Moderate to Severe Genital PsoriasisPhase 3NCT06611163
A Study to Evaluate the Efficacy and Safety of Subcutaneous Tildrakizumab in Subjects With Moderate to Severe Genital Psoriasis.
A Phase 3 study testing Tildrakizumab 100 mg in people with Moderate to Severe Genital Psoriasis, run by Sun Pharmaceutical Industries Limited at 56 sites in 5 countries.
Trial summary
Phase 3 study to evaluate the efficacy and safety of subcutaneous Tildrakizumab in subjects with moderate to severe genital psoriasis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Moderate to Severe Genital Psoriasis
- What is being tested?
- Tildrakizumab 100 mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 206 participants
- Where
- 56 sitesin 5 countries
- Study dates
- 21 Mar 2025to Feb 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ability to understand the purpose and risks of the trial, willingness and ability to comply with the protocol, and provide written informed consent in accordance with institutional and regulatory guidelines
- Age ≥ 18 years of age at the time of signing consent
- Diagnosis of moderate to severe psoriasis of the genital area at Screening and baseline defined as modified sPGA-G score of ≥3.
- Presence of non-genital plaque psoriasis (BSA ≥1%) at both Screening and Baseline.
- Presence of psoriasis of the genital area that is inadequately controlled with topical therapy or the subject is intolerant to topical therapy
- Negative evaluation for TB within 4 weeks before initiating IMP, defined as a negative QuantiFERON test. Subjects with a positive QuantiFERON test or 2 successive indeterminate
Show all 12Show fewer
- QuantiFERON tests are allowed if they have all of the following:
- no history of active tuberculosis (TB) or symptoms of TB,
- a posteroanterior chest radiograph (with associated report available at the site) performed within 3 months of Screening with no evidence of active TB (or of any other pulmonary infectious diseases),
- if prior latent TB infection, must have history of adequate prophylaxis (per local standard of care),
- if presence of latent TB is established, then treatment according to local country guidelines must have been followed for 4 weeks, prior to dosing in the study at Visit 2-Week 0.
- A maximum of 2 QuantiFERON tests of no more than 3 weeks apart are allowed. A re-test is only permitted if the first is indeterminate; the result of the second test will then be used
Who cannot join
- Predominantly non-plaque forms of psoriasis specifically erythrodermic psoriasis, predominantly pustular psoriasis, medication-induced or medication-exacerbated psoriasis, or new-onset guttate psoriasis.
- Planned surgical intervention between Baseline and the Week 16 evaluation for a pre-treatment condition.
- Active infection or history of infections as follows:
- any active infection (bacterial, fungal or viral) for which systemic anti-infectives were used within 28 days prior to first investigational medicinal product (IMP) dose, with the last dose having been received within 7 days of Screening,
- a serious infection, defined as requiring hospitalization or intravenous (IV) anti-infectives within 8 weeks prior to the first IMP dose, with the last dose having been received within 7 days of Screening,
- recurrent or chronic infections, e.g., chronic pyelonephritis, chronic osteomyelitis, bronchiectasis, or other active infection that, in the opinion of the Investigator, might cause participation in this study to be detrimental to the subject.
- Any concurrent medical condition or uncontrolled, clinically significant systemic disease ( e.g., renal failure, heart failure, hypertension, liver disease, diabetes, or anemia) that, in the opinion of the Investigator, could jeopardize subject safety or compliance with the protocol.
Trial locations and contacts
56 sites in 5 countries.
56 sites in 5 countries
United States36 sites
Smary Cures Clinical Research
Anaheim, California, 92806
Arlington Research Center, inc.
Arlington, Texas, 76011
Dermatology Affiliates Research Institute, LLC
Atlanta, Georgia, 30305
Oakland Hills Dermatology PC
Auburn Hills, Michigan, 48326
James Song, MD (James Song)
Bellevue, Washington, 98004
The Indiana Clinical Trials Center Optima Research Boardman
Boardman, Ohio, 44512
The Derm Institute of West Michigan
Caledonia, Michigan, 49316
Coral Gables Dermatology & Aesthetics
Coral Cables, Florida, 33134
Florida Academic Centers Research and Education, LLC
Coral Gables, Florida, 33134
California Dermatology & Clinical Research Institute
Encinitas, California, 92024
T. Joseph Raoof MD, Inc./Encino Research Center
Encino, California, 91436
Center for Dermatology Clinical Research, Inc
Fremont, California, 94538
Goodlettsville Dermatology Research
Goodlettsville, Tennessee, 37072
The Moses H. Cone Memorial Hospital Operating Corporation
Greensboro, North Carolina, 27401
Hickory Dermatology Research Center, LLC
Hickory, North Carolina, 28602
Homestead Associates in Research Inc
Homestead, Florida, 33033
Center for Clinical Studies, LTD. LLP
Houston, Texas, 77004
Forest Hills Dermatology
Kew Gardens, New York, 11415
Dermatology Research Associates
Los Angeles, California, 90045
LA Universal Research Center Inc, Suite 1
Los Angeles, California, 90057
Javara Inc/ Tryon Medical Partners, PLLC
Matthews, North Carolina, 28105
Genomics Medical Research
Miami, Florida, 33157
Med-Care Research
Miami, Florida, 33165
Advanced Research Experts
Nashville, Tennessee, 37211
Equity Medical
New York, New York, 10023
Amicis Research Center
Northridge, California, 91324
Skin Specialists, PC
Omaha, Nebraska, 68144
The Indiana Clinical Trials Center
Plainfield, Indiana, 46168
Oregon Medical Research Center
Portland, Oregon, 97201
Progressive Clinical Research
San Antonio, Texas, 78213
Texas Dermatology and Laser Specialists
San Antonio, Texas, 78218
Therapeutics Clinical Research
San Diego, California, 92123
Dermatology Institute and Skin Care Center, Inc. DBA Clinical Science Institute
Santa Monica, California, 90404
Mcintosh Clinic, PC
Thomasville, Georgia, 31792
Center for Clinical Studies, LTD. LLP
Webster, Texas, 77598
Paradigm Clinical Research
Wheat Ridge, Colorado, 80033
Poland11 sites
Zdrowie Osteo-Medic s.c.
Bialystok-Podlaskie, 15-351
Care Access Holsamed Katowice
Katowice, 40-600
Centrum Medyczne \All-Med\ spolka komandytowa
Krakow, Malopolska, 30-033
Lidia Rajzer-Specjalistyczny Gabinet Dermatologiczno-Kosmetyczny
Krakow, 30-438
Luxderm Specjalistyczny Gabinet Dermatologiczny
Lublin, Lubslskie, 20-573
Clinical Best Solution Sp. z o.o Sp. k. w Lublinie
Lublin, 20-011
"Centrum Badawcze Panaceum Agnieszka Brzezicka Magdalena Lenkiewicz Sp. z o.o"
Malbork, Warmian-Masurian Voivodeship, 82-200
Uniwersytecki Szpital Kliniczny, Klinika Dermatologii
Rzeszw, Podkarpackie Voivodeship, 35-055
Clinical Best Solutions SP. Z.O.O. SP.K.
Warsaw, 00-710
Klinika Ambroziak
Warszswa, 02-953
Niepubliczny Zakladu Opieki Zdrowotnej MultiMedica s.c.
Wroclaw, Lower Silesian Voivodeship, 51-503
Georgia5 sites
JSC Curatio
Tbilisi, 144
New Vision Univestiry Hospital
Tbilisi, 159
Aversi Clinic
Tbilisi, 160
David Abuladze Clinic (DAC)
Tbilisi, 179
Raymann
Tbilisi, 186
Bulgaria2 sites
MC Medconsult-Lovech
Lovech, 5500
Medconsult Pleven
Pleven, 5800
Hungary2 sites
Allergo-Derm Bakos Kft
Baross U 20., 5000
University of Debrecen Dept of Dermatology
Debrecen, Hajdú-Bihar, H-4032
About this study
Official title: A Phase 3, Randomized, Double-blind, Placebo Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Subcutaneous Tildrakizumab in Subjects With Moderate to Severe Genital Psoriasis
Phase 3 study to evaluate the efficacy and safety of subcutaneous Tildrakizumab in subjects with moderate to severe genital psoriasis.
- Conditions
- Moderate to Severe Genital Psoriasis
- Being tested
- Tildrakizumab 100 mg, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tildrakizumab 100 mgDrug
Tildrakizumab 100 mg SC injection on Day 1, Week 4 and every 12 weeks thereafter
PlaceboDrug
Placebo SC injection at Day 1 and Week 4
| Study group | Role | What they receive |
|---|---|---|
| Tildrakizumab 100 mg | Experimental | Participants will receive Tildrakizumab 100 milligrams (mg) subcutaneous (SC) injection on Day 1, Week 4 and every 12 weeks thereafter until the end of treatment. Receives: Drug: Tildrakizumab 100 mg |
| Placebo | Placebo comparator | Participants will receive placebo SC injection at Day 1 and Week 4. Participants initially randomized to placebo will be switched to receive Tildrakizumab 100 mg at Week 16, week 20 and every 12 weeks thereafter until the end of treatment. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects with a modified sPGA-G score of clear (0) or minimal (1) with at-least a 2- point reduction from baseline
The modified sPGA-G is a 5-point scale ranging from clear (0), almost clear (1), mild (2), moderate (3), to severe (4) and incorporates an assessment of the severity of the three primary signs of the disease: erythema, elevation, and scaling. Higher scores indicate greater disease severity.
Measured: Week 16
Secondary outcomes (6)
Proportion of subjects, with a baseline score of ≥ 4, who achieve at-least 4-point improvement in weekly average genital psoriasis itch numerical rating scale [GPI-NRS] within the GPSS for subjects
The GPI-NRS is a self-reported measure where participants will assess their psoriasis symptoms in the genital area and select a number on a scale of 0-10, where 0 represents no itch, and 10 represents the worst imaginable itch.
Measured: Week 16
Mean change from baseline in the affected Body Surface Area (BSA)
The BSA will be measured using the palm method where the palm of the subject's hand (including the palmar aspect of the fingers) represents 1 % of the BSA. The affected areas are then calculated by their size compared to the subject's palm.
Measured: Week 16
Change from baseline in genital psoriasis symptoms scale [GPSS] total score and individual items scores
The GPSS contains eight items regarding genital psoriasis symptoms. The items separately address itch, pain, discomfort, stinging, burning, redness, scaling, and cracking on an 11-point scale where 0 represents ''no symptom'' and 10 represents ''worst symptom imaginable".
Each of the eight items are scored separately; in addition, a total score ranging from 0 (no genital psoriasis symptoms) to 80 (worst imaginable genital psoriasis symptoms) is reported.
Measured: Week 16
Proportion of subjects with psoriasis area and severity index [PASI] 75 response
The PASI combines the assessment of the severity of lesions and the area affected into a single score in the range 0 (no psoriasis on the body) to 72 (the most severe case of psoriasis).
Measured: Week 16
Proportion of subjects with PASI 90 response
The PASI combines the assessment of the severity of lesions and the area affected into a single score in the range 0 (no psoriasis on the body) to 72 (the most severe case of psoriasis).
Measured: Week 16
Proportion of subjects with PASI 100 response, in subjects with BSA <10%
The PASI combines the assessment of the severity of lesions and the area affected into a single score in the range 0 (no psoriasis on the body) to 72 (the most severe case of psoriasis).
Measured: Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2024
- Study start21 Mar 2025
- Primary completion21 Jan 2026
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moderate to Severe Genital PsoriasisStudies of the same condition, open and under way.
- More trials run by Sun Pharmaceutical Industries LimitedThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 206 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Pharmaceutical Industries Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06611163
- Sponsor's protocol ID
- TILD-24-01
- Other IDs
- 2024-515672-12
- Status last verified
- Jul 2026
- First submitted
- 23 Sep 2024
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Randomized, Double-blind, Placebo Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Subcutaneous Tildrakizumab in Subjects With Moderate to Severe Genital Psoriasis
- ClinicalTrials.gov ID
- NCT06611163
- Acronym / sponsor ID
- TILD-24-01
- Conditions
- Moderate to Severe Genital Psoriasis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 206 participants (actual)
- Lead sponsor
- Sun Pharmaceutical Industries LimitedIndustry (pharma, biotech, devices)
- Study start
- 21 Mar 2025 (actual)
- Primary completion
- 21 Jan 2026 (actual)
- Study completion
- Feb 2027 (estimated)
- First posted
- 24 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Phase 3 study to evaluate the efficacy and safety of subcutaneous Tildrakizumab in subjects with moderate to severe genital psoriasis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tildrakizumab 100 mg | Experimental | Drug: Tildrakizumab 100 mgParticipants will receive Tildrakizumab 100 milligrams (mg) subcutaneous (SC) injection on Day 1, Week 4 and every 12 weeks thereafter until the end of treatment. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will receive placebo SC injection at Day 1 and Week 4. Participants initially randomized to placebo will be switched to receive Tildrakizumab 100 mg at Week 16, week 20 and every 12 weeks thereafter until the end of treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Ability to understand the purpose and risks of the trial, willingness and ability to comply with the protocol, and provide written informed consent in accordance with institutional and regulatory guidelines
- Age ≥ 18 years of age at the time of signing consent
- Diagnosis of moderate to severe psoriasis of the genital area at Screening and baseline defined as modified sPGA-G score of ≥3.
- Presence of non-genital plaque psoriasis (BSA ≥1%) at both Screening and Baseline.
- Presence of psoriasis of the genital area that is inadequately controlled with topical therapy or the subject is intolerant to topical therapy
Key exclusion criteria (7 listed)
- Predominantly non-plaque forms of psoriasis specifically erythrodermic psoriasis, predominantly pustular psoriasis, medication-induced or medication-exacerbated psoriasis, or new-onset guttate psoriasis.
- Planned surgical intervention between Baseline and the Week 16 evaluation for a pre-treatment condition.
- Active infection or history of infections as follows:
- Any concurrent medical condition or uncontrolled, clinically significant systemic disease ( e.g., renal failure, heart failure, hypertension, liver disease, diabetes, or anemia) that, in the opinion of the Investigator, could jeopardize subject safety or compliance with the protocol.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tildrakizumab 100 mgTildrakizumab 100 mg SC injection on Day 1, Week 4 and every 12 weeks thereafter | Drug | Tildrakizumab 100 mg |
| PlaceboPlacebo SC injection at Day 1 and Week 4 | Drug | Placebo |
Primary outcome
Proportion of subjects with a modified sPGA-G score of clear (0) or minimal (1) with at-least a 2- point reduction from baseline
Time frame: Week 16
The modified sPGA-G is a 5-point scale ranging from clear (0), almost clear (1), mild (2), moderate (3), to severe (4) and incorporates an assessment of the severity of the three primary signs of the disease: erythema, elevation, and scaling. Higher scores indicate greater disease severity.
6 secondary outcomes
Proportion of subjects, with a baseline score of ≥ 4, who achieve at-least 4-point improvement in weekly average genital psoriasis itch numerical rating scale [GPI-NRS] within the GPSS for subjects
Time frame: Week 16
Mean change from baseline in the affected Body Surface Area (BSA)
Time frame: Week 16
Change from baseline in genital psoriasis symptoms scale [GPSS] total score and individual items scores
Time frame: Week 16
Proportion of subjects with psoriasis area and severity index [PASI] 75 response
Time frame: Week 16
Proportion of subjects with PASI 90 response
Time frame: Week 16
Proportion of subjects with PASI 100 response, in subjects with BSA <10%
Time frame: Week 16
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
Related trials for Moderate to Severe Genital Psoriasis
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Real-World Study of Xeligekimab for Moderate to Severe Plaque Psoriasis(XP-Real)
Plaque Psoriasis, Psoriatic Arthritis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
56 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tildrakizumab 100 mg in people with Moderate to Severe Genital Psoriasis, run by Sun Pharmaceutical Industries Limited at 56 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 56 sites in United States, Poland, Georgia, Bulgaria, Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of subjects with a modified sPGA-G score of clear (0) or minimal (1) with at-least a 2- point reduction from baseline (time frame: Week 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2026.