Skin Transcriptional Profiles In Psoriatic Patients Under Adalimumab Biotherapy

NCT01872546 | Completed Phase 2 Results

• 1 other identifier: CYTOPSO
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

The expertise in the characterization of transcriptomics profile in lesional psoriatic skin and on the availability of innovative therapy for these patients.The investigators propose to follow the modification of the skin transcriptomics profile in psoriatic patients during successful Adalimumab biotherapy. Skin transcriptomics profiles of normal skin, psoriatic non lesional skin, and psoriatic lesional skin before and after biotherapy will be compared. The investigators will focus on the modification of the cytokine "signature" in these skin lesions and of some markers of keratinocyte inflammation. The modification of the transcriptomics profile induced by the biotherapy will be correlated to the clinical response Psoriasis Area and Severity Index.

Conditions

Chronic Plaque Psoriasis

Outcome Measures

Primary Outcomes (1)

• Area and Severity Index (PASI)

  Number of patients with a reduction in PASI score at 4 weeks

  4 weeks

Secondary Outcomes (1)

• Dermatology Life Quality Index (DLQI) Scores

  4 weeks

Study Arms (1)

Adalimumab

EXPERIMENTAL

Adalimumab was administered subcutaneously at a dose of 80 mg at Week 0 and 40 mg every other week starting from Week 1 to Week 16.

Drug: Adalimumab Every Week

Interventions

Adalimumab Every Week DRUG

Adalimumab was administered subcutaneously at a dose of 80 mg at Week 0 and 40 mg every other week starting from Week 1 to Week 16.

Adalimumab

Eligibility Criteria

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

You may qualify if:

• Adults with chronic plaque psoriasis involving at least 10% of body surface area with no previous biotherapy.
• Adalimumab prescribed in usual practice

You may not qualify if:

• Patients presenting a contraindication to the use of Adalimumab: hypersensibility in Adalimumab or in one of the excipients.
• Patients presenting an evolutionary tuberculosis or the other severe infections such as sepsis and opportunist infections.
• Patients with one cardiac insufficiencies moderated in severe.
• Patients under anakinra or abatacept.
• Patients with a current participation in another study of clinical research.

Sponsors & Collaborators

• Poitiers University Hospital: lead

Study Sites (1)

Chu Poitiers

Poitiers, 86021, France

Location

Related Publications (2)

• Croquette M, Faugeroux A, Fonlupt C, Godet J, Frouin E, Garcia M, Bernard FX, Cordier-Dirikoc S, Pedretti N, Larid G, Favot L, Roblot P, Boutin D, Hainaut-Wierzbicka E, Heymann D, Lecron JC, Morel F, Jegou JF. IL-34 Exerts Anti-Inflammatory Activities on Keratinocytes and Is Downregulated in Psoriatic-Inflamed Skin. J Invest Dermatol. 2023 Dec;143(12):2521-2524.e5. doi: 10.1016/j.jid.2023.05.023. Epub 2023 Jun 12. No abstract available.

  PMID: 37315881 RESULT

• Buffiere-Morgado A, Couderc E, Delwail A, Favot L, Jegou JF, Solau E, Guillet G, Lecron JC, Morel F. Characterization of skin Th17 transcriptional profiles in psoriatic patients under adalimumab biotherapy. Eur J Dermatol. 2017 Dec 1;27(6):579-589. doi: 10.1684/ejd.2017.3127.

  PMID: 29171393 RESULT

Results Point of Contact

• Title: Frank MOREL
• Organization: Université de Poitiers

franck.morel@univ-poitiers.fr

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: March 27, 2013
• First Posted: June 7, 2013
• Study Start: January 1, 2013
• Primary Completion: April 1, 2013
• Study Completion: September 1, 2013
• Last Updated: June 24, 2026
• Results First Posted: June 24, 2026

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)