Phase 2
Completed N=390
Study Testing Response Effect of KY1005 Against Moderate-to-Severe Atopic Dermatitis, The STREAM-AD Study
Source: ClinicalTrials.gov NCT05131477 ↗Enrolled (actual)
390
Serious AEs
2.4%
Results posted
Jul 2025
Primary outcomePrimary: Percentage Change in EASI (Eczema Area and Severity Index) From Baseline to Week 16 (Part 1) — -61.5; -56.8; -51.6; -59.6 percentage of change — p=<0.0001
Summary
This is an interventional, randomized, parallel group, treatment, Phase IIb, double blind, 5-arm study to assess the effect of Anti-OX40L Monoclonal Antibody (KY1005) in adult participants with moderate to severe atopic dermatitis.
The estimated duration is 28 days for screening and then up to approximately day 477 (last dose no later than day 337+140 days safety follow-up) for all patients unless enrolled into the Long-Term Extension (LTE) protocol (NCT05492578) at either Day 169 depending on responder status or no later than Day 365 due to loss of clinical response.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage Change in EASI (Eczema Area and Severity Index) From Baseline to Week 16 (Part 1) |
-61.5; -56.8; -51.6; -59.6; -29.4 | <0.0001 sig |
| SECONDARY Percentage Change in EASI (Eczema Area and Severity Index) From Baseline to Week 24 (Part 1) |
-64.4; -52.2; -53.7; -54.4; -27.6 | <0.0001 sig |
| SECONDARY Percentage of Participants With at Least a 75% Reduction From Baseline in EASI (EASI 75) at Week 16 and Week 24 (Part 1) |
40.3; 38.5; 42.9; 40.5; 11.4; 54.5 | < 0.0001 sig |
| SECONDARY Percentage of Participants With a Response of IGA (Investigator Global Assessment) 0 or 1 and a Reduction From Baseline ≥ 2 Points (Part 1) |
22.1; 14.1; 19.5; 25.3; 5.1; 45.5 | 0.0022 sig |
| 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) |
24.7; 19.2; 20.8; 22.8; 5.1; 31.2 | 0.0006 sig |
| 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) |
53.8; 41.2; 75.0; 35.7; 58.3; 45.5 | — |
| SECONDARY Absolute Change From Baseline in EASI (Eczema Area and Severity Index) (Part 1) |
-8.49; -5.27; -6.17; -7.51; -3.98; -11.21 | — |
| SECONDARY Percentage Change From Baseline in EASI (Eczema Area and Severity Index) (Part 1) |
-27.94; -17.75; -19.09; -26.03; -15.26; -36.85 | — |
| SECONDARY Absolute Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2) |
-29.65; -26.28; -27.60; -18.90; -27.10; -22.45 | — |
| SECONDARY Percentage Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2) |
-91.71; -81.85; -84.20; -72.72; -90.91; -74.56 | — |
| SECONDARY Percentage of Participants With at Least a 50% Reduction From Baseline in EASI (EASI 50) (Part 1) |
19.5; 15.4; 16.9; 22.8; 13.9; 29.9 | — |
| SECONDARY Percentage of Participants With at Least a 75% Reduction From Baseline in EASI (EASI 75) (Part 1) |
9.1; 2.6; 2.6; 2.5; 5.1; 9.1 | — |
| SECONDARY Percentage of Participants With at Least a 90% Reduction From Baseline in EASI (EASI 90) (Part 1) |
2.6; 1.3; 0; 1.3; 0; 6.5 | — |
| SECONDARY Percentage of Participants With a 100% Reduction From Baseline in EASI (EASI 100) (Part 1) |
0; 1.3; 0; 0; 0; 2.6 | — |
| SECONDARY Change in IGA (Investigator Global Assessment) From Baseline to (Week 24) (Part 1) |
-0.33; -0.21; -0.29; -0.23; -0.18; -0.57 | — |
| SECONDARY Change in IGA (Investigator Global Assessment) From Baseline (Part 2) |
-2.31; -1.91; -2.00; -1.82; -2.42; -1.82 | — |
| SECONDARY Percentage of Participants With a Score of IGA (Investigator Global Assessment) 0 or 1 and a Reduction From Baseline of ≥ 2 Points (Part 1) |
1.3; 0; 0; 0; 1.3; 5.2 | — |
| SECONDARY Absolute Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 1) |
-15.30; -12.27; -15.89; -14.43; -11.13; -22.39 | — |
| SECONDARY Absolute Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2) |
-52.22; -44.25; -42.44; -36.77; -49.87; -41.65 | — |
| SECONDARY Percentage Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 1) |
-22.02; -18.52; -22.76; -21.42; -16.67; -31.84 | — |
| SECONDARY Percentage Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2) |
-76.47; -63.86; -60.09; -57.73; -72.55; -58.96 | — |
| SECONDARY Absolute Change in Affected Body Surface Area (BSA) From Baseline (Part 1) |
-4.50; -5.61; -9.08; -7.41; -4.84; -12.83 | — |
| SECONDARY Absolute Change in Affected BSA From Baseline (Part 2) |
-46.92; -37.94; -37.17; -28.14; -41.17; -33.81 | — |
| SECONDARY Percentage Change in Affected BSA From Baseline (Part 1) |
-10.11; -12.23; -19.43; -15.06; -11.45; -26.45 | — |
| SECONDARY Percentage Change in Affected BSA From Baseline (Part 2) |
-88.09; -78.75; -80.67; -67.85; -85.29; -71.05 | — |
| SECONDARY Absolute Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 1) |
-4.40; -4.01; -5.42; -4.08; -2.32; -7.03 | — |
| SECONDARY Absolute Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2) |
-15.31; -11.97; -11.58; -9.25; -11.75; -10.42 | — |
| SECONDARY Percentage Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 1) |
-20.81; -21.02; -22.77; -17.94; -8.99; -33.06 | — |
| SECONDARY Percentage Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2) |
-72.61; -61.00; -54.05; -46.08; -60.03; -51.61 | — |
| SECONDARY Absolute Change in Dermatology Life Quality Index (DLQI) From Baseline (Parts 1) |
-3.63; -2.82; -3.32; -3.40; -2.09; -6.13 | — |
| SECONDARY Absolute Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2) |
-12.54; -9.00; -9.08; -7.57; -11.42; -8.26 | — |
| SECONDARY Percentage Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 1) |
-22.68; -11.95; -16.80; -22.73; -10.30; -36.87 | — |
| SECONDARY Percentage Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2) |
-75.53; -61.64; -64.74; -44.26; -72.47; -47.08 | — |
| SECONDARY Absolute Change in Atopic Dermatitis Control Tool (ADCT) From Baseline (Part 1) |
-6.70; -5.41; -6.22; -6.61; -2.50; -7.35 | — |
| SECONDARY Absolute Change in Atopic Dermatitis Control Tool (ADCT) From Baseline (Part 2) |
-11.23; -8.64; -9.83; -7.44; -9.83; -8.42 | — |
| SECONDARY Percentage Change in Atopic Dermatitis Control Tool (ADCT) From Baseline (Part 1) |
-40.56; -33.42; -36.42; -38.72; -17.04; -45.18 | — |
| SECONDARY Percentage Change in Atopic Dermatitis Control Tool (ADCT) From Baseline (Part 2) |
-66.75; -57.08; -56.01; -49.97; -65.46; -53.10 | — |
| SECONDARY Absolute Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 1) |
-2.20; -2.07; -2.35; -3.29; -0.97; -2.67 | — |
| SECONDARY Absolute Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2) |
-4.54; -1.73; -5.58; -2.81; -3.67; -4.42 | — |
| SECONDARY Percentage Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 1) |
-18.40; -11.76; -10.22; -13.15; -0.66; -18.12 | — |
| SECONDARY Percentage Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2) |
-28.01; -17.89; -34.27; -13.63; -20.28; -32.24 | — |
| SECONDARY Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) |
-0.54; -0.56; -0.49; -0.45; -0.28; -0.65 | — |
| SECONDARY Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) |
-3.63; -2.83; -4.00; -2.25; -4.34; -2.92 | — |
| SECONDARY Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) |
-6.26; -7.25; -6.18; -6.05; -3.70; -7.50 | — |
| SECONDARY Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) |
-49.61; -38.71; -52.36; -29.76; -56.60; -42.27 | — |
| SECONDARY Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 3 With a Baseline Pruritus NRS ≥ 3 From Baseline (Part 1) |
2.6; 1.3; 1.3; 1.3; 1.3; 3.9 | — |
| SECONDARY Incidence Rate of Loss of EASI 50 (Part 2) |
0; 0.272; 0.188; 0.089; 0.165; 0.071 | — |
| SECONDARY Incidence Rate of Loss of EASI 75 (Part 2) |
0; 0.587; 0.375; 0.486; 0.395; 0.446 | — |
| SECONDARY Incidence Rate of Loss of IGA 0/1 (Part 2) |
1.267; 1.039; 0.981; 1.930; 1.154; 1.045 | — |
| SECONDARY Serum KY1005 Concentration Assessed Throughout the Study (Part 1) |
0.00; 0.00; 0.01; 0.00; 58.29; 30.49 | — |
| SECONDARY Serum KY1005 Concentration Assessed Throughout the Study (Part 2) |
45.13; 36.68; 45.00; 43.17; 19.03; 19.48 | — |
| SECONDARY Percentage of Participants With at Least One Treatment-emergent Adverse Event (TEAE) and Any Serious TEAE (Part 1) |
66.2; 66.7; 67.5; 67.9; 60.3; 2.6 | — |
| SECONDARY Percentage of Participants With at Least One Treatment-emergent Adverse Event (TEAE) and Any Serious TEAE (Part 2) |
84.6; 67.6; 63.6; 78.6; 66.7; 87.5 | — |
| SECONDARY Percentage of Participants With Treatment-emergent ADA (Part 1) |
2.6; 6.4; 13.2; 32.1 | — |
| SECONDARY Percentage of Participants With Treatment-emergent ADA (Part 2) |
7.7; 9.1; 9.1; 19.2; 0; 35.5 | — |
Eligibility Criteria
Inclusion Criteria
- Adults (18 to 150 kg at Baseline.
- Treatment with a live (attenuated) immunization within 12 weeks prior to Baseline.
- Men and women (of reproductive potential) unwilling to use birth control and women who are pregnant or breastfeeding.
- Any malignancies or history of malignancies prior to Baseline (except for non-melanoma skin cancer that has been excised and cured for more than 3 years prior to Baseline; in situ cervical carcinoma that has been excised and cured).
- Positive for human immunodeficiency virus (HIV), hepatitis B or hepatitis C at the screening visit.
- Severe concomitant illness that would in the Investigator's opinion inhibit the patient's participation in the study, including for example, but not limited to, hypertension, renal disease, neurological conditions, heart failure and pulmonary disease.
- In the Investigator's opinion, any clinically significant laboratory results from the clinical chemistry, hematology or urinalysis tests at the Screening Visit.
- Concurrent participation in any other clinical study, including non-interventional studies.
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Data sourced from ClinicalTrials.gov (NCT05131477). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.