Plaque PsoriasisPhase 1NCT05442788
A Study of HB0017 in Patients With Moderate to Severe Plaque Psoriasis
A Phase 1 study of Plaque Psoriasis, run by Huabo Biopharm Co., Ltd. at 1 site in China.
Trial summary
This is a randomized, double-blind, placebo-controlled, dose-escalation Phase Ib study to evaluate the safety, tolerability, and pharmacokinetics of HB0017 following multiple dose in patients with moderate to severe plaque psoriasis. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Plaque Psoriasis
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 2 Sep 2021to 31 May 2022
- Phase
- Phase 1
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Subjects must meet the following criteria to be eligible for study entry:
- Male or female subjects age≥18 and ≤60 years.
- Weight≥50kg,Body Mass Index(BMI)≥18 and ≤28kg/m2.
- Subjects with stable moderate to severe chronic plaque psoriasis of ≥6 months' duration with or without psoriatic arthritis.
- Baseline subjects with moderate or severe plaque psoriasis, defined as below: body surface area (BSA) involvement ≥10%,Psoriasis Area and Severity Index (PASI) ≥12, Static Physician Global Assessment (sPGA) ≥3.
- Candidates for systemic therapy or phototherapy judged by the investigator or accepted systemic therapy or phototherapy at least one time before.
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- Women who are at childbearing age(not pregnant or breast-feeding), and subjects and their partners voluntarily use contraceptive methods deemed effective by the investigator during treatment and for at least 6 months after the last study medication.
- During the study, Prolonged exposure to sunlight and the use of ultraviolet health rooms or other ultraviolet light sources must be avoided.
- Informed consent must be obtained in writing for all subjects enrolled into the study.
- Subjects must be willing and able to complete study procedures and follow-up examinations.
Who cannot join
- Subjects who meet any of the following criteria will be excluded from study entry:
- Screening for psoriasis other than chronic plaque (such as pustular erythroderma and guttate psoriasis).
- Drug-induced psoriasis (including, but not limited to, new psoriasis or exacerbations of psoriasis caused by beta blockers calcium channel inhibitors or lithium).
- Have other active skin diseases or skin infections (bacterial, fungal or viral) that may interfere with clinical evaluation of psoriasis.
- Patients with symptoms or signs of progressive or uncontrolled kidney, liver, blood, gastrointestinal, endocrine, lung, heart, nerve, mental or brain diseases, or other chronic diseases that are not suitable for the study.
- Screening of patients with radiographic abnormalities within the preceding 3 months suggesting pulmonary infection or fibrosis or tumor.
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- History of exposure to active tuberculosis (TB); History of TB infection; TB lesions on chest X-ray/chest CT. QuantiFERON®-TB Gold orT-SPOT®.TB positive in the 6 weeks prior to first administration.
- Having any severe systemic or local infection within 2 months prior to screening.
- History of chronic recurrent infectious diseases, including but not limited to chronic kidney infections chronic chest infections (such as bronchiectasis) complex urinary tract infections (recurrent pyelonephritis or chronic cystitis) or open,drainage or skin wound infections or ulcers.
- History of underlying or active granulomatous infection, including histoplasmosis or coccosis.
- Non-tuberculous mycobacterial infection or opportunistic infection (e.g.,cytomegalovirus infection with pneumocystis carinii and aspergillosis) within 6 months prior to screening.
- Subjects whose blood pressure is higher than 140 mmHg/90 mmHg (if their blood pressure exceeds this threshold, they may be retested after at least 10 minutes of quiet rest at the discretion of the investigator; if their blood pressure is lower than this threshold, they may be enrolled; Patients who have a history of hypertension but have stable blood pressure control and meet the requirements of the program can be included in the group).
- Having unstable cardiovascular disease was defined as having had a clinical deterioration in the last 3 months (e.g., unstable angina or rapid atrial fibrillation) or having been hospitalized for heart disease in the last 3 months.
- Significant abnormalities in heart rate, ECG and respiratory system, and has been judged to be of clinical significance by the investigator.
- Liver, kidney and blood abnormalities, including:
- Glutamate aminotransferase (AST) or aspartate aminotransferase (ALT) exceeds 2 times the normal value (if the first measured value of AST and ALT exceeds this limit, the retest can be carried out once within 7 days; if the retest value is lower than the standard limit, the retest value is acceptable).
- Hemoglobin (HGB)< 100g/L.
- Platelet count(PLT)<100*109/L.
- White blood cells(WBC) <3.5*109/L.
- absolute value of neutrophils（NEUT#）<2*109/L.
- Serum creatinine was higher than the upper limit of normal value.
- Abnormal results of other laboratory tests may, in the investigator's judgment, affect the completion of the test or interfere with the test results.
- Patients who have had malignant tumors (except basal cell carcinoma of the skin and cervical cancer in situ, which have been cured and have no signs of recurrence) or lymphoproliferative diseases, or cervical diseases caused by HPV.
- Patients who were allergic to any component of the study drug, or had a history of severe allergic reaction to monoclonal antibodies, or were admitted to the study as determined by the investigator to be at risk of allergy.
- History of alcohol or drug abuse or have positive results of drug abuse at screening.
- Hepatitis C virus antibody positive, human immunodeficiency virus positive, treponema pallidum antibody positive;Hepatitis B virus screening program includes hepatitis B virus surface antigen (HbsAg), hepatitis B virus surface antibody (HBsAb) and hepatitis B virus core antibody (HBcAb) : HbsAg positive subjects, screening failure,Only HBcAb positive subjects must be further tested for Hepatitis B virus (HBV) DNA load. If HBV DNA is positive or above the upper limit of normal, screening will fail.
- Use of topical anti-psoriasis therapy (including topical use of non-weak glucocorticoids, retinoids, vitamin D3 derivatives, salicylic acid, anthracene, etc.) within 2 weeks prior to screening.
- Use of anti-rheumatism drugs (DMARDs), antimalarial drugs, interferon and lithium within 4 weeks prior to screening.
- Use of physical therapy (including photochemotherapy, uv therapy, self-therapy on tanning beds, etc.) within 4 weeks prior to screening.
- Use of systemic nonbiological psoriasis therapy (glucocorticoids, retinoids, ciclosporin , methotrexate, Tripterygium wilfordii, azathioprine, Mycophenolate Mofetil, the treatment of psoriasis related Chinese medicine,etc.) within 4 weeks prior to screening.
- Participation in another research 3 months prior to screening or now.
- Have received or plan to receive any live vaccines 2 months prior to screening.
- Treatment with biological agents(secukinumab, Ixekizumab,or other IL-17 antibodies≤6 months prior to screening.
- Treatment with Natalizumab, Rituximab, Alemtuzumab, Abatacept,or other drugs that regulate B or T cells) ≤6 months prior to screening.
- Before screening, the elution period of the following biologics was shorter than the following: Etanercept, Infliximab and Adalimumab < 60 days; Ustekinumab, Risankizumab or other interleukin-23 antagonists < 6 months; Or other anti-psoriasis treatments not listed and within its 5 half-life.
- Previous or current autoimmune diseases (e.g. Rheumatoid arthritis, systemic lupus erythematosus, inflammatory bowel disease, scleroderma, inflammatory myopathy, mixed connective tissue disease, overlap syndrome,etc.).
- Organ transplantation (except corneal transplantation more than 3 months prior to the first administration).
- History of demyelinating disease (including myelitis) or neurological symptoms suggestive of demyelinating disease, or have a family history of demyelinating disease.
- History of neurological or mental disorders, such as epilepsy, dementia, poor compliance.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, 233070
About this study
Official title: A Phase Ib, Randomized, Double-blind, Placebo-controlled, Dose-escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of HB0017 Following Multiple Dose in Patients With Moderate to Severe Plaque Psoriasis
This is a randomized, double-blind, placebo-controlled, dose-escalation Phase Ib study to evaluate the safety, tolerability, and pharmacokinetics of HB0017 following multiple dose in patients with moderate to severe plaque psoriasis.
Read the detailed description
The study is a randomized, double-blinded, placebo-controlled, multiple dose-escalation study to evaluate the safety, tolerability, PK and immunogenicity of HB0017 in patients with Moderate to severe plaque psoriasis be given HB0017 at doses of 150mg, 300mg and 450mg or placebo by SC administration every 3 weeks. Each cohort of 10 subjects is randomly assigned to receive either a single dose of HB0017 or matching placebo at a ratio of 4:1. Each subject receive injection at week0(Day1), week 3(Day22), week 6(Day43) and week 9(Day64), respectively. After the evaluation and unblinding is completed at week 12(Day 85), the subjects in placebo group completed all study periods, and the HB0017 group continued to be followed up until the end of week 20(D141).
- Conditions
- Plaque Psoriasis
- Being tested
- HB0017 150mg or matching placebo, HB0017 300mg or matching placebo, HB0017 450mg or matching placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HB0017 150mg or matching placeboBiological
Each subject receive injection at week0(Day1), week 3(Day22), week 6(Day43) and week 9(Day64), respectively.
HB0017 300mg or matching placeboBiological
Each subject receive injection at week0(Day1), week 3(Day22), week 6(Day43) and week 9(Day64), respectively.
HB0017 450mg or matching placeboBiological
Each subject receive injection at week0(Day1), week 3(Day22), week 6(Day43) and week 9(Day64), respectively.
| Study group | Role | What they receive |
|---|---|---|
| HB0017 150mg | Experimental | 10 subjects is randomly assigned to receive HB0017 150mg or matching placebo at a ratio of 4:1. Receives: Biological: HB0017 150mg or matching placebo |
| HB0017 300mg | Experimental | 10 subjects is randomly assigned to receive HB0017 300mg or matching placebo at a ratio of 4:1. Receives: Biological: HB0017 300mg or matching placebo |
| HB0017 450mg | Experimental | 10 subjects is randomly assigned to receive HB0017 450mg or matching placebo at a ratio of 4:1. Receives: Biological: HB0017 450mg or matching placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment emergent AE/SAEs
Measured: From baseline through week 20
Elimination half-life (T1/2)
Measured: From baseline through week 20
Area under drug-time curve (AUC)
Measured: From baseline through week 20
Total clearance (CL/F)
Measured: From baseline through week 20
Maximum serum concentrations (Cmax)
Measured: From baseline through week 20
Mean retention time (MRT)
Measured: From baseline through week 20
Volume of distribution (Vz/F)
Measured: From baseline through week 20
Peak time(Tmax)
Measured: From baseline through week 20
Secondary outcomes (5)
PASI 75
Proportion of subjects who achieve PASI 75 response or higher at week 12
Measured: Week 12
PASI 90
Proportion of subjects who achieve PASI 90 response or higher at week 12
Measured: Week 12
PASI 100
Proportion of subjects who achieve PASI 100 response at week 12
Measured: Week 12
sPGA
Proportion of subjects who achieve sPGA 0 or 1 at week 12
Measured: Week 12
Immunogenicity
Immunogenicity: number and percentage of subjects with ADA positive anti-HB0017 antibody.
Measured: From baseline through week 20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2022
- Study start2 Sep 2021
- Primary completion31 May 2022
- Study completion31 May 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Huabo Biopharm Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Congjun Jiang, Master, Principal investigator, The First Affiliated Hospital of Bengbu Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05442788
- Sponsor's protocol ID
- HB0017-02
- Status last verified
- Jul 2022
- First submitted
- 22 Jun 2022
- Last updated
- 7 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jiang C, Du Y, Liu X, Wang J, Ge C, Xu J, Wang S, Li B, Zhu G, Zhang W, Qian Q, Ma C, Zhu X, Zhan Y, Yang Y. Safety, tolerability, pharmacokinetics and efficacy of HB0017, a humanized monoclonal antibody that targets interleukin-17A, in healthy participants and patients with moderate-to-severe plaque psoriasis. Br J Dermatol. 2023 Dec 20;190(1):28-36. doi: 10.1093/bjd/ljad315.
PubMed 37669307
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib, Randomized, Double-blind, Placebo-controlled, Dose-escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of HB0017 Following Multiple Dose in Patients With Moderate to Severe Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT05442788
- Acronym / sponsor ID
- HB0017-02
- Conditions
- Plaque Psoriasis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Huabo Biopharm Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 2 Sep 2021 (actual)
- Primary completion
- 31 May 2022 (actual)
- Study completion
- 31 May 2022 (actual)
- First posted
- 5 Jul 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.
This is a randomized, double-blind, placebo-controlled, dose-escalation Phase Ib study to evaluate the safety, tolerability, and pharmacokinetics of HB0017 following multiple dose in patients with moderate to severe plaque psoriasis.
Detailed description
The study is a randomized, double-blinded, placebo-controlled, multiple dose-escalation study to evaluate the safety, tolerability, PK and immunogenicity of HB0017 in patients with Moderate to severe plaque psoriasis be given HB0017 at doses of 150mg, 300mg and 450mg or placebo by SC administration every 3 weeks. Each cohort of 10 subjects is randomly assigned to receive either a single dose of HB0017 or matching placebo at a ratio of 4:1. Each subject receive injection at week0(Day1), week 3(Day22), week 6(Day43) and week 9(Day64), respectively. After the evaluation and unblinding is completed at week 12(Day 85), the subjects in placebo group completed all study periods, and the HB0017 group continued to be followed up until the end of week 20(D141).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HB0017 150mg | Experimental | Biological: HB0017 150mg or matching placebo10 subjects is randomly assigned to receive HB0017 150mg or matching placebo at a ratio of 4:1. |
| HB0017 300mg | Experimental | Biological: HB0017 300mg or matching placebo10 subjects is randomly assigned to receive HB0017 300mg or matching placebo at a ratio of 4:1. |
| HB0017 450mg | Experimental | Biological: HB0017 450mg or matching placebo10 subjects is randomly assigned to receive HB0017 450mg or matching placebo at a ratio of 4:1. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Male or female subjects age≥18 and ≤60 years.
- Weight≥50kg,Body Mass Index(BMI)≥18 and ≤28kg/m2.
- Subjects with stable moderate to severe chronic plaque psoriasis of ≥6 months' duration with or without psoriatic arthritis.
- Baseline subjects with moderate or severe plaque psoriasis, defined as below: body surface area (BSA) involvement ≥10%,Psoriasis Area and Severity Index (PASI) ≥12, Static Physician Global Assessment (sPGA) ≥3.
- Candidates for systemic therapy or phototherapy judged by the investigator or accepted systemic therapy or phototherapy at least one time before.
Key exclusion criteria (39 listed)
- Screening for psoriasis other than chronic plaque (such as pustular erythroderma and guttate psoriasis).
- Drug-induced psoriasis (including, but not limited to, new psoriasis or exacerbations of psoriasis caused by beta blockers calcium channel inhibitors or lithium).
- Have other active skin diseases or skin infections (bacterial, fungal or viral) that may interfere with clinical evaluation of psoriasis.
- Patients with symptoms or signs of progressive or uncontrolled kidney, liver, blood, gastrointestinal, endocrine, lung, heart, nerve, mental or brain diseases, or other chronic diseases that are not suitable for the study.
- Screening of patients with radiographic abnormalities within the preceding 3 months suggesting pulmonary infection or fibrosis or tumor.
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 |
|---|---|---|
| HB0017 150mg or matching placeboEach subject receive injection at week0(Day1), week 3(Day22), week 6(Day43) and week 9(Day64), respectively. | Biological | HB0017 150mg |
| HB0017 300mg or matching placeboEach subject receive injection at week0(Day1), week 3(Day22), week 6(Day43) and week 9(Day64), respectively. | Biological | HB0017 300mg |
| HB0017 450mg or matching placeboEach subject receive injection at week0(Day1), week 3(Day22), week 6(Day43) and week 9(Day64), respectively. | Biological | HB0017 450mg |
Primary outcome
Incidence of treatment emergent AE/SAEs
Time frame: From baseline through week 20
Elimination half-life (T1/2)
Time frame: From baseline through week 20
Area under drug-time curve (AUC)
Time frame: From baseline through week 20
Total clearance (CL/F)
Time frame: From baseline through week 20
Maximum serum concentrations (Cmax)
Time frame: From baseline through week 20
Mean retention time (MRT)
Time frame: From baseline through week 20
Volume of distribution (Vz/F)
Time frame: From baseline through week 20
Peak time(Tmax)
Time frame: From baseline through week 20
5 secondary outcomes
PASI 75
Time frame: Week 12
PASI 90
Time frame: Week 12
PASI 100
Time frame: Week 12
sPGA
Time frame: Week 12
Immunogenicity
Time frame: From baseline through week 20
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 7 Jul 2022.
- Derived from this study: PubMed 37669307Jiang C, Du Y, Liu X, Wang J, Ge C, Xu J, Wang S, Li B, Zhu G, Zhang W, Qian Q, Ma C, Zhu X, Zhan Y, Yang Y. Safety, tolerability, pharmacokinetics and efficacy of HB0017, a humanized monoclonal antibody that targets interleukin-17A, in healthy participants and patients with moderate-to-severe plaque psoriasis. Br J Dermatol. 2023 Dec 20;190(1):28-36. doi: 10.1093/bjd/ljad315.
- 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.
Congjun Jiang, Master principal investigator
The First Affiliated Hospital of Bengbu Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study of Plaque Psoriasis, run by Huabo Biopharm 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 39 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 7 Jul 2022. 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Incidence of treatment emergent AE/SAEs (time frame: From baseline through week 20). The study lists 8 primary outcomes in all. 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 NCT05442788, 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 7 Jul 2022.