Moderate to Severe Atopic Dermatitis

11

Review clinical trials related to Moderate to Severe Atopic Dermatitis. Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Not yet recruiting

Pharmacokinetics, Safety and Efficacy of Nemolizumab in Participants Aged 6 to 23 Months With Moderate-to Severe Atopic Dermatitis

The primary objective of the study is to assess the pharmacokinetics (PK) and safety of nemolizumab in pediatric participants (aged 6-23 months) with moderate-to-severe atopic dermatitis (AD) who are not adequately controlled with topical treatments.

Participants needed: 35
Trial details
Phase: Phase 2Age: 6-23Biological sex: AllType: InterventionalSponsor: Galderma R&DUpdated: Jun 22, 2026
Eligibility criteria

Participants greater than and equal to (>=) 6 to less than (<) 24 months of age... [+10]

Body weight < 5 Kilograms (kg). [+16]

Status: Recruiting

Phase 1a/1b Study of TRB-061 in Healthy Participants & Patients With Atopic Dermatitis

This Phase 1a/1b randomized, double-blind, placebo-controlled study evaluates the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of subcutaneously (SC) administered TRB-061 in healthy adults and patients with moderate-to-severe atopic dermatitis (AD). The number of dosing cohorts may be increased or decreased in Part 1 (SAD) or Part 2 (MAD). Part 1 (SAD): Healthy participants receiving single doses of TRB-061 or placebo. Part 2 (MAD): Healthy participants receiving multiple doses (3 doses over 8 weeks) of TRB-061 or placebo. Part 3 (Phase 1b): Participants with moderate-to-severe AD receiving repeated doses (4 doses over 12 weeks) of TRB-061 or placebo.

Participants needed: 115
Trial details
Phase: Phase 1Age: 18-70Biological sex: AllType: InterventionalSponsor: TRex Bio, Inc.Updated: Jun 16, 2026Locations: 15
Eligibility criteria

Male or female participants aged 18 to 70 years, inclusive, at the time of infor... [+8]

History of any clinically significant disease or disorder which, in the opinion... [+17]

Status: Recruiting

A 3-part Study of SYX-5219 in Healthy Volunteers and Participants With Atopic Dermatitis

The purpose of this study is to evaluate the study drug, SYX-5219, in a multi-part First-in-Human (FiH) study to be conducted in healthy volunteers and participants with Atopic Dermatitis (AD). The objectives of this study are to determine the safety, tolerability and levels of SYX-5219 in the blood and urine when SYX-5219 is given in each part of the study (SAD, MAD, Food Effect and Participants with AD). The study will be split into up to 3 parts as follows: * Part 1 - Single Ascending Dose (SAD) and Food Effect in healthy volunteers * Part 2 - Multiple Ascending Dose (MAD) in healthy volunteers * Part 3 - Multiple Dose in Participants with AD - enrolling up to 45 males and females with a confirmed diagnosis of AD of at least 6 months, evaluating multiple dose administrations of SYX-5219 or placebo daily over a period of 42 days.

Participants needed: 149
Trial details
Phase: Phase 1Age: 18-65Biological sex: AllType: InterventionalSponsor: Sitryx Therapeutics LtdUpdated: Apr 30, 2026Locations: 14
Eligibility criteria

Healthy male and female participant, between ≥ 18 to ≤ 65 years of age, inclusiv... [+8]

Any clinically significant medical condition or physical/laboratory/ECG/vital si... [+2]

Status: Recruiting

A Study to Investigate the Efficacy and Safety of SHR-1905 in Patients With Moderate-to-severe Atopic Dermatitis

This trial was designed to evaluate the efficacy and safety of SHR-1905 in patients with moderate-to-severe atopic dermatitis.

Participants needed: 75
Trial details
Phase: Phase 2Age: 18-75Biological sex: AllType: InterventionalSponsor: Guangdong Hengrui Pharmaceutical Co., LtdUpdated: Apr 8, 2026Locations: 1
Eligibility criteria

The subjects have voluntarily signed the informed consent form prior to the star... [+2]

Hypersensitivity to the study drug or any ingredient in the study drug. [+4]

Status: Not yet recruiting

A Study to Evaluate the Efficacy and Safety of AK139 in Patients With Moderate-to-severe Atopic Dermatitis

This is a randomized, double-blind phase II clinical study to evaluate the efficacy and safety of AK139 in the treatment of patients with moderate-to-severe atopic dermatitis.

Participants needed: 168
Trial details
Phase: Phase 2Age: 18-75Biological sex: AllType: InterventionalSponsor: AkesoUpdated: Mar 30, 2026
Eligibility criteria

Able to understand the study and voluntarily sign the ICF. [+5]

Acute onset of AD within the first 4 weeks of randomization. [+5]

Status: Not yet recruiting

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase Ⅱ Clinical Study to Evaluate the Efficacy and Safety of CMS-D001 in Adult Patients With Moderate to Severe Atopic Dermatitis

This study is a multicenter, randomized, double-blind, placebo-controlled Phase II clinical trial, aiming to evaluate the efficacy, safety, and tolerability of CMS-D001 in participants with moderate to severe atopic dermatitis, as well as to assess the pharmacokinetic (PK) and pharmacodynamic (PD) characteristics of CMS-D001 and its major metabolites (as applicable) in participants with moderate to severe atopic dermatitis, so as to provide a basis for the dosage of the Phase III confirmatory clinical trial.

Participants needed: 160
Trial details
Phase: Phase 2Age: 18-75Biological sex: AllType: InterventionalSponsor: Dermavon Holdings LimitedUpdated: Mar 11, 2026Locations: 28
Eligibility criteria

Aged 18-75 years, willing to sign the ICF [+4]

Other active skin conditions that may interfere with AD assessment. [+11]

Status: Not yet recruiting

Evaluation of the Efficacy and Safety of Oral LW402 Tablets for the Treatment of Patients With Moderate-to-Severe Atopic Dermatitis

This Phase 3, double-blind (sponsor-open), multicenter, placebo-controlled study aims to evaluate the efficacy and safety of oral LW402 tablets in patients with moderate to severe atopic dermatitis.

Participants needed: 480
Trial details
Phase: Phase 3Age: 18-75Biological sex: AllType: InterventionalSponsor: Shanghai Longwood Biopharmaceuticals Co., Ltd.Updated: Jan 29, 2026Locations: 1
Eligibility criteria

Subjects voluntarily provided informed consent and agreed to participate in the... [+5]

Subjects with a documented history of hypersensitivity to Janus kinase (JAK) inh... [+1]

Status: Not yet recruiting

A Phase II Study of QLS12010 Capsules in Adults With Moderate to Severe Atopic Dermatitis

This trial was designed to evaluate the efficacy and safety of QLS12010 Capsules in adults with moderate-to-severe atopic dermatitis.

Participants needed: 160
Trial details
Phase: Phase 2Age: 18-75Biological sex: AllType: InterventionalSponsor: Qilu Pharmaceutical Co., Ltd.Updated: Jan 15, 2026
Eligibility criteria

At screening, the diagnosis of atopic dermatitis (AD) shall meet the Hanifin-Raj... [+2]

Participants with other medical conditions (excluding AD) that, as determined by... [+4]

Status: Recruiting

Efficacy and Safety of Methotrexate Versus Placebo in Adults With Atopic Dermatitis.

Atopic dermatitis is an ongoing condition that causes skin irritation, redness, and itchiness. Treatments are usually topical - applied to the skin (e.g., moisturisers or medicated creams) - but a wider variety of systemic treatments (that target the whole body) are needed for those whose condition does not improve with topical treatments. Methotrexate, a drug approved for similar conditions such as arthritis and psoriasis, has been shown to improve atopic dermatitis. This randomised, controlled clinical trial will investigate how effective.

Participants needed: 277
Trial details
Phase: Phase 3Age: 18+Biological sex: AllType: InterventionalSponsor: medac GmbHUpdated: Aug 27, 2025Locations: 30
Eligibility criteria

Woman of childbearing potential must have a negative pregnancy test at the Scree... [+8]

Pregnant or breast-feeding women, or planning to become pregnant, or to breastfe... [+27]

Status: Recruiting

TREATgermany: German National Clinical Registry for Patients With Moderate-to-severe Atopic Dermatitis

About 60% of all patients with AD are adults. However, the prevalence and incidence is significantly higher in childhood and adolescence. Some children, adolescents and adults with moderate-to-severe AD cannot be sufficiently controlled with topical treatments alone and require intermittent or continuous treatment with systemic immunomodulating agents or UV-therapy. Systematic reviews indicate that although several different interventions for moderate-to-severe AD have been studied in clinical trials, strong recommendations are only possible for Dupilumab in adults and the short-term use of cyclosporin A (CSA). Pharmaceutical treatment of patients suffering from AE is diverse and frequently not in line with the current guidelines (for example S2-guideline in Germany). Large head-to-head trials are missing so that long-term effectiveness of systemic interventions for moderate-to-severe AD is speculative. In this situation, clinical registries can provide valuable information for evidence-based clinical decision making. Extension of TREATgermany to children and adolescents is necessary as * moderate-to-severe AD is frequent in this age group, but the effectiveness of existing topical and systemic agents in the routine care setting on clinical severity, patient-reported outcomes, and the course of AD and associated atopic and non-atopic comorbidities over time is still poorly understood * it is unclear how many children and adolescents cannot be effectively controlled with the avoidance of trigger factors, patient education, and topical anti-inflammatory treatment alone * innovative agents will become available for these age groups within the next years and reference data will be necessary to evaluate their effectiveness and indication criteria * adequate evidence regarding patient needs in children and adolescents with moderate-to-severe AD is urgently needed to provide value-based healthcare for this vulnerable patient group * Best-practice models of transition from adolescent to adult care of patients with moderate-to-severe AD do not exist yet, but constitute a prerequisite for the establishment of efficient patient care

Participants needed: 2,800
Trial details
Biological sex: AllType: ObservationalSponsor: Technische Universität DresdenUpdated: May 9, 2022Locations: 3Duration: 5 Years
Eligibility criteria

AD according to the United Kingdom (UK) working party diagnostic criteria [+2]