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

Plaque Psoriasis Clinical Trial

Official title:

A Randomized, Double-blind, Multi-center, Parallel Control Phase 3 Study to Compare the Efficacy and Safety of Full Human Anti-TNF Alpha Antibody (HLX03) Versus Adalimumab (Humira®) in Patients With Moderate to Severe Plaque Psoriasis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03316781
• Other study ID #: HLX03-Ps03
• Status: Completed
• Phase: Phase 3
• Start date: October 27, 2017
• Est. completion date: April 22, 2019

Study information

• Verified date: May 2022
• Source: Shanghai Henlius Biotech
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 262
• Est. completion date: April 22, 2019
• Est. primary completion date: July 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Able and willing to give written informed consent.

2. Men or women is =18 and = 75 years of age at time of screening.

3. Stable moderate to severe plaque psoriasis for at least 6 months before Screening.

4. 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.

5. Acceptable to systemic therapy, as judged by the investigator.

6. 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.

7. At time of screening, lab tests have to meet the following:

1. Hemoglobin = 90 g/L

2. WBC = 3.5 × 10^9/L

3. Platelets = 100 × 10^9/L

4. Serum creatinine =1.5 × upper limit of normal (ULN)

5. AST and ALT =2 × ULN

8. For women of child-bearing age, a negative serum pregnancy test during screening, and a negative urine pregnancy test at baseline.

9. During the study to 150 days after the last dose of study medicine, subjects should use effective contraceptive measures

10. Subject is willing and able to comply with the visit schedule and other requirements of the study.

Exclusion Criteria:

1. 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.

2. 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.

3. Participants were given the following treatment, or will be required to receive the

following treatment during the study period:

1. The use of topical drugs within the first two weeks before screening;

2. 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;

3. 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

4. Subjects had live vaccination in the first four weeks before screening, or have the intention to receive live vaccination during the study period.

5. Subjects with history of mycobacterium tuberculosis infection, or with active tuberculosis, or with latent tuberculosis, or with suspected tuberculosis infection judged by clinical phenotypes.

6. Anti-HIV antibody positive, or antibody positive for treponema pallidum, or anti-HCV antibody positive, or HBV HBsAg and/or HBcAb positive at screening.

7. Accompanying active infection or history:

1. Within 4 weeks before screening, systemic anti-infection treatment;

2. Within 8 weeks before screening, severe infection with hospitalization or intravenous anti-infection treatment;

3. Recurrent, chronic, or other active infections, which may increase the study risk as evaluated by the investigator.

8. 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).

9. 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.

10. 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.

11. Moderate to severe heart failure (NYHA III/IV)

12. 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.

13. Participated in another study and received an experimental related drugs within the previous 3 months before screening.

14. Pregnant or lactating women.

15. History of alcohol or substance abuse or dependence, mental disorders.

16. Any condition that will lead to no treatment benefit or affect efficacy evaluation, as judged by the investigator.

Related Conditions & MeSH terms

• Plaque Psoriasis
• Psoriasis

Intervention

Drug:
• HLX03
80 mg SC at Week 0, 40 mg SC at Week 1, and 40 mg every other week thereafter.
• adalimumab
80 mg SC at Week 0, 40 mg SC at Week 1, and 40 mg every other week thereafter.

Locations

Country	Name	City	State
China	Peking University People's Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Henlius Biotech

Country where clinical trial is conducted

China, 

References & Publications (1)

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 Modera — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Week 16
Secondary	PASI 75 response	75% or greater improvement in PASI score	Week 4, 8, 12, 16, 24, 32, 50
Secondary	PASI percent improvement		Week 4, 8, 12, 24, 32, 50
Secondary	Static Physician's Global Assessment (sPGA) responses (with 0 or 1 being a positive result)		Week 4, 8, 12, 16, 24, 32, 50
Secondary	Change of DLQI from baseline		Week 4, 8, 12, 16, 24, 32, 50

External Links

•   EADV 2020 (Poster); official website,and our poster is No. 1362.