A Study to Evaluate Safety and Effectiveness of Cendakimab (CC-93538) in Participants With Moderate to Severe Atopic Dermatitis

Celgene

Status and phase: Completed; Phase 2

Conditions: Dermatitis, Atopic; Eczema

Treatments: Other: Placebo; Drug: CC-93538

Study type: Interventional

Funder types: Industry

Identifiers

NCT04800315

2020-005212-22 (EudraCT Number)

1111-1260-5462 (Registry Identifier)

CC-93538-AD-001

Details and patient eligibility

About

The purpose of this study is to evaluate the effectiveness and safety of 3 dose regimen of CC-93538 in adult participants with moderate to severe Atopic Dermatitis (AD).

Enrollment: 221 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Participants must satisfy the following criteria to be enrolled in the study:

1. Participant must be ≥ 18 years and ≤ 75 years of age and have a body weight of ≥ 40 kg (88.2 lb) at the time of signing the informed consent form (ICF).

2. Participant has chronic atopic dermatitis (AD) as defined by Hanifin and Rajka that has been present for ≥ 1 year prior to the baseline visit (Day 1).

3. Participant has moderate to severe, active, and symptomatic AD defined by meeting all of the following criteria on the day of the baseline visit (Day 1):

   1. Body Surface Area (BSA) ≥ 10%, and
   2. EASI score ≥ 16, and
   3. vIGA-AD ≥ 3, and
   4. Pruritus Numeric Rating Scale (NRS) severity score ≥ 4.

4. Participant must have a documented history of inadequate response to treatment with topical medications for at least 4 weeks, unless topical treatments are otherwise medically inadvisable or has required systemic therapy for control of disease.

5. Participant must be willing to apply a stable dose of topical emollient (eg, over-the-counter moisturizer, non-medicated emollient, etc.) twice daily for ≥ 7 days prior to the Baseline visit and continue application throughout the study.

6. Participant must commit to avoid prolonged exposure to the sun and not to use tanning booths, sun lamps or other ultraviolet light sources during the study.

7. Participants currently receiving concomitant medications for any reason other than AD, such as inhaled corticosteroids, leukotriene receptor antagonists (eg, montelukast), or mast cell stabilizers (eg, cromolyn sodium) for asthma, must be on a stable regimen, which is defined as not starting a new drug, changing, or stopping dosage within 7 days or 5 half-lives (whichever is longer) prior to Day 1 and through the treatment duration of the study.

8. Female participants of childbearing potential must agree to practice a highly effective method of contraception.

Exclusion criteria

1. The presence of any of the following will exclude a participant from enrollment: Evidence of an active and/or concurrent inflammatory skin condition (eg, seborrheic dermatitis, psoriasis, acute allergic contact dermatitis, etc.) that would interfere with the Investigator or participant-driven evaluations of AD.
2. Evidence of acute AD flare between the Screening and Baseline/ Randomization (eg, doubling of the EASI score between Screening and Baseline).
3. Use of topical treatments that could affect the assessment of AD (eg, corticosteroids, calcineurin inhibitors, tars, antibiotic creams, topical antihistamines) within 7 days of the Day 1 visit.
4. Received phototherapy narrowband UVB (NB-UVB) or broad band phototherapy within 4 weeks prior to the Baseline visit.
5. Evidence of immunosuppression, participant is receiving, or has received systemic immunosuppressive or immunomodulating drugs (eg, azathioprine, cyclosporine, systemic corticosteroids, interferon gamma (IFN-γ), Janus kinase inhibitors, methotrexate, mycophenolate-mofetil, etc.) within 4 weeks prior to the Baseline visit.
6. Treatment with immunomodulatory biologics
7. Concurrent treatment with another IP
8. Received a live attenuated vaccine within 1 month prior to the first Screening Visit or anticipates the need to be vaccinated with a live attenuated vaccine during the study.
9. Active parasitic/helminthic infection or a suspected parasitic/helminthic infection.
10. Ongoing infection
11. A history of idiopathic anaphylaxis or a major immunologic reaction (such as anaphylactic reaction, anaphylactoid reaction, or serum sickness) to an immunoglobulin G (IgG) containing agent. A known hypersensitivity to any ingredient in the investigational product (IP) is also exclusionary.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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221 participants in 4 patient groups, including a placebo group

Dose 1: CC-93538 SC QW

Experimental group

Description:

Administration of CC-93538 Subcutaneous (SC) Once weekly (QW) for 16 weeks.

Treatment:

Drug: CC-93538

Dose 2: CC-93538 SC Q2W and Placebo alternating every other week SC Q2W

Experimental group

Description:

Starting at the baseline visit, active IP will be administered. On the alternate weeks, placebo will be administered to maintain the blind.

Treatment:

Other: Placebo

Drug: CC-93538

Dose 3: CC-93538 SC Q2W and Placebo SC weekly

Experimental group

Description:

Starting at the baseline visit, active IP and matching placebo will be administered. On the alternate weeks, placebo will be administered weekly to maintain the blind.

Treatment:

Other: Placebo

Drug: CC-93538

Placebo SC QW

Placebo Comparator group

Description:

Administration of placebo each week.

Treatment:

Other: Placebo