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Moderate-to-severe Atopic DermatitisPhase 2NCT05017480

A Study to Evaluate the Efficacy and Safety of CBP-201 in Moderate to Severe Atopic Dermatitis in China

A Phase 2 study testing CBP-201 in people with Moderate-to-severe Atopic Dermatitis, run by Connect Biopharm LLC at 48 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This study will evaluate the efficacy and safety of CBP-201 in Chinese subjects with moderate to severe atopic dermatitis. Read more about this study

Who is it for?
Ages 12 to 75 years
Conditions the study is for
Moderate-to-severe Atopic Dermatitis
What is being tested?
CBP-201
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
330 participants
Where
48 sitesChina
Study dates
31 Aug 2021to 28 Sep 2023
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 12 to 75 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 12≤ 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 screening, visit and:
  • The subject has been suffering from the disease for more than 1 year at the time of screening, and according to the judgment of the investigator, the subject has had poor response to topical drugs such as corticosteroids, phosphodiesterase-4 (PDE-4) inhibitors or calcineurin inhibitors (TCI), or it is not medically suitable for the subject to receive topical drug treatment (e.g., there are important side effects or safety risks);
  • Note: Poor response is defined as any of the following conditions:
  • The patient has not achieved and maintained response or reached a low disease activity state (equivalent to IGA 0=asymptomatic to 2=mild) despite regular use of topical therapy during the 1 year before baseline; ii. The patient has received systemic treatment for AD despite regular use of topical therapy during the 1 year before baseline.
  • At the screening and baseline visit, Investigator's Global Assessment (IGA) score ≥3 (according to the validated Investigator Global Assessment for Atopic Dermatitis [vIGA-AD™] scale, see Section 17.4 Appendix D), Eczema Area and Severity Index (EASI) score≥16 (see Section 17.5, Appendix E), and≥10% body surface area (BSA) of AD involvement(see Section 17.6, Appendix F); c. The average score of the maximum pruritus intensity in the Peak Pruritus Numerical Rating Scale (PP-NRS) ≥4 (see Section 17.1, Appendix A).
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  • Note: The baseline average score of maximum pruritus intensity in the PP-NRS will be calculated based on the average value of the maximum pruritus intensity in the PP-NRS score [daily score range 0-10] every day within 7 days before randomization. In these 7 days, the scores of at least 4 days are required for the calculation of the baseline average score. If the patient's reporting days are less than 4 days in the 7 days before the planned date of randomization, randomization should be postponed until the requirements are met, but it is not allowed to exceed the maximum screening period of 28 days.
  • Able and willing to use a stable dose of a mild emollient at the AD involvement area twice a day starting from at least 7 days before baseline and continue to use it during the study period (see Section 8.1.1.2 Emollients).
  • Female subjects of childbearing potential (FCBP) and male subjects who have not undergone vasectomy must take highly effective contraceptive measures during the entire study period, including the 8-week follow-up period after discontinuation of study drug. Postmenopausal women (determined by testing follicle stimulating hormone [FSH]) 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; iv. Exceptions are: a) 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; or b) surgical sterilization (e.g., hysterectomy, bilateral oophorectomy).
  • Subjects and/or their guardians have the ability to learn the study requirements and process, and voluntarily take part in the clinical trial and sign an informed consent form (ICF); note: for subjects ≥18 years: subjects voluntarily agree to take part in the study by themselves and sign ICF; for subjects aged 12-17 years: subjects and their guardians voluntarily agree to take part in the study, the guardians sign the ICF, and the subjects sign the informed assent form for minors by themselves.
  • Subjects and/or their guardians are willing and able to comply with study visits and related procedures.

Who cannot join

  • Patients who have received any of the following treatments:
  • Treatment with dupilumab or any anti-IL-4Rα or IL-13 antibodies;
  • Topical drugs for treatment of AD or have the potential to affect the assessment of AD, including but not limited to corticosteroids, PDE-4 inhibitors, Janus kinase (JAK) inhibitors, aromatic hydrocarbon receptor agonists, tacrolimus or pimecrolimus, or traditional Chinese medicine (TCM) or herbal medicine, etc. within 2 weeks before baseline;
  • Have undergone bleaching baths ≥ twice within 2 weeks before baseline;
  • Have begun to use prescription emollients or emollients containing additives (e.g., ceramide, hyaluronic acid, urea, or filaggrin breakdown products) to treat AD from the screening period (if the subject has started using this kind of emollient before the screening visit, they can continue to use it at a stable dose; if the subject is intolerable to the emollients provided uniformly by the sponsor during the screeing period, he/she can change to emollient of this kind used previously, but it must be used at a stable dose for at least 7 days before baseline and during the study period);
  • Treatment with systemic corticosteroids or other immunosuppressive/immunomodulating substances (e.g., cyclosporine, mycophenolate mofetil, azathioprine, methotrexate, or oral JAK inhibitors) due to AD or other diseases within 4 weeks before baseline (except for corticosteroid inhalers and nasal sprays);
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  • Treatment with systemic TCM or herbal treatment within 4 weeks before baseline (note: except for those for the treatment of diseases other than AD, which are necessary and will neither increase the risks of the subjects nor affect the assessment of the study in accordance with the medical judgements of the investigator and/or specialist physician);
  • Treatment with phototherapy (narrow band ultraviolet B [NBUVB], ultraviolet B [UVB], ultraviolet A1 [UVA1], psoralen + ultraviolet A [PUVA]), sunbed or any other light emitting device (LED) therapy within 4 weeks before baseline;
  • Have used any investigational drug/treatment within 4 weeks before baseline or 5 drug half-lives, whichever is longer;
  • Treatment with other biological agents (e.g., omalizumab) within 3 months before baseline or 5 drug half-lives (if known), whichever is longer;
  • Have been vaccinated with live (attenuated) vaccine within 8 weeks before baseline;
  • Treatment with cell depletion agents (e.g., rituximab) within 6 months before baseline;
  • Treatment with allergen specific immunotherapy (SIT) within 6 months before baseline (except those who were already on stable-dose therapy before baseline).
  • Eligibility criteria Inclusion criteria
  • Patients must meet all of the following criterias to be enrolled into this study:
  • Patients who meet any of the following:
  • History of hypersensitivity to L-histidine, trehalose or Tween 80;
  • Other skin complications in addition to AD that may interfere with the study assessments;
  • Any history of vernal keratoconjunctivitis (VKC) and atopic keratoconjunctivitis (AKC);
  • History of malignant tumor within 5 years before screening, except for cervical carcinoma in situ or non-metastatic cutaneous squamous cell carcinoma or basal cell carcinoma;
  • Active tuberculosis (TB) at the screening visit, latent tuberculosis or a history of non-tuberculous Mycobacterium infection
  • Note:
  • Unless there is a clear specialist record proving that the patient 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 necessary, T-spot test may be used for auxiliary diagnosis of suspected tuberculosis patients; f. 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 RNA polymerase chain reaction; or serologically positive for human immunodeficiency virus (HIV) at the screening visit; g. Any of the following laboratory test abnormalities at the screening visit: i. Aspartate aminotransferase or alanine aminotransferase > 2 times the upper limit of normal (ULN), or total bilirubin > 1.5×ULN ii. Serum creatinine > 1.2×ULN iii. Hemoglobin < 8.5 g/dl (85.0 g/L) in male patients and < 8.0 g/dl (80.0 g/L) in female patients iv. White blood cell count <3.0×109/L or ≥14×109/L v. Platelet count <100×109/L h. Planning to undergo major surgical operations during the study period; i. Used systemic treatment with antibiotics, antiviral drugs, antiparasitic drugs, antigenic drugs, or antifungal drugs due to infection within 4 weeks before the baseline visit, or suffered from superficial skin infection (e.g., impetigo) within 2 weeks before baseline (after the infection subsides, the subjects can be rescreened); j. History of parasite infection (e.g., helminth) within 6 months before baseline; k. According to the investigator's judgment, there is a known or suspected history of immunosuppression within 6 months before baseline, including a history of invasive opportunistic infections, such as aspergillosis, coccidiosis, histoplasmosis, HIV, listeriosis, Pneumocystis or tuberculosis, even if the infection has subsided; or there is an abnormally frequently recurrent or persistent infection; l. History of alcohol or drug abuse within 2 years before the screening visit; m. Any other medical or psychological condition (including clinically significant laboratory test abnormalities, ECG parameters, etc.) at the screening visit, which, as judged by the investigator, may indicate new and/or insufficiently understood diseases, may put the patient at an unreasonable risk due to his/her participation in the clinical trial, may lead to unreliable results of the patient's participation, or may interfere with the study assessments. The specific reasons for patients excluded due to this criterion will be indicated in the study documents (medical records, eCRF, etc.).
  • Pregnant or lactating women, or subjects with pregnancy or lactation plans during the study period.

Trial locations and contacts

48 sites in 1 country.

48 sites in 1 country

China48 sites

  • Connect Investigative Site 35

    Baotou, Inner Mongolia

  • Connect Investigative Site 01

    Beijing, Beijing Municipality

  • Connect Investigative Site 02

    Beijing, Beijing Municipality

  • Connect Investigative Site 03

    Beijing, Beijing Municipality

  • Connect Investigative Site 17

    Beijing, Beijing Municipality

  • Connect Investigative Site 47

    Beijing, Beijing Municipality

  • Connect Investigative Site 28

    Chongqing, Chongqing Municipality

  • Connect Investigative Site 29

    Chongqing, Chongqing Municipality

  • Connect Investigative Site 30

    Chongqing, Chongqing Municipality

  • Connect Investigative Site 36

    Chongqing, Chongqing Municipality

  • Connect Investigative Site 38

    Fuzhou, Fujian

  • Connect Investigative Site 07

    Guangzhou, Guangdong

  • Connect Investigative Site 25

    Guangzhou, Guangdong

  • Connect Investigative Site 37

    Guangzhou, Guangdong

  • Connect Investigative Site 46

    Guangzhou, Guangdong

  • Connect Investigative Site 48

    Guangzhou, Guangdong

  • Connect Investigative Site 41

    Haikou, Hainan

  • Connect Investigative Site 42

    Haikou, Hainan

  • Connect Investigative Site 14

    Hangzhou, Zhejiang

  • Connect Investigative Site 15

    Hangzhou, Zhejiang

  • Connect Investigative Site 16

    Hangzhou, Zhejiang

  • Connect Investigative Site 33

    Hefei, Anhui

  • Connect Investigative Site 11

    Jinan, Shandong

  • Connect Investigative Site 50

    Jinan, Shandong

  • Connect Investigative Site 51

    Jinan, Shandong

  • Connect Investigative Site 19

    Jinhua, Zhejiang

  • Connect Investigative Site 34

    Nanchang, Jiangxi

  • Connect Investigative Site 26

    Nanjing, Jiangsu

  • Connect Investigative Site 45

    Nanyang, Henan

  • Connect Investigative Site 53

    Qujing, Yunnan

  • Connect Investigative Site 13

    Shanxi, Xi'an

  • Connect Investigative Site 43

    Shaoguan, Guangdong

  • Connect Investigative Site 52

    Shenzhen, Guangdong

  • Connect Investigative Site 32

    Shijiazhuang, Hebei

  • Connect Investigative Site 18

    Suzhou, Jiangsu

  • Connect Investigative Site 08

    Taiyuan, Shanxi

  • Connect Investigative Site 24

    Taiyuan, Shanxi

  • Connect Investigative Site 05

    Tianjin, Tianjin Municipality

  • Connect Investigative Site 06

    Tianjin, Tianjin Municipality

  • Connect Investigative Site 22

    Ürümqi, Xinjiang

  • Connect Investigative Site 49

    Wuhan, Hubei

  • Connect Investigative Site 55

    Wuxi, Jiangsu

  • Connect Investigative Site 54

    Xinxiang, Henan

  • Connect Investigative Site 12

    Yantai, Shandong

  • Connect Investigative Site 44

    Yinchuan, Ningxia

  • Connect Investigative Site 39

    Yuncheng, Shanxi

  • Connect Investigative Site 20

    Zhengzhou, He'an

  • Connect Investigative Site 10

    Zhenjiang, Jiangsu

Other trials in China

About this study

Official title: A Double-blind, Multi-center, Randomized Controlled Clinical Study to Evaluate the Efficacy and Safety of CBP-201 in Chinese Subjects With Moderate to Severe Atopic Dermatitis

This study will evaluate the efficacy and safety of CBP-201 in Chinese subjects with moderate to severe atopic dermatitis.

Read the detailed description

This study is a randomized, double-blind, multi-center, controlled study designed to assess the efficacy, safety and PK characteristics of CBP-201 in eligible subjects with moderate to severe AD.

The study includes a screening period, a treatment period and a follow-up period. The treatment period is divided into two stages.

Being tested
CBP-201, Placebo

What participants receive

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

  • CBP-201Drug

    CBP-201 subcutaneous(SC) injection.

  • PlaceboDrug

    subcutaneous(SC) injection

Study groups in NCT05017480
Study groupRoleWhat they receive
CBP-201 DoseExperimentalCBP-201 Dose subcutaneous (SC) injection
Receives: Drug: CBP-201
PlaceboPlacebo comparatorsubcutaneous (SC) injection
Receives: Drug: Placebo

What is being measured

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

  1. Investigator Global Assessment (IGA) (0-1)

    The percentage of subjects whose IGA score is 0-1 and decreased by ≥2 points

    The Validated Investigator Global Assessment for AD (vIGA-AD™) Scale is a 5-point classification scale based on the overall appearance of the skin lesions at a specific time point (0=clear; 1=almost clear; 2=mild; 3=moderate; 4=severe).

    Measured: Baseline to Week16

Secondary outcomes (6)

  1. Eczema Area and Severity Index (EASI)-75

    The percentage of subjects achieving EASI-75 (EASI score is decreased by ≥75% from baseline)

    The total EASI score ranges from 0 (lowest) to 72 (highest); the higher the score, the higher the severity of AD (more severe).

    Measured: Baseline to Week16

  2. Change in Peak Pruritus Numerical Rating Scale(PP-NRS) (Decreased by ≥ 4 Points)

    The percentage of subjects whose weekly average PP-NRS is decreased by ≥ 4 points

    The score ranges from 0 to 10, in which 0 represents "no pruritus" and 10 "worst imaginable pruritus".

    Measured: Baseline to Week16

  3. Change in Peak Pruritus Numerical Rating Scale(PP-NRS) (Decreased by ≥ 3 Points)

    The percentage of subjects whose weekly average PP-NRS is decreased by ≥ 3 points

    The score ranges from 0 to 10, in which 0 represents "no pruritus" and 10 "worst imaginable pruritus".

    Measured: Baseline to Week16

  4. Change in the Weekly Average Peak Pruritus Numerical Rating Scale(PP-NRS)

    Change in the weekly average PP-NRS

    The score ranges from 0 to 10, in which 0 represents "no pruritus" and 10 "worst imaginable pruritus".

    Measured: Baseline to Week16

  5. Eczema Area and Severity Index (EASI)-90

    The percentage of subjects achieving EASI-90 (EASI score is decreased by ≥90% from baseline)

    The total EASI score ranges from 0 (lowest) to 72 (highest); the higher the score, the higher the severity of AD (more severe).

    Measured: Baseline to Week16

  6. Percentage Change in the Weekly Average Peak Pruritus Numerical Rating Scale(PP-NRS)

    Percentage change in the weekly average PP-NRS

    The score ranges from 0 to 10, in which 0 represents "no pruritus" and 10 "worst imaginable pruritus".

    Measured: Baseline to Week16

Timeline

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

  1. First posted23 Aug 2021
  2. Study start31 Aug 2021
  3. Primary completion1 Dec 2022
  4. Study completion28 Sep 2023

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
330 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05017480
Sponsor's protocol ID
CBP-201-CN002
Status last verified
Apr 2024
First submitted
13 Aug 2021
Last updated
1 May 2024
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing CBP-201 in people with Moderate-to-severe Atopic Dermatitis, run by Connect Biopharm LLC at 48 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 13 inclusion and 25 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 1 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 48 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. Some participants in this study may receive a placebo. 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?

Yes. Results are posted in the registry (first posted 1 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Investigator Global Assessment (IGA) (0-1) (time frame: Baseline to Week16). 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 NCT05017480.

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 1 May 2024.

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