Preliminary Efficacy and Safety of Apremilast in the Treatment of Acne Conglobata

NCT04161456 | Completed Phase 2 DMC

• 1 other identifier: TMP-0517
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

Apremilast mediates its clinical effect through the cAMP-PKA-NFkappaB pathway which results in a clinical picture changes to a decrease of all signs of inflammation. Due to the NFkappaB mediated chronical inflammation in the pathogenesis of acne conglobata, a treatment with Apremilast seems to be an effective option. In this study, treatment with Apremilast (Otezla®) will be performed in patients with acne conglobata to observe its preliminary efficacy and safety in an open label, single-centre proof of concept study design.

Conditions

Acne Conglobata

Keywords

Acne conglobata; Phosphodiesterase (PDE)-Inhibitor

Outcome Measures

Primary Outcomes (1)

• 50% reduction in number of lesion

  proportion of subjects who achieve at least a 50% reduction in total number of inflammatory lesions

  24 weeks

Secondary Outcomes (47)

• Proportionof subjects in Investigator global assessment (IGA)

  Baseline to visit 3 (week 2)

• proportion of subjects in Investigator global assessment (IGA)

  Baseline to visit 4 (week 4)

• proportion of subjects in Investigator global assessment (IGA)

  Baseline to visit 5 (week 8)

• proportion of subjects in Investigator global assessment (IGA)

  Baseline to visit 6 (week 16)

• proportion of subjects in Investigator global assessment (IGA)

  Baseline to visit 7 (week 24)

Study Arms (1)

Apremilast

EXPERIMENTAL

Apremilast twice daily 30 mg

Drug: Apremilast

Interventions

Apremilast DRUG

Apremilast twice daily 30 mg

Also known as: Otezla

Apremilast

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of acne conglobata for a minimum of 6 months
• Active condition of acne conglobata, defined as minimum IGA of 2 (5-point scale) of severity of acne conglobate
• No clinical significant or severe abnormality of skin (e.g. scars, other severe skin disease) based on medical/medication history or physical examination as determined by the treating physician
• Number of abscesses ≤ 2
• Written informed consent obtained from the patients prior to the initiation of any protocol-required procedures
• Compliance to study procedures and study protocol
• Age 18 - 65 years
• patients who do not tolerate or no longer tolerate therapies or for whom the following treatment options are contraindicated:
• Topical retinoid therapy
• isotretinoin and/or acitretin as standard therapy
• Topical treatment with antibiotics, glucocorticoids, retinoids, Vit-D-analogue, calcineurin inhibitors
• systemic antibiotics, systemic glucocorticoids
• systemic retinoids

You may not qualify if:

• Previous use of Apremilast, or any other PDE-4 inhibitor
• According to Summary of Product characteristics (SmPC); see special warnings regarding suicidal ideation and behaviour
• Known hypersensitivity to any component of the investigator medicinal product (IMP)
• Current use of strong CYP3A4 enzyme inducers (e.g., rifampicin, phenobarbital, carbamazepine, phenytoin, and St. John's Wort) Active dermatologic conditions which may confound the diagnosis of acne conglobata or would interfere with the assessment of treatment (e.g., acne inversa, atopic dermatitis, seborrheic dermatitis, ichthyosis, and psoriasis)
• History of clinically significant infection within the last 4 weeks before screening, which, in the opinion of the treating physician, may compromise the safety of the patient
• Presentation of special type of acne, including but not limited to:
• Medication related acne (e.g., steroid abuse)
• Acne with facial edema
• Recalcitrant acne
• Acne cosmetic, pomade acne
• Acne mechanica
• Chloracne
• History of any kind of cancer or carcinoma in situ within the last 5 years before screening
• History of chronic alcohol/drug abuse within the last 12 months before screening
• Pregnant or breastfeeding women

Sponsors & Collaborators

• Dr. Frank Behrens: lead
• Dermatology Department University Hospital Frankfurt: collaborator
• Celgene: collaborator

Study Sites (1)

University Hospital Frankfurt

Frankfurt, Hessia, 60590, Germany

Location

MeSH Terms

Conditions

Acne Conglobata

Interventions

apremilast

Condition Hierarchy (Ancestors)

Acne Vulgaris; Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Study Officials

• Andreas Pinter, MD

  University Hospital of Goethe-University Frankfurt

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor representative

Model Details: Patients will be treated with Apremilast

Study Record Dates

• First Submitted: November 5, 2019
• First Posted: November 13, 2019
• Study Start: October 9, 2019
• Primary Completion: February 8, 2021
• Study Completion: February 8, 2021
• Last Updated: March 2, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)