Apremilast Added to Antihistamines in Chronic Urticaria

NCT07850843 | Enrolling By Invitation Phase 2

• 1 other identifier: RLMC-DERM-APR-CU-2026
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates whether adding oral apremilast, a phosphodiesterase-4 inhibitor, to second-generation H1 antihistamines improves disease activity and quality of life in adults with chronic urticaria that is not controlled by antihistamines alone. Patients who chose apremilast plus antihistamines were compared over 12 weeks with patients who continued antihistamines alone. Disease activity was measured with the weekly Urticaria Activity Score (UAS7), quality of life with the Dermatology Life Quality Index (DLQI), and adverse effects were recorded at every visit.

Conditions

Chronic Urticaria; Chronic Spontaneous Urticaria; Chronic Inducible Urticaria

Keywords

apremilast; phosphodiesterase 4 inhibitor; antihistamine; urticaria activity score; dermatology life quality index

Outcome Measures

Primary Outcomes (1)

• Change in weekly Urticaria Activity Score (UAS7) from baseline to week 12

  UAS7 is the sum of daily wheal (0-3) and itch (0-3) scores over 7 days, range 0-42; higher scores mean more active disease. Change is compared between groups.

  Baseline and 12 weeks

Secondary Outcomes (6)

• Change in Dermatology Life Quality Index (DLQI) from baseline to week 12

  Baseline and 12 weeks

• Proportion of patients with at least 50% reduction in UAS7

  12 weeks

• Proportion of patients with well-controlled disease (UAS7 of 6 or less)

  12 weeks

• UAS7 at follow-up visits

  Weeks 2, 4, 8 and 12

• Antihistamine requirement

  12 weeks

Study Arms (2)

Apremilast plus antihistamine

EXPERIMENTAL

Apremilast titrated over 5 days from 10 mg to 30 mg orally twice daily and continued for 12 weeks, in addition to the patient's second-generation H1 antihistamine at standard or up to fourfold dose.

Drug: Apremilast; Drug: Second-generation H1 antihistamine

Antihistamine alone

ACTIVE COMPARATOR

Second-generation H1 antihistamine at standard or up to fourfold dose for 12 weeks without apremilast.

Drug: Second-generation H1 antihistamine

Interventions

Apremilast DRUG

Oral apremilast, 5-day titration (10 mg to 30 mg) then 30 mg twice daily for 12 weeks.

Also known as: Otezla

Apremilast plus antihistamine

Second-generation H1 antihistamine DRUG

Oral second-generation H1 antihistamine at the licensed dose or up-dosed up to fourfold, continued throughout the 12-week study.

Antihistamine alone; Apremilast plus antihistamine

Eligibility Criteria

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

You may qualify if:

• Adults aged 18 to 65 years of either gender.
• Chronic spontaneous urticaria, chronic inducible urticaria or both, lasting more than 6 weeks.
• Moderate to severe disease (weekly Urticaria Activity Score, UAS7, of 16 or more) despite at least 4 weeks of second-generation H1 antihistamines at standard or up-dosed (up to fourfold) dose.
• Inadequate response to, intolerance of, contraindication to or inability to access omalizumab or cyclosporine.
• Written informed consent.

You may not qualify if:

• Pregnancy, planned pregnancy or lactation.
• Uncontrolled depression or other uncontrolled psychiatric illness.
• Urticarial vasculitis.
• Use of omalizumab or cyclosporine within the previous 3 months.

Sponsors & Collaborators

• Rashid Latif Medical College: lead

Study Sites (1)

Arif Memorial Teaching Hospital, Rashid Latif Medical College

Lahore, Punjab Province, Pakistan

Location

MeSH Terms

Conditions

Chronic Urticaria; Chronic Inducible Urticaria

Interventions

apremilast; Histamine H1 Antagonists, Non-Sedating

Condition Hierarchy (Ancestors)

Urticaria; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Histamine H1 Antagonists; Histamine Antagonists; Histamine Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Physiological Effects of Drugs

Study Officials

• Merrium Mahrukh, MBBS

  Rashid Latif Medical College

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postgraduate Resident, Department of Dermatology

Model Details: Two parallel groups: apremilast plus second-generation H1 antihistamine versus second-generation H1 antihistamine alone for 12 weeks.

Study Record Dates

• First Submitted: September 23, 2026
• First Posted: September 30, 2026
• Study Start: September 23, 2026
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: September 30, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)