Plaque PsoriasisPhase 2NCT04121143
A Clinical Study of SHR-1314 Injection in the Treatment of Moderate to Severe Plaque Psoriasis in Adults
A Phase 2 study testing IL-17A Antagonist in people with Plaque Psoriasis, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
This is a multicenter, placebo-controlled, parallel-randomized, double-blind, phase II study to investigate the efficacy, safety, tolerability and Pharmacokinetics of SHR-1314 injection with moderate to severe plaque psoriasis in adults Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Plaque Psoriasis
- What is being tested?
- IL-17A Antagonist
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 9 Nov 2019to 30 Dec 2020
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provide written informed consent before any study assessment is performed.
- Male or female at least 18 years of age at screening.
- Chronic plaque psoriasis history ≥ 6 months;At the time of randomization, moderate to severe plaque psoriasis.
- Subject is a candidate for systemic psoriasis therapy and/or phototherapy and/or chemo phototherapy.
- The body mass index (BMI) was ≥18 kg/m2 and ≤35 kg/m2 at screening.
Who cannot join
- Diagnosis of psoriasis at screening is not chronic plaque psoriasis
- Severe infection or systemic infection before baseline
- There are other skin problems that researchers believe will hinder the evaluation of psoriasis.
- Subject has a history or symptom of malignancy within 5 years prior to screening, regardless of whether or not treatment has been received, with or without signs of recurrence or metastasis.
- The investigators believe that the subject is not suitable for any clinical condition involved in the clinical study.
- Those who are allergic to the study ingredients or excipients, or who are allergic to other biological agents.
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- There is evidence that hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) confirmation test is positive.
- Subject's medical history, symptoms and examination results suggest active tuberculosis or latent tuberculosis.
- Laboratory tests have clinical implications at screening, and the investigators believe that participation in the study may pose unacceptable risks to the subject or impede data analysis.
- Women who are pregnant or breastfeeding at screening or at baseline
- The investigator believes that it will prevent the subject from following and completing any other circumstances of the study protocol.
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Hengrui Pharmaceutical Co., Ltd.
Shanghai, Shanghai Municipality, 200122
About this study
Official title: Multicenter, Placebo-controlled, Parallel-randomized, Double-blind, Phase II Study to Investigate the Efficacy, Safety, Tolerability and Pharmacokinetics of SHR-1314 Injection With Moderate to Severe Plaque Psoriasis in Adults
This is a multicenter, placebo-controlled, parallel-randomized, double-blind, phase II study to investigate the efficacy, safety, tolerability and Pharmacokinetics of SHR-1314 injection with moderate to severe plaque psoriasis in adults
Read the detailed description
This study was a multicenter, parallel, randomized, double-blind, placebo-controlled clinical trial designed to evaluate the efficacy ,safety, tolerance, and pharmacokinetics (PK) of different SHR-1314 dosing regimens in moderate to severe chronic plaque psoriasis in adults.
- Conditions
- Plaque Psoriasis
- Being tested
- IL-17A Antagonist, Placebos
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IL-17A AntagonistBiological
Also called SHR-1314
SHR-1314 subcutaneous injection
PlacebosBiological
placebo subcutaneous injection to maintain consistency and to prevent blindness
| Study group | Role | What they receive |
|---|---|---|
| Treatment group A | Active comparator | SHR-1314 low dose short intervals of subcutaneous injection Receives: Biological: IL-17A Antagonist |
| Treatment group B | Active comparator | SHR-1314 high dose long intervals of subcutaneous injection Receives: Biological: IL-17A Antagonist; Biological: Placebos |
| Treatment group C | Active comparator | SHR-1314 high dose short intervals of subcutaneous injection Receives: Biological: IL-17A Antagonist; Biological: Placebos |
| Placebo group | Placebo comparator | Placebo was subcutaneously injected into the 16 weeks turnover SHR-1314 subcutaneous injection Receives: Biological: IL-17A Antagonist; Biological: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects reach to PASI 75 response at 16 weeks
Proportion of subjects with a Psoriatic Area and Severity Index (PASI) score improved by at least 75% (to achieve a PASI 75 response) relative to the baseline PASI score at Week 16
Measured: 16 week
Secondary outcomes (1)
Proportion of subjects achieving PASI 90 response at week 16
Proportion of subjects with a Psoriatic Area and Severity Index (PASI) score improved by at least 90% (to achieve a PASI 90 response) relative to the baseline PASI score at Week 16 will be evaluated.
Measured: 16 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2019
- Study start9 Nov 2019
- Primary completion30 Jun 2020 (estimated)
- Study completion30 Dec 2020 (estimated)
Why it stopped: sponsor's decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plaque PsoriasisStudies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine Co., Ltd.The 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04121143
- Sponsor's protocol ID
- SHR-1314-202
- Status last verified
- Mar 2020
- First submitted
- 27 Sep 2019
- Last updated
- 23 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Placebo-controlled, Parallel-randomized, Double-blind, Phase II Study to Investigate the Efficacy, Safety, Tolerability and Pharmacokinetics of SHR-1314 Injection With Moderate to Severe Plaque Psoriasis in Adults
- ClinicalTrials.gov ID
- NCT04121143
- Acronym / sponsor ID
- SHR-1314-202
- Conditions
- Plaque Psoriasis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: sponsor's decision
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 9 Nov 2019 (actual)
- Primary completion
- 30 Jun 2020 (estimated)
- Study completion
- 30 Dec 2020 (estimated)
- First posted
- 9 Oct 2019 (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 multicenter, placebo-controlled, parallel-randomized, double-blind, phase II study to investigate the efficacy, safety, tolerability and Pharmacokinetics of SHR-1314 injection with moderate to severe plaque psoriasis in adults
Detailed description
This study was a multicenter, parallel, randomized, double-blind, placebo-controlled clinical trial designed to evaluate the efficacy ,safety, tolerance, and pharmacokinetics (PK) of different SHR-1314 dosing regimens in moderate to severe chronic plaque psoriasis in adults.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Treatment group A | Active comparator | Biological: IL-17A AntagonistSHR-1314 low dose short intervals of subcutaneous injection |
| Treatment group B | Active comparator | Biological: IL-17A Antagonist, Biological: PlacebosSHR-1314 high dose long intervals of subcutaneous injection |
| Treatment group C | Active comparator | Biological: IL-17A Antagonist, Biological: PlacebosSHR-1314 high dose short intervals of subcutaneous injection |
| Placebo group | Placebo comparator | Biological: IL-17A Antagonist, Biological: PlacebosPlacebo was subcutaneously injected into the 16 weeks turnover SHR-1314 subcutaneous injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Provide written informed consent before any study assessment is performed.
- Male or female at least 18 years of age at screening.
- Chronic plaque psoriasis history ≥ 6 months;At the time of randomization, moderate to severe plaque psoriasis.
- Subject is a candidate for systemic psoriasis therapy and/or phototherapy and/or chemo phototherapy.
- The body mass index (BMI) was ≥18 kg/m2 and ≤35 kg/m2 at screening.
Key exclusion criteria (11 listed)
- Diagnosis of psoriasis at screening is not chronic plaque psoriasis
- Severe infection or systemic infection before baseline
- There are other skin problems that researchers believe will hinder the evaluation of psoriasis.
- Subject has a history or symptom of malignancy within 5 years prior to screening, regardless of whether or not treatment has been received, with or without signs of recurrence or metastasis.
- The investigators believe that the subject is not suitable for any clinical condition involved in the clinical study.
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 |
|---|---|---|
| IL-17A AntagonistAlso: SHR-1314SHR-1314 subcutaneous injection | Biological | Placebo group, Treatment group A, Treatment group B, Treatment group C |
| Placebosplacebo subcutaneous injection to maintain consistency and to prevent blindness | Biological | Placebo group, Treatment group B, Treatment group C |
Primary outcome
Proportion of subjects reach to PASI 75 response at 16 weeks
Time frame: 16 week
Proportion of subjects with a Psoriatic Area and Severity Index (PASI) score improved by at least 75% (to achieve a PASI 75 response) relative to the baseline PASI score at Week 16
1 secondary outcome
Proportion of subjects achieving PASI 90 response at week 16
Time frame: 16 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2020.
- Individual participant dataSharing planned: No
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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 2 study testing IL-17A Antagonist in people with Plaque Psoriasis, run by Jiangsu HengRui Medicine 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 5 inclusion and 11 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: paused, as of the sponsor's last update on 23 Mar 2020. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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 reach to PASI 75 response at 16 weeks (time frame: 16 week). 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 23 Mar 2020.