Plaque PsoriasisPhase 3NCT05108766
A Phase Ⅲ Study to Evaluate Tildrakizumab in the Treatment of Chinese Subjects With Moderate to Severe Plaquetype Psoriasis
A Phase 3 study testing Tildrakizumab 100 mg in people with Plaque Psoriasis, run by Shenzhen Kangzhe Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
This is a phase Ⅲ, randomized, double-blind, placebo-controlled, parallel design, multicenter trial to evaluate the efficacy, safety, tolerability, and immunogenicity of subcutaneous Tildrakizumab in subjects with moderate to severe chronic plaque psoriasis. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Plaque 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
- 220 participants
- Where
- 1 siteChina
- Study dates
- 17 Dec 2020to 8 Jul 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must give a written, signed and dated informed consent.
- Subject must be 18-70 years of age, of either sex.
- Diagnosis of predominantly plaque psoriasis for over 6 months (Plaque psoriasis in stable phase, and in non-progressive phase as determined by subject interview and confirmation of diagnosis through physical examination by investigator).
- Subject is considered to be a candidate for phototherapy or systemic therapy.
- Psoriasis BSA involvement ≥ 10% at baseline.
- PASI score ≥ 12 at baseline.
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- PGA of at least moderate disease (≥ 3) at baseline.
- No history of active TB or symptoms of TB; No recent history of intimate contact with patients with active TB;
- Subject is a male or a non-sterilized, pre-menopausal female and agrees to abstain from heterosexual activity OR use a medically accepted method of contraception OR use appropriate effective contraception as per local regulations or guidelines. Medically accepted methods of contraception include, but are not limited to, condoms (male or female) with or without a spermicidal agent, diaphragm or cervical cap with spermicide, medically prescribed IUD, inert or copper-containing IUD, hormone-releasing IUD, systemic hormonal contraceptive, and surgical sterilization (e.g., hysterectomy or tubal ligation).
- For a woman of childbearing potential, a negative serum pregnancy test at Screening/baseline.
Who cannot join
- Presence of predominantly non-plaque forms of psoriasis：guttate psoriasis, erythrodermic psoriasis, pustular psoriasis, medication-induced or medication-exacerbated psoriasis.
- Subjects who are expected to require additional topical therapy, phototherapy, or systemic therapy other than trial drug for the treatment of psoriasis during the trial.
- Presence of any infection or history of recurrent infection requiring treatment with systemic antibiotics within 2 weeks prior to Screening, or severe infection (e.g., pneumonia, cellulitis, bone, or joint infections) requiring hospitalization or treatment with IV antibiotics within 8 weeks prior to Screening.
- Subject is known to be allergic to Tildrakizumab or related excipients.
- Women of childbearing potential who are pregnant or are lactating, female subject or male subject with partner intend to become pregnant (during the trial OR within 6 months of the last administration of the trial drug).
- Positive human immunodeficiency virus (HIV) antibody (HIV Ab)test result and/or positive Treponema pallidum-specific antibody test result, and/or positive hepatitis C virus antibody (HCV Ab) test result with positive HCV-RNA reverse transcription polymerase chain reaction test result, indicating a past or current infection of hepatitis C virus; and/or positive result of hepatitis B surface antigen (HbsAg) , or positive result of hepatitis B core antibody (HBcAb) with positive result of HBV-DNA polymerase chain reaction test, indicating an current infection of HBV; .
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- Subject has the following clinically significant abnormal laboratory tests according to the investigators' evaluation.
- Prior malignancy or concurrent malignancy (excluding successfully treated basal cell carcinoma, squamous cell carcinoma of the skin in situ, squamous cell carcinoma with no evidence of recurrence within 5 years or carcinoma in situ of the cervix that has been adequately treated).
- Subject who has received a live attenuated vaccine within 4 weeks prior to first dose or who intends to receive live attenuated vaccine during the trial.
- Subject who is currently participating in another interventional clinical trial or has participated in an interventional clinical trial within 4 weeks prior to first dose.
- The subject is among the personnel of the investigational site or sponsor/designee directly involved with this trial.
- Within 6 months prior to Screening, subject has any significant organ dysfunction or clinically significant laboratory abnormalities that place the subject at unacceptable risk for participation in a trial of an immunomodulatory therapy in the judgment of the investigator.
- Within 6 months prior to screening, subject has decompensated cardiac insufficiency (New York Heart Association (NYHA) class III or IV) ; presence of unstable angina, myocardial infarction, history of coronary artery bypass graft, or coronary stent implantation; presence of cardiac arrhythmias (such as long QT syndrome, etc.) that requires medical treatment and is evaluated as ineligible for participation in this clinical trial according to the investigator; hospitalization due to an acute cardiovascular event, cardiovascular illness, or cardiovascular surgery.
- Subject has sustained uncontrolled hypertension (systolic blood pressure of ≥ 160 mm Hg and/or diastolic blood pressure of ≥ 100 mm Hg at screening) and/or uncontrolled diabetes (fasting glucose ≥ 7 mmol/L and HbA1C ≥ 7.0%).
- Subject who, has history of alcohol abuse (i.e., alcohol abuse > 2 units of alcohol per day (1 unit = 360 mL of beer or 45 mL of alcohol in 40% of Chinese spirits or 150 mL of wine)) or history of drug abuse.
- Subject was treated with IL-23/Th-17 pathway inhibitors, including p40, p19 and IL-17 antagonists and failed.
- Subject has current signs or symptoms of severe, progressive, or uncontrollable renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurologic and cerebral and/or psychiatric illness.
- Subject is in other conditions deemed unsuitable for the trial by the investigator.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Air Force Medical University of PLA
Xi'an
About this study
Official title: A Phase Ⅲ, Multicenter, Randomized, Double-blind, Placebo Controlled Trial Evaluating the Efficacy and Safety of Tildrakizumab in the Treatment of Chinese Subjects With Moderate to Severe Plaquetype Psoriasis
This is a phase Ⅲ, randomized, double-blind, placebo-controlled, parallel design, multicenter trial to evaluate the efficacy, safety, tolerability, and immunogenicity of subcutaneous Tildrakizumab in subjects with moderate to severe chronic plaque psoriasis.
The trial was divided into two parts: the base study (Week 0- Week 12) and the extension study (Week 13- Week 54).
Read the detailed description
Base Study： 220 subjects were randomized in a 1: 1 ratio into the trial, and the treatment group received 100 mg subcutaneous Tildrakizumab at Week 0 and Week 4, 100 mg subcutaneous placebo at Week 12, while the placebo group received 100 mg subcutaneous placebo at Week 0 and Week 4, and 100 mg subcutaneous Tildrakizumab at Week 12, and subjects will be evaluated for efficacy, safety, tolerability, and immunogenicity as specified in this protocol. At the end of the base study, procedures such as data cleaning, locking and unblinding of base study data were performed.
Extension Study： Subjects entered the extension study after completion of the base study and will receive 100 mg subcutaneous Tildrakizumab at Week 16, 28, 40, and 52, and will be evaluated for efficacy, safety, tolerability, and immunogenicity by the investigator according to the regulations of this study.
At the end of the extension study, all data from the extension study will be entered into the database, after the data is reviewed, cleaned, and locked, the entire trial will be analyzed.
- Conditions
- Plaque 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
Also called SCH 90022, MK-3222
Tildrakizumab 100 mg administered SC. Each PFS contains 1 mL of solution, tildrakizumab 100 mg/mL.
PlaceboDrug
Matching placebo to tildrakizumab administered SC
| Study group | Role | What they receive |
|---|---|---|
| Tildrakizumab | Experimental | Subjects will receive 100 mg subcutaneous (SC) Tildrakizumab at Week 0 and Week 4, 100 mg subcutaneous placebo at Week 12. Subjects entered the extension study after completion of the base study and will receive 100 mg subcutaneous Tildrakizumab at Week 16, 28, 40, and 52. Receives: Drug: Tildrakizumab 100 mg |
| Placebo | Placebo comparator | Subjects will receive 100 mg subcutaneous placebo at Week 0 and Week 4, and 100 mg subcutaneous Tildrakizumab at Week 12. Subjects entered the extension study after completion of the base study and will receive 100 mg subcutaneous Tildrakizumab at Week 16, 28, 40, and 52. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of subjects with at least 75% improvement in the Psoriasis Area and Severity Index (PASI 75) at Week 12 from baseline in each group.
The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0-4 scale), weighed by the area of involvement. Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status.
Measured: Week 12
Secondary outcomes (3)
The proportion of subjects in each group with a Physician's Global Assessment (PGA) score of "clear" or "minimal" and at least a 2-grade reduction from baseline at Week 4, 8, and 12.
The PGA is used to determine the overall severity of a participant's psoriasis lesions at a given time point. Overall lesions will be graded for thickness, erythema, and scaling on a scale from 0 to 5. The sum of the 3 scales will be divided by 3 to obtain the PGA score. PGA is assessed as: 0= Cleared, except for residual discoloration. 1= Minimal, majority of lesions have individual scores that average 1. 2 =Mild, majority of lesions have individual scores that average 2. 3= Moderate, majority of lesions have individual scores that average 3. 4= Marked, majority of lesions have individual scores that average 4. 5= Severe, majority of lesions have individual scores that average 5.
Measured: Week 4, 8, and 12
Change from baseline in the Dermatology Life Quality Index (DLQI) at Week 12 in each group.
The DLQI questionnaire consists of 10 questions, where each question is scored from 0 (not affected at all) to 3 (very much affected). The DLQI score is the sum of the 10 individual question scores and ranges from 0 to 30, with lower scores indicating better quality of life.
Measured: Week 12
Change from baseline in PASI 75, 90, and 100 responses over time from Week 0 to Week 12 in each group.
The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0-4 scale), weighed by the area of involvement. Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status.
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2021
- Study start17 Dec 2020
- Primary completion7 Jun 2021
- Study completion8 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Plaque PsoriasisStudies of the same condition, open and under way.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shenzhen Kangzhe Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05108766
- Sponsor's protocol ID
- Tildra-PsO-001
- Status last verified
- Apr 2023
- First submitted
- 27 Oct 2021
- Last updated
- 12 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yu C, Geng S, Yang B, Deng Y, Li F, Kang X, Bi M, Zhang F, Zhao Y, Pan W, Tian Z, Xu J, Zhang Z, Yu N, Duan X, Guo S, Sun Q, Li W, Tao J, Liu Z, Yin Y, Wang G. Tildrakizumab for moderate-to-severe plaque psoriasis in Chinese patients: A 12-week randomized placebo-controlled phase III trial with long-term extension. Chin Med J (Engl). 2024 May 20;137(10):1190-1198. doi: 10.1097/CM9.0000000000002873. Epub 2024 Jan 9.
PubMed 38192233
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ⅲ, Multicenter, Randomized, Double-blind, Placebo Controlled Trial Evaluating the Efficacy and Safety of Tildrakizumab in the Treatment of Chinese Subjects With Moderate to Severe Plaquetype Psoriasis
- ClinicalTrials.gov ID
- NCT05108766
- Acronym / sponsor ID
- Tildra-PsO-001
- Conditions
- Plaque Psoriasis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Shenzhen Kangzhe Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 17 Dec 2020 (actual)
- Primary completion
- 7 Jun 2021 (actual)
- Study completion
- 8 Jul 2022 (actual)
- First posted
- 5 Nov 2021 (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.
This is a phase Ⅲ, randomized, double-blind, placebo-controlled, parallel design, multicenter trial to evaluate the efficacy, safety, tolerability, and immunogenicity of subcutaneous Tildrakizumab in subjects with moderate to severe chronic plaque psoriasis.
The trial was divided into two parts: the base study (Week 0- Week 12) and the extension study (Week 13- Week 54).
Detailed description
Base Study： 220 subjects were randomized in a 1: 1 ratio into the trial, and the treatment group received 100 mg subcutaneous Tildrakizumab at Week 0 and Week 4, 100 mg subcutaneous placebo at Week 12, while the placebo group received 100 mg subcutaneous placebo at Week 0 and Week 4, and 100 mg subcutaneous Tildrakizumab at Week 12, and subjects will be evaluated for efficacy, safety, tolerability, and immunogenicity as specified in this protocol. At the end of the base study, procedures such as data cleaning, locking and unblinding of base study data were performed.
Extension Study： Subjects entered the extension study after completion of the base study and will receive 100 mg subcutaneous Tildrakizumab at Week 16, 28, 40, and 52, and will be evaluated for efficacy, safety, tolerability, and immunogenicity by the investigator according to the regulations of this study.
At the end of the extension study, all data from the extension study will be entered into the database, after the data is reviewed, cleaned, and locked, the entire trial will be analyzed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tildrakizumab | Experimental | Drug: Tildrakizumab 100 mgSubjects will receive 100 mg subcutaneous (SC) Tildrakizumab at Week 0 and Week 4, 100 mg subcutaneous placebo at Week 12. Subjects entered the extension study after completion of the base study and will receive 100 mg subcutaneous Tildrakizumab at Week 16, 28, 40, and 52. |
| Placebo | Placebo comparator | Drug: PlaceboSubjects will receive 100 mg subcutaneous placebo at Week 0 and Week 4, and 100 mg subcutaneous Tildrakizumab at Week 12. Subjects entered the extension study after completion of the base study and will receive 100 mg subcutaneous Tildrakizumab at Week 16, 28, 40, and 52. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Subjects must give a written, signed and dated informed consent.
- Subject must be 18-70 years of age, of either sex.
- Diagnosis of predominantly plaque psoriasis for over 6 months (Plaque psoriasis in stable phase, and in non-progressive phase as determined by subject interview and confirmation of diagnosis through physical examination by investigator).
- Subject is considered to be a candidate for phototherapy or systemic therapy.
- Psoriasis BSA involvement ≥ 10% at baseline.
Key exclusion criteria (18 listed)
- Presence of predominantly non-plaque forms of psoriasis：guttate psoriasis, erythrodermic psoriasis, pustular psoriasis, medication-induced or medication-exacerbated psoriasis.
- Subjects who are expected to require additional topical therapy, phototherapy, or systemic therapy other than trial drug for the treatment of psoriasis during the trial.
- Presence of any infection or history of recurrent infection requiring treatment with systemic antibiotics within 2 weeks prior to Screening, or severe infection (e.g., pneumonia, cellulitis, bone, or joint infections) requiring hospitalization or treatment with IV antibiotics within 8 weeks prior to Screening.
- Subject is known to be allergic to Tildrakizumab or related excipients.
- Women of childbearing potential who are pregnant or are lactating, female subject or male subject with partner intend to become pregnant (during the trial OR within 6 months of the last administration of the trial drug).
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 mgAlso: SCH 90022, MK-3222Tildrakizumab 100 mg administered SC. Each PFS contains 1 mL of solution, tildrakizumab 100 mg/mL. | Drug | Tildrakizumab |
| PlaceboMatching placebo to tildrakizumab administered SC | Drug | Placebo |
Primary outcome
The proportion of subjects with at least 75% improvement in the Psoriasis Area and Severity Index (PASI 75) at Week 12 from baseline in each group.
Time frame: Week 12
The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0-4 scale), weighed by the area of involvement. Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status.
3 secondary outcomes
The proportion of subjects in each group with a Physician's Global Assessment (PGA) score of "clear" or "minimal" and at least a 2-grade reduction from baseline at Week 4, 8, and 12.
Time frame: Week 4, 8, and 12
Change from baseline in the Dermatology Life Quality Index (DLQI) at Week 12 in each group.
Time frame: Week 12
Change from baseline in PASI 75, 90, and 100 responses over time from Week 0 to Week 12 in each group.
Time frame: Week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2023.
- Derived from this study: PubMed 38192233Yu C, Geng S, Yang B, Deng Y, Li F, Kang X, Bi M, Zhang F, Zhao Y, Pan W, Tian Z, Xu J, Zhang Z, Yu N, Duan X, Guo S, Sun Q, Li W, Tao J, Liu Z, Yin Y, Wang G. Tildrakizumab for moderate-to-severe plaque psoriasis in Chinese patients: A 12-week randomized placebo-controlled phase III trial with long-term extension. Chin Med J (Engl). 2024 May 20;137(10):1190-1198. doi: 10.1097/CM9.0000000000002873. Epub 2024 Jan 9.
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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.
1 site in 1 country: 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 Plaque Psoriasis, run by Shenzhen Kangzhe Pharmaceutical Co., Ltd. at 1 site in China.
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 10 inclusion and 18 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: finished, as of the sponsor's last update on 12 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The proportion of subjects with at least 75% improvement in the Psoriasis Area and Severity Index (PASI 75) at Week 12 from baseline in each group. (time frame: Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05108766, which also lists 1 linked publication.
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 12 Apr 2023.