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Plaque PsoriasisPhase 2NCT05531682

A Study to Evaluate the Efficacy and Safety of HB0017 in Patients With Moderate to Severe Plaque Psoriasis

A Phase 2 study testing HB0017 in people with Plaque Psoriasis, run by Huabo Biopharm Co., Ltd. at 21 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a randomized, double-blind, placebo-controlled, multi-center Phase 2 study to evaluate the efficacy and safety of HB0017 in subjects with moderate to severe plaque psoriasis. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Plaque Psoriasis
What is being tested?
HB0017
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
160 participants
Where
21 sitesChina
Study dates
25 Oct 2022to 4 Jan 2024
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

  • Subject has provided informed consent
  • Diagnosis of chronic plaque psoriasis with or without psoriatic arthritis for at least 6 months prior to Screening
  • Psoriasis Area and Severity Index(PASI)>=12 and body surface area(BSA) >=10% and static Physician's Global Assessment (sPGA) score 3 or greater on a 5-point scale
  • Candidates for systemic psoriasis therapy and/or phototherapy and/or chemo phototherapy
  • 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

Who cannot join

  • Forms of psoriasis other than chronic plaque psoriasis.
  • History or evidence of active tuberculosis, Patients with evidence of latent tuberculosis may enter the trial after sufficient treatment according to protocol.
  • Positive results of confirmatory serology test for hepatitis B, hepatitis C, HIV or syphilis at screening.
  • History of a serious or systemic infection within 4 weeks before screening.
  • History of malignancy of any organ system within the past 5 years.
  • Inadequate washout period for prior drug therapy.
  • Previous use of secukinumab, ixekizumab or any other drug that targets Interleukin 17( IL-17) or IL-17 receptor.
  • Any medical conditions, in the opinion of the Investigator or the Sponsor's medical monitor, would place the subject at risk, interfere with study participation or study results interpretation.

Trial locations and contacts

21 sites in 1 country.

21 sites in 1 country

China21 sites

  • Peking University People's Hospital

    Beijing

  • Peking University Third Hospital

    Beijing

  • The First Affiliated Hospital of Bengbu Medical College

    Bengbu, Anhui

  • The Second Xiangya Hospital of Central South University

    Changsha, Hunan

  • The Third Xiangya Hospital of Central South University

    Changsha, Hunan

  • Xiangya Hospital of Central South University

    Changsha, Hunan

  • Dermatology Hospital of Southern Medical University

    Guangzhou, Guangdong

  • Guangdong Provincial People's Hospital

    Guangzhou, Guangdong

  • Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang

  • The First Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang

  • The Third People's Hospital of Hangzhou

    Hangzhou, Zhejiang

  • The First Affiliated Hospital of Anhui Medical University

    Hefei, Anhui

  • The Second Hospital of Anhui Medical University

    Hefei, Anhui

  • Shandong Provincial Hospital Affiliated to Shandong First Medical University

    Jinan, Shandong

  • Skin Disease Hospital of Shandong First Medical University

    Jinan, Shandong

  • Dermatology Hospital of Jiangxi Province

    Nanchang, Jiangxi

  • Shanghai Skin Disease Hospital

    Shanghai

  • The first hospital of Hebei Medical University

    Shijiazhuang, Hebei

  • The First Affiliated Hospital of Wannan Medical College

    Wuhu, Anhui

  • Yantai Yuhuangding hospital

    Yantai, Shandong

  • Affiliated Hospital of Jiangsu University

    Zhenjiang, Jiangsu

Other trials in China

About this study

Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Efficacy and Safety of Different Dosing Regimens of HB0017 Injection in Patients With Moderate to Severe Plaque Psoriasis

This is a randomized, double-blind, placebo-controlled, multi-center Phase 2 study to evaluate the efficacy and safety of HB0017 in subjects with moderate to severe plaque psoriasis.

Read the detailed description

This is a randomized, double-blind, placebo-controlled, multi-center Phase 2 study to evaluate the efficacy and safety of HB0017 in subjects with moderate to severe plaque psoriasis. The study will consist of 3 periods: up to 5 weeks screening period, 28 weeks treatment period, 8 weeks Safety Follow-Up period.

Being tested
Placebo, HB0017
Keywords
HB0017, Chronic Plaque Psoriasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlaceboOther

    Subjects will receive several injections of Placebo

  • HB0017Drug

    Also called HB0017 dosing regimens

    Subjects will receive HB0017 in different dosing regimens

Study groups in NCT05531682
Study groupRoleWhat they receive
Experimental: HB0017 dosing regimen 1ExperimentalHB0017 low dose short intervals of subcutaneous injection
Receives: Drug: HB0017
Experimental: HB0017 dosing regimen 2ExperimentalHB0017 low dose long intervals of subcutaneous injection
Receives: Drug: HB0017
Experimental: HB0017 dosing regimen 3ExperimentalHB0017 high dose long intervals of subcutaneous injection
Receives: Drug: HB0017
Placebo Comparator: placebo groupPlacebo comparatorPlacebo was subcutaneously injected into the 12 weeks turnover HB0017 subcutaneous injection
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. PASI 90 response

    Proportion of subjects who achieve Psoriasis Area and Severity Index (PASI) 90 response or higher at week 12

    Measured: Week 12

  2. sPGA 0/1 response

    Proportion of subjects who achieve static Physician Global Assessment (sPGA) 0 or 1

    Measured: Week 12

Secondary outcomes (9)

  1. PASI 75 response

    Proportion of subjects who achieve PASI 75 response or higher

    Measured: Week 12

  2. Adverse events

    Treatment Related Adverse events (TEAEs)/serious adverse events (SAEs)

    Measured: From baseline through 36 weeks

  3. Immunity

    Number and proportion of subjects who developed anti-drug antibodies (ADAs) Following Study Treatment

    Measured: From baseline through 36 weeks

  4. PK characteristics

    Population pharmacokinetics (PK), Apparent Total Clearance (CL/F)， Apparent Volume of Distribution (V/F) of HB0017

    Measured: From Baseline through 36 weeks

  5. PASI responses up to 36 Weeks

    Proportion of subjects who achieve PASI 50, PASI 75, PASI 90 , PASI 100 response up to 36 weeks

    Measured: From Baseline through 36 weeks

  6. sPGA 0/1 up to 36 Weeks

    Proportion of subjects who achieve

    Measured: From Baseline through 36 weeks

  7. PD characterestics

    HB0017 concentrations in serum at different time points

    Measured: From Baseline through 36 weeks

  8. PASI score change

    change in PASI From Baseline to Week 36

    Measured: From Baseline through 36 weeks

  9. Percent change in PASI

    Percent change in PASI From Baseline to Week 36

    Measured: From Baseline through 36 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Sep 2022
  2. Study start25 Oct 2022
  3. Primary completion23 May 2023
  4. Study completion4 Jan 2024

Resources

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
160 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05531682
Sponsor's protocol ID
HB0017-05
Status last verified
Sep 2022
First submitted
31 Aug 2022
Last updated
21 Jun 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing HB0017 in people with Plaque Psoriasis, run by Huabo Biopharm Co., Ltd. at 21 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 5 inclusion and 8 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 21 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 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?

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?

PASI 90 response (time frame: Week 12). The study lists 2 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 NCT05531682.

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 21 Jun 2024.

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