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Tralokinumab Monotherapy for Adolescent Subjects With Moderate to Severe Atopic Dermatitis - ECZTRA 6 (ECZema TRAlokinumab Trial no. 6).
Phase 3 trial testing Tralokinumab in Atopic Dermatitis in 301 participants. Completed in 16 March 2021.
| Lead sponsor | LEO Pharma |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 301 |
| Start date | 19 June 2018 |
| Primary completion | 15 April 2020 |
| Estimated completion | 16 March 2021 |
| Sites | 87 locations across France, Japan, Netherlands, Belgium, United Kingdom, Germany, Poland, Canada |
LEO Pharma — full company profile →
Adults 12 to 17, any sex, with Atopic Dermatitis. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
The IGA is an instrument used in clinical trials to rate the severity of the subject's global AD and is based on a 5-point scale ranging from 0 (clear) to 4 (severe).
| Group | Value | 95% CI |
|---|---|---|
| Initial Treatment Period - Tralokinumab 300 mg Q2W | 17 | |
| Initial Treatment Period - Tralokinumab 150 mg Q2W | 21 | |
| Initial Treatment Period - Placebo | 4 |
The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. The EASI is a composite index with scores ranging from 0 to 72, with higher values indicating more severe and/or more extensive condition.
| Group | Value | 95% CI |
|---|---|---|
| Initial Treatment Period - Tralokinumab 300 mg Q2W | 27 | |
| Initial Treatment Period - Tralokinumab 150 mg Q2W | 28 | |
| Initial Treatment Period - Placebo | 6 |
The Adolescent Worst Pruritus NRS is used by subjects to assess their worst itch over the past 24 hours using an 11-point NRS with 0 indicating 'no itch' and 10 indicating 'worst itch possible'.
| Group | Value | 95% CI |
|---|---|---|
| Initial Treatment Period - Tralokinumab 300 mg Q2W | 24 | |
| Initial Treatment Period - Tralokinumab 150 mg Q2W | 22 | |
| Initial Treatment Period - Placebo | 3 |
The SCORAD is a validated tool to evaluate the extent and severity of AD lesions, along with subjective symptoms. The maximum total score is 103, with higher values indicating more severe disease.
| Group | Value | 95% CI |
|---|---|---|
| Initial Treatment Period - Tralokinumab 300 mg Q2W | -29.1 | ± 2.4 |
| Initial Treatment Period - Tralokinumab 150 mg Q2W | -27.5 | ± 2.4 |
| Initial Treatment Period - Placebo | -9.5 | ± 3.0 |
The CDLQI is a validated questionnaire with content specific to those with dermatology conditions. It consists of 10 items addressing the subject's perception of the impact of their skin disease on various aspects of their quality of life over the last week such as dermatology-related symptoms and feelings, leisure, school or holidays, personal relationships, sleep, and the treatment. Each item is scored on a 4-point Likert scale (0 = 'not at all'; 1 = 'only a little'; 2 = 'quite a lot'; 3 = 'very much'). Item 7 (on school time) has one additional response category 'prevented school', which is
| Group | Value | 95% CI |
|---|---|---|
| Initial Treatment Period - Tralokinumab 300 mg Q2W | -6.7 | ± 0.6 |
| Initial Treatment Period - Tralokinumab 150 mg Q2W | -6.1 | ± 0.6 |
| Initial Treatment Period - Placebo | -4.1 | ± 0.7 |
Number of AEs during the Initial treatment period is presented. For a summary of AEs and SAEs by MedDRA system organ class (SOC) and preferred term (PT) during the initial treatment period, maintenance treatment period, open-label treatment period, and safety follow-up period, see the Adverse Events Overview section.
| Group | Value | 95% CI |
|---|---|---|
| Initial Treatment Period - Tralokinumab 300 mg Q2W | 130 | |
| Initial Treatment Period - Tralokinumab 150 mg Q2W | 175 | |
| Initial Treatment Period - Placebo | 134 |
Anti-tralokinumab antibody levels were analysed using a validated bioanalytical method.
| Group | Value | 95% CI |
|---|---|---|
| Initial Treatment Period - Tralokinumab 300 mg Q2W | 1 | |
| Initial Treatment Period - Tralokinumab 150 mg Q2W | 7 | |
| Initial Treatment Period - Placebo | 2 |
The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. The EASI is a composite index with scores ranging from 0 to 72, with higher values indicating more severe and/or more extensive condition.
| Group | Value | 95% CI |
|---|---|---|
| Initial Treatment Period - Tralokinumab 300 mg Q2W | 50 | |
| Initial Treatment Period - Tralokinumab 150 mg Q2W | 45 | |
| Initial Treatment Period - Placebo | 13 |
The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. The EASI is a composite index with scores ranging from 0 to 72, with higher values indicating more severe and/or more extensive condition.
| Group | Value | 95% CI |
|---|---|---|
| Initial Treatment Period - Tralokinumab 300 mg Q2W | 17 | |
| Initial Treatment Period - Tralokinumab 150 mg Q2W | 19 | |
| Initial Treatment Period - Placebo | 4 |
The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. The EASI is a composite index with scores ranging from 0 to 72, with higher values indicating more severe and/or more extensive condition.
| Group | Value | 95% CI |
|---|---|---|
| Initial Treatment Period - Tralokinumab 300 mg Q2W | -18.1 | ± 1.3 |
| Initial Treatment Period - Tralokinumab 150 mg Q2W | -18.1 | ± 1.4 |
| Initial Treatment Period - Placebo | -8.7 | ± 1.6 |
The SCORAD is a validated tool to evaluate the extent and severity of atopic dermatitis lesions, along with subjective symptoms. The score ranges from 0 to 103, with a higher values indicating a more extensive and/or severe condition.
| Group | Value | 95% CI |
|---|---|---|
| Initial Treatment Period - Tralokinumab 300 mg Q2W | 12 | |
| Initial Treatment Period - Tralokinumab 150 mg Q2W | 16 | |
| Initial Treatment Period - Placebo | 1 |
The SCORAD is a validated tool to evaluate the extent and severity of atopic dermatitis lesions, along with subjective symptoms. The score ranges from 0 to 103, with a higher values indicating a more extensive and/or severe condition.
| Group | Value | 95% CI |
|---|---|---|
| Initial Treatment Period - Tralokinumab 300 mg Q2W | 30 | |
| Initial Treatment Period - Tralokinumab 150 mg Q2W | 30 | |
| Initial Treatment Period - Placebo | 5 |
Time frame: Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Initial Treatment Period -… | Initial Treatment Period -… | Initial Treatment Period -… | Maintenance Treatment Peri… | Maintenance Treatment Peri… | Maintenance Treatment Peri… | Maintenance Treatment Peri… | Maintenance Treatment Peri… | Open-label Treatment - Tra… | Safety Follow-up |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Gastritis | Gastrointestinal disorders | — | — | — | — | — | — | — | — | — | — |
| Anaphylactic reaction | Immune system disorders | — | — | — | — | — | — | — | — | — | — |
| Appendicitis perforated | Infections and infestations | — | — | — | — | — | — | — | — | — | — |
| Cellulitis | Infections and infestations | — | — | — | — | — | — | — | — | — | — |
| Infectious mononucleosis | Infections and infestations | — | — | — | — | — | — | — | — | — | — |
| Concussion | Injury, poisoning and procedural complications | — | — | — | — | — | — | — | — | — | — |
| Intentional overdose | Injury, poisoning and procedural complications | — | — | — | — | — | — | — | — | — | — |
| Radius fracture | Injury, poisoning and procedural complications | — | — | — | — | — | — | — | — | — | — |
| Cerebrovascular accident | Nervous system disorders | — | — | — | — | — | — | — | — | — | — |
| Anorexia nervosa | Psychiatric disorders | — | — | — | — | — | — | — | — | — | — |
| Obsessive-compulsive disorder | Psychiatric disorders | — | — | — | — | — | — | — | — | — | — |
| Suicidal ideation | Psychiatric disorders | — | — | — | — | — | — | — | — | — | — |
| Renal injury | Renal and urinary disorders | — | — | — | — | — | — | — | — | — | — |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | — | — | — | — | — | — | — | — | — | — |
| Asthma | Respiratory, thoracic and mediastinal disorders | — | — | — | — | — | — | — | — | — | — |
| Dermatitis atopic | Skin and subcutaneous tissue disorders | — | — | — | — | — | — | — | — | — | — |
| Reaction | System | Initial Treatment Period -… | Initial Treatment Period -… | Initial Treatment Period -… | Maintenance Treatment Peri… | Maintenance Treatment Peri… | Maintenance Treatment Peri… | Maintenance Treatment Peri… | Maintenance Treatment Peri… | Open-label Treatment - Tra… | Safety Follow-up |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Viral upper respiratory tract infection | Infections and infestations | — | — | — | — | — | — | — | — | — | — |
| Upper respiratory tract infection | Infections and infestations | — | — | — | — | — | — | — | — | — | — |
| Dermatitis atopic | Skin and subcutaneous tissue disorders | — | — | — | — | — | — | — | — | — | — |
| Headache | Nervous system disorders | — | — | — | — | — | — | — | — | — | — |
| Injection site reaction | General disorders | — | — | — | — | — | — | — | — | — | — |
| Oral herpes | Infections and infestations | — | — | — | — | — | — | — | — | — | — |
| Pharyngitis | Infections and infestations | — | — | — | — | — | — | — | — | — | — |
| Conjunctivitis allergic | Eye disorders | — | — | — | — | — | — | — | — | — | — |
| Fatigue | General disorders | — | — | — | — | — | — | — | — | — | — |
| Conjunctivitis | Infections and infestations | — | — | — | — | — | — | — | — | — | — |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | — | — | — | — | — | — | — | — | — | — |
| Acne | Skin and subcutaneous tissue disorders | — | — | — | — | — | — | — | — | — | — |
| Influenza | Infections and infestations | — | — | — | — | — | — | — | — | — | — |
| Malaise | General disorders | — | — | — | — | — | — | — | — | — | — |
| Inappropriate schedule of drug administration | Injury, poisoning and procedural complications | — | — | — | — | — | — | — | — | — | — |
| Migraine | Nervous system disorders | — | — | — | — | — | — | — | — | — | — |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | — | — | — | — | — | — | — | — | — | — |
| Adrenal insufficiency | Endocrine disorders | — | — | — | — | — | — | — | — | — | — |
| Cataract | Eye disorders | — | — | — | — | — | — | — | — | — | — |
| Hypersensitivity | Immune system disorders | — | — | — | — | — | — | — | — | — | — |
| Acute sinusitis | Infections and infestations | — | — | — | — | — | — | — | — | — | — |
| Bacterial vaginosis | Infections and infestations | — | — | — | — | — | — | — | — | — | — |
| Furuncle | Infections and infestations | — | — | — | — | — | — | — | — | — | — |
| Herpes zoster | Infections and infestations | — | — | — | — | — | — | — | — | — | — |
| Infectious mononucleosis | Infections and infestations | — | — | — | — | — | — | — | — | — | — |
| Procedural anxiety | Injury, poisoning and procedural complications | — | — | — | — | — | — | — | — | — | — |
| Wrong drug administered | Injury, poisoning and procedural complications | — | — | — | — | — | — | — | — | — | — |
| Bursitis | Musculoskeletal and connective tissue disorders | — | — | — | — | — | — | — | — | — | — |
| Abnormal behaviour | Psychiatric disorders | — | — | — | — | — | — | — | — | — | — |
| Attention deficit/hyperactivity disorder | Psychiatric disorders | — | — | — | — | — | — | — | — | — | — |
| Dermatitis allergic | Skin and subcutaneous tissue disorders | — | — | — | — | — | — | — | — | — | — |
| Dermatitis contact | Skin and subcutaneous tissue disorders | — | — | — | — | — | — | — | — | — | — |
Most-reported serious reactions: Gastritis, Anaphylactic reaction, Appendicitis perforated, Cellulitis, Infectious mononucleosis, Concussion, Intentional overdose, Radius fracture.
Data from ClinicalTrials.gov NCT03526861 adverse events section.
Primary objective: To evaluate the efficacy of subcutaneous (SC) administration of tralokinumab compared with placebo in treating adolescent subjects (age 12 to \<18 years) with moderate-to-severe AD. Secondary objectives: To evaluate the efficacy of tralokinumab on severity and extent of AD, itch, and health-related quality of life compared with placebo. To investigate the safety, immunogenicity, and tolerability of SC administration of tralokinumab compared with placebo when used to treat adolescent subjects (age 12 to \<18 years) with moderate-to-severe AD.
8 peer-reviewed publications reference this trial (live from Europe PMC):
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Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03526861.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing