PsoriasisPhase 2NCT05604898
A Phase 2 Study of Recombinant Anti-IL-17A Humanized Monoclonal Antibody in Chinese Participants With Moderate-to-Severe Plaque Psoriasis
A Phase 2 study testing Recombinant Anti-IL-17A Humanized Monoclonal Antibody Injection in people with Psoriasis, run by Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. at 3 sites in China.
Trial summary
The purpose of this study is to determine the efficacy and safety of the study drug recombinant anti-IL-17A humanized monoclonal antibody in Chinese participants with moderate-to-severe plaque psoriasis. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Psoriasis
- What is being tested?
- Recombinant Anti-IL-17A Humanized Monoclonal Antibody Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 139 participants
- Where
- 3 sitesChina
- Study dates
- 1 Apr 2021to Aug 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must be 18 Years to 65 Years, both male and female.
- BMI ≥18 kg/m^2 and ≤32 kg/m^2 ，and male weight ≥50 kg, female weight ≥45 kg during the screening.
- Chronic plaque psoriasis (PSO) for at least 6 months prior to the randomizationas as determined by the investigator..
- Psoriasis Area Severity Index (PASI) >=12 and body surface area (BSA) affected by PSO >=10% and Static Physician Global Assessment (sPGA) score >=3.
- According to the judgment of the investigator, the subject needs to receive systemic treatment and / or phototherapy (including subjects who have used local treatment, and / or phototherapy, and / or poor control of previous systemic treatment).
- Subject must be able to understand and comply with the requirements of the study. and must participate voluntarily and sign the written informed consent.
Who cannot join
- History of pustular or erythrodermic psoriasis other than plaque psoriasis at screening or baseline.
- History of drug-induced psoriasis.
- Ongoing use of prohibited treatments.
- Have previously received any drug that directly targets IL-17.
- Have concurrent or recent use of any biologic agent within washout periods or <5 half-lives prior to randomization.
- Chronic infections including HIV, viral hepatitis (hepatitis B, hepatitis C), syphilis and/ or active tuberculosis.
- Pregnant or lactating women.
Trial locations and contacts
3 sites in 1 country.
China3 sites
The First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, 650000
Huashan Hospital Fudan University
Shanghai, Shanghai Municipality, 200040
Shanghai Dermatology Hospital
Shanghai, Shanghai Municipality, 200050
About this study
Official title: A Phase 2，Multicenter, Randomized, Double-blind, Placebo-controlled，Multiple-dose Escalation and Dose Finding Study to Evaluate the Safety，PK and Efficacy of Recombinant Anti-IL-17A Humanized Monoclonal Antibody in Chinese Patients With Moderate-to-Severe Plaque Psoriasis
The purpose of this study is to determine the efficacy and safety of the study drug recombinant anti-IL-17A humanized monoclonal antibody in Chinese participants with moderate-to-severe plaque psoriasis.
Read the detailed description
Study SSGJ-608-PsO-II-01 is a phase 2, multicenter, randomized, double-blind, placebo-controlled, multiple-dose escalation and dose finding study to identify the doses of treatments ，and to further evaluate the effect of different dose regimens of recombinant anti-IL-17A humanized monoclonal antibody versus placebo in Chinese participants with moderate-to-severe plaque psoriasis during an induction dosing period with dosing for 12 weeks, followed by a randomized, double-blind, 40-week maintenance dosing period. Phase Ib One of three dose levels of copanlisib is assigned at registration according to the dose escalation scheme. Phase II The copanlisib dose for the Phase II part of the trial will be based on the MTD established in the Phase Ib part of the study.
- Conditions
- Psoriasis
- Being tested
- Recombinant Anti-IL-17A Humanized Monoclonal Antibody Injection, Placebo
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant Anti-IL-17A Humanized Monoclonal Antibody InjectionDrug
Also called 608
608 will be administered subcutaneously.
PlaceboOther
Also called PBO
Participants will receive Placebo to maintain the blinding of the Investigational Medicinal Products.
Recombinant Anti-IL-17A Humanized Monoclonal Antibody InjectionDrug
Also called 608
608 will be provided at pre-specified time intervals.
PlaceboOther
Also called PBO
Participants will receive Placebo at pre-specified time points to maintain the blinding of the Investigational Medicinal Products.
| Study group | Role | What they receive |
|---|---|---|
| Part 1：608 40 mg | Experimental | Randomized in a 6:2 ratio to 608 40mg or placebo 2-weekly by subcutaneous injection during induction period. During the maintenance period, participants will receive 608 40mg or placebo 4-weekly. Receives: Drug: Recombinant Anti-IL-17A Humanized Monoclonal Antibody Injection; Other: Placebo |
| Part 1：608 80 mg | Experimental | Randomized in a 10:2 ratio to 608 80mg or placebo 2-weekly by subcutaneous injection during induction period. During the maintenance period, participants will receive 608 80mg or placebo 4-weekly. Receives: Drug: Recombinant Anti-IL-17A Humanized Monoclonal Antibody Injection; Other: Placebo |
| Part 1：608 160 mg | Experimental | Randomized in a 10:2 ratio to 608 160mg or placebo 2-weekly by subcutaneous injection during induction period. During the maintenance period, participants will receive 608 160mg or placebo 4-weekly. Receives: Drug: Recombinant Anti-IL-17A Humanized Monoclonal Antibody Injection; Other: Placebo |
| Part 2：608 160 mg W0+80 mg Q2W+80 mg Q4W | Experimental | Participants will receive starting dose of 160 mg 608 at week 0 followed by 80mg 608 once every two weeks (Q2W) by subcutaneous injection during induction period. During the maintenance period, participants will receive 80mg 608 once every four weeks (Q4W). Receives: Drug: Recombinant Anti-IL-17A Humanized Monoclonal Antibody Injection; Other: Placebo |
| Part 2：608 160 mg Q2W+160 mg Q4W | Experimental | Participants will receive 160mg 608 once every two weeks (Q2W) by subcutaneous injection during induction period followed by 160mg 608 once every four weeks (Q4W) during maintenance period. Receives: Drug: Recombinant Anti-IL-17A Humanized Monoclonal Antibody Injection |
| Part 2：608 160 mg Q4W+160 mg Q8W | Experimental | Participants will receive 160mg 608 once every four weeks (Q4W) by subcutaneous injection during induction period followed by 160mg 608 once every eight weeks (Q8W) during maintenance period. Receives: Drug: Recombinant Anti-IL-17A Humanized Monoclonal Antibody Injection; Other: Placebo |
| Part 2：Placebo | Placebo comparator | Participants will receive Placebo by subcutaneous injection. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of treatment emergent adverse event (TEAE).
The incidence and severity of treatment emergent adverse event (TEAE), including adverse events (AEs)，serious adverse event (SAE) and AEs associated with the use of the drug, as well as clinical symptoms, and any abnormalities of vital signs, physical examinations，electrocardiogram，laboratory tests and, etc.
Measured: Up to 64 Weeks
Secondary outcomes (13)
Cmax
To assess the maximum plasma level of 608.
Measured: Week 0 to 16
Tmax
To assess the time to peak 608 concentration.
Measured: Week 0 to 16
AUC0-last
To assess the area under the concentration time-curves from time zero to the time of the last quantifiable concentration after dosing.
Measured: Week 0 to 16
AUC0-tau
To assess the area under the concentration time-curves from time zero to the dosing interval tau.
Measured: Week 0 to 16
Cmin
To assess the minimum plasma level of 608.
Measured: Week 0 to 48
Rac_Cmax
Accumulation ratio based on maximum plasma concentration (Cmax) calculated as: Rac_Cmax = Cmax at steady state (ss) divided by Cmax at first dose.
Measured: week 0,12
Rac_AUC0-tau
Accumulation ratio calculated as, Rac obtained from Area Under the Concentration Time Curve (AUCτau) from time 0-τau（Week 12） divided by AUC from time 0-τau （Week 0）
Measured: week 0,12
Number of Participants Positive for Anti-Drug Antibody (ADA) in Part 1.
Serum ADA positivity is determined over course of the trial duration.
Measured: Week 0,4,8,12,16,24,48,64
Number of Participants Positive for Anti-Drug Antibody (ADA) in Part 2.
Serum ADA positivity is determined over course of the trial duration.
Measured: Week 0,8,20,44,64
Percentage of Participants Achieving a ≥75% Improvement in Psoriasis Area and Severity Index (PASI 75)
The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs). For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored by itself and the scores then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region * area score * weighing factor [head (0.1), upper limbs (0.2), trunk (0.3), lower limbs(0.4)]. Overall scores range from 0 (no Ps) to 72 (the most severe disease).
Measured: At Week 12
Percentage of Participants With a Static Physician Global Assessment (sPGA) Score of Clear (0) or Minimal (1) With at Least a 2 Point Improvement
The sPGA is the physician's determination of the participant's Ps lesions overall at a given time point. Lesions were categorized by descriptions for induration, erythema, and scaling. Participants Ps were assessed as 0 (clear), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe), or 5 (very severe). An sPGA responder was defined as having a postbaseline sPGA score of "0" or "1" with at least a 2-point improvement from baseline.
Measured: At Week 12
Percentage of Participants Achieving a ≥90% Improvement in Psoriasis Area and Severity Index (PASI 90)
The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs). For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored by itself and the scores then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region * area score * weighing factor [head (0.1), upper limbs (0.2), trunk (0.3), lower limbs(0.4)]. Overall scores range from 0 (no Ps) to 72 (the most severe disease).
Measured: At Week 12
Percentage of Participants Achieving a 100% Improvement in Psoriasis Area and Severity Index (PASI 100)
The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs). For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored by itself and the scores then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region * area score * weighing factor [head (0.1), upper limbs (0.2), trunk (0.3), lower limbs(0.4)]. Overall scores range from 0 (no Ps) to 72 (the most severe disease).
Measured: At Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2022
- Study start1 Apr 2021
- Primary completionMay 2023 (estimated)
- Study completionAug 2023 (estimated)
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 Sunshine Guojian Pharmaceutical (Shanghai) 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
- 139 participants (actual)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jinhua Xu, MD, Principal investigator, Shanghai Huanshan Hospital Fudan University-Dermatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05604898
- Sponsor's protocol ID
- SSGJ -608- Psoriasis-II-01
- Status last verified
- Nov 2022
- First submitted
- 31 Oct 2022
- Last updated
- 8 Nov 2022
- 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 8 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2，Multicenter, Randomized, Double-blind, Placebo-controlled，Multiple-dose Escalation and Dose Finding Study to Evaluate the Safety，PK and Efficacy of Recombinant Anti-IL-17A Humanized Monoclonal Antibody in Chinese Patients With Moderate-to-Severe Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT05604898
- Acronym / sponsor ID
- SSGJ -608- Psoriasis-II-01
- Conditions
- Psoriasis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 139 participants (actual)
- Lead sponsor
- Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- May 2023 (estimated)
- Study completion
- Aug 2023 (estimated)
- First posted
- 3 Nov 2022 (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 determine the efficacy and safety of the study drug recombinant anti-IL-17A humanized monoclonal antibody in Chinese participants with moderate-to-severe plaque psoriasis.
Detailed description
Study SSGJ-608-PsO-II-01 is a phase 2, multicenter, randomized, double-blind, placebo-controlled, multiple-dose escalation and dose finding study to identify the doses of treatments ，and to further evaluate the effect of different dose regimens of recombinant anti-IL-17A humanized monoclonal antibody versus placebo in Chinese participants with moderate-to-severe plaque psoriasis during an induction dosing period with dosing for 12 weeks, followed by a randomized, double-blind, 40-week maintenance dosing period. Phase Ib One of three dose levels of copanlisib is assigned at registration according to the dose escalation scheme. Phase II The copanlisib dose for the Phase II part of the trial will be based on the MTD established in the Phase Ib part of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Part 1：608 40 mg | Experimental | Drug: Recombinant Anti-IL-17A Humanized Monoclonal Antibody Injection, Other: PlaceboRandomized in a 6:2 ratio to 608 40mg or placebo 2-weekly by subcutaneous injection during induction period. During the maintenance period, participants will receive 608 40mg or placebo 4-weekly. |
| Part 1：608 80 mg | Experimental | Drug: Recombinant Anti-IL-17A Humanized Monoclonal Antibody Injection, Other: PlaceboRandomized in a 10:2 ratio to 608 80mg or placebo 2-weekly by subcutaneous injection during induction period. During the maintenance period, participants will receive 608 80mg or placebo 4-weekly. |
| Part 1：608 160 mg | Experimental | Drug: Recombinant Anti-IL-17A Humanized Monoclonal Antibody Injection, Other: PlaceboRandomized in a 10:2 ratio to 608 160mg or placebo 2-weekly by subcutaneous injection during induction period. During the maintenance period, participants will receive 608 160mg or placebo 4-weekly. |
| Part 2：608 160 mg W0+80 mg Q2W+80 mg Q4W | Experimental | Drug: Recombinant Anti-IL-17A Humanized Monoclonal Antibody Injection, Other: PlaceboParticipants will receive starting dose of 160 mg 608 at week 0 followed by 80mg 608 once every two weeks (Q2W) by subcutaneous injection during induction period. During the maintenance period, participants will receive 80mg 608 once every four weeks (Q4W). |
| Part 2：608 160 mg Q2W+160 mg Q4W | Experimental | Drug: Recombinant Anti-IL-17A Humanized Monoclonal Antibody InjectionParticipants will receive 160mg 608 once every two weeks (Q2W) by subcutaneous injection during induction period followed by 160mg 608 once every four weeks (Q4W) during maintenance period. |
| Part 2：608 160 mg Q4W+160 mg Q8W | Experimental | Drug: Recombinant Anti-IL-17A Humanized Monoclonal Antibody Injection, Other: PlaceboParticipants will receive 160mg 608 once every four weeks (Q4W) by subcutaneous injection during induction period followed by 160mg 608 once every eight weeks (Q8W) during maintenance period. |
| Part 2：Placebo | Placebo comparator | Other: PlaceboParticipants will receive Placebo by subcutaneous injection. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Must be 18 Years to 65 Years, both male and female.
- BMI ≥18 kg/m^2 and ≤32 kg/m^2 ，and male weight ≥50 kg, female weight ≥45 kg during the screening.
- Chronic plaque psoriasis (PSO) for at least 6 months prior to the randomizationas as determined by the investigator..
- Psoriasis Area Severity Index (PASI) >=12 and body surface area (BSA) affected by PSO >=10% and Static Physician Global Assessment (sPGA) score >=3.
- According to the judgment of the investigator, the subject needs to receive systemic treatment and / or phototherapy (including subjects who have used local treatment, and / or phototherapy, and / or poor control of previous systemic treatment).
Key exclusion criteria (7 listed)
- History of pustular or erythrodermic psoriasis other than plaque psoriasis at screening or baseline.
- History of drug-induced psoriasis.
- Ongoing use of prohibited treatments.
- Have previously received any drug that directly targets IL-17.
- Have concurrent or recent use of any biologic agent within washout periods or <5 half-lives prior to randomization.
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 |
|---|---|---|
| Recombinant Anti-IL-17A Humanized Monoclonal Antibody InjectionAlso: 608608 will be administered subcutaneously. | Drug | Part 1：608 160 mg, Part 1：608 40 mg, Part 1：608 80 mg |
| PlaceboAlso: PBOParticipants will receive Placebo to maintain the blinding of the Investigational Medicinal Products. | Other | Part 1：608 160 mg, Part 1：608 40 mg, Part 1：608 80 mg |
| Recombinant Anti-IL-17A Humanized Monoclonal Antibody InjectionAlso: 608608 will be provided at pre-specified time intervals. | Drug | Part 2：608 160 mg Q2W+160 mg Q4W, Part 2：608 160 mg Q4W+160 mg Q8W, Part 2：608 160 mg W0+80 mg Q2W+80 mg Q4W |
| PlaceboAlso: PBOParticipants will receive Placebo at pre-specified time points to maintain the blinding of the Investigational Medicinal Products. | Other | Part 2：608 160 mg Q4W+160 mg Q8W, Part 2：608 160 mg W0+80 mg Q2W+80 mg Q4W, Part 2：Placebo |
Primary outcome
Incidence and severity of treatment emergent adverse event (TEAE).
Time frame: Up to 64 Weeks
The incidence and severity of treatment emergent adverse event (TEAE), including adverse events (AEs)，serious adverse event (SAE) and AEs associated with the use of the drug, as well as clinical symptoms, and any abnormalities of vital signs, physical examinations，electrocardiogram，laboratory tests and, etc.
13 secondary outcomes
Cmax
Time frame: Week 0 to 16
Tmax
Time frame: Week 0 to 16
AUC0-last
Time frame: Week 0 to 16
AUC0-tau
Time frame: Week 0 to 16
Cmin
Time frame: Week 0 to 48
Rac_Cmax
Time frame: week 0,12
Rac_AUC0-tau
Time frame: week 0,12
Number of Participants Positive for Anti-Drug Antibody (ADA) in Part 1.
Time frame: Week 0,4,8,12,16,24,48,64
Number of Participants Positive for Anti-Drug Antibody (ADA) in Part 2.
Time frame: Week 0,8,20,44,64
Percentage of Participants Achieving a ≥75% Improvement in Psoriasis Area and Severity Index (PASI 75)
Time frame: At Week 12
Percentage of Participants With a Static Physician Global Assessment (sPGA) Score of Clear (0) or Minimal (1) With at Least a 2 Point Improvement
Time frame: At Week 12
Percentage of Participants Achieving a ≥90% Improvement in Psoriasis Area and Severity Index (PASI 90)
Time frame: At Week 12
Percentage of Participants Achieving a 100% Improvement in Psoriasis Area and Severity Index (PASI 100)
Time frame: At Week 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2022.
- 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.
Jinhua Xu, MD principal investigator
Shanghai Huanshan Hospital Fudan University-Dermatology
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Recombinant Anti-IL-17A Humanized Monoclonal Antibody Injection in people with Psoriasis, run by Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. at 3 sites 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 6 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: status not confirmed, as of the sponsor's last update on 8 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Incidence and severity of treatment emergent adverse event (TEAE). (time frame: Up to 64 Weeks). 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 8 Nov 2022.