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Plaque PsoriasisPhase 3NCT03316781

Study of Efficacy and Safety of HLX03 in Subjects With Moderate to Severe Plaque Psoriasis

A Phase 3 study testing HLX03 and adalimumab in people with Plaque Psoriasis, run by Shanghai Henlius Biotech at 1 site 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 multicenter, randomized, double-blind, positive drug parallel-group controlled clinical study in China to evaluate efficacy, safety, tolerability and immunogenicity of HLX03 and adalimumab (Humira) 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?
HLX03 and adalimumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
262 participants
Where
1 siteChina
Study dates
27 Oct 2017to 22 Apr 2019
Phase
Phase 3
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

  • Able and willing to give written informed consent.
  • Men or women is ≥18 and ≤ 75 years of age at time of screening.
  • Stable moderate to severe plaque psoriasis for at least 6 months before Screening.
  • Moderate to severe psoriasis as defined at Baseline by:
  • BSA of ≥ 10% involvement at the Baseline visit. PGA score of ≥ 3 at the Baseline visit. PASI score of ≥ 12 at the Baseline visit.
  • Acceptable to systemic therapy, as judged by the investigator.
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  • Previously received at least one traditional psoriasis treatment (for example, methotrexate, cyclosporine A, psoralen plus UVA or UVB, tretinoin, Chinese medicine, etc.), and was insensitive, intolerant, contraindicated to, or failed the treatment, as judged by the investigator.
  • At time of screening, lab tests have to meet the following:
  • Hemoglobin ≥ 90 g/L
  • WBC ≥ 3.5 × 10^9/L
  • Platelets ≥ 100 × 10^9/L
  • Serum creatinine ≤1.5 × upper limit of normal (ULN)
  • AST and ALT ≤2 × ULN
  • For women of child-bearing age, a negative serum pregnancy test during screening, and a negative urine pregnancy test at baseline.
  • During the study to 150 days after the last dose of study medicine, subjects should use effective contraceptive measures
  • Subject is willing and able to comply with the visit schedule and other requirements of the study.

Who cannot join

  • At screening visit, subjects with erythrodermic psoriasis, pustule psoriasis, bit type psoriasis, drug-induced psoriasis, other skin lesions (such as eczema), other systemic autoimmune inflammatory lesions, which may affect the efficacy evaluation of the treatment.
  • The subject has surgery plan during the study period (excluding surgery that is related to the study disease), except that there will be no increased risk for the subjects or no influence on the study treatment or adherence to the study as judged by the investigator.
  • Participants were given the following treatment, or will be required to receive the following treatment during the study period:
  • The use of topical drugs within the first two weeks before screening;
  • The use of UVA and/or UVB treatment, and non-biological drugs (such as methotrexate, cyclosporin, tretinoin, traditional Chinese medicine, proprietary Chinese medicine, etc) within the first four weeks before screening;
  • In the first 4 weeks before screening, the use of Etanercept or Etanercept; in the first 12 weeks before screening, the use of other biological agents
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  • Subjects had live vaccination in the first four weeks before screening, or have the intention to receive live vaccination during the study period.
  • Subjects with history of mycobacterium tuberculosis infection, or with active tuberculosis, or with latent tuberculosis, or with suspected tuberculosis infection judged by clinical phenotypes.
  • Anti-HIV antibody positive, or antibody positive for treponema pallidum, or anti-HCV antibody positive, or HBV HBsAg and/or HBcAb positive at screening.
  • Accompanying active infection or history:
  • Within 4 weeks before screening, systemic anti-infection treatment;
  • Within 8 weeks before screening, severe infection with hospitalization or intravenous anti-infection treatment;
  • Recurrent, chronic, or other active infections, which may increase the study risk as evaluated by the investigator.
  • Known malignancy or history of malignancy (except for the following: in situ skin squamous carcinoma after thorough treatment with no sign of recurrence, basal cell carcinoma, cervical cancer in situ, or skin squamous carcinoma at least five years prior to randomization with no signs of recurrence after treatment).
  • Ongoing, severe, progressive, or uncontrolled diseases, including but not limited to diseases at the endocrine system, blood system, urinary system, liver and gallbladder, respiratory system, nervous system, cardiovascular system, gastrointestinal system or infectious diseases, with increased risk to participate the study as assessed by the investigator.
  • The subjects with active neuropathies, such as multiple sclerosis, Guillain-Barre Syndrome, optic neuritis, transverse myelitis, or neurological symptoms suggestive of the demyelinating diseases of the central nervous system.
  • Moderate to severe heart failure (NYHA III/IV)
  • History of allergic reactions to the active components of the study drugs (HLX03 and adalimumab (Humira®)) and their formulation gradients, or medicines belonging to the same pharmacology and biological category.
  • Participated in another study and received an experimental related drugs within the previous 3 months before screening.
  • Pregnant or lactating women.
  • History of alcohol or substance abuse or dependence, mental disorders.
  • Any condition that will lead to no treatment benefit or affect efficacy evaluation, as judged by the investigator.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Peking University People's Hospital

    Beijing

Other trials in China

About this study

Official title: A Randomized, Double-Blind, Multi-Center, Active-Controlled, Parallel-Group Phase III Clinical Study to Compare the Efficacy and Safety of Recombinant Anti-TNFα Human Monoclonal Antibody Injection (HLX03) and Adalimumab Injection (Humira®) in Patients With Moderate to Severe Plaque Psoriasis

This is a multicenter, randomized, double-blind, positive drug parallel-group controlled clinical study in China to evaluate efficacy, safety, tolerability and immunogenicity of HLX03 and adalimumab (Humira) in subjects with moderate to severe plaque psoriasis. This study will recruit 216 subjects (18-75 years old, male and female) with moderate to severe plaque psoriasis. The 216 subjects will be randomly assigned per 1:1 ratio into the following two treatment groups (HLX03 OR Adalimumab). The study will be conducted in three periods, including the screening period, treatment period and follow-up period. For each participating subjects, the maximal length of the study will be 56 weeks (including up to four weeks of screening time).

Being tested
HLX03, adalimumab

What participants receive

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

  • HLX03Drug

    80 mg SC at Week 0, 40 mg SC at Week 1, and 40 mg every other week thereafter.

  • adalimumabDrug

    80 mg SC at Week 0, 40 mg SC at Week 1, and 40 mg every other week thereafter.

Study groups in NCT03316781
Study groupRoleWhat they receive
HLX03 groupExperimentalNot described
Receives: Drug: HLX03
adalimumab groupActive comparatorNot described
Receives: Drug: adalimumab

What is being measured

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

  1. Percentage improvement of PASI from baseline to Week 16

    Percent improvement of PASI from baseline to Week 16 will be calculated as the following formula: (PASI baseline-PASI Week 16) x 100% /PASI baseline

    Measured: Week 16

Secondary outcomes (4)

  1. PASI 75 response

    75% or greater improvement in PASI score

    Measured: Week 4, 8, 12, 16, 24, 32, 50

  2. PASI percent improvement

    Measured: Week 4, 8, 12, 24, 32, 50

  3. Static Physician's Global Assessment (sPGA) responses (with 0 or 1 being a positive result)

    Measured: Week 4, 8, 12, 16, 24, 32, 50

  4. Change of DLQI from baseline

    Measured: Week 4, 8, 12, 16, 24, 32, 50

Timeline

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

  1. First posted20 Oct 2017
  2. Study start27 Oct 2017
  3. Primary completion15 Jul 2018
  4. Study completion22 Apr 2019

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
262 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03316781
Sponsor's protocol ID
HLX03-Ps03
Status last verified
Aug 2025
First submitted
17 Oct 2017
Last updated
13 Aug 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Cai L, Li L, Cheng H, Ding Y, Biao Z, Zhang S, Geng S, Liu Q, Fang H, Song Z, Lu Y, Li S, Guo Q, Tao J, He L, Gu J, Yang Q, Han X, Gao X, Deng D, Li S, Wang Q, Zhu J, Zhang J. Efficacy and Safety of HLX03, an Adalimumab Biosimilar, in Patients with Moderate-to-Severe Plaque Psoriasis: A Randomized, Double-Blind, Phase III Study. Adv Ther. 2022 Jan;39(1):583-597. doi: 10.1007/s12325-021-01899-0. Epub 2021 Nov 23.

    PubMed 34816373

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing HLX03 and adalimumab in people with Plaque Psoriasis, run by Shanghai Henlius Biotech 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 16 inclusion and 22 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 13 Aug 2025. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 improvement of PASI from baseline to 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?

On the ClinicalTrials.gov record for NCT03316781, 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 13 Aug 2025.

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