Trial · NCT05131477
Study Testing Response Effect of KY1005 Against Moderate-to-Severe Atopic Dermatitis, The STREAM-AD Study
NCT05131477, Phase 2, Completed, Kymab Limited; results first posted 2025-07-03
3 sourcestrials-2026-11-12-0.4.0
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ConductScience Library. Study Testing Response Effect of KY1005 Against Moderate-to-Severe Atopic Dermatitis, The STREAM-AD Study. Trials, record NCT05131477. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05131477
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study Testing Response Effect of KY1005 Against Moderate-to-Severe Atopic Dermatitis, The STREAM-AD Study
- NCT number
- NCT05131477
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 390 participants, actual
- Lead sponsor
- Kymab Limited
- Conditions
- Eczema, Atopic Dermatitis
- Interventions
- Amlitelimab, Placebo
- First posted
- 2021-11-23
- Last updated
- 2025-07-03
- Other registries' IDs
- eudract:2021-000725-28
- Results first posted
- 2025-07-03
Source ClinicalTrials.gov
Registered outcomes55
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage Change in EASI (Eczema Area and Severity Index) From Baseline to Week 16 (Part 1) | Baseline to week 16 | Eczema Area and Severity Index-The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD with scores from 0 to 72. Higher scores indicate worse condition. |
| Secondary | Percentage Change in EASI (Eczema Area and Severity Index) From Baseline to Week 24 (Part 1) | Baseline to week 24 | Eczema Area and Severity Index-The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD with scores from 0 to 72. Higher scores indicate worse condition. |
| Secondary | Percentage of Participants With at Least a 75% Reduction From Baseline in EASI (EASI 75) at Week 16 and Week 24 (Part 1) | Baseline to week 16 and week 24 | Eczema Area and Severity Index-The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD with scores from 0 to 72. Higher scores indicate worse condition. |
| Secondary | Percentage of Participants With a Response of IGA (Investigator Global Assessment) 0 or 1 and a Reduction From Baseline ≥ 2 Points (Part 1) | Baseline to week 16 and week 24 | The IGA is a five-point scale that provides a global clinical assessment of AD severity ranging from 0 to 4, where 0 indicates clear,1 is almost clear, 2 is mild, 3 is moderate, and 4 indicates severe AD. |
| Secondary | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 1) | Baseline to week 16 and week 24 | The pruritus NRS is a simple assessment tool to report the intensity of their pruritus (itch) ranges from 0 to 10 with 0 being 'no itch' and 10 being the 'worst itch imaginable'. |
| Secondary | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Baseline to weeks week 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, & 52 | The pruritus NRS is a simple assessment tool to report the intensity of their pruritus (itch) ranges from 0 to 10 with 0 being 'no itch' and 10 being the 'worst itch imaginable'. |
| Secondary | Absolute Change From Baseline in EASI (Eczema Area and Severity Index) (Part 1) | Baseline to weeks 2, 4, 8, 12, 16, 20 and 24 | Eczema Area and Severity Index-The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD with scores from 0 to 72. Higher scores indicate worse condition. |
| Secondary | Percentage Change From Baseline in EASI (Eczema Area and Severity Index) (Part 1) | Baseline to weeks 2,4, 8,12,16, 20 and 24 | Eczema Area and Severity Index-The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD with scores from 0 to 72. Higher scores indicate worse condition. |
| Secondary | Absolute Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2) | Baseline to weeks 24, 28, 32, 36, 40, 44, 48, & 52 | Eczema Area and Severity Index-The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD with scores from 0 to 72. Higher scores indicate worse condition. |
| Secondary | Percentage Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2) | Baseline to weeks 24, 28, 32, 36, 40, 44, 48, & 52 | Eczema Area and Severity Index-The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD with scores from 0 to 72. Higher scores indicate worse condition. |
1 to 10 of 55Source ClinicalTrials.gov
See all 55 registered outcomesOutcomes55
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage Change in EASI (Eczema Area and Severity Index) From Baseline to Week 16 (Part 1) | Baseline to week 16 | Full Analysis Set for Part 1. The Full Analysis Set (FAS1) for Part 1 included all randomized participants up to week 24. Efficacy analyses were based on treatment allocated at randomization. The Primary efficacy endpoint is the percentage of change in EASI from Baseline to Day 113 (Week 16). The primary analysis was conducted on FAS1 after all the randomized patients had reached the Day 169 (Week 24) visit/ early termination. Missing data were imputed by multiple imputation. | percentage of change | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage Change in EASI (Eczema Area and Severity Index) From Baseline to Week 24 (Part 1) | Baseline to week 24 | The Full Analysis Set (FAS1) for Part 1 included all randomized participants up to week 24. The primary analysis was conducted on the FAS1 after all randomized patients had reached day 169 (Week 24) visit/ early termination. Percentage change from baseline in EASI at Day 169 (Week 24). Missing data were imputed by multiple imputation. | percentage of change | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants With at Least a 75% Reduction From Baseline in EASI (EASI 75) at Week 16 and Week 24 (Part 1) | Baseline to week 16 and week 24 | The Full Analysis Set (FAS1) for Part 1 included all randomized participants up to week 24. The primary analysis was conducted on the FAS1 after all randomized patients had reached day 169 (Week 24) visit/ early termination. Percentage of patients with at least 75% reduction from baseline in EASI (EASI 5) at days 113 (Week 16) and Day 169 (Week 24). Participants with missing data were considered as non-responders. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With a Response of IGA (Investigator Global Assessment) 0 or 1 and a Reduction From Baseline ≥ 2 Points (Part 1) | Baseline to week 16 and week 24 | The Full Analysis Set (FAS1) for Part 1 included all randomized participants up to week 24. The primary analysis was conducted on the FAS1 after all randomized patients had reached day 169 (Week 24) visit/ early termination. Percentage of patients with a response of IGA 0 or 1 and a reduction from baseline of ≥ 2 points at Days 113 (Week 16) and Day 169 (Week 24). Participants with missing data were considered as non-responders. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 1) | Baseline to week 16 and week 24 | The Full Analysis Set (FAS1) for Part 1 included all randomized participants up to week 24. The primary analysis was conducted on the FAS1 after all randomized patients had reached day 169 (Week 24) visit/ early termination. Proportion of patients with improvement (reduction) of weekly average of pruritus NRS ≥ 4 a baseline pruritus NRS of ≥ 4 from baseline to Days 113 (Week 16) and Day 169 (Week 24). Participants with missing data were considered as non-responders. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Baseline to weeks week 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, & 52 | The Full Analysis Set (FAS2) for Part 2 included all re-randomized at week 24. Only those participants with data available at specified time points are reported. Participants with missing data were considered as non-responders. | Percentage of participants | NUMBER |
| SECONDARY | Absolute Change From Baseline in EASI (Eczema Area and Severity Index) (Part 1) | Baseline to weeks 2, 4, 8, 12, 16, 20 and 24 | The Full Analysis Set (FAS1) for Part 1 included all randomized participants up to week 24. Only those participants with data available at specified timepoints are reported. | score on a scale | MEAN |
| SECONDARY | Percentage Change From Baseline in EASI (Eczema Area and Severity Index) (Part 1) | Baseline to weeks 2,4, 8,12,16, 20 and 24 | The Full Analysis Set (FAS1) for Part 1 included all randomized participants up to week 24. Only those participants with data available at specified time points are reported. | Percentage of change | MEAN |
| SECONDARY | Absolute Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2) | Baseline to weeks 24, 28, 32, 36, 40, 44, 48, & 52 | The Full Analysis Set (FAS2) for Part 2 included all re-randomized at week 24. Only those participants with data available at specified timepoints are reported. | Score on a scale | MEAN |
| SECONDARY | Percentage Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2) | Baseline to weeks 24, 28, 32, 36, 40, 44, 48, & 52 | The Full Analysis Set (FAS2) for Part 2 included all re-randomized at week 24. Only those participants with data available at specified timepoints are reported. | Percentage of change | MEAN |
1 to 10 of 55Source ClinicalTrials.gov
See all 55 outcomesResults by group2,914
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage Change in EASI (Eczema Area and Severity Index) From Baseline to Week 16 (Part 1) | 250 mg (500 mg LD) KY1005 (Part 1) | -61.5 | Standard Error 4.68 | percentage of change | |
| Percentage Change in EASI (Eczema Area and Severity Index) From Baseline to Week 16 (Part 1) | 250 mg (no LD) KY1005 (Part 1) | -56.8 | Standard Error 4.59 | percentage of change | |
| Percentage Change in EASI (Eczema Area and Severity Index) From Baseline to Week 16 (Part 1) | 125 mg KY1005 (Part 1) | -51.6 | Standard Error 4.59 | percentage of change | |
| Percentage Change in EASI (Eczema Area and Severity Index) From Baseline to Week 16 (Part 1) | 62.5 mg KY1005 (Part 1) | -59.6 | Standard Error 4.53 | percentage of change | |
| Percentage Change in EASI (Eczema Area and Severity Index) From Baseline to Week 16 (Part 1) | Placebo (Part 1) | -29.4 | Standard Error 4.76 | percentage of change | |
| Percentage Change in EASI (Eczema Area and Severity Index) From Baseline to Week 24 (Part 1) | 250 mg (500 mg LD) KY1005 (Part 1) | -64.4 | Standard Error 5.17 | percentage of change | |
| Percentage Change in EASI (Eczema Area and Severity Index) From Baseline to Week 24 (Part 1) | 250 mg (no LD) KY1005 (Part 1) | -52.2 | Standard Error 5.14 | percentage of change | |
| Percentage Change in EASI (Eczema Area and Severity Index) From Baseline to Week 24 (Part 1) | 125 mg KY1005 (Part 1) | -53.7 | Standard Error 5.08 | percentage of change | |
| Percentage Change in EASI (Eczema Area and Severity Index) From Baseline to Week 24 (Part 1) | 62.5 mg KY1005 (Part 1) | -54.4 | Standard Error 5.09 | percentage of change | |
| Percentage Change in EASI (Eczema Area and Severity Index) From Baseline to Week 24 (Part 1) | Placebo (Part 1) | -27.6 | Standard Error 5.29 | percentage of change |
1 to 10 of 2,914Source ClinicalTrials.gov
See all 2,914 results by groupParticipant flow126
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| PART 1 | STARTED | 250 mg (500 mg LD) KY1005 (Part 1) | 77 | |
| PART 1 | STARTED | 250 mg (no LD) KY1005 (Part 1) | 78 | |
| PART 1 | STARTED | 125 mg KY1005 (Part 1) | 77 | |
| PART 1 | STARTED | 62.5 mg KY1005 (Part 1) | 79 | |
| PART 1 | STARTED | Placebo (Part 1) | 79 | |
| PART 1 | STARTED | 250 mg KY1005 Re-Randomized From the 250 mg (LD) Arm (Part 2) | 0 | |
| PART 1 | STARTED | Placebo Re-Randomized From the 250 mg (LD) Arm (Part 2) | 0 | |
| PART 1 | STARTED | 250 mg KY1005 Re-randomized From the 250 mg (No LD) Arm (Part 2) | 0 | |
| PART 1 | STARTED | Placebo Re-Randomized From the 250 mg (No LD) Arm (Part 2) | 0 | |
| PART 1 | STARTED | 125 mg KY1005 Re-randomized From the 125 mg Arm (Part 2) | 0 |
1 to 10 of 126Source ClinicalTrials.gov
See all 126 participant flowAdverse events952
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | ABDOMINAL PAIN | Gastrointestinal disorders | 250 mg (500 mg LD) KY1005 (Part 1) | 1 | 77 | 1 |
| other | ABDOMINAL PAIN | Gastrointestinal disorders | 250 mg (no LD) KY1005 (Part 1) | 0 | 78 | 0 |
| other | ABDOMINAL PAIN | Gastrointestinal disorders | 125 mg KY1005 (Part 1) | 1 | 77 | 1 |
| other | ABDOMINAL PAIN | Gastrointestinal disorders | 62.5 mg KY1005 (Part 1) | 0 | 78 | 0 |
| other | ABDOMINAL PAIN | Gastrointestinal disorders | Placebo (Part 1) | 0 | 78 | 0 |
| other | ABDOMINAL PAIN | Gastrointestinal disorders | 250 mg KY1005 Re-Randomized From the 250 mg (LD) Arm (Part 2) | 1 | 13 | 1 |
| other | ABDOMINAL PAIN | Gastrointestinal disorders | Placebo Re-Randomized From the 250 mg (LD) Arm (Part 2) | 0 | 34 | 0 |
| other | ABDOMINAL PAIN | Gastrointestinal disorders | 250 mg KY1005 Re-randomized From the 250 mg (No LD) Arm (Part 2) | 0 | 11 | 0 |
| other | ABDOMINAL PAIN | Gastrointestinal disorders | Placebo Re-Randomized From the 250 mg (No LD) Arm (Part 2) | 0 | 28 | 0 |
| other | ABDOMINAL PAIN | Gastrointestinal disorders | 125 mg KY1005 Re-randomized From the 125 mg Arm (Part 2) | 0 | 12 | 0 |
1 to 10 of 952Source ClinicalTrials.gov
See all 952 adverse eventsAdverse event totals42
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 250 mg (500 mg LD) KY1005 (Part 1) | 0 | 77 |
| Total, all-cause mortality | 250 mg (no LD) KY1005 (Part 1) | 0 | 78 |
| Total, all-cause mortality | 125 mg KY1005 (Part 1) | 0 | 77 |
| Total, all-cause mortality | 62.5 mg KY1005 (Part 1) | 0 | 78 |
| Total, all-cause mortality | Placebo (Part 1) | 0 | 78 |
| Total, all-cause mortality | 250 mg KY1005 Re-Randomized From the 250 mg (LD) Arm (Part 2) | 0 | 13 |
| Total, all-cause mortality | Placebo Re-Randomized From the 250 mg (LD) Arm (Part 2) | 0 | 34 |
| Total, all-cause mortality | 250 mg KY1005 Re-randomized From the 250 mg (No LD) Arm (Part 2) | 0 | 11 |
| Total, all-cause mortality | Placebo Re-Randomized From the 250 mg (No LD) Arm (Part 2) | 0 | 28 |
| Total, all-cause mortality | 125 mg KY1005 Re-randomized From the 125 mg Arm (Part 2) | 0 | 12 |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 adverse event totalsPapers3
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05131477
GET https://conductscience.org/api/trials/v1/NCT05131477/registered?page=2