NCT03689829

A Study to Test Safety, Tolerability, and the Way the Body Absorbs, Distributes, and Gets Rid of a Study Drug Called MOR106, in Healthy Subjects and in Patients With Moderate to Severe Atopic Dermatitis

Terminated Phase 1 Last updated 18 March 2020

What this trial tests

Phase 1 trial testing MOR106 in Healthy in 44 participants. Terminated before completion.

Timeline

13 August 2018

Primary endpoint
2 March 2020

2 March 2020

Quick facts

Lead sponsor	Galapagos NV
Phase	Phase 1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	basic science
Enrollment	44
Start date	13 August 2018
Primary completion	2 March 2020
Estimated completion	2 March 2020
Sites	15 locations across Ukraine, United Kingdom, Germany, Spain

Drugs / interventions tested

• MOR106 — full drug profile →
• Placebo

Conditions studied

• Healthy — all drugs for Healthy →
• Atopic Dermatitis — all drugs for Atopic Dermatitis →

Sponsor

Galapagos NV — full company profile →

Who can join

Adults 18 to 65, any sex, with Healthy or Atopic Dermatitis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The clinical study consists of three parts:

* Part 1 with healthy volunteers.
* Part 2 and Part 3 including subjects with moderate to severe atopic dermatitis (a skin disease).

For Part 1 the main goal of the study is to compare the safety, tolerability, and exposure of administration of the test drug via an injection in a skin layer just under the surface (subcutaneous), to administration of the test drug into the vein (intravenous).

For Part 2 and Part 3 the main goal of the study is to assess the safety and tolerability of administration of the test drug via an injection in a skin layer just under the surface (subcutaneous) during 12 weeks of treatment.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. Much More Than IL-17A: Cytokines of the IL-17 Family Between Microbiota and Cancer.
   Brevi A, Cogrossi LL, Grazia G, Masciovecchio D, et al · · 2020 · cited 81× · PMID 33244315 · DOI 10.3389/fimmu.2020.565470
2. From Emollients to Biologicals: Targeting Atopic Dermatitis.
   Salvati L, Cosmi L, Annunziato F. · · 2021 · cited 32× · PMID 34638722 · DOI 10.3390/ijms221910381
3. Exosomes with overexpressed miR 147a suppress angiogenesis and infammatory injury in an experimental model of atopic dermatitis.
   Shi C, Pei S, Ding Y, Tao C, et al · · 2023 · cited 20× · PMID 37264030 · DOI 10.1038/s41598-023-34418-y
4. A Systematic Review of Atopic Dermatitis: The Intriguing Journey Starting from Physiopathology to Treatment, from Laboratory Bench to Bedside.
   Radi G, Campanti A, Diotallevi F, Martina E, et al · · 2022 · cited 17× · PMID 36359220 · DOI 10.3390/biomedicines10112700
5. Phase 1 and 2 Randomized Clinical Studies Determine Lack of Efficacy for Anti-IL-17C Antibody MOR106 in Moderate-Severe Atopic Dermatitis.
   Thaçi D, Singh D, Lee M, Timmis H, et al · · 2022 · cited 10× · PMID 36498818 · DOI 10.3390/jcm11237244
6. The Efficacy and Effectiveness of the Biological Treatment of Pruritus in the Course of Atopic Dermatitis.
   Hołdrowicz AM, Woźniacka A. · · 2024 · cited 6× · PMID 38541978 · DOI 10.3390/jcm13061754