A Phase 3 interventional study of HLX03 and adalimumab in Plaque Psoriasis, sponsored by Shanghai Henlius Biotech. Completed at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-08-13.
Sponsored by Shanghai Henlius Biotech (part of Fosun Pharma) · Phase 3, Interventional, and Treatment
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Among 206 studies in Psoriasis with a site in China — 56 open to participants now, 66 under way, 22 of them phase 3. Psoriasis · China.
Among the 206 studies in Psoriasis with a site in China, this one is the 62nd largest by enrollment of the 182 interventional ones that give a count, is one of 8 that started in 2017, is one of 58 in phase 3, and was the 29th registered.
2,030 studies on the registry are indexed under Psoriasis; 276 are open to participants now.
Browse Psoriasis studies →56 of the 206 studies in Psoriasis with a site in China are open now. Recruiting first, the newest first:
Fujian Shengdi Pharmaceutical Co., Ltd. · Sites in China
Ages 18–55 · Healthy volunteers
Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. · Sites in China
Ages 18–75
Guangdong Hengrui Pharmaceutical Co., Ltd · Sites in China
Ages 18+
Xijing Hospital · Sites in China
Ages 18–65
Zhejiang Wenda Pharma Technology LTD. · Sites in China
Ages 18–75 · Healthy volunteers
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
Of the 173 Psoriasis studies recruiting now, 91 (53%) set no upper age limit and 66 (38%) stop at 75 or younger; 25 take children under 18; 40 take healthy volunteers.
This study: 18 Years to 75 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
206 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 48 · Phase 2 55 · Phase 3 60 · Phase 4 12
First in 2005; this study’s year is marked. 8 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 262 is above the median of 75 across 1,567 interventional studies indexed under Psoriasis.
Median enrollment 161 across the 182 interventional studies, 191 across the 24 observational. Of the 111 that completed or were terminated, 16 (14%) have results posted.
This tab as a report to print or save as PDF → With an account.
144 of 206 have an industry lead sponsor. The 10 most frequent:
This study is registered under Shanghai Henlius Biotech, one of the names counted as Fosun Pharma. Under that name alone:
Shanghai Henlius Biotech is the lead sponsor of 132 studies on the registry; 56 are open to participants now.
Fosun Pharma has 1 study filed under Psoriasis — fewer than ten, so there is no comparison to draw.
20 of the studies in Psoriasis with a site in China that are under way reach primary completion within a year, 5 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07672561Phase 3Zhejiang Wenda Pharma Technology LTD.A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase Ⅲ Study to Evaluate the Efficacy and Safety of WD-890 Tablets for the Treatment of Moderate to Severe Plaque Psoriasis | 2026-11-30 |
| NCT07543224Phase 3Reistone Biopharma Company LimitedA Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of RSS0393 Ointment in Adult Patients With Plaque Psoriasis. | 2027-01 |
| NCT07326813Phase 3InventisBio Co., LtdA Clinical Study to Evaluate the Efficacy and Safety of D-2570 in the Treatment of Moderate to Severe Plaque Psoriasis | 2027-07-12 |
| NCT07130604Phase 3InventisBio Co., LtdEvaluate the Efficacy and Safety of D-2570 in Subjects With Moderate to Severe Plaque Psoriasis | 2027-07-28 |
| NCT07724366Phase 3Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.A Clinical Trial of TQH3906 Capsules in Adult Patients With Moderate to Severe Plaque Psoriasis | 2027-09 |
Add all 20 to your calendar (.ics) → With an account.
Among the 206 studies in Psoriasis with a site in China, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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.
At time of screening, lab tests have to meet the following:
Exclusion Criteria:
Participants were given the following treatment, or will be required to receive the following treatment during the study period:
Accompanying active infection or history:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: HLX03
Drug: adalimumab
80 mg SC at Week 0, 40 mg SC at Week 1, and 40 mg every other week thereafter.
80 mg SC at Week 0, 40 mg SC at Week 1, and 40 mg every other week thereafter.
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
Time frame: Week 16
PASI 75 response
75% or greater improvement in PASI score
Time frame: Week 4, 8, 12, 16, 24, 32, 50
PASI percent improvement
Time frame: Week 4, 8, 12, 24, 32, 50
Static Physician's Global Assessment (sPGA) responses (with 0 or 1 being a positive result)
Time frame: Week 4, 8, 12, 16, 24, 32, 50
Change of DLQI from baseline
Time frame: Week 4, 8, 12, 16, 24, 32, 50
Ran from Oct 2017 to primary completion in Jul 2018, 8 months.
Of 217 industry-sponsored phase 3 interventional studies under Psoriasis, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 26. This study's 8 months is below that.
Counting every sponsor, half of 227 studies reached it within 15 months; a quarter within 10 and three quarters within 26.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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