PsoriasisPhase 2NCT05003531
A Study to Evaluate IBI112 in the Treatment of Subjects With Moderate to Severe Plaque Psoriasis
A Phase 2 study testing IBI112 dose 2, IBI112 dose 4 and IBI112 dose 1 in people with Psoriasis, run by Innovent Biologics (Suzhou) Co. Ltd. at 1 site in China.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of IBI112 administered in different dose regimens for the treatment of patients with plaque psoriasis Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Psoriasis
- What is being tested?
- IBI112 dose 2, IBI112 dose 4 and IBI112 dose 1
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 250 participants
- Where
- 1 siteChina
- Study dates
- 23 Sep 2021to 17 Jan 2023
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of plaque-type psoriasis with or without psoriatic arthritis for at least 6 months prior to first administration of any study agent
- Must be a candidate for phototherapy or systemic treatment for psoriasis (either new to treatment or having had previous treatment)
Who cannot join
- History of or current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, cerebral, or psychiatric disease
- Participant has history of erythrodermic psoriasis, generalized or localized pustular psoriasis, medication-induced or medication-exacerbated psoriasis, or new onset guttate psoriasis
- Has received any therapeutic agent directly targeted to IL-12, IL-17, or IL-23within 6 months of the first administration of study agent
- Has received any therapeutic agent directly targeted toTNF-a within 3 months of the first administration of study agent
- Has received any conventional therapeutic agent within 1 months of the first administration of study agent
- Has received any topic therapeutic agent within 2 weeks of the first administration of study agent
Trial locations and contacts
1 site in 1 country.
China1 site
PeKing University People's Hostpital
Beijing, Beijing Municipality, 100044
About this study
Official title: A Phase II Multicenter, Randomized, Double-blind, Parallel, Placebo-controlled Trial to Evaluate the Efficacy and Safety of IBI112 in Different Dose Regimens for the Treatment of Subjects With Moderate-to-severe Plaque Psoriasis
The purpose of this study is to evaluate the efficacy and safety of IBI112 administered in different dose regimens for the treatment of patients with plaque psoriasis
- Conditions
- Psoriasis
- Being tested
- IBI112 dose 2, IBI112 dose 4, IBI112 dose 1, IBI112 dose 3, placebo
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IBI112 dose 2Drug
Participants will receive placebo or dose 2 IBI112 SC
IBI112 dose 4Drug
Participants will receive placebo or dose 4 IBI112 SC
IBI112 dose 1Drug
Participants will receive placebo or dose 1 IBI112 SC
IBI112 dose 3Drug
Participants will receive placebo or dose 3 IBI112 SC
placeboDrug
Participants will receive placebo SC
| Study group | Role | What they receive |
|---|---|---|
| IBI112 dose 1 | Experimental | Participants will receive IBI112 dose 1 subcutaneous injection(SC) Receives: Drug: IBI112 dose 1 |
| IBI112 dose 4 | Experimental | Participants will receive IBI112 dose 4 subcutaneous injection(SC) Receives: Drug: IBI112 dose 4 |
| IBI112 dose 2 | Experimental | Participants will receive IBI112 dose 2 subcutaneous injection(SC) Receives: Drug: IBI112 dose 2 |
| IBI112 dose 3 | Experimental | Participants will receive IBI112 dose 3 subcutaneous injection(SC) Receives: Drug: IBI112 dose 3 |
| Placebo | Placebo comparator | Participants will receive placebo subcutaneous injection(SC) Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients achieving Psoriasis Area and severity index(PASI) 90 at week 16
PASI 90 is defined as at least a 90% reduction in PASI relative to baseline
Measured: Week 16
Secondary outcomes (11)
Percentage of patients achieving Psoriasis Area and severity index(PASI) 75 at week 16
PASI 75 is defined as at least a 75% reduction in PASI relative to baseline
Measured: Week 16
Percentage of patients achieving Psoriasis Area and severity index(PASI) 100 at week 16
PASI 100 is defined as at least a 100% reduction in PASI relative to baseline
Measured: Week 16
Percentage of patients with Physician Global Assessment(PGA) Score of Cleared(0) or Minimal(1) at week 16
PGA of psoriasis is used to determine the participant's psoriasis lesions overall at a given time point.PGA score ranges from 0-4,0=cleared, 1= minimal ,2=mild, 3= moderate, 4= marked, 5= severe
Measured: Week 16
Percentage of patients with Physician Global Assessment(PGA) Score of Cleared(0) at week 16
PGA of psoriasis is used to determine the participant's psoriasis lesions overall at a given time point.PGA score ranges from 0-4,0=cleared, 1= minimal ,2=mild, 3= moderate, 4= marked, 5= severe
Measured: Week 16
Change from Baseline in Dermatology life quality index(DLQI) at week 16
The DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life
Measured: Week 16
Percentage of patients achieving Psoriasis Area and severity index(PASI) 90 at week 52
PASI 90 is defined as at least a 90% reduction in PASI relative to baseline
Measured: Week 52
Percentage of patients achieving Psoriasis Area and severity index(PASI) 100 at week 52
PASI 100 is defined as at least a 100% reduction in PASI relative to baseline
Measured: Week 52
Percentage of patients achieving Psoriasis Area and severity index(PASI) 75 at week 52
PASI 75 is defined as at least a 75% reduction in PASI relative to baseline
Measured: Week 52
Percentage of patients with Physician Global Assessment(PGA) Score of Cleared(0) or Minimal(1) at week 52
PGA of psoriasis is used to determine the participant's psoriasis lesions overall at a given time point.PGA score ranges from 0-4,0=cleared, 1= minimal ,2=mild, 3= moderate, 4= marked, 5= severe
Measured: Week 52
Percentage of patients with Physician Global Assessment(PGA) Score of Cleared(0) at week 52
PGA of psoriasis is used to determine the participant's psoriasis lesions overall at a given time point.PGA score ranges from 0-4,0=cleared, 1= minimal ,2=mild, 3= moderate, 4= marked, 5= severe
Measured: Week 52
Change from Baseline in Dermatology life quality index(DLQI) at week 52
The DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life
Measured: Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2021
- Study start23 Sep 2021
- Primary completion25 Mar 2022
- Study completion17 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- More trials run by Innovent Biologics (Suzhou) 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
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05003531
- Sponsor's protocol ID
- CIBI112A201
- Status last verified
- Jan 2024
- First submitted
- 5 Aug 2021
- Last updated
- 25 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Multicenter, Randomized, Double-blind, Parallel, Placebo-controlled Trial to Evaluate the Efficacy and Safety of IBI112 in Different Dose Regimens for the Treatment of Subjects With Moderate-to-severe Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT05003531
- Acronym / sponsor ID
- CIBI112A201
- Conditions
- Psoriasis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 23 Sep 2021 (actual)
- Primary completion
- 25 Mar 2022 (actual)
- Study completion
- 17 Jan 2023 (actual)
- First posted
- 12 Aug 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.
The purpose of this study is to evaluate the efficacy and safety of IBI112 administered in different dose regimens for the treatment of patients with plaque psoriasis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| IBI112 dose 1 | Experimental | Drug: IBI112 dose 1Participants will receive IBI112 dose 1 subcutaneous injection(SC) |
| IBI112 dose 4 | Experimental | Drug: IBI112 dose 4Participants will receive IBI112 dose 4 subcutaneous injection(SC) |
| IBI112 dose 2 | Experimental | Drug: IBI112 dose 2Participants will receive IBI112 dose 2 subcutaneous injection(SC) |
| IBI112 dose 3 | Experimental | Drug: IBI112 dose 3Participants will receive IBI112 dose 3 subcutaneous injection(SC) |
| Placebo | Placebo comparator | Drug: placeboParticipants will receive placebo subcutaneous injection(SC) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of plaque-type psoriasis with or without psoriatic arthritis for at least 6 months prior to first administration of any study agent
- Must be a candidate for phototherapy or systemic treatment for psoriasis (either new to treatment or having had previous treatment)
Key exclusion criteria (6 listed)
- History of or current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, cerebral, or psychiatric disease
- Participant has history of erythrodermic psoriasis, generalized or localized pustular psoriasis, medication-induced or medication-exacerbated psoriasis, or new onset guttate psoriasis
- Has received any therapeutic agent directly targeted to IL-12, IL-17, or IL-23within 6 months of the first administration of study agent
- Has received any therapeutic agent directly targeted toTNF-a within 3 months of the first administration of study agent
- Has received any conventional therapeutic agent within 1 months of the first administration of study agent
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 |
|---|---|---|
| IBI112 dose 2Participants will receive placebo or dose 2 IBI112 SC | Drug | IBI112 dose 2 |
| IBI112 dose 4Participants will receive placebo or dose 4 IBI112 SC | Drug | IBI112 dose 4 |
| IBI112 dose 1Participants will receive placebo or dose 1 IBI112 SC | Drug | IBI112 dose 1 |
| IBI112 dose 3Participants will receive placebo or dose 3 IBI112 SC | Drug | IBI112 dose 3 |
| placeboParticipants will receive placebo SC | Drug | Placebo |
Primary outcome
Percentage of patients achieving Psoriasis Area and severity index(PASI) 90 at week 16
Time frame: Week 16
PASI 90 is defined as at least a 90% reduction in PASI relative to baseline
11 secondary outcomes
Percentage of patients achieving Psoriasis Area and severity index(PASI) 75 at week 16
Time frame: Week 16
Percentage of patients achieving Psoriasis Area and severity index(PASI) 100 at week 16
Time frame: Week 16
Percentage of patients with Physician Global Assessment(PGA) Score of Cleared(0) or Minimal(1) at week 16
Time frame: Week 16
Percentage of patients with Physician Global Assessment(PGA) Score of Cleared(0) at week 16
Time frame: Week 16
Change from Baseline in Dermatology life quality index(DLQI) at week 16
Time frame: Week 16
Percentage of patients achieving Psoriasis Area and severity index(PASI) 90 at week 52
Time frame: Week 52
Percentage of patients achieving Psoriasis Area and severity index(PASI) 100 at week 52
Time frame: Week 52
Percentage of patients achieving Psoriasis Area and severity index(PASI) 75 at week 52
Time frame: Week 52
Percentage of patients with Physician Global Assessment(PGA) Score of Cleared(0) or Minimal(1) at week 52
Time frame: Week 52
Percentage of patients with Physician Global Assessment(PGA) Score of Cleared(0) at week 52
Time frame: Week 52
Change from Baseline in Dermatology life quality index(DLQI) at week 52
Time frame: Week 52
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 25 Jan 2024.
- 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 IBI112 dose 2, IBI112 dose 4 and IBI112 dose 1 in people with Psoriasis, run by Innovent Biologics (Suzhou) 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 2 inclusion and 6 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 25 Jan 2024. 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?
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?
Percentage of patients achieving Psoriasis Area and severity index(PASI) 90 at week 16 (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 25 Jan 2024.