Chronic UrticariaPhase 2APREM-CUNCT07850843
Apremilast Added to Antihistamines in Chronic Urticaria
A Phase 2 study testing Apremilast and Second-generation H1 antihistamine in people with Chronic Urticaria and Chronic Spontaneous Urticaria, run by Rashid Latif Medical College at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Urticaria, Chronic Spontaneous Urticaria, Chronic Inducible Urticaria
- What is being tested?
- Apremilast and Second-generation H1 antihistamine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 sitePakistan
- Study dates
- 23 Sep 2026to 31 Oct 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Pregnancy, planned pregnancy or lactation.
- Uncontrolled depression or other uncontrolled psychiatric illness.
- Urticarial vasculitis.
- Use of omalizumab or cyclosporine within the previous 3 months.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site
Arif Memorial Teaching Hospital, Rashid Latif Medical College
Lahore, Punjab Province
About this study
Official title: Evaluating the Therapeutic Potential of Apremilast as Add-on Therapy to Second-Generation H1 Antihistamines in the Management of Chronic Urticaria: A Non-Randomised Controlled Trial
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.
Read the detailed description
Chronic urticaria is a mast cell-driven skin disease with recurrent wheals, angioedema or both for more than 6 weeks. Many patients remain symptomatic on up-dosed second-generation H1 antihistamines, and second- and third-line options (omalizumab, cyclosporine) are costly or need laboratory monitoring. Apremilast is an oral phosphodiesterase-4 inhibitor approved for psoriasis, psoriatic arthritis and Behcet disease; PDE4 is expressed in mast cells, basophils and eosinophils.
Design: single-centre, open-label, non-randomised, parallel-group controlled trial at the Department of Dermatology, Arif Memorial Teaching Hospital, Rashid Latif Medical College, Lahore, Pakistan. Eighty-six patients were enrolled by non-probability consecutive sampling (43 per group). Sample size was calculated with 95% confidence and 80% power using an expected response of 76.92% with add-on therapy versus 48.08% with antihistamines alone.
Allocation: after counselling on cost, off-label use and expected adverse effects, patients who agreed to take apremilast formed the experimental group; the others formed the control group.
Intervention: apremilast titrated over 5 days from 10 mg to 30 mg twice daily and continued for 12 weeks, in addition to the patient's second-generation H1 antihistamine. Controls continued the antihistamine alone.
Assessments: UAS7 at baseline and weeks 2, 4, 8 and 12; DLQI and body weight at baseline and week 12; adverse effects, compliance and antihistamine requirement at each visit. Data were analysed in SPSS version 26 with the independent and paired t-tests and the chi-square or Fisher's exact test; p of 0.05 or less was considered significant.
- Being tested
- Apremilast, Second-generation H1 antihistamine
- Keywords
- apremilast, phosphodiesterase 4 inhibitor, antihistamine, urticaria activity score, dermatology life quality index
- Medical subject headings
- Chronic Urticaria, Chronic Inducible Urticaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ApremilastDrug
Also called Otezla
Oral apremilast, 5-day titration (10 mg to 30 mg) then 30 mg twice daily for 12 weeks.
Second-generation H1 antihistamineDrug
Oral second-generation H1 antihistamine at the licensed dose or up-dosed up to fourfold, continued throughout the 12-week study.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Second-generation H1 antihistamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 12 weeks
Secondary outcomes (6)
Change in Dermatology Life Quality Index (DLQI) from baseline to week 12
DLQI is a 10-item questionnaire scored 0-30; higher scores mean greater impairment of quality of life.
Measured: Baseline and 12 weeks
Proportion of patients with at least 50% reduction in UAS7
Treatment response defined as a fall of 50% or more from baseline UAS7.
Measured: 12 weeks
Proportion of patients with well-controlled disease (UAS7 of 6 or less)
UAS7 of 0 to 6 at week 12.
Measured: 12 weeks
UAS7 at follow-up visits
Mean UAS7 at each follow-up visit compared between groups.
Measured: Weeks 2, 4, 8 and 12
Antihistamine requirement
Antihistamine dose at week 12 recorded as reduced, unchanged or increased compared with baseline.
Measured: 12 weeks
Number of participants with adverse effects
Nausea, vomiting, diarrhoea, headache, abdominal discomfort, weight loss (3% or more of baseline weight), mood changes and other events recorded at each visit.
Measured: Up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2026
- Study start23 Sep 2026
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic UrticariaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Two parallel groups: apremilast plus second-generation H1 antihistamine versus second-generation H1 antihistamine alone for 12 weeks.
- Masking
- None (open label)
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rashid Latif Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merrium Mahrukh, Rashid Latif Medical College
- Investigators
- Merrium Mahrukh, MBBS, Principal investigator, Rashid Latif Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07850843
- Sponsor's protocol ID
- RLMC-DERM-APR-CU-2026
- Acronym
- APREM-CU
- Status last verified
- Sep 2026
- First submitted
- 23 Sep 2026
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Therapeutic Potential of Apremilast as Add-on Therapy to Second-Generation H1 Antihistamines in the Management of Chronic Urticaria: A Non-Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT07850843
- Acronym / sponsor ID
- APREM-CU / RLMC-DERM-APR-CU-2026
- Keywords
- apremilast, phosphodiesterase 4 inhibitor, antihistamine, urticaria activity score, dermatology life quality index
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- Rashid Latif Medical CollegeUniversity, hospital or other
- Study start
- 23 Sep 2026 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 30 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Chronic urticaria is a mast cell-driven skin disease with recurrent wheals, angioedema or both for more than 6 weeks. Many patients remain symptomatic on up-dosed second-generation H1 antihistamines, and second- and third-line options (omalizumab, cyclosporine) are costly or need laboratory monitoring. Apremilast is an oral phosphodiesterase-4 inhibitor approved for psoriasis, psoriatic arthritis and Behcet disease; PDE4 is expressed in mast cells, basophils and eosinophils.
Design: single-centre, open-label, non-randomised, parallel-group controlled trial at the Department of Dermatology, Arif Memorial Teaching Hospital, Rashid Latif Medical College, Lahore, Pakistan. Eighty-six patients were enrolled by non-probability consecutive sampling (43 per group). Sample size was calculated with 95% confidence and 80% power using an expected response of 76.92% with add-on therapy versus 48.08% with antihistamines alone.
Allocation: after counselling on cost, off-label use and expected adverse effects, patients who agreed to take apremilast formed the experimental group; the others formed the control group.
Intervention: apremilast titrated over 5 days from 10 mg to 30 mg twice daily and continued for 12 weeks, in addition to the patient's second-generation H1 antihistamine. Controls continued the antihistamine alone.
Assessments: UAS7 at baseline and weeks 2, 4, 8 and 12; DLQI and body weight at baseline and week 12; adverse effects, compliance and antihistamine requirement at each visit. Data were analysed in SPSS version 26 with the independent and paired t-tests and the chi-square or Fisher's exact test; p of 0.05 or less was considered significant.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two parallel groups: apremilast plus second-generation H1 antihistamine versus second-generation H1 antihistamine alone for 12 weeks.
| Arm | Type | Receives |
|---|---|---|
| Apremilast plus antihistamine | Experimental | Drug: Apremilast, Drug: Second-generation H1 antihistamineApremilast 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. |
| Antihistamine alone | Active comparator | Drug: Second-generation H1 antihistamineSecond-generation H1 antihistamine at standard or up to fourfold dose for 12 weeks without apremilast. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- Pregnancy, planned pregnancy or lactation.
- Uncontrolled depression or other uncontrolled psychiatric illness.
- Urticarial vasculitis.
- Use of omalizumab or cyclosporine within the previous 3 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ApremilastAlso: OtezlaOral apremilast, 5-day titration (10 mg to 30 mg) then 30 mg twice daily for 12 weeks. | Drug | Apremilast plus antihistamine |
| Second-generation H1 antihistamineOral second-generation H1 antihistamine at the licensed dose or up-dosed up to fourfold, continued throughout the 12-week study. | Drug | Antihistamine alone, Apremilast plus antihistamine |
Primary outcome
Change in weekly Urticaria Activity Score (UAS7) from baseline to week 12
Time frame: Baseline and 12 weeks
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.
6 secondary outcomes
Change in Dermatology Life Quality Index (DLQI) from baseline to week 12
Time frame: Baseline and 12 weeks
Proportion of patients with at least 50% reduction in UAS7
Time frame: 12 weeks
Proportion of patients with well-controlled disease (UAS7 of 6 or less)
Time frame: 12 weeks
UAS7 at follow-up visits
Time frame: Weeks 2, 4, 8 and 12
Antihistamine requirement
Time frame: 12 weeks
Number of participants with adverse effects
Time frame: Up to 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Chronic Urticaria
Not yet recruitingObservational study
Remibrutinib in Real-world Clinical Practice - a South Korea Sub-Study
Chronic Spontaneous Urticaria
RecruitingPhase 3
A Study to Investigate Efficacy, Safety and Tolerability of Barzolvolimab Versus Placebo in Adults With Cold Induced Urticaria and Symptomatic Dermographism Inadequately Controlled by H1-antihistamines (EMBARQ - ColdU and SD)
Chronic Inducible Urticaria, Cold Urticaria
Enrolling by invitationPhase 3
Long-term Efficacy and Safety Extension (LTE) Study of Barzolvolimab in Participants With Chronic Spontaneous Urticaria
Chronic Spontaneous Urticaria
RecruitingPhase 2
A Study to Assess the Efficacy and Safety of THB335 in Adults With Chronic Spontaneous Urticaria (CSU)
Chronic Spontaneous Urticaria (CSU), Chronic Idiopathic Urticaria
RecruitingPhase 1
A Phase 1 Study of GTX-B001 in Healthy Subjects and Patients With Chronic Inducible Urticaria
Healthy Subjects, Cold Urticaria
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Merrium Mahrukh, MBBS principal investigator
Rashid Latif Medical College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Apremilast and Second-generation H1 antihistamine in people with Chronic Urticaria and Chronic Spontaneous Urticaria, run by Rashid Latif Medical College at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in weekly Urticaria Activity Score (UAS7) from baseline to week 12 (time frame: Baseline and 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.