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Moderate-to-severe Atopic DermatitisPhase 2NCT04444752

A Study to Assess the Efficacy and Safety of CBP-201 in Adult Subjects With Moderate to Severe Atopic Dermatitis

A Phase 2 study testing CBP-201 in people with Moderate-to-severe Atopic Dermatitis, run by Connect Biopharm LLC at 59 sites in 4 countries.

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, safety, pharmacokinetics and pharmacodynamics of CBP-201 in adult 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
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
226 participants
Where
59 sitesin 4 countries
Study dates
17 Jul 2020to 22 Sep 2021
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 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Be an adult ≥18 and ≤ 75 years of age at the screening visit (Screening) with atopic dermatitis according to American Academy of Dermatology Consensus Criteria, (Eichenfield 2014)
  • Present for at least 1 year prior to the baseline visit (Baseline) with an inadequate response, in the judgement of the Investigator, to AD treatment with a topical regimen of corticosteroids, phosphodiesterase inhibitors or calcineurin inhibitors, or for whom topical treatments are otherwise medically inadvisable (eg, because of important side effect or safety risks)
  • Investigator Global Assessment (IGA) score ≥ 3 at Screening and Baseline.
  • Eczema Area and Severity Index (EASI) score ≥ 16 at Screening and Baseline
  • Body Surface Area (BSA) for total AD involvement ≥ 10% at Screening and Baseline
  • Able and willing to apply a stable dose of a bland emollient twice a day to affected areas for at least 7 days before Baseline and to continue for the duration of the study
  • Females of child-bearing potential (FCBP) and males who have not undergone a vasectomy must abstain from heterosexual activities or agree to use effective contraception throughout the entire study period.

Who cannot join

  • Have any of the following laboratory abnormalities at Screening:
  • Hemoglobin ≤ 90% of the lower limit of normal range (LLN)
  • White blood cell (WBC) below the LLN
  • Neutrophil count below the LLN
  • Platelet count below the LLN
  • Have undergone treatment with any of the following:
Show all 25Show fewer
  • Topical agents such as corticosteroids, phosphodiesterase (PDE) inhibitors, Janus kinase (JAK) inhibitors, tacrolimus or pimecrolimus within 1 week prior to Baseline. Note that low to medium potency topical corticosteroids (TCS) are permitted after randomization to treat AD flares
  • Prior treatment with dupilumab or any antibody against IL-4Rα or IL-13
  • Systemic treatment for AD or other condition with steroids or other immunosuppressive/immunomodulating substances, e.g., cyclosporine, mycophenolate-mofetil, azathioprine, methotrexate or oral Janus kinase (JAK) inhibitors within 4 weeks prior to Baseline. Use of steroid inhalers and nasal corticosteroids is allowed.
  • Cell depleting agents, e.g. rituximab, within 6 months of Baseline or treatment with other biologics within 5 half-lives (if known) or 3 months prior to baseline visit, whichever is longer
  • Phototherapy (narrow band ultraviolet B [NBUVB], ultraviolet B [UVB], ultraviolet A1 [UVA1], psoralen + ultraviolet A [PUVA]), tanning beds, or any other light emitting device (LED), within 4 weeks of Baseline
  • ≥ 2 bleach baths within 2 weeks of Baseline
  • Prescription emollient to treat AD (e.g. Atopiclair®, MimyX®, Epicerum®, etc.) within 2 weeks of Baseline
  • Any investigational drug within 30 days or within 5 half-lives, whichever is longer, before Baseline.
  • Live (attenuated) vaccine within 8 weeks of Baseline.
  • Treatment with systemic traditional Chinese medicine (TCM) or herbal medications within 4 weeks before Baseline or treatment with topical TCM or herbal medications within 1 week before Baseline visit
  • Have any of the following:
  • Infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 4 weeks before Baseline, or superficial skin infection, such as impetigo, within 2 weeks before the Baseline (subjects may be rescreened after the infection has resolved)
  • A history of parasitic infection (e.g. helminth), within 6 months of Baseline
  • Per investigator judgement, known or suspected history of immunosuppression within 6 months of Baseline, including a history of invasive opportunistic infections, such as aspergillosis, coccidioidomycosis, histoplasmosis, human immunodeficiency virus (HIV), listeriosis, pneumocystosis, or tuberculosis, despite infection resolution; or unusually frequent, recurrent or prolonged infections.
  • Any history of vernal keratoconjunctivitis (VKC) and atopic keratoconjunctivitis (AKC)
  • A history of malignancy with the following exceptions: completely treated carcinoma in situ of cervix or non-metastatic squamous or basal cell carcinoma of the skin
  • Positive results at Screening for hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb) or hepatitis C antibody with positive HCV RNA polymerase chain reaction; positive HIV serology at screening
  • An allergy to L-histidine, trehalose or Tween (polysorbate) 80
  • Women must not be pregnant, planning to become pregnant or breast-feed during the study

Trial locations and contacts

59 sites in 4 countries.

59 sites in 4 countries

United States38 sites

  • Connect Investigative Site 326

    Albuquerque, New Mexico, 87102

  • Connect Investigative Site 327

    Canoga Park, California, 91303

  • Connect Investigative Site 333

    Chicago, Illinois, 60640

  • Connect Investigative Site 303

    Chicago, Illinois, 60660

  • Connect Investigative Site 330

    Cincinnati, Ohio, 45231

  • Connect Investigative Site 332

    Coral Gables, Florida, 33144

  • Connect Investigative Site 324

    Encinitas, California, 92024

  • Connect Investigative Site 301

    Fremont, California, 94538

  • Connect Investigative Site 310

    Glendale, Arizona, 85308

  • Connect Investigative Site 320

    Hialeah, Florida, 33016

  • Connect Investigative Site 306

    Hollywood, Florida, 33021

  • Connect Investigative Site 334

    Houston, Texas, 77065

  • Connect Investigative Site 319

    Hunt Valley, Maryland, 21030

  • Connect Investigative Site 312

    Huntington Beach, California, 92647

  • Connect Investigative Site 308

    Jacksonville, Florida, 32256

  • Connect Investigative Site 336

    Las Vegas, Nevada, 89109

  • Connect Investigative Site 305

    Little Rock, Arkansas, 72204

  • Connect Investigative Site 311

    Louisville, Kentucky, 40241

  • Connect Investigative Site 314

    Maitland, Florida, 32751

  • Connect Investigative Site 309

    Memphis, Tennessee, 38119

  • Connect Investigative Site 331

    Miami, Florida, 33155

  • Connect Investigative Site 337

    Miami, Florida, 33155

  • Connect Investigative Site 321

    Miami, Florida, 33173

  • Connect Investigative Site 329

    Mission Viejo, California, 92691

  • Connect Investigative Site 307

    New Albany, Indiana, 47150

  • Connect Investigative Site 304

    Orlando, Florida, 32801

  • Connect Investigative Site 338

    Phoenix, Arizona, 85001

  • Connect Investigative Site 328

    Rapid City, South Dakota, 57702

  • Connect Investigative Site 335

    Saint Joseph, Missouri, 64506

  • Connect Investigative Site 322

    San Diego, California, 92123

  • Connect Investigative Site 323

    San Luis Obispo, California, 93405

  • Connect Investigative Site 317

    Santa Ana, California, 92703

  • Connect Investigative Site 318

    Sherman Oaks, California, 91403

  • Connect Investigative Site 315

    St Louis, Missouri, 63110

  • Connect Investigative Site 316

    Tempe, Arizona, 85284

  • Connect Investigative Site 325

    Thousand Oaks, California, 91320

  • Connect Investigative Site 313

    West Lafayette, Indiana, 47906

  • Connect Investigative Site 340

    Weston, Florida, 33331

Other trials in United States

China9 sites

  • Connect Investigative Site 408

    Beijing, Beijing Municipality, 100020

  • Connect Investigative Site 404

    Beijing, Beijing Municipality, 100050

  • Connect Investigative Site 403

    Hangzhou, Zhejiang, 310003

  • Connect Investigative Site 402

    Jinan, Shandong, 250013

  • Connect Investigative Site 401

    Shanghai, Shanghai Municipality, 200040

  • Connect Investigative Site 406

    Shanghai, Shanghai Municipality, 200071

  • Connect Investigative Site 410

    Tianjin, Tianjin Municipality, 300120

  • Connect Investigative Site 405

    Wuxi, Jiangsu, 214002

  • Connect Investigative Site 409

    Zhenjiang, Jiangsu, 212001

Other trials in China

Australia8 sites

  • Connect Investigative Site 101

    Brisbane, Queensland, 4102

  • Connect Investigative Site 111

    Canberra, Australian Capital Territory, 2606

  • Connect Investigative Site 104

    Darlinghurst, New South Wales, 2010

  • Connect Investigative Site 106

    Fremantle, Western Australia, 6160

  • Connect Investigative Site 108

    Kanwal, New South Wales, 2259

  • Connect Investigative Site 102

    Melbourne, Victoria, 3002

  • Connect Investigative Site 103

    Perth, Western Australia, 6009

  • Connect Investigative Site 105

    Sydney, New South Wales, 2289

Other trials in Australia

New Zealand4 sites

  • Connect Investigative Site 203

    Auckland, 1010

  • Connect Investigative Site 202

    Havelock North, Hawke's Bay Region, 4130

  • Connect Investigative Site 204

    Tauranga, Bay of Plenty, 3110

  • Connect Investigative Site 205

    Waikanae, Kapiti Coast, 5036

Other trials in New Zealand

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled Multi-Centered Study of the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of CBP-201 in Adult Subjects With Moderate to Severe Atopic Dermatitis

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

Read the detailed description

This is a randomized, double-blind, placebo-controlled, dose regimen finding study to assess the efficacy, safety, and steady-state PK profile of CBP-201 administered to eligible adult subjects with moderate to severe atopic dermatitis compared to placebo. CBP-201 is administered as a subcutaneous (SC) injection. The study is divided into a treatment period of 16 weeks and a follow-up period of 8 weeks.

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 NCT04444752
Study groupRoleWhat they receive
CBP-201 Dose 1ExperimentalCBP-201 Dose 1 subcutaneous (SC) injection
Receives: Drug: CBP-201
CBP-201 Dose 2ExperimentalCBP-201 Dose 2 subcutaneous (SC) injection
Receives: Drug: CBP-201
CBP-201 Dose 3ExperimentalCBP-201 Dose 3 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. Percent Reduction in EASI Score From Baseline to Week 16

    EASI=Eczema Area Severity Index is a validated physician score for signs of atopic dermatitis. EASI can range from 0 to 72. An EASI score of 0 indicates clear/no eczema, 0.1 to 1.0 almost clear, 1.1 to 7 mild disease, 7.1 to 21 moderate disease, 21.1 to 50 severe disease, and 51-72 indicates very severe disease. EASI Sub-scale ranges are as follows: Head/neck can range from 0-7.2, Trunk 0-14.4, Upper Extremities 0-21.6, Lower Extremities can range from 0-28.8. To calculate EASI, % involvement is first assessed by body region with an Area involvement Score of 0-6 for each region: 0=0%, 1=1-9%, 2=10-29%, 3=30-39%, 4=50-69%, 5=70-89%, 6=90-100% involvement. Then 4 attributes (Erythema, Edema/Papulation, Excoriation, and Lichenification) are scored for severity (0= none, 1=mild, 2=moderate, 3=severe). A multiplier is applied head/neck=0.1, trunk=0.2, upper extremities= 0.3, lower extremities=0.4. The total EASI score is the sum of 4 regional sub-scores.

    Measured: Reduction from baseline to 16 weeks

Secondary outcomes (1)

  1. vIGA of 0/1 at Week 16

    Validated Investigator Global Assessment Score (vIGA) is assigned by the physician based on morphologic presentation of the disease in the clinic. The physician considers extent and severity of erythema, induration/papulation, lichenification, and oozing/crusting. A vIGA Score of 0=Clear, 1=Almost Clear, 2= Mild dermatitis, 3=Moderate dermatitis, and 4= Severe dermatitis. Patients are required to have a baseline IGA of 3 or 4. The response rate or percentage of patients achieving a vIGA of 0 or 1 (improved to clear or almost clear) at week 16 is the outcome.

    Measured: Response Rate at 16 weeks

Timeline

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

  1. First posted24 Jun 2020
  2. Study start17 Jul 2020
  3. Primary completion28 Jul 2021
  4. Study completion22 Sep 2021

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
226 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04444752
Sponsor's protocol ID
CBP-201-WW001
Status last verified
Jul 2023
First submitted
15 Jun 2020
Last updated
1 Aug 2023
Data monitoring committee
No
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 59 sites in 4 countries.

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 7 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 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 59 sites in United States, China, Australia, New Zealand. 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 Aug 2023). 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?

Percent Reduction in EASI Score From Baseline to Week 16 (time frame: Reduction from baseline to 16 weeks). 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 NCT04444752.

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 Aug 2023.

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