Generalized Pustular PsoriasisPhase 1NCT06433531
A Clinical Study of TQH2929 Injection in Treatment With Generalized Pustular Psoriasis (GPP)
A Phase 1 study testing TQH2929 Injection in people with Generalized Pustular Psoriasis, run by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. at 7 sites in China.
Trial summary
This study is a multicenter, single-group, open-label study to evaluate the safety and tolerability of TQH2929 injection at a dose of 900mg in adult subjects with active Generalized Pustular Psoriasis (GPP), and to preliminarily evaluate the efficacy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Generalized Pustular Psoriasis
- What is being tested?
- TQH2929 Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 7 sitesChina
- Study dates
- 19 Jun 2024to Dec 2025
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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
- Adults aged between 18 and 75 years (inclusive)，both male and female；
- A known and documented history of Generalized Pustular Psoriasis diagnosed with European Rare and Severe Psoriasis Expert Network (ERASPEN) criteria in 2017；
- Presenting with a moderate-severe flare of Generalized Pustular Psoriasis (GPP)
- Body mass index (BMI) within 18~36 kg/m2；
- Major organ function is good;
- Patients must be able to understand and sign a written informed consent document;
- Patients must be able to complete study-related procedures and questionnaires;
- Female and male subjects of childbearing age should agree to use contraceptive measures during the study period and within 6 months after the end of the study; Female subjects need to serum pregnancy pregnancy test within 7 days before study enrollment.
Who cannot join
- Patients with primary plaque psoriasis vulgaris with pustules that are restricted to psoriatic plaques；
- Immediate life-threatening flare of Generalized Pustular Psoriasis or requiring intensive care treatment, according, to the judgment of the investigator；
- Computed Tomography of the chest shows active or occult tuberculosis or a history of contact with an open tuberculosis (TB) subject within the past 6 months. Subjects positive for tuber closes spot(T-SPOT) (or other tuberculosis diagnostic test) result;
- Active hepatitis during the screening period, or positive for hepatitis B surface antigen (HBsAg)；
- History of human immunodeficiency virus (HIV) infection, or positive HIV serological results at screening during screening；
- Positive antibodies to treponema pallidum during screening；
Show all 27Show fewer
- History of serious infection leading to hospitalization or intravenous infusion of antibiotics or antiviral therapy within 3 months prior to baseline;
- Active systemic infections requiring systemic antibiotics or systemic antiviral therapy within 4 weeks prior to baseline;
- History of opportunistic infection and parasitic infection within 6 months prior to the screening period；
- History of herpes zoster infection within 2 months prior to baseline；
- Subject has known or suspected autoimmune disease;
- Receive major surgery within 4 weeks prior to the first dose;
- Subjects with any type of active malignancy or a history of malignancy (except cervical cancer or non-metastatic cutaneous squamous cell carcinoma, basal cell carcinoma and papillary thyroid carcinoma) that has been cured for more than 5 years prior to the screening period;
- Subjects have history of significant drug allergies；
- Use of the following medications within the prescribed time:
- Receive topical drugs for the treatment of skin diseases within 1 weeks prior to baseline;
- Receive systemic therapy within 4 weeks prior to baseline;
- Receive regular phototherapy within 4 weeks prior to baseline;
- Within 12 weeks prior to baseline, receive live (attenuated) vaccine;
- Receive antibiotics and antivirals within 4 weeks prior to baseline.
- People who are alcoholic, drug addicts, and known drug dependents;
- Pregnant or Breasting feeding subject;
- Received a blood transfusion within 4 weeks prior to the first dose;
- Subject is unable to tolerate intravenous infusion administration;
- During the period of participation in this study, participants had planned surgical procedures;
- Have participated in clinical trials of other drugs or medical devices within 4 weeks prior to baseline;
- In the judgment of the investigator or sponsoring medical auditor, it is believed that there are any medical or psychiatric symptoms that put the subject at risk, interfere with participation in the study, or interfere with the interpretation of the results of the study.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
China7 sites
Peking University First Hospital
Beijing, Beijing Municipality, 100871
Second People's Hospital of Chengdu
Chengdu, Sichuan, 610052
Dermatology Hospital of Southern Medical Universitye
Guangzhou, Guangdong, 510091
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310000
The First Hospital of China Medical University
Shenyang, Liaoning, 110000
The First Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050000
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050000
About this study
Official title: Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Profile, and Efficacy of TQH2929 in Healthy Adult Subjects and Psoriasis Subjects
This study is a multicenter, single-group, open-label study to evaluate the safety and tolerability of TQH2929 injection at a dose of 900mg in adult subjects with active Generalized Pustular Psoriasis (GPP), and to preliminarily evaluate the efficacy.
- Conditions
- Generalized Pustular Psoriasis
- Being tested
- TQH2929 Injection
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TQH2929 InjectionDrug
TQH2929 injection is a humanized monoclonal antibody that interfering with the signal cascade.
| Study group | Role | What they receive |
|---|---|---|
| TQH2929 Injection (900 mg) | Experimental | TQH2929 Injection is administered as a single dose. Receives: Drug: TQH2929 Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events (AE)
The occurrence of all adverse events (AE).
Measured: From the first dose to 113 days after the last dose
Serious adverse events (SAE)
The occurrence of all serious adverse events (SAE).
Measured: From the first dose to 113 days after the last dose
Treatment-related adverse events(TRAE)
The occurrence of all treatment-related adverse events(TRAE).
Measured: From the first dose to 113 days after the last dose
Clinical laboratory abnormalities
Incidence of participants with clinical laboratory abnormalities
Measured: From the first dose to 113 days after the last dose
Secondary outcomes (15)
Time to reach maximum observed serum concentration (Tmax)
Time to reach maximum (peak) serum concentration following drug administration.
Measured: Single dose: within 1 hour (pre-dose), 0, 0.5, 1, 2, 6, 12, 24, 48, 72, 168, 336, 504, 672, 840, 1008, 1344, 1680, 2016, 2353, 2688 hours post-dose
Maximum serum concentration (Cmax)
The Cmax is the maximum observed serum concentration of study drug.
Measured: Single dose: within 1 hour (pre-dose), 0, 0.5, 1, 2, 6, 12, 24, 48, 72, 168, 336, 504, 672, 840, 1008, 1344, 1680, 2016, 2353, 2688 hours post-dose
Area Under the Concentration-Time Curve From Zero to Infinity (AUC [0-infinity])
Area under the concentration-time curve of the TQH2929 Injection in serum over the time interval from 0 extrapolated to infinity.
Measured: Single dose: within 1 hour (pre-dose), 0, 0.5, 1, 2, 6, 12, 24, 48, 72, 168, 336, 504, 672, 840, 1008, 1344, 1680, 2016, 2353, 2688 hours post-dose
Area Under the Concentration-Time Curve From 0 to Last Observation (AUC [0-t])
Area under the concentration-time curve of the TQH2929 Injection in serum over the time interval from 0 extrapolated to the last quantifiable data point.
Measured: Single dose: within 1 hour (pre-dose), 0, 0.5, 1, 2, 6, 12, 24, 48, 72, 168, 336, 504, 672, 840, 1008, 1344, 1680, 2016, 2353, 2688 hours post-dose
Apparent volume of distribution (Vd/F)
Apparent volume of distribution of the TQH2929 Injection in serum.
Measured: Single dose: within 1 hour (pre-dose), 0, 0.5, 1, 2, 6, 12, 24, 48, 72, 168, 336, 504, 672, 840, 1008, 1344, 1680, 2016, 2353, 2688 hours post-dose
Apparent clearance (CL/F)
Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the body.
Measured: Single dose: within 1 hour (pre-dose), 0, 0.5, 1, 2, 6, 12, 24, 48, 72, 168, 336, 504, 672, 840, 1008, 1344, 1680, 2016, 2353, 2688 hours post-dose
Half-life (t1/2)
Terminal phase elimination half-life (T1/2) is the time required for half of the drug to be eliminated from the serum.
Measured: Single dose: within 1 hour (pre-dose), 0, 0.5, 1, 2, 6, 12, 24, 48, 72, 168, 336, 504, 672, 840, 1008, 1344, 1680, 2016, 2353, 2688 hours post-dose
Anti-drug antibodies (ADA)
A participant was considered ADA-positive across the study if they had a positive reading at any time point during the study.
Measured: Single dose: within 1 hour (pre-dose), Days 15, 57, 85, and 113 post-dose
Proportion of patients with a generalized pustular psoriasis physician global assessment (GPPGA) pustulation subscore of 0/1 at Weeks 1,2,4
The Generalized Pustular Psoriasis Physician Global Assessment (GPPGA) relies on clinical assessment of the Generalized Pustular Psoriasis (GPP) patient's skin presentation. The investigator (or qualified site personnel) scored the erythema, pustules, and scaling of all GPP lesions from 0 to 4. A lower GPPGA pustulation subscore indicates a better outcome. A GPPGA pustulation subscore of 0 means no visible pustules. The proportion of patients who achieved a GPPGA pustulation subscore of 0/1 at Week 1,2,4 is reported.
Measured: 1, 2 and 4 weeks post-dose
Percent change in generalized pustular psoriasis area and severity index (GPPASI) from baseline at weeks 1,2,4
GPPASI provides a numeric scoring for a patient's overall Generalized Pustular Psoriasis (GPP) disease state, ranging from 0 (no disease) to 72 (worse disease state). It is a linear combination of percent of surface area of skin affected by erythema, pustules, and scaling and the severity of erythema, pustules, and scaling (desquamation) over 4 body regions (head, trunk, upper limbs and lower limbs).
Measured: Baseline and 1,2,4 weeks post-dose
Proportion of patients with a generalized pustular psoriasis physician global assessment (GPPGA) score of 0 or 1 at week 1
GPPGA relied on clinical assessment of the Generalized Pustular Psoriasis (GPP) patient's skin presentation. The GPPGA total score was calculated by taking the mean of the erythema subscore, pustules subscore and scaling/crusting subscore. The severity of each subscore was assessed using a 5 point scale score ranging from 0 to 4 (0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe).
A lower GPPGA score indicates a better outcome, with 0 being clear and 1 being almost clear. The proportion of patients with a GPPGA score of 0 or 1 at Week 1,2,4 is reported.
Measured: Baseline and 1,2,4 weeks post-dose
Change in generalized pustular psoriasis area and severity index (GPPASI) from baseline at week 1,2,4.
Generalized Pustular Psoriasis Area and Severity Index (GPPASI) provides a numeric scoring for a patient's overall Generalized Pustular Psoriasis (GPP) disease state, ranging from 0 to 72. It is a linear combination of percent of surface area of skin affected by erythema, pustules, and scaling and the severity of erythema, pustules, and scaling (desquamation) over 4 body regions (head, trunk, upper limbs and lower limbs). A higher score indicates a worse disease state, while a score of 0 indicates no disease.
Measured: Baseline and 1,2,4 weeks post-dose
Change from baseline in psoriasis symptom scale (PSS) score at week 1,2,4
PSS is a 4-item patient-reported outcome instrument that assesses the severity of psoriasis symptoms in moderate to severe psoriasis patients. The symptoms included are: pain, redness, itching, and burning. The symptom severity was assessed using a 5 point scale ranging from 0 to 4 where 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe. The symptom scores are added to an unweighted total score (range: 0 to 16). A lower PSS score indicates a better outcome.
Measured: Baseline and 1,2,4 weeks post-dose
Proportion of patients with psoriasis symptom scale (PSS) score of 0 at week 1,2,4.
PSS is a 4-item patient-reported outcome instrument that assesses the severity of psoriasis symptoms in moderate to severe psoriasis patients. The symptoms included are: pain, redness, itching, and burning. The symptom severity was assessed using a 5 point scale ranging from 0 to 4 where 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe.
Measured: 1,2,4 weeks post-dose
Change from baseline in dermatology life quality index (DLQI) score at weeks 1,2,4
The DLQI is a 10-item questionnaire that asks participants to evaluate the degree that their skin problem has affected their quality of life in the last week in the following 6 aspects: symptoms and feelings, daily activities, leisure, work or school activities, personal relationships and treatment related feelings. Participants answer the 10 questions on a scale from 0 (not at all) to 3 (very much). The DLQI is calculated by summing the scores of the 10 questions, resulting in a maximum of 30 and a minimum of 0 with higher scores indicating more impaired quality of life. A negative change from Baseline indicates improvement.
Measured: Baseline and 1,2,4 weeks post-dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2024
- Study start19 Jun 2024
- Primary completion8 Jul 2025
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Generalized Pustular PsoriasisStudies of the same condition, open and under way.
- More trials run by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06433531
- Sponsor's protocol ID
- TQH2929-I-01 (Ib)
- Status last verified
- Jul 2025
- First submitted
- 23 May 2024
- Last updated
- 30 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Profile, and Efficacy of TQH2929 in Healthy Adult Subjects and Psoriasis Subjects
- ClinicalTrials.gov ID
- NCT06433531
- Acronym / sponsor ID
- TQH2929-I-01 (Ib)
- Conditions
- Generalized Pustular Psoriasis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 19 Jun 2024 (actual)
- Primary completion
- 8 Jul 2025 (actual)
- Study completion
- Dec 2025 (estimated)
- First posted
- 29 May 2024 (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 study is a multicenter, single-group, open-label study to evaluate the safety and tolerability of TQH2929 injection at a dose of 900mg in adult subjects with active Generalized Pustular Psoriasis (GPP), and to preliminarily evaluate the efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TQH2929 Injection (900 mg) | Experimental | Drug: TQH2929 InjectionTQH2929 Injection is administered as a single dose. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Adults aged between 18 and 75 years (inclusive)，both male and female；
- A known and documented history of Generalized Pustular Psoriasis diagnosed with European Rare and Severe Psoriasis Expert Network (ERASPEN) criteria in 2017；
- Presenting with a moderate-severe flare of Generalized Pustular Psoriasis (GPP)
- Body mass index (BMI) within 18~36 kg/m2；
- Major organ function is good;
Key exclusion criteria (27 listed)
- Patients with primary plaque psoriasis vulgaris with pustules that are restricted to psoriatic plaques；
- Immediate life-threatening flare of Generalized Pustular Psoriasis or requiring intensive care treatment, according, to the judgment of the investigator；
- Computed Tomography of the chest shows active or occult tuberculosis or a history of contact with an open tuberculosis (TB) subject within the past 6 months. Subjects positive for tuber closes spot(T-SPOT) (or other tuberculosis diagnostic test) result;
- Active hepatitis during the screening period, or positive for hepatitis B surface antigen (HBsAg)；
- History of human immunodeficiency virus (HIV) infection, or positive HIV serological results at screening during screening；
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 |
|---|---|---|
| TQH2929 InjectionTQH2929 injection is a humanized monoclonal antibody that interfering with the signal cascade. | Drug | TQH2929 Injection (900 mg) |
Primary outcome
Adverse events (AE)
Time frame: From the first dose to 113 days after the last dose
The occurrence of all adverse events (AE).
Serious adverse events (SAE)
Time frame: From the first dose to 113 days after the last dose
The occurrence of all serious adverse events (SAE).
Treatment-related adverse events(TRAE)
Time frame: From the first dose to 113 days after the last dose
The occurrence of all treatment-related adverse events(TRAE).
Clinical laboratory abnormalities
Time frame: From the first dose to 113 days after the last dose
Incidence of participants with clinical laboratory abnormalities
15 secondary outcomes
Time to reach maximum observed serum concentration (Tmax)
Time frame: Single dose: within 1 hour (pre-dose), 0, 0.5, 1, 2, 6, 12, 24, 48, 72, 168, 336, 504, 672, 840, 1008, 1344, 1680, 2016, 2353, 2688 hours post-dose
Maximum serum concentration (Cmax)
Time frame: Single dose: within 1 hour (pre-dose), 0, 0.5, 1, 2, 6, 12, 24, 48, 72, 168, 336, 504, 672, 840, 1008, 1344, 1680, 2016, 2353, 2688 hours post-dose
Area Under the Concentration-Time Curve From Zero to Infinity (AUC [0-infinity])
Time frame: Single dose: within 1 hour (pre-dose), 0, 0.5, 1, 2, 6, 12, 24, 48, 72, 168, 336, 504, 672, 840, 1008, 1344, 1680, 2016, 2353, 2688 hours post-dose
Area Under the Concentration-Time Curve From 0 to Last Observation (AUC [0-t])
Time frame: Single dose: within 1 hour (pre-dose), 0, 0.5, 1, 2, 6, 12, 24, 48, 72, 168, 336, 504, 672, 840, 1008, 1344, 1680, 2016, 2353, 2688 hours post-dose
Apparent volume of distribution (Vd/F)
Time frame: Single dose: within 1 hour (pre-dose), 0, 0.5, 1, 2, 6, 12, 24, 48, 72, 168, 336, 504, 672, 840, 1008, 1344, 1680, 2016, 2353, 2688 hours post-dose
Apparent clearance (CL/F)
Time frame: Single dose: within 1 hour (pre-dose), 0, 0.5, 1, 2, 6, 12, 24, 48, 72, 168, 336, 504, 672, 840, 1008, 1344, 1680, 2016, 2353, 2688 hours post-dose
Half-life (t1/2)
Time frame: Single dose: within 1 hour (pre-dose), 0, 0.5, 1, 2, 6, 12, 24, 48, 72, 168, 336, 504, 672, 840, 1008, 1344, 1680, 2016, 2353, 2688 hours post-dose
Anti-drug antibodies (ADA)
Time frame: Single dose: within 1 hour (pre-dose), Days 15, 57, 85, and 113 post-dose
Proportion of patients with a generalized pustular psoriasis physician global assessment (GPPGA) pustulation subscore of 0/1 at Weeks 1,2,4
Time frame: 1, 2 and 4 weeks post-dose
Percent change in generalized pustular psoriasis area and severity index (GPPASI) from baseline at weeks 1,2,4
Time frame: Baseline and 1,2,4 weeks post-dose
Proportion of patients with a generalized pustular psoriasis physician global assessment (GPPGA) score of 0 or 1 at week 1
Time frame: Baseline and 1,2,4 weeks post-dose
Change in generalized pustular psoriasis area and severity index (GPPASI) from baseline at week 1,2,4.
Time frame: Baseline and 1,2,4 weeks post-dose
Change from baseline in psoriasis symptom scale (PSS) score at week 1,2,4
Time frame: Baseline and 1,2,4 weeks post-dose
Proportion of patients with psoriasis symptom scale (PSS) score of 0 at week 1,2,4.
Time frame: 1,2,4 weeks post-dose
Change from baseline in dermatology life quality index (DLQI) score at weeks 1,2,4
Time frame: Baseline and 1,2,4 weeks post-dose.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TQH2929 Injection in people with Generalized Pustular Psoriasis, run by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. at 7 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 8 inclusion and 27 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: under way, not looking for participants, as of the sponsor's last update on 30 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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. 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?
This study is still under way. Results are not available in the source record yet.
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?
Adverse events (AE) (time frame: From the first dose to 113 days after the last dose). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Jul 2025.