Efficacy and mode of action of apremilast (Otezla) in moderate hidradenitis suppurativa. An exploratory pilot study.

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-000859-27-NL

Enrollment

Unknown

Registered

2016-06-27

Start date

2017-01-23

Completion date

Unknown

Last updated

2017-01-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hidradenitis suppurativa, acne inversa, ectopic acne

Interventions

Trade Name: Apremilast (Otezla) Product Name: Apremilast Product Code: CC-10004 Pharmaceutical Form: Tablet

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Key inclusion criteria: adult (= 18 years of age) male or female patients with moderate HS according to a PGA of 3 on the 5-point HS-Physician Global Assessment (HS-PGA); HS of more than 6 months duration; have lesions in at least two anatomical locations. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 10 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Key exclusion criteria: contraindication for apremilast; previous use of apremilast; have any current and/or recurrent clinically significant skin condition in the treatment area other than HS; presence of other uncontrolled major disease; pregnant or lactating women.

Design outcomes

Primary

Measure	Time frame
Main Objective: Primary objectives: To evaluate the effects of apremilast on the expression of inflammatory cytokines in HS lesional skin at week one (t=1), week four (t=4) and week sixteen (t=16) relative to baseline (t=0), in relation to its clinical efficacy. ;Secondary Objective: Secondary objectives: - To prospectively evaluate the clinical efficacy of apremilast. - To assess the effect of apremilast on patient reported outcomes measures. - To assess the short-term safety and tolerability of apremilast in patients with hidradenitis suppurativa.;Primary end point(s): The expression levels of inflammatory cytokine protein and mRNA in HS lesional skin will be analyzed at week one (t=1), week four (t=4) and week sixteen (t=16) relative to baseline (t=0), in relation to its clinical efficacy. The proteins and genes of interest to be measured are IL-1ß, IL-6, TNF-a, IL-10, IL-12, IL-23, IL-17, IFN-?, IL-31. Exactly the same cytokines will be measured using ELISA and qPCR in order to correlate the data.;Timepoint(s) of evaluation of this end point: at week one (t=1), week four (t=4) and week sixteen (t=16) relative to baseline (t=0),	—

Measure

Time frame

Main Objective: Primary objectives: To evaluate the effects of apremilast on the expression of inflammatory cytokines in HS lesional skin at week one (t=1), week four (t=4) and week sixteen (t=16) relative to baseline (t=0), in relation to its clinical efficacy. ;Secondary Objective: Secondary objectives: - To prospectively evaluate the clinical efficacy of apremilast. - To assess the effect of apremilast on patient reported outcomes measures. - To assess the short-term safety and tolerability of apremilast in patients with hidradenitis suppurativa.;Primary end point(s): The expression levels of inflammatory cytokine protein and mRNA in HS lesional skin will be analyzed at week one (t=1), week four (t=4) and week sixteen (t=16) relative to baseline (t=0), in relation to its clinical efficacy. The proteins and genes of interest to be measured are IL-1ß, IL-6, TNF-a, IL-10, IL-12, IL-23, IL-17, IFN-?, IL-31. Exactly the same cytokines will be measured using ELISA and qPCR in order to correlate the data.;Timepoint(s) of evaluation of this end point: at week one (t=1), week four (t=4) and week sixteen (t=16) relative to baseline (t=0),

—

Secondary

Measure	Time frame
Secondary end point(s): The clinical efficacy will be measured using the following scoring systems: • Individual inflammatory lesion count (Appendix 3) • HS-Physician Global Assessment (HS-PGA)(16) (Appendix 4) • Hidradenitis Suppurativa Clinical Response (HiSCR) (17) (Appendix 5) The patient reported outcomes will be measured using the following scoring sytems: • NRS to assess pain, pruritus and patient disease global assessment score (Appendix 6, 7, 8) • DLQI (18) (Appendix 9);Timepoint(s) of evaluation of this end point: week 0, 2, 4, 8, 12, 16	—

Measure

Time frame

Secondary end point(s): The clinical efficacy will be measured using the following scoring systems: • Individual inflammatory lesion count (Appendix 3) • HS-Physician Global Assessment (HS-PGA)(16) (Appendix 4) • Hidradenitis Suppurativa Clinical Response (HiSCR) (17) (Appendix 5) The patient reported outcomes will be measured using the following scoring sytems: • NRS to assess pain, pruritus and patient disease global assessment score (Appendix 6, 7, 8) • DLQI (18) (Appendix 9);Timepoint(s) of evaluation of this end point: week 0, 2, 4, 8, 12, 16

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Countries

Netherlands

Contacts

Public ContactMedical Affairs NL

Celgene BV

jmsprengers@celgene.com+313030 28 44 524

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026