NCT05017480|CompletedPhase 2ResultsFDA Drug

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

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

Connect Biopharm LLC ClinicalTrials.gov

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1 other identifier

CBP-201-CN002

Study Type

interventional

Target

330

Locations

1 country

Sites

Timeline

RegisteredAug 2021

StartedAug 2021

CompletionSep 2023

Brief Summary

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

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

330

participants targeted

Target at P75+ for phase_2

Timeline

Completed

Started Aug 2021

Geographic Reach

1 country

48 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.1 years study duration

First Submitted

Initial submission to the registry

August 13, 2021

Completed

10 days until next milestone

First Posted

Study publicly available on registry

August 23, 2021

Completed

8 days until next milestone

Study Start

First participant enrolled

August 31, 2021

Completed

1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed

10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 28, 2023

Completed

7 months until next milestone

Results Posted

Study results publicly available

May 1, 2024

Completed

Last Updated

May 1, 2024

Status Verified

April 1, 2024

Enrollment Period

1.3 years

First QC Date

August 13, 2021

Results QC Date

February 1, 2024

Last Update Submit

April 8, 2024

Conditions

Moderate-to-severe Atopic Dermatitis

Outcome Measures

Primary Outcomes (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).
Baseline to Week16

Secondary Outcomes (6)

Eczema Area and Severity Index (EASI)-75
Baseline to Week16
Change in Peak Pruritus Numerical Rating Scale(PP-NRS) (Decreased by ≥ 4 Points)
Baseline to Week16
Change in Peak Pruritus Numerical Rating Scale(PP-NRS) (Decreased by ≥ 3 Points)
Baseline to Week16
Change in the Weekly Average Peak Pruritus Numerical Rating Scale(PP-NRS)
Baseline to Week16
Eczema Area and Severity Index (EASI)-90
Baseline to Week16
+1 more secondary outcomes

Study Arms (2)

CBP-201 Dose

EXPERIMENTAL

CBP-201 Dose subcutaneous (SC) injection

Drug: CBP-201

Placebo

PLACEBO COMPARATOR

subcutaneous (SC) injection

Drug: Placebo

Interventions

CBP-201DRUG

CBP-201 subcutaneous(SC) injection.

CBP-201 Dose

PlaceboDRUG

subcutaneous(SC) injection

Placebo

Eligibility Criteria

Age12 Years - 75 Years

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

≤ 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:
a) 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:
i. 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.
b. 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).
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:
i. 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.

You may not qualify if:

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);
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).
Patients must meet all of the following criterias to be enrolled into this study:
Patients who meet any of the following:
+9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Connect Biopharm LLClead

Study Sites (48)

Connect Investigative Site 33

Hefei, Anhui, China

Location

Connect Investigative Site 01