A Phase 1 interventional study of M5542 in Eczema, sponsored by Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany. Not yet recruiting at 1 site in Germany. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-11-12.
Sponsored by Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany (part of Merck KGaA, Darmstadt, Germany) · Phase 1, Interventional, and Treatment
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Among 81 studies in Eczema with a site in Germany — 8 open to participants now, 12 under way, 3 of them phase 3. Eczema · Germany.
Among the 81 studies in Eczema with a site in Germany, this one is the 67th largest by planned enrollment of the 78 interventional ones that give a count, is one of 2 that started in 2026, is one of 4 in phase 1, reaches primary completion later than 7 of the 11 other live ones, and was the 81st registered.
505 studies on the registry are indexed under Eczema; 90 are open to participants now.
Browse Eczema studies →8 of the 81 studies in Eczema with a site in Germany are open now. Recruiting first, the newest first:
Apollo Therapeutics Ltd · Sites in Germany, United States, Bulgaria and 5 more countries
Ages 18–65
Pfizer · Sites in Germany, United States, Bulgaria and 6 more countries
Ages 18–64
Novartis Pharmaceuticals · Sites in Germany, United States, Argentina and 14 more countries
Ages 18–100
Bielefeld University · Sites in Germany
Ages 0 days–14 days · Healthy volunteers
Universitätsklinikum Hamburg-Eppendorf · Sites in Germany
Ages 18+
A study can be open while its sites in Germany have not opened yet or have stopped. Only those recruiting at a site in Germany →
Of the 67 Eczema studies recruiting now, 31 (46%) set no upper age limit and 28 (42%) stop at 75 or younger; 35 take children under 18; 23 take healthy volunteers.
This study: 18 Years to 75 Years · all sexes · no healthy volunteers.
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81 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 4 · Phase 2 32 · Phase 3 36 · Phase 4 2
First in 2001; this study’s year is marked. 2 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 56 is below the median of 91 across 402 interventional studies indexed under Eczema.
Median enrollment 248 across the 78 interventional studies, 1,200 across the 3 observational. Of the 67 that completed or were terminated, 48 (72%) have results posted.
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76 of 81 have an industry lead sponsor. The 10 most frequent:
This study is registered under Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany, one of the names counted as Merck KGaA, Darmstadt, Germany. Under that name alone:
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany is the lead sponsor of 56 studies on the registry; 5 are open to participants now.
Merck KGaA, Darmstadt, Germany has 1 study filed under Eczema — fewer than ten, so there is no comparison to draw.
3 of the studies in Eczema with a site in Germany that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06807268Phase 3PfizerA Study of the Medicine Called Abrocitinib in Children 6 to Less Than 12 Years of Age With Moderate-to-Severe Eczema | 2027-05-02 |
| NCT07105488Bluefin Biomedicine, Inc.A Study Evaluating BFB759 in Moderate to Severe Atopic Dermatitis | 2027-02-28 |
| NCT07599813Apollo Therapeutics LtdA Phase 2b Study of the Effects of Camoteskimab in Adults With Moderate-to-Severe Atopic Dermatitis | 2027-10-31 |
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Among the 81 studies in Eczema with a site in Germany, from their registry updates:
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The main purpose of this study is to evaluate the safety and tolerability of multiple ascending dose (MAD) of M5542 in participants with Eczema.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biological: M5542
Participants will receive loading dose of M5542 followed by maintenance doses as determined by the Safety Monitoring Committee (SMC).
Number of Participants with Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs) and AEs Leading to Study Intervention Discontinuation
Time frame: From Day 1 (Baseline) up to end of Safety Follow-Up (Week 29)
Number of Participants with Clinically Significant Changes from Baseline in Safety Laboratory Assessments
Time frame: From Day 1 (Baseline) up to end of Safety Follow-Up (Week 29)
Number of Participants with Clinically Significant Changes from Baseline in 12-Lead Electrocardiograms (ECGs)
Time frame: From Day 1 (Baseline) up to end of Safety Follow-Up (Week 29)
Number of Participants with Clinically Significant Changes from Baseline in Vital Signs
Time frame: From Day 1 (Baseline) up to end of Safety Follow-Up (Week 29)
Pharmacokinetic (PK) Serum Concentrations of M5542
Time frame: Pre-dose on Days 1, 15, 43 and 113; 72 hours post-dose on Day 8; 24 hours post-dose on Day 120; 48 hours post-dose on Day 127; 72 hours post-dose on Days 141, 176 and 197
Plan to share: No — IPD will not be shared for Phase I interventional or observational studies. Further information on how to request data can be found on our website bit.ly/IPD21.
Start is estimated for Dec 2026; primary completion for Aug 2028, 19 months later.
Of 16 phase 1 interventional studies under Eczema, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 20. This study's planned 19 months is above that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany →