Can a new pill quiet stubborn chronic hives?
NCT ID NCT07764003
First seen Aug 13, 2026 · Last updated Aug 25, 2026 · Updated 3 times
Summary
This phase II trial tests whether an experimental oral drug called TLL-018 can reduce itching and hives in adults with moderate-to-severe chronic spontaneous urticaria (CSU) that hasn't responded to standard antihistamines. Participants will take either a low or high dose of TLL-018 or a placebo daily for 12 weeks, while keeping a symptom diary and attending clinic visits every four weeks. The study compares changes in itch and hive severity scores to see which dose works best and how safe the drug is.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- TLL-018 tablets taken by mouth
- What this could lead to
- If successful, TLL-018 could offer a new treatment option for people with chronic hives that don't improve with standard antihistamines, potentially reducing itch and hives.
- What could go wrong
- This is an early-phase trial with a small number of participants, so results may not hold up in larger studies. The drug may cause side effects or may not work better than a placebo.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
About 140 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
-
Sep 2026
An estimate. Start dates often move.
- Expected to finish
-
Dec 2027
An estimate. End dates often move.
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 75 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Aged between 18 and 75. * Diagnosis of CSU refractory to second-generation H1-AH. * CSU diagnosis for ≥ 6 months. * The presence of itch and hives despite current use of an approved dose of H1-AH prior to randomization. * UAS7 score (range 0-42) ≥ 16 and ISS7 (range 0-21) ≥ 8 during 7 days prior to randomization. * Participants were required to take a stable standard dose of a second generation H1-AH concomitantly according to local guidelines. * Willing and able to complete UPDD during the study; participants must not have more than one missing UPDD symptom score (either morning or evening) within the 7-day period prior to randomization. * Evidence of urticaria confirmed by the investigator prior to randomization. * Women of Child Bearing Potential (WOCBP) should not be pregnant or breastfeeding and the pregnancy test should be negative before randomization. * Participants and their partners must agree to have adequate barrier contraception during the whole treatment period and at least 90 days after treatment; subjects should avoid the sperm or ovum donation for at least six months after treatment. * The trial participant understands the informed consent form and voluntarily agrees to participate in the study. Exclusion Criteria: * Participants meeting diagnosis criteria of chronic spontaneous urticaria with the following concomitant diseases cannot be enrolled: 1. Progressive or uncontrolled signs or symptoms of renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, cardiovascular, neurologic, psychiatric, or cerebral disease, as judged by the investigator to place the subject at unacceptable risk by study participation. 2. Clearly defined underlying etiology for chronic urticarias other than CSU. E.g. induced urticaria, including but not limited to artificial urticaria. 3. Any disease, which may have symptoms of urticaria and/or angioedema, including but not limited to urticaria and vasculitis. 4. Suffering from other chronic pruritic diseases that may affect the assessment of efficacy, such as psoriasis, atopic dermatitis, etc. 5. Previous malignancy, herpes zoster, active tuberculosis. * Participants with any of the following prior therapies or medications cannot be enrolled: 1. Have received treatment with JAK inhibitors (e.g., tofacitinib, baricitinib, ruxolitinib, etc.) or BTK inhibitors (e.g., remibrutinib) within 4 weeks prior to randomization; 2. Have received any investigational product within 4 weeks prior to randomization or within 5 elimination half-lives, whichever is longer; 3. Have received omalizumab/omalizumab biosimilar treatment within 4 months prior to randomization; 4. Have received biologics with potential therapeutic effects for chronic spontaneous urticaria (e.g., dupilumab, etc.) within 3 months prior to randomization or within 5 elimination half-lives, whichever is longer; 5. Have received immunosuppressive or immunomodulatory drug therapy within 4 weeks prior to randomization, e.g., systemic corticosteroids, etc. * Known allergy to any active ingredients or excipients of H1-AH or TLL-018. * Abnormal laboratory test results that may interfere with the conduct of the study by the assessment from the investigator. * Any other situation or condition that, in the investigator's judgment, would render the participant unsuitable for study participation.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Chronic spontaneous urticaria (CSU) are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a new pill silence stubborn hives?
- New pill aims to quiet chronic hives without the itch
- New pill aims to stop chronic hives fast when antihistamines fail
- Could a bacterial extract help tame stubborn hives?
- New shot could tame stubborn hives for good
- Biosimilar switch for asthma and hives under Real-World study