investigator Global Assessment (IGA) of =3
* Psoriasis Scalp Severity Index (PSSI) score of =12
* =30% or scalp surface area affected.
4. Subject must have moderate to severe plaque psoriasis at Screening and Baseline defined by

* Physician Global Assessment for Skin (PGA-S) of at least moderate severity (score of =3 on a 5-pointer scale)
* PASI score of =12
* Body Surface Area (BSA) involvement of >10%
5. Subjects must be considered candidates for systemic therapy, meaning scalp psoriasis inadequately controlled by topical treatments (corticosteroids), and/or phototherapy, and/or previous systemic therapy.
6. Subjects has a negative evaluation for tuberculosis (TB) within 4 weeks before initiating study treatment, defined as a negative QuantiFERON® test. Subjects with a positive or 2 successive indeterminate. QuantiFERON® tests are allowed if they have all of the following:

* No history of active TB or symptoms of TB.
* A posterior-anterior chest radiogram (with associated report available at study center) performed within 3 months of Screening with no evidence of active TB (or of any other pulmonary infectious diseases).
* If prior latent TB infection (LTBI), must have history of adequate prophylaxis (per local standard of care).
* If presence of LTBI is established, then treatment according to local country guidelines must have been followed for 4 weeks prior to inclusion in the study.

A maximum of 2 QuantiFERON® tests are allowed. A re-test is only permitted if the first is indeterminate; the result of the second test will then be used.
7. Subjects are unlikely to conceive, as indicated by at least one "Yes" answer to the following questions:

* Subject is a male.
* Subject is a female and agrees to abstain from heterosexual activity OR use a highly effective method of contraception as per Appendix 7.
* Male subjects with female partners of childbearing potential who are not using birth control as described above must use a barrier method of contraception (eg, condom) if not surgically sterile (ie, vasectomy).
* Subject is a surgically sterilized female or is documented to be postmenopausal. For contraceptive guidance see Appendix 7.
8. For women of childbearing potential, a negative serum pregnancy test at Screening and a negative urine pregnancy test within 24 hours prior to Day 1 and on subsequent visits at which study treatment doses are scheduled.
9. Subjects must have results of a physical examination within normal limits or clinically acceptable limits to the Investigator prior to Day 1. The Investigator is encouraged to consult with the Medical Monitor (or appropriate designee) if there are questions regarding the significance of any out-of-range values.
10. Subjects must be capable of giving signed informed consent as described in Appendix 2, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Subjects who have laboratory abnormalities at Screening including any of the following:

* Alanine aminotransferase or aspartate aminotransferase =2.5 × the upper limit of normal
* Creatinine =2 × the upper limit of normal
* Serum direct bilirubin =1.5 mg/dL
* White blood cell count <3.0×103/µL
* Any other laboratory abnormality, which, in the opinion of the Investigator, will prevent the subject from completing the study or will interfere with the interpretation of the study results.
2. Subjects who have predominantly non-plaque forms of psoriasis specifically erythrodermic psoriasis, predominantly pustular psoriasis, medication-induced or medication-exacerbated psoriasis, or new-onset guttate psoriasis.
3. Women of childbearing potential who are pregnant, intend to become pregnant (within 6 months of completing the study), or are lactating.
4. Subjects with any infection or history of recurrent infection requiring treatment with systemic antibiotics within 2 weeks prior to Screening, or severe infection (eg, pneumonia, cellulitis, bone or joint infections) requiring hospitalization or treatment with intravenous (IV) antibiotics within 6 weeks prior to Screening.
5. Subjects with any previous use of tildrakizumab or other IL-23/Th-17 pathway inhibitors, including p40, p19 and IL-17 antagonists for psoriasis.

• Prior use of TNF-alpha inhibitors with a wash-out period of 12 weeks would be allowed. However, the number of subjects with prior use of TNF-alpha inhibitors would be capped at 40% and the analysis will be stratified based on prior use of these biologics.
6. Subjects with a positive human immunodeficiency virus test result, hepatitis B surface antigen, or hepatitis C virus test result.
7. Subjects with a prior malignancy or concurrent malignancy (excluding successfully treated basal cell carcinoma, squamous cell carcinoma of the skin in situ, squamous cell carcinoma of skin with no evidence of recurrence within 5 years or carcinoma in situ of the cervix that has been adequately treated).
8. Subjects who have received live viral or bacterial vaccination within 4-weeks prior to Baseline or who intend to receive live viral or bacterial vaccination during the study.
9. Subjects who are currently participating in another interventional clinical study or has participated in an interventional clinical study within 5-half-lives (of the drug) to wash-out prior to randomization (Subjects participating in observational studies or non-interventional registry studies may be included in the study).
10. Subjects or a family member is among the personnel of the study center or Sponsor/designee staff directly involved with this study.
11. Subjects who have any concomitant medical condition which in the opinion of the Investigator could affect the study outcome or present an unacceptable risk.
12. Subjects who were hospitalized due to an acute cardiovascular event (such as myocardial infarction, cerebrovascular accident, cardiovascular illness [eg, angina pectoris], or cardiovascular surgery [such as coronary artery bypass grafting]) within 6 months before Screening.
13. Subjects who, in the opinion of the Investigator, will not be a reliable participant in the study and those who can confound the results of the study.
14. Subjects who have a history of alcohol or drug abuse in the previous year.
15. Subjects who have high risk of suicidality at the Screening assessment based on Investigator's judgment or, if appropriate, as indicated by a response of "yes" within the last 12 months to Questions 4 or 5 in the suicidal ideation section, or any positive response in the behavioral section of the Columbia-Suicide Severity Rating Scale
16. Subjects with any other clinically significant laboratory abnormality, which, in the opinion of the Investigator, will prevent the subject from completing the study or will interfere with the interpretation of the study results.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
29/03/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
17/02/2022
Sample size
Target
Accrual to date
Final
231
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
SPARC Site 23 - Kogarah
Recruitment hospital [2] 0 0
SPARC Site 27 - Kogarah
Recruitment hospital [3] 0 0
SPARC Site 26 - Woolloongabba
Recruitment hospital [4] 0 0
SPARC Site 25 - Carlton
Recruitment hospital [5] 0 0
SPARC Site 24 - East Melbourne
Recruitment hospital [6] 0 0
SPARC Site 22 - Fremantle
Recruitment postcode(s) [1] 0 0
2217 - Kogarah
Recruitment postcode(s) [2] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [3] 0 0
3053 - Carlton
Recruitment postcode(s) [4] 0 0
3002 - East Melbourne
Recruitment postcode(s) [5] 0 0
6160 - Fremantle
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
New Jersey
Country [4] 0 0
United States of America
State/province [4] 0 0
New York
Country [5] 0 0
United States of America
State/province [5] 0 0
Ohio
Country [6] 0 0
United States of America
State/province [6] 0 0
Oregon
Country [7] 0 0
United States of America
State/province [7] 0 0
Rhode Island
Country [8] 0 0
United States of America
State/province [8] 0 0
Texas

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Sun Pharmaceutical Industries Limited
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT03897088