Atopic DermatitisPhase 2NCT05905133
A Study to Evaluate the Safety and Efficacy of CBP-201 in Chinese Adult Subjects With Moderate to Severe AD
A Phase 2 study testing CBP-201 in people with Atopic Dermatitis, run by Connect Biopharm LLC at 38 sites in China.
Trial summary
This study is a single-arm, open-label, multi-center clinical study designed to assess the safety and efficacy of CBP-201 in eligible subjects with moderate to severe Atopic Dermatitis. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- CBP-201
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 38 sitesChina
- Study dates
- 15 Jul 2023to 30 Jun 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
- 18 ≤ age ≤ 75 years at the screening visit, male or female.
- Diagnosed with atopic dermatitis (according to the American Academy of Dermatology's Guidelines of care for the management of atopic dermatitis, 2014[1]) at the time of screening, and meeting all the 4 criteria below:
- Suffering from the disease for more than 1 year at the time of screening;
- At the screening and baseline visit, IGA score ≥ 3 (according to the validated Investigator Global Assessment for Atopic Dermatitis [vIGA-AD™] scale);
- EASI score ≥ 12;
- Percentage of total BSA affected by AD ≥ 10%.
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- Female subjects of childbearing potential (FCBP) and male subjects who have not undergone vasectomy must agree to take highly effective contraceptive measures during the entire study period (from the signing of informed consent forms (ICFs) to the 8-week follow-up period after discontinuation of study drug). Postmenopausal women (determined by testing follicle stimulating hormone [FSH]; defined as the women who have had amenorrhea for at least 12 consecutive months without using drugs known to cause amenorrhea, and have a recorded FSH level greater than 40 mIU/mL or in the postmenopausal range) and women with a record of surgical sterilization (i.e., tubal ligation or hysterectomy or bilateral oophorectomy) before the screening visit can be considered infertile.
- Highly effective contraceptive measures include:
- Abstinence (acceptable only if it is part of the subject's routine lifestyle); ii. Hormones (oral, patch, ring, injection, implant) combined with male condoms. This measure must be used at least 30 days before the first study drug administration. Otherwise, another acceptable method of contraception must be used; iii. Intrauterine device (IUD) combined with male condoms.
- Subjects are willing and able to comply with study visits and related procedures.
- Subjects have the ability to learn the study requirements and process, and voluntarily take part in the clinical trial and sign an ICF.
Who cannot join
- Received prior treatment with anti-interleukin-4 receptor α (IL-4Rα)/anti-interleukin-13 (IL-13) antibodies with a poor response (including treatment failure or development of unacceptable treatment-related adverse reactions).
- Have received any of the following topical treatments within 2 weeks before D1 visit: phosphodiesterase-4 (PDE-4) inhibitors, Janus kinase (JAK) inhibitors, or aromatic hydrocarbon receptor agonists.
- Have received systemic treatment with corticosteroids (except for corticosteroid inhalers and nasal sprays) or other immunosuppressive/immunomodulatory agents (including but not limited to cyclosporine, mycophenolate mofetil, azathioprine, methotrexate, JAK inhibitors, and various biological agents) within 2 weeks before D1 visit or 5 drug half-lives (if known), whichever is longer.
- Have received treatment with immune cell depletion agents (e.g., rituximab) within 6 months before D1 visit.
- Have received any investigational drug/treatment within 4 weeks before D1 visit or 5 drug half-lives (if known), whichever is longer.
- Other skin complications in addition to AD that may interfere with the study assessments.
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- There is a known or suspected history of immunosuppression/immunodeficiency within 6 months before D1 visit (including but not limited to a history of invasive opportunistic infections, such as aspergillosis, coccidiosis, histoplasmosis, acquired immunodeficiency syndrome (AIDS), listeriosis, or Pneumocystis, even if the infection has subsided), or there is an abnormally frequently recurrent or persistent infection.
- Received systemic treatment with anti-infective drugs (including but not limited to antibiotics, antiviral drugs, antiparasitic drugs, antiprotozoal drugs, or antifungal drugs) due to acute or chronic infection within 1 week before D1 visit (after the infection subsides, the subjects can be rescreened).
- History of malignant tumor within 5 years before D1 visit (except for completely cured cervical carcinoma in situ or non-metastatic cutaneous squamous cell carcinoma or basal cell carcinoma).
- History of parasite infection within 6 months before D1 visit.
- Positive for hepatitis B surface antigen (HBsAg), or positive for hepatitis B core antibody (HBcAb) and HBV-DNA, or positive for hepatitis C antibody and HCV ribonucleic acid (RNA) polymerase chain reaction, or serologically positive for human immunodeficiency virus (HIV) at the screening visit.
- Subjects with active tuberculosis, latent tuberculosis, or a history of nontuberculous mycobacterial infection at screening;
- Note:
- Unless there is a clear medical record proving that the subject has received adequate treatment and is currently able to start receiving biological treatment (based on the medical judgment of the investigator and/or infectious disease specialist);
- If needed, an interferon gamma release assay may be used to assist diagnosis of suspected tuberculosis.
- Any of the following laboratory test abnormalities at the screening visit:
- Aspartate aminotransferase or alanine aminotransferase > 2 times the upper limit of normal (ULN);
- Total bilirubin > 1.5 × ULN;
- Serum creatinine > 1.2 × ULN;
- White blood cell count < 3.0 × 109/L or ≥ 14 × 109/L; Note: If the subjects have the above laboratory test abnormalities at screening, after being assessed as necessary by the investigator, they are allowed to receive a retest on another day within 28 days of the screening period, and those qualified for the retest are permitted to be enrolled (it is forbidden to conduct drug intervention for those laboratory test abnormalities before retest).
- History of hypersensitivity to L-histidine, trehalose or Tween (polysorbate) 80, or systemic hypersensitivity reactions to any biological agents (except local injection site reactions).
- History of alcohol or drug abuse within 2 years before D1 visit.
- Have been vaccinated with (attenuated) live vaccine within 8 weeks before D1 visit, or planning to be vaccinated during the study period.
- Planning to undergo major surgical operations during the study period.
- Pregnant or lactating women, or subjects with pregnancy or lactation plans during the study period.
- Any other conditions (e.g., those may increase the risks of the subjects, or may affect/interfere with the assessment of the study) that the investigator deems unsuitable for participation in this study, including but not limited to: prior or current physical or mental illness, clinically significant physical examination results, vital signs, or safety laboratory test abnormalities at screening. The specific reasons for subjects excluded due to this criterion will be indicated in the study documents (including medical records and electronic case report form (eCRF)).
Trial locations and contacts
38 sites in 1 country.
38 sites in 1 country
China38 sites
Connect Investigative Site 24
Baotou, Nei Monggol
Connect Investigative Site 01
Beijing, Beijing Municipality
Connect Investigative Site 41
Beijing, Beijing Municipality
Connect Investigative Site 26
Changsha, Hunan
Connect Investigative Site 23
Chengdu, Sichuan
Connect Investigative Site 30
Dongying, Shandong
Connect Investigative Site 14
Fuzhou, Fujian
Connect Investigative Site 25
Fuzhou, Fujian
Connect Investigative Site 03
Guangzhou, Guangdong
Connect Investigative Site 11
Guangzhou, Guangdong
Connect Investigative Site 13
Guangzhou, Guangdong
Connect Investigative Site 20
Guangzhou, Guangdong
Connect Investigative Site 16
Haikou, Hainan
Connect Investigative Site 17
Haikou, Hainan
Connect Investigative Site 07
Hangzhou, Zhejiang
Connect Investigative Site 08
Hangzhou, Zhejiang
Connect Investigative Site 33
Hangzhou, Zhejiang
Connect Investigative Site 37
Hangzhou, Zhejiang
Connect Investigative Site 40
Jiangxi, Nanchang
Connect Investigative Site 21
Jinan, Shandong
Connect Investigative Site 35
Jinan, Shandong
Connect Investigative Site 34
Nanjing, Jiangsu
Connect Investigative Site 31
Nanning, Guangxi
Connect Investigative Site 19
Nanyang, Henan
Connect Investigative Site 32
Ningbo, Zhejiang
Connect Investigative Site 36
Shanghai, Shanghai Municipality
Connect Investigative Site 29
Shenyang, Liaoning
Connect Investigative Site 22
Shenzhen, Guangdong
Connect Investigative Site 39
Suzhou, Jiangsu
Connect Investigative Site 10
Taiyuan, Shanxi
Connect Investigative Site 02
Tianjin, Tianjin Municipality
Connect Investigative Site 09
Ürümqi, Xinjiang
Connect Investigative Site 27
Wuhan, Hubei
Connect Investigative Site 06
Xi’an, Shanxi
Connect Investigative Site 28
Yichang, Hubei
Connect Investigative Site 18
Yinchuan, Ningxia
Connect Investigative Site 15
Yuncheng, Shanxi
Connect Investigative Site 05
Zhenjiang, Jiangsu
About this study
Official title: A Multi-Center, Single-Arm, Open-Label Clinical Study to Evaluate the Safety and Efficacy of CBP-201 in Chinese Adult Subjects With Moderate to Severe Atopic Dermatitis
This study is a single-arm, open-label, multi-center clinical study designed to assess the safety and efficacy of CBP-201 in eligible subjects with moderate to severe Atopic Dermatitis.
Read the detailed description
The study includes a screening period, a treatment period and a follow-up period.
The subjects will receive a subcutaneous injection of CBP-201 600 mg (4 mL in total, 2 injections of 2 mL each in different sites) on Day1, begin to receive a subcutaneous injection of CBP-201 300 mg (2 mL) from Week2, and receive CBP-201 300 mg (2 mL) every 2 weeks thereafter until Week10.
- Conditions
- Atopic Dermatitis
- Being tested
- CBP-201
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBP-201Drug
Also called CBP-201 injection
subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| CBP-201 | Experimental | The subjects will receive CBP-201 600 mg (4 mL in total, 2 injections of 2 mL each in different sites) on Day1, begin to receive a subcutaneous injection of CBP-201 300 mg (2 mL) from Week2, and receive CBP-201 300 mg (2 mL) every 2 weeks thereafter until Week10. Receives: Drug: CBP-201 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment-emergent adverse events (TEAEs)
cases/person-years
Measured: From Day 1 study drug first administrated to Week 20
Secondary outcomes (29)
Incidence of treatment-related treatment-emergent adverse events (TEAEs)
cases/person-years
Measured: From Day 1 study drug first administrated to Week 20
Incidence of serious adverse events (SAEs)
cases/person-years
Measured: From Day 1 study drug first administrated to Week 20
Incidence of treatment-related serious adverse events (SAEs)
cases/person-years
Measured: From Day 1 study drug first administrated to Week 20
Incidence of adverse events of special interest (AESIs)
cases/person-years
Measured: From Day 1 study drug first administrated to Week 20
Abnormal changes in vital signs
Vital signs (VS): including body temperature, respiration rate, blood pressure, and heart rate.
Measured: Pre-dose, Day1, Day15, Day29, Day43, Day57, Day71, Day85, Day113, Day141
Abnormal changes in physical examination
Physical examination included are as follows: general appearance, skin, ears/nose/throat, head and neck, cardiovascular system, respiratory system, abdomen, limbs, lymph nodes, musculoskeletal and nervous systems.
Measured: Pre-dose, Day85, Day141
Abnormal changes in laboratory tests: Hematology
White blood cell count, Hemoglobin, Hematocrit, Red blood cell count, Platelet count, Neutrophil percentage, Lymphocyte percentage, Monocyte percentage, Basophil percentage, Eosinophil percentage, Absolute neutrophil count, Absolute lymphocyte count, Absolute monocyte count, Absolute eosinophil count, Absolute basophil count
Measured: Pre-dose, Day1, Day15, Day29, Day57, Day85, Day141
Abnormal changes in laboratory tests: Blood biochemistry
Sodium, Potassium, Calcium, Chlorine, Serum urea/urea nitrogen, Creatinine, Glucose, Total protein, Albumin, Total bilirubin, Alanine aminotransaminase, Aspartate aminotransferase, γ-glutamyltransferase, Alkaline phosphatase, Lactate dehydrogenase, Creatine phosphokinase, Total cholesterol, Low-density lipoprotein, High-density lipoprotein
Measured: Pre-dose, Day1, Day15, Day29, Day57, Day85, Day141
Abnormal changes in laboratory tests: Urinalysis
Urine bilirubin, Urine red blood cells, Urine white blood cells, Urine glucose, Urine ketone, Urine nitrite, Urine pH, Urine protein, Urine specific gravity, Urobilinogen, Microscopic examination (if necessary)
Measured: Pre-dose, Day1, Day15, Day29, Day57, Day85, Day141
Abnormal changes in electrocardiogram (ECG) parameters
ECG variables include ventricular heart rate and PR, QRS, QT, and QTcF intervals.
Measured: Pre-dose, Day1, Day141
Proportion of subjects achieving greater than or equal to 75% improvement in Eczema Area and Severity Index (EASI-75)
The Eczema Area and Severity Index (EASI) scale quantifies the severity and extent of Atopic Dermatitis, as well as the severity of erythema, infiltration, excoriation, and lichenification of the four anatomical regions-head and neck, trunk, upper extremities, and lower extremities.
Measured: Day1, Day15, Day29, Day57, Day85, Day113, Day141
Proportion of subjects whose Investigator Global Assessment (IGA) score is 0-1 and decreased by ≥ 2 points from baseline
The Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD™) Scale is a 5-point classification scale based on the overall appearance of the skin lesions at a specific time point.
Measured: Day1, Day15, Day29, Day57, Day85, Day113, Day141
Proportion of subjects achieving greater than or equal to 50% improvement in Eczema Area and Severity Index (EASI-50)
The Eczema Area and Severity Index (EASI) scale quantifies the severity and extent of Atopic Dermatitis, as well as the severity of erythema, infiltration, excoriation, and lichenification of the four anatomical regions-head and neck, trunk, upper extremities, and lower extremities.
Measured: Day1, Day15, Day29, Day57, Day85, Day113, Day141
Proportion of subjects achieving greater than or equal to 90% improvement in Eczema Area and Severity Index (EASI-90)
The Eczema Area and Severity Index (EASI) scale quantifies the severity and extent of Atopic Dermatitis, as well as the severity of erythema, infiltration, excoriation, and lichenification of the four anatomical regions-head and neck, trunk, upper extremities, and lower extremities.
Measured: Day1, Day15, Day29, Day57, Day85, Day113, Day141
Proportion of subjects achieving 100% improvement in Eczema Area and Severity Index (EASI-100)
The Eczema Area and Severity Index (EASI) scale quantifies the severity and extent of Atopic Dermatitis, as well as the severity of erythema, infiltration, excoriation, and lichenification of the four anatomical regions-head and neck, trunk, upper extremities, and lower extremities.
Measured: Day1, Day15, Day29, Day57, Day85, Day113, Day141
Proportion of subjects whose IGA score is decreased by ≥ 2 points from baseline
The Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD™) Scale is a 5-point classification scale based on the overall appearance of the skin lesions at a specific time point.
Measured: Day1, Day15, Day29, Day57, Day85, Day113, Day141
Proportion of subjects with IGA score ≤ 2 (equivalent to reaching a low disease activity state)
The Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD™) Scale is a 5-point classification scale based on the overall appearance of the skin lesions at a specific time point.
Measured: Day1, Day15, Day29, Day57, Day85, Day113, Day141
Proportion of subjects whose weekly average Peak Pruritus Numerical Rating Scale (PP-NRS) is decreased by ≥ 3 points from baseline
Peak Pruritus Numerical Rating Scale (PP-NRS) is a single self-reported item designed to measure the peak pruritus or the "worst" pruritus in the previous 24 hours.
Measured: Day1, Day15, Day29, Day43, Day57, Day71, Day85, Day113, Day141
Proportion of subjects whose weekly average Peak Pruritus Numerical Rating Scale (PP-NRS) is decreased by ≥ 4 points from baseline
Peak Pruritus Numerical Rating Scale (PP-NRS) is a single self-reported item designed to measure the peak pruritus or the "worst" pruritus in the previous 24 hours.
Measured: Day1, Day15, Day29, Day43, Day57, Day71, Day85, Day113, Day141
Change and percentage change in the EASI score from baseline
The Eczema Area and Severity Index (EASI) scale quantifies the severity and extent of Atopic Dermatitis, as well as the severity of erythema, infiltration, excoriation, and lichenification of the four anatomical regions-head and neck, trunk, upper extremities, and lower extremities.
Measured: Day1, Day15, Day29, Day57, Day85, Day113, Day141
Change and percentage change in the weekly average PP-NRS from baseline
Peak Pruritus Numerical Rating Scale (PP-NRS) is a single self-reported item designed to measure the peak pruritus or the "worst" pruritus in the previous 24 hours.
Measured: Day1, Day15, Day29, Day43, Day57, Day71, Day85, Day113, Day141
Change and percentage change in the body surface area (BSA) affected by Atopic Dermatitis from baseline
The "Rule of Nines" is used to estimate the maximum percentage of Atopic Dermatitis-affected body surface area (BSA): head and neck [9%], anterior trunk [18%], back [18%], upper limbs [18%], lower limbs [36%], and genitals [1%].
Measured: Day1, Day15, Day29, Day57, Day85, Day113, Day141
Change and percentage change in the Dermatology Life Quality Index (DLQI) score from baseline
Dermatology Life Quality Index (DLQI) is a questionnaire containing 10 items to assess the impact of Atopic Dermatitis on quality of life (QOL) in the past week, and the scores range from 0 (no disease) to 30 (severe disease); the higher the score, the worse the quality of life.
Measured: Day1, Day15, Day29, Day57, Day85, Day113, Day141
Proportion of subjects receiving concomitant medications for the treatment of the disease under study (Atopic Dermatitis)
except emollients; the proportion will be summarized separately by all concomitant medications and the ATC2 codes for concomitant medications
Measured: from Day1 to Week12
Proportion of subjects receiving concomitant medications for the treatment of the disease under study (Atopic Dermatitis) prohibited by the protocol
(except emollients; the proportion will be summarized separately by all concomitant medications, local therapy, systemic treatment, and the ATC2 codes for concomitant medications)
Measured: from Day1 to Week12
Proportion of subjects receiving topical corticosteroids (TCS) for the treatment of the disease under study (Atopic Dermatitis)
If topical corticosteroids (TCS) is considered necessary by the investigator.
Measured: from Day1 to Week12
Duration of TCS use for the treatment of the disease under study (Atopic Dermatitis)
days/person-years
Measured: from Day1 to Week12
Percentage of subjects positive for anti-drug antibody (ADA) and ADA titer range
Descriptive statistics will be used to summarize the baseline values of related measurements (ADA, NAb) and the changes from baseline to each visit.
Measured: Day1, Day15, Day29, Day57, Day85, Day141
Percentage of subjects positive for neutralizing antibody (NAb) in subjects positive for ADA
Descriptive statistics will be used to summarize the baseline values of related measurements (ADA, NAb) and the changes from baseline to each visit.
Measured: Day1, Day15, Day29, Day57, Day85, Day141
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2023
- Study start15 Jul 2023
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 360 participants (actual)
Sponsor and investigators
- Lead sponsor
- Connect Biopharm LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Suzhou Connect, Study director, Connect Biopharm LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05905133
- Sponsor's protocol ID
- CBP-201-CN003
- Status last verified
- Dec 2023
- First submitted
- 5 Jun 2023
- Last updated
- 11 Dec 2023
- 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 11 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Single-Arm, Open-Label Clinical Study to Evaluate the Safety and Efficacy of CBP-201 in Chinese Adult Subjects With Moderate to Severe Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT05905133
- Acronym / sponsor ID
- CBP-201-CN003
- Conditions
- Atopic Dermatitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 360 participants (actual)
- Lead sponsor
- Connect Biopharm LLCIndustry (pharma, biotech, devices)
- Study start
- 15 Jul 2023 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 15 Jun 2023 (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 single-arm, open-label, multi-center clinical study designed to assess the safety and efficacy of CBP-201 in eligible subjects with moderate to severe Atopic Dermatitis.
Detailed description
The study includes a screening period, a treatment period and a follow-up period.
The subjects will receive a subcutaneous injection of CBP-201 600 mg (4 mL in total, 2 injections of 2 mL each in different sites) on Day1, begin to receive a subcutaneous injection of CBP-201 300 mg (2 mL) from Week2, and receive CBP-201 300 mg (2 mL) every 2 weeks thereafter until Week10.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CBP-201 | Experimental | Drug: CBP-201The subjects will receive CBP-201 600 mg (4 mL in total, 2 injections of 2 mL each in different sites) on Day1, begin to receive a subcutaneous injection of CBP-201 300 mg (2 mL) from Week2, and receive CBP-201 300 mg (2 mL) every 2 weeks thereafter until Week10. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 18 ≤ age ≤ 75 years at the screening visit, male or female.
- Diagnosed with atopic dermatitis (according to the American Academy of Dermatology's Guidelines of care for the management of atopic dermatitis, 2014[1]) at the time of screening, and meeting all the 4 criteria below:
- Female subjects of childbearing potential (FCBP) and male subjects who have not undergone vasectomy must agree to take highly effective contraceptive measures during the entire study period (from the signing of informed consent forms (ICFs) to the 8-week follow-up period after discontinuation of study drug). Postmenopausal women (determined by testing follicle stimulating hormone [FSH]; defined as the women who have had amenorrhea for at least 12 consecutive months without using drugs known to cause amenorrhea, and have a recorded FSH level greater than 40 mIU/mL or in the postmenopausal range) and women with a record of surgical sterilization (i.e., tubal ligation or hysterectomy or bilateral oophorectomy) before the screening visit can be considered infertile.
- Subjects are willing and able to comply with study visits and related procedures.
- Subjects have the ability to learn the study requirements and process, and voluntarily take part in the clinical trial and sign an ICF.
Key exclusion criteria (26 listed)
- Received prior treatment with anti-interleukin-4 receptor α (IL-4Rα)/anti-interleukin-13 (IL-13) antibodies with a poor response (including treatment failure or development of unacceptable treatment-related adverse reactions).
- Have received any of the following topical treatments within 2 weeks before D1 visit: phosphodiesterase-4 (PDE-4) inhibitors, Janus kinase (JAK) inhibitors, or aromatic hydrocarbon receptor agonists.
- Have received systemic treatment with corticosteroids (except for corticosteroid inhalers and nasal sprays) or other immunosuppressive/immunomodulatory agents (including but not limited to cyclosporine, mycophenolate mofetil, azathioprine, methotrexate, JAK inhibitors, and various biological agents) within 2 weeks before D1 visit or 5 drug half-lives (if known), whichever is longer.
- Have received treatment with immune cell depletion agents (e.g., rituximab) within 6 months before D1 visit.
- Have received any investigational drug/treatment within 4 weeks before D1 visit or 5 drug half-lives (if known), whichever is longer.
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 |
|---|---|---|
| CBP-201Also: CBP-201 injectionsubcutaneous injection | Drug | CBP-201 |
Primary outcome
Incidence of treatment-emergent adverse events (TEAEs)
Time frame: From Day 1 study drug first administrated to Week 20
cases/person-years
29 secondary outcomes
Incidence of treatment-related treatment-emergent adverse events (TEAEs)
Time frame: From Day 1 study drug first administrated to Week 20
Incidence of serious adverse events (SAEs)
Time frame: From Day 1 study drug first administrated to Week 20
Incidence of treatment-related serious adverse events (SAEs)
Time frame: From Day 1 study drug first administrated to Week 20
Incidence of adverse events of special interest (AESIs)
Time frame: From Day 1 study drug first administrated to Week 20
Abnormal changes in vital signs
Time frame: Pre-dose, Day1, Day15, Day29, Day43, Day57, Day71, Day85, Day113, Day141
Abnormal changes in physical examination
Time frame: Pre-dose, Day85, Day141
Abnormal changes in laboratory tests: Hematology
Time frame: Pre-dose, Day1, Day15, Day29, Day57, Day85, Day141
Abnormal changes in laboratory tests: Blood biochemistry
Time frame: Pre-dose, Day1, Day15, Day29, Day57, Day85, Day141
Abnormal changes in laboratory tests: Urinalysis
Time frame: Pre-dose, Day1, Day15, Day29, Day57, Day85, Day141
Abnormal changes in electrocardiogram (ECG) parameters
Time frame: Pre-dose, Day1, Day141
Proportion of subjects achieving greater than or equal to 75% improvement in Eczema Area and Severity Index (EASI-75)
Time frame: Day1, Day15, Day29, Day57, Day85, Day113, Day141
Proportion of subjects whose Investigator Global Assessment (IGA) score is 0-1 and decreased by ≥ 2 points from baseline
Time frame: Day1, Day15, Day29, Day57, Day85, Day113, Day141
Proportion of subjects achieving greater than or equal to 50% improvement in Eczema Area and Severity Index (EASI-50)
Time frame: Day1, Day15, Day29, Day57, Day85, Day113, Day141
Proportion of subjects achieving greater than or equal to 90% improvement in Eczema Area and Severity Index (EASI-90)
Time frame: Day1, Day15, Day29, Day57, Day85, Day113, Day141
Proportion of subjects achieving 100% improvement in Eczema Area and Severity Index (EASI-100)
Time frame: Day1, Day15, Day29, Day57, Day85, Day113, Day141
Proportion of subjects whose IGA score is decreased by ≥ 2 points from baseline
Time frame: Day1, Day15, Day29, Day57, Day85, Day113, Day141
Proportion of subjects with IGA score ≤ 2 (equivalent to reaching a low disease activity state)
Time frame: Day1, Day15, Day29, Day57, Day85, Day113, Day141
Proportion of subjects whose weekly average Peak Pruritus Numerical Rating Scale (PP-NRS) is decreased by ≥ 3 points from baseline
Time frame: Day1, Day15, Day29, Day43, Day57, Day71, Day85, Day113, Day141
Proportion of subjects whose weekly average Peak Pruritus Numerical Rating Scale (PP-NRS) is decreased by ≥ 4 points from baseline
Time frame: Day1, Day15, Day29, Day43, Day57, Day71, Day85, Day113, Day141
Change and percentage change in the EASI score from baseline
Time frame: Day1, Day15, Day29, Day57, Day85, Day113, Day141
Change and percentage change in the weekly average PP-NRS from baseline
Time frame: Day1, Day15, Day29, Day43, Day57, Day71, Day85, Day113, Day141
Change and percentage change in the body surface area (BSA) affected by Atopic Dermatitis from baseline
Time frame: Day1, Day15, Day29, Day57, Day85, Day113, Day141
Change and percentage change in the Dermatology Life Quality Index (DLQI) score from baseline
Time frame: Day1, Day15, Day29, Day57, Day85, Day113, Day141
Proportion of subjects receiving concomitant medications for the treatment of the disease under study (Atopic Dermatitis)
Time frame: from Day1 to Week12
Proportion of subjects receiving concomitant medications for the treatment of the disease under study (Atopic Dermatitis) prohibited by the protocol
Time frame: from Day1 to Week12
Proportion of subjects receiving topical corticosteroids (TCS) for the treatment of the disease under study (Atopic Dermatitis)
Time frame: from Day1 to Week12
Duration of TCS use for the treatment of the disease under study (Atopic Dermatitis)
Time frame: from Day1 to Week12
Percentage of subjects positive for anti-drug antibody (ADA) and ADA titer range
Time frame: Day1, Day15, Day29, Day57, Day85, Day141
Percentage of subjects positive for neutralizing antibody (NAb) in subjects positive for ADA
Time frame: Day1, Day15, Day29, Day57, Day85, Day141
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2023.
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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.
Suzhou Connect study director
Connect Biopharm LLC
38 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CBP-201 in people with Atopic Dermatitis, run by Connect Biopharm LLC at 38 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 11 inclusion and 26 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: status not confirmed, as of the sponsor's last update on 11 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 38 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 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?
Results are not available in the source record.
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?
Incidence of treatment-emergent adverse events (TEAEs) (time frame: From Day 1 study drug first administrated to Week 20). 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 11 Dec 2023.